Amoxicillin

Amoxicillin Manufacturers

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age *Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.†The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  Infection

  Severity*

  Usual Adult Dose

  Usual Dose for Children > 3 Months†

  Ear/Nose/Throat

  Skin/Skin Structure

  Genitourinary Tract

  Mild/Moderate

  500 mg every 12 hours
  or

  250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses

  every 8 hours

  Severe

  875 mg every 12 hours
  or

  500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Lower Respiratory

  Tract

  Mild/Moderate or

  Severe

  875 mg every 12 hours
  or

  500 mg every 8 hours

  45 mg/kg/day in divided doses

  every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, Uncomplicated Ano-Genital and Urethral Infections in Males and Females

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment•Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.•Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose.•Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.•Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.•Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension

  Strength

  Bottle Size

  Amount of Water

  Required for Reconstitution

  Oral Suspension 125 mg/5 mL

  80 mL

  62 mL

  100 mL

  77 mL

  150 mL

  113 mL

  Oral Suspension 250 mg/5 mL

  80 mL

  47 mL

  100 mL

  60 mL

  150 mL

  90 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  Amoxicillin capsules may be given without regard to meals.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months Infection Severity* Usual Adult Dose Usual Dose for Children >3 months† * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections. † The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Ear/Nose/Throat Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children: 50 mg/kg Amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  NOTE: SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS: Laboratory Tests section.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/Clarithromycin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE section.)

  Dual Therapy Amoxicillin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE section.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS section, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
  

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  
  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  
  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin tablets is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  
  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
  
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
  
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  
  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.
  

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
  

   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
  

  Mild/Moderate
  

  500 mg every 12 hours
  or
  250 mg every 8 hours
  

   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
  

  Severe
  

  875 mg every 12 hours
  or
  500 mg every 8 hours
  

   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
  

   Lower Respiratory Tract
  

  Mild/Moderate or Severe
  

  875 mg every 12 hours
  or
  500 mg every 8 hours
  

   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
  

   Gonorrhea
   Acute, uncomplicated ano-genital and urethral infections in males and females
  

  3 grams as single oral dose
  

   Prepubertal children: 50 mg/kg amoxicillin for oral suspension, combined with 25 mg/kg probenecid as a single dose.
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  

  2.2 Dosing in Neonates and Infants Aged12 Weeks ( 3 Months)

  
  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin for oral suspension is 30 mg/kg/day divided every 12 hours.  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  
  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin for oral suspension, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.
   
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin for oral suspension and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.
   
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875 mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  
  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.
  

  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water
  Required for
  Reconstitution

  Oral Suspension 200 mg/5 mL
  

  50 mL
  

  35 mL
  

  75 mL
  

  52 mL
  

  100 mL
  

  69 mL
  

  Oral Suspension 400 mg/5 mL
  

  50 mL
  

  35 mL
  

  75 mL
  

  52 mL
  

  100 mL
  

  69 mL
  

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.
  
  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children
  > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
  

   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
  

  Mild/Moderate
  

   500 mg every 12 hours or
   250 mg every 8 hours
  

   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
  

   Severe
  

   875 mg every 12 hours or
   500 mg every 8 hours
  

   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
  

   Lower Respiratory Tract
  

   Mild/Moderate
   or Severe
  

   875 mg every 12 hours or
   500 mg every 8 hours
  

   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
  

   Gonorrhea
   Acute, uncomplicated
   ano-genital and
   urethral infections in
   males and females
  

   
  

   3 grams as single oral dose
  

   Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
   
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin tablets is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
  
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
  
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age

   Infection

   Severity a

   Usual Adult Dose

   Usual Dose for Children > 3 Monthsb 

  Ear/Nose/Throat
  Skin/ Skin Structure
  Genitourinary Tract

  Mild/
  Moderate

  500 mg every 12 hours or 250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours
  

   

  Severe

  875 mg every 12 hours or 500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
  

   Lower Respiratory Tract
  

  Mild/
  Moderate or Severe

  875 mg every 12 hours or 500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
  

  Gonorrhea
  Acute, uncomplicated ano-genital and urethral infections in males and females

   

  3 grams as single oral dose

  Prepubertal children:
  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  Note: since probenecid is contraindicated in children under 2 years. Do not use this regimen in children under 2 years of age.  

  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.
  • Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose.
  • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.
  • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
  • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension

   Strength

   Bottle Size

   Amount of Water
  Required for Reconstitution

   Oral Suspension 125 mg /5 mL

   80 mL

   66 mL

   

   100 mL

   83 mL

   

   150 mL

   125 mL

   Oral Suspension 200 mg /5 mL

   50 mL

   39 mL

   

   75 mL

   59 mL

   

   100 mL

   78 mL

   Oral Suspension 250 mg /5 mL

   80 mL

   59 mL

   

   100 mL

   73 ml

   

   150 mL

   110 mL

   Oral Suspension 400 mg /5 mL

   50 mL

   34 mL

   

   75 mL

   51 mL

   

   100 mL

   68 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  Infection

  Severity*

  Usual Adult Dose

  Usual Dose for Children > 3 Months†

  Ear/Nose/Throat

  Skin/Skin Structure

  Genitourinary Tract

  Mild/Moderate

  500 mg every 12 hours
  or

  250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses

  every 8 hours

  Severe

  875 mg every 12 hours
  or

  500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Lower Respiratory

  Tract

  Mild/Moderate or

  Severe

  875 mg every 12 hours
  or

  500 mg every 8 hours

  45 mg/kg/day in divided doses

  every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, Uncomplicated Ano-Genital and Urethral Infections in Males and Females

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension

  Strength

  Bottle Size

  Amount of Water

  Required for Reconstitution

  Oral Suspension 125 mg/5 mL

  80 mL

  62 mL

  100 mL

  77 mL

  150 mL

  113 mL

  Oral Suspension 250 mg/5 mL

  80 mL

  47 mL

  100 mL

  60 mL

  150 mL

  90 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age

  Infection

  Severitya

  Usual Adult Dose

  Usual Dose for Children > 3 Monthsb

  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  Ear/Nose/Throat
  Skin/Skin Structure
  Genitourinary Tract
  Mild/Moderate
  500 mg every 12 hours
  or
  250 mg every 8 hours
  25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours

  Severe
  875 mg every 12 hours
  or
  500 mg every 8 hours
  45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours

  Lower Respiratory Tract
  Mild/Moderate or Severe
  875 mg every 12 hours
  or
  500 mg every 8 hours
  45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours

  Gonorrhea
  Acute, uncomplicated ano-genital and urethral infections in males and females
  3 grams as single oral dose
  Prepubertal children: 50 mg/kg amoxicillin for oral suspension, combined with 25 mg/kg probenecid as a single dose.
  Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  2.2 Dosing in Neonates and Infants Aged12 Weeks ( 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin for oral suspension is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin for oral suspension, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin for oral suspension and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment
  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.
  Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875 mg dose.
  Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.
  Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension

  Strength

  Bottle Size

  Amount of Water
  Required for
  Reconstitution

  Oral Suspension 200 mg/5 mL
  50 mL
  35 mL

  75 mL
  52 mL

  100 mL
  69 mL

  Oral Suspension 400 mg/5 mL
  50 mL
  35 mL

  75 mL
  52 mL

  100 mL
  69 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  • this product does not contain directions or complete warnings for adult use • do not give more than directed (see overdose warning) • shake well before using • mL = milliliter; tsp = teaspoonful • find right dose on chart below. If possible, use weight to dose; otherwise, use age. • remove the child protective cap and squeeze your child’s dose into the dosing cup • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours

  Weight (lb)

  Age (yr)

  Dose (mL or tsp)*

  under 24

  under 2 years

  ask a doctor

  24-35

  2-3 years

  5 mL (1 tsp)

  36-47

  4-5 years

  7.5 mL (1 1/2 tsp)

  48-59

  6-8 years

  10 mL (2 tsp)

  60-71

  9-10 years

  12.5 mL (2 1/2 tsp)

  72-95

  11 years

  15 mL (3 tsp)

  *or as directed by a doctor

  Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  Infection

  Severity*

  Usual Adult Dose

  Usual Dose for Children > 3 Months†

  Ear/Nose/Throat

  Skin/Skin Structure

  Genitourinary Tract

  Mild/Moderate

  500 mg every 12 hours
  or

  250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses

  every 8 hours

  Severe

  875 mg every 12 hours
  or

  500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Lower Respiratory

  Tract

  Mild/Moderate or

  Severe

  875 mg every 12 hours
  or

  500 mg every 8 hours

  45 mg/kg/day in divided doses

  every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, Uncomplicated Ano-Genital and Urethral Infections in Males and Females

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension

  Strength

  Bottle Size

  Amount of Water

  Required for Reconstitution

  Oral Suspension 125 mg/5 mL

  80 mL

  62 mL

  100 mL

  77 mL

  150 mL

  113 mL

  Oral Suspension 250 mg/5 mL

  80 mL

  47 mL

  100 mL

  60 mL

  150 mL

  90 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenesto prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity* Usual Adult Dose Usual Dose for Children
  > 3 Months† * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.   Ear/Nose/Throat   Skin/Skin Structure   Genitourinary Tract

  Mild/Moderate

    500 mg every 12 hours or   250 mg every 8 hours   25 mg/kg/day in divided doses   every 12 hours   or   20 mg/kg/day in divided doses   every 8 hours

  Severe

    875 mg every 12 hours or   500 mg every 8 hours   45 mg/kg/day in divided doses   every 12 hours   or   40 mg/kg/day in divided doses   every 8 hours   Lower Respiratory   Tract   Mild/Moderate or   Severe   875 mg every 12 hours or   500 mg every 8 hours   45 mg/kg/day in divided doses   every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, uncomplicated

  ano-genital and urethral infections in males and females

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenesto prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water Required for Reconstitution

  Oral Suspension 125 mg/5 mL

  80 mL

  55 mL

  100 mL

  68 mL

  150 mL

  102 mL

  Oral Suspension 200 mg/5 mL

  50 mL

  34 mL

  75 mL

  51 mL

  100 mL

  68 mL

  Oral Suspension 250 mg/5 mL

  80 mL

  55 mL

  100 mL

  68 mL

  150 mL

  102 mL

  Oral Suspension 400 mg/5 mL

  50 mL

  34 mL

  75 mL

  51 mL

  100 mL

  68 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
  

   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
  

  Mild/Moderate
  

  500 mg every 12 hours
  or
  250 mg every 8 hours
  

   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
  

  Severe
  

  875 mg every 12 hours
  or
  500 mg every 8 hours
  

   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
  

   Lower Respiratory Tract
  

  Mild/Moderate or Severe
  

  875 mg every 12 hours
  or
  500 mg every 8 hours
  

   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
  

   Gonorrhea
   Acute, uncomplicated ano-genital and urethral infections in males and females
  

  3 grams as single oral dose
  

   Prepubertal children: 50 mg/kg amoxicillin for oral suspension, combined with 25 mg/kg probenecid as a single dose.
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks ( ≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin for oral suspension is

  30 mg/kg/day divided every 12 hours.  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin for oral suspension, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.
  
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin for oral suspension and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.
  
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875 mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water
  Required for
  Reconstitution

  Oral Suspension 200 mg/5 mL
  

  50 mL
  

  35 mL
  

  75 mL
  

  52 mL
  

  100 mL
  

  69 mL
  

  Oral Suspension 400 mg/5 mL
  

  50 mL
  

  35 mL
  

  75 mL
  

  52 mL
  

  100 mL
  

  69 mL
  

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.
  
  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
  

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  
  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity a Usual Adult Dose Usual Dose for Children
  > 3 Months b a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
  Mild/Moderate
   500 mg every 12 hours or
   250 mg every 8 hours
   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
   Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Lower Respiratory Tract
   Mild/Moderate
   or Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Gonorrhea
   Acute, uncomplicated
   ano-genital and
   urethral infections in
   males and females
   
   3 grams as single oral dose
    Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
   
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  
  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin tablets is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  
  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
   
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
   
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 4. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age

  * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.

  † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  Infection

  Severity*

  Usual Adult Dose

  Usual Dose for Children > 3 Months†

  Ear/Nose/Throat

  Skin/Skin Structure

  Genitourinary Tract

  Mild/Moderate

  500 mg every 12 hours
  or

  250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses

  every 8 hours

  Severe

  875 mg every 12 hours
  or

  500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Lower Respiratory

  Tract

  Mild/Moderate or

  Severe

  875 mg every 12 hours
  or

  500 mg every 8 hours

  45 mg/kg/day in divided doses

  every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, Uncomplicated Ano-Genital and Urethral Infections in Males and Females

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function. NOTE: Chewable tablets (125 mg and 250 mg) contain aspartame and should not be used by phenylketonurics. [see PRECAUTIONS]

  Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  Dosing in Renal Impairment

  •Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.•Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose.•Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.•Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.•Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  Directions for Mixing Oral Suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/2 of the total amount of water for reconstitution (see Table 5) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously. Each teaspoon (5 mL) will contain 125 mg or 250 mg of amoxicillin.

  Table 5. Amount of Water for Mixing Oral Suspension

  Strength

  Bottle Size

  Amount of Water

  Required for Reconstitution

  Oral Suspension 125 mg/5 mL

  80 mL

  69 mL

  100 mL

  86 mL

  150 mL

  128 mL

  Oral Suspension 250 mg/5 mL

  80 mL

  56 mL

  100 mL

  70 mL

  150 mL

  104 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  Amoxicillin | Remedyrepack Inc.

  

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  Amoxicillin capsules may be given without regard to meals. However, food effect studies have not been performed with the 500 mg formulation.

   

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and pediatric patients >3 months:  Infection  Severity*  Usual  Usual Dose      Adult Dose  for Children        >3 months†  Ear/nose/throat  Mild/Moderate  500 mg  25 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      250 mg  or      every 8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg  or      every 8 hours  40 mg/kg/day        in divided doses        every 8 hours  Lower respiratory  Mild/Moderate  875 mg  45 mg/kg/day  Tract  or Severe  every 12 hours  in divided doses      or  every 12 hours      500 mg every  or      8 hours  40 mg/kg/day        in divided doses        every 8 hours  Skin/Skin  Mild/Moderate  500 mg  25 mg/kg/day  Structure    every 12 hours  in divided doses      or  every 12 hours      250 mg every  or      8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg every  or      8 hours  40 mg/kg/day        in divided doses        every 8 hours  Genitourinary  Mild/Moderate  500 mg  25 mg/kg/day  Tract    every 12 hours  in divided doses      or  every 12 hours      250 mg every  or      8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg  or      every 8 hours  40 mg/kg/day        in divided doses        every 8 hours  Gonorrhea    3 grams  Prepubertal  Acute,    as  children:  uncomplicated    single oral dose  50 mg/kg  ano-genital and      amoxicillin        combined with        25 mg/kg        probenecid  urethral infections      as a single dose.  in males and      NOTE: SINCE  females      PROBENECID IS        CONTRAINDICATED        IN CHILDREN        UNDER 2 YEARS.        DO NOT USE
  THIS REGIMEN        IN THESE CASES.

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

   † The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS - Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

   

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

   

  Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

   

  Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

   

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875-mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

   

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age  Infection Severity a  Usual Adult Dose  Usual Dose for Children> 3 Monthsb Ear/Nose/Throat
  Skin/Skin Structure
  Genitourinary Tract
  Mild/
  Moderate
  500 mg every 12
  hours or 250 mg
  every 8 hours
   25 mg/kg/day in divided doses every
   12 hours
   or
   20 mg/kg/day in divided doses every 8
   hours
  Severe
  875 mg every 12
  hours or
  500 mg every 8
  hours
   45 mg/kg/day in divided doses every
   12 hours
   or
   40 mg/kg/day in divided doses every 8
    hours
  Lower Respiratory
  Tract
  Mild/
  Moderate
  or Severe
  875 mg every 12
  hours or 500 mg
  every 8 hours
   45 mg/kg/day in divided doses every
   12 hours
   or
   40 mg/kg/day in divided doses every 8
   hours
  Gonorrhea Acute,uncomplicated
  ano-genital and urethral
  infections in males
  and females
    
  3 grams as single
  oral dose
  Prepubertal children:
  50 mg/kg amoxicillin, combined with
  25 mg/kg probenecid as a single dose.
  Note: Since probenecid is
  contraindicated in children under 2
  years. Do not use this regimen in
  children under 2 years of age.
  

  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.

  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30   mL/min. should not receive a 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should   receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children > 3 Monthsb Ear/Nose/Throat
  Skin/Skin Structure
  Genitourinary Tract Mild/Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided doses
  every 12 hours
  or
  20 mg/kg/day in divided doses
  every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided doses
  every 12 hours
  or
  40 mg/kg/day in divided doses
  every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided doses
  every 12 hours
  or
  40 mg/kg/day in divided doses
  every 8 hours Gonorrhea
  Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children:
  50 mg/kg amoxicillin, combined with
  25 mg/kg probenecid as a single dose.
  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.

  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  
  

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  
  

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  
  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water
  Required for Reconstitution Oral Suspension 125 mg/5 mL 80 mL 62 mL 100 mL 78 mL 150 mL 116 mL Oral Suspension 200 mg/5 mL 50 mL 39 mL 75 mL 57 mL 100 mL 76 mL Oral Suspension 250 mg/5 mL 80 mL 59 mL 100 mL 74 mL 150 mL 111 mL Oral Suspension 400 mg/5 mL 50 mL 36 mL 75 mL 54 mL 100 mL 71 mL
  

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  
  

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  ---

  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks ( ≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin capsules is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.
  Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose.
  Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.
  Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  Amoxicillin capsules may be given without regard to meals.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
  † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity* Usual Adult Dose Usual Dose for Children >3 Months† Ear/Nose/
  Throat Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Lower Respiratory Tract Mild/ Moderate or Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Skin/Skin Structure Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Genitourinary Tract Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children:
  50 mg/kg Amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  NOTE: SINCE
  PROBENECID ISCONTRAINDICATED N CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS:Laboratory Tests section.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary.  Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pyloriEradication to Reduce the Risk of Duodenal Ulcer Recurrence

  Triple Therapy

  Amoxicillin/Clarithromycin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE section.)

  Dual Therapy

  Amoxicillin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE section.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS section, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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  Amoxicillin capsules may be given without regard to meals. However, food effect studies have not been performed with the 500 mg formulation.

  Neonates and infants aged ≤ 12 weeks (≤ 3 months):

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and pediatric patients >3 months:

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

  † The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  Infection Severity* Usual Usual Dose Adult Dose for Children >3 months† Ear/nose/throat Mild/Moderate 500 mg 25 mg/kg/day every 12 hours in divided doses or every 12 hours 250 mg or every 8 hours 20 mg/kg/day in divided doses every 8 hours Severe 875 mg 45 mg/kg/day every 12 hours in divided doses or every 12 hours 500 mg or every 8 hours 40 mg/kg/day in divided doses every 8 hours Lower respiratory Mild/Moderate 875 mg 45 mg/kg/day Tract or Severe every 12 hours in divided doses or every 12 hours 500 mg every or 8 hours 40 mg/kg/day in divided doses every 8 hours Skin/Skin Mild/Moderate 500 mg 25 mg/kg/day Structure every 12 hours in divided doses or every 12 hours 250 mg every or 8 hours 20 mg/kg/day in divided doses every 8 hours Severe 875 mg 45 mg/kg/day every 12 hours in divided doses or every 12 hours 500 mg every or 8 hours 40 mg/kg/day in divided doses every 8 hours Genitourinary Mild/Moderate 500 mg 25 mg/kg/day Tract every 12 hours in divided doses or every 12 hours 250 mg every or 8 hours 20 mg/kg/day in divided doses every 8 hours Severe 875 mg 45 mg/kg/day every 12 hours in divided doses or every 12 hours 500 mg or every 8 hours 40 mg/kg/day in divided doses every 8 hours Gonorrhea 3 grams Prepubertal Acute, as children: uncomplicated single oral dose 50 mg/kg ano-genital and amoxicillin combined with 25 mg/kg probenecid urethral infections as a single dose. in males and NOTE: SINCE females PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS. DO NOT USE
  THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS - Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

  General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori eradication to reduce the risk of duodenal ulcer recurrence:

  Triple therapy: Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

  Dual therapy: Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing recommendations for adults with impaired renal function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875-mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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  Amoxicillin capsules, chewable tablets, and oral suspensions may be given without regard to meals. The 400 mg suspension, 400 mg chewable tablet and the 875 mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations.

  Amoxicillin tablets, chewable should be chewed before swallowing

  Neonates and Infants aged ≤ 12 weeks (≤ 3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 months

  Infection Severity‡ Usual Adult Dose Usual Dose for Children >3 months§ π Ear/Nose/Throat Mild/Moderate 500 mg every12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours   Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/Moderate 500 mg every12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours   Severe 875 mg every12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/Moderate 500 mg every12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours   Severe 875 mg every12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females   3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.NOTE: SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  ‡ Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

  § The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  π Each strength of the suspension of amoxicillin is available as a chewable tablet for use by older children.

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

  General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: Triple Therapy: Amoxicillin/clarithromycin/ lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

  Dual Therapy:Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for Mixing Oral Suspension: Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  200 mg/5 mL

  Bottle Size Amount of Water Required for Reconstitution     50 mL 33 mL 75 mL 49 mL 100 mL 66 mL

  Each teaspoonful (5 mL) will contain 200 mg amoxicillin

  400 mg/5 mL

  Bottle Size Amount of Water Required for Reconstitution 50 mL 33 mL 75 mL 49 mL 100 mL 66 mL

  Each teaspoonful (5 mL) will contain 400 mg amoxicillin.

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  Amoxicillin | Dava International, Inc.

  

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  Capsules, tablets, and oral suspensions of amoxicillin may be given without regard to meals. The 875-mg tablet has been studied only when administered at the start of a light meal. However, food effect studies have not been performed with 500-mg formulations.

  Neonates and Infants Aged ≤12 weeks (≤3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months:

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity* Usual Adult Dosage Usual Dose for Children > 3 Months† Ear/Nose/ Throat Mild/ Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/ Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/ Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/ Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose

  Prepubertal children: 50 mg/kg amoxicillin combined with 25 mg/kg probenecid as single dose.

  NOTE: SINCE PROBENICID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: Triple therapy: Amoxicillin/clarithromycin/ lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q 12h) for 14 days. (See INDICATIONS AND USAGE).

  Dual therapy: Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q 8h) for 14 days. (See INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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• Blenheim Pharmacal, Inc.
  

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  Amoxicillin | Blenheim Pharmacal, Inc.

  

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  Capsules, tablets, and oral suspensions of amoxicillin may be given without regard to meals. The 875-mg tablet has been studied only when administered at the start of a light meal. However, food effect studies have not been performed with 500-mg formulations.

  Neonates and Infants Aged ≤12 weeks (≤3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months:

  Infection Severity Usual Adult Dosage Usual Dose for Children > 3 Months Ear/Nose/ Throat Mild/ Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/ Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/ Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/ Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose

  Prepubertal children: 50 mg/kg amoxicillin combined with 25 mg/kg probenecid as single dose.

  NOTE: SINCE PROBENICID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: Triple therapy: Amoxicillin/clarithromycin/ lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q 12h) for 14 days. (See INDICATIONS AND USAGE).

  Dual therapy: Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q 8h) for 14 days. (See INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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• Rebel Distributors Corp.
  

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  Amoxicillin | Rebel Distributors Corp.

  

  ---

  
  Capsules, chewable tablets, and oral suspensions of amoxicillin may be given without regard to meals. The 400 mg suspension, 400 mg chewable tablet, and the 875 mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations. Neonates and Infants Aged ≤12 Weeks (≤3 Months)
  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h. Adults and Pediatric Patients >3 Months
  * Dosing for infections caused by less susceptible organisms should follow the recommendations for
      severe infections.
  †  The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg
     or more should be dosed according to the adult recommendations.
  ‡  Each strength of the suspension of amoxicillin is available as a chewable tablet for use by older children.
     Infection
     Severity*
     Usual Adult Dose
     Usual Dose for Children
     >3 Months†‡
     Ear/Nose/Throat
     Mild/Moderate
     500 mg every 12 hours
     or
     250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Lower Respiratory Tract   
     Mild/Moderate 
     or Severe  
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Skin/Skin Structure
     Mild/Moderate
     500 mg every 12 hours 
     or
     250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Genitourinary Tract    
     Mild/Moderate
     500 mg every 12 hours 
     or
     250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Gonorrhea Acute,
     uncomplicated
     ano-genital and
     urethral infections
     in males and females
  
   
     3 grams as single oral 
     dose   
     Prepubertal children:
     50 mg/kg amoxicillin,    
     combined with 25 mg/kg   
     probenecid as a single   
     dose.
     NOTE: SINCE
     PROBENECID IS
     CONTRAINDICATED
     IN CHILDREN UNDER   
     2 YEARS, DO NOT USE   
     THIS REGIMEN IN
     THESE CASES.
  
  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS: Laboratory Tests.)
   
  Larger doses may be required for stubborn or severe infections. General
  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole
  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.) Dual Therapy Amoxicillin/lansoprazole
  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)
   
  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients. Dosing Recommendations for Adults with Impaired Renal Function
  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of  <30 mL/min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
   
  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
  
  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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• Rebel Distributors Corp.
  

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  Amoxicillin | Rebel Distributors Corp.

  

  ---

  Amoxicillin capsules, chewable tablets, and oral suspensions may be given without regard to meals.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months Infection Severity Usual Adult Dose Usual Dose for Children > 3 Months Ear/Nose/Throat Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose. NOTE:SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis (see PRECAUTIONS, Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days (see INDICATIONS AND USAGE).

  Dual Therapy Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days (see INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults With Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/ min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for Mixing Oral Suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  125 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 62 mL 100 mL 77 mL 150 mL 113 mL

  Each teaspoonful (5 mL) will contain 125 mg amoxicillin (as the trihydrate).

  250 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 47 mL 100 mL 60 mL 150 mL 90 mL

  Each teaspoonful (5 mL) will contain 250 mg amoxicillin (as the trihydrate).

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  2.2 Dosing in Neonates and Infants Aged  12 Weeks (  3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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• Dispensing Solutions Inc.
  

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  Amoxicillin | Dispensing Solutions Inc.

  

  ---

  
  Oral suspensions of amoxicillin may be given without regard to meals. The 400 mg suspension has been studied only when administered at the start of a light meal.
  
  Neonates and Infants Aged ≤12 Weeks (≤3 Months)
   
  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.
   
  Adults and Pediatric Patients >3 Months
  * Dosing for infections caused by less susceptible organisms should follow the recommendations for
      severe infections.
  †  The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg
     or more should be dosed according to the adult recommendations.
  
     Infection
  
     Severity*
  
     Usual Adult Dose
  
     Usual Dose for Children
     >3 Months†
     Ear/Nose/Throat
  
     Mild/Moderate
  
     500 mg every 12 hours
     or
     250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
  
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Lower Respiratory Tract   
  
     Mild/Moderate 
     or Severe  
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Skin/Skin Structure
  
     Mild/Moderate
  
     500 mg every 12 hours 
     or
     250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
  
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Genitourinary Tract    
  
     Mild/Moderate
  
     500 mg every 12 hours 
     or
     250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
  
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Gonorrhea Acute,
     uncomplicated
     ano-genital and
     urethral infections
     in males and females
  
   
  
     3 grams as single oral 
     dose   
     Prepubertal children:
     50 mg/kg amoxicillin,    
     combined with 25 mg/kg   
     probenecid as a single   
     dose.
     NOTE: SINCE
     PROBENECID IS
     CONTRAINDICATED
     IN CHILDREN UNDER   
     2 YEARS, DO NOT USE   
     THIS REGIMEN IN
     THESE CASES.
  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.
   
  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS: Laboratory Tests.)
   
  Larger doses may be required for stubborn or severe infections.
  
  General
   
  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.
  
  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
  
  Triple Therapy
  
  Amoxicillin/clarithromycin/lansoprazole
   
  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)
  
  Dual Therapy
  
  Amoxicillin/lansoprazole
   
  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)
   
  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.
  
  Dosing Recommendations for Adults with Impaired Renal Function
   
  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
   
  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
  
  There are currently no dosing recommendations for pediatric patients with impaired renal function.
   
  Directions for Mixing Oral Suspension
   
  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.
  
                                               200 mg/5 mL
                                                                                              Amount of Water
  Bottle Size                                                                   Required for Reconstitution
    50 mL                                                                                       35 mL
    75 mL                                                                                       52 mL
  100 mL                                                                                       69 mL
  
  Each teaspoonful (5 mL) will contain 200 mg amoxicillin.
   
                                               400 mg/5 mL
  
                                                                                             Amount of Water
  Bottle Size                                                                   Required for Reconstitution
    50 mL                                                                                       35 mL
    75 mL                                                                                       52 mL
  100 mL                                                                                       69 mL
  
  Each teaspoonful (5 mL) will contain 400 mg amoxicillin.
  
  NOTE:  SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

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• Apotheca Inc.
  

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  Amoxicillin | Apotheca Inc.

  

  ---

  Amoxicillin capsules, chewable tablets, and oral suspensions may be given without regard to meals. The 400 mg suspension, 400 mg chewable tablet and the 875 mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations.

  Amoxicillin tablets, chewable should be chewed before swallowing

  Neonates and Infants aged ≤ 12 weeks (≤ 3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 months

  Infection Severity‡ Usual Adult Dose Usual Dose for Children >3 months§ π Ear/Nose/Throat Mild/Moderate 500 mg every12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours   Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/Moderate 500 mg every12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours   Severe 875 mg every12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/Moderate 500 mg every12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours   Severe 875 mg every12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females   3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.NOTE: SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  ‡ Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

  § The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  π Each strength of the suspension of amoxicillin is available as a chewable tablet for use by older children.

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

  GeneralIt should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. H. pylori Eradication to Reduce the Risk of Duodenal Ulcer RecurrenceTriple Therapy Amoxicillin/clarithromycin/lansoprazole
  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.) Dual Therapy Amoxicillin/lansoprazole
  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)
   
  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients. Dosing Recommendations for Adults with Impaired Renal FunctionPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of less than 30 mL/min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
   
  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
  
  There are currently no dosing recommendations for pediatric patients with impaired renal function. GeneralIt should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. H. pylori Eradication to Reduce the Risk of Duodenal Ulcer RecurrenceTriple Therapy Amoxicillin/clarithromycin/lansoprazole
  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.) Dual Therapy Amoxicillin/lansoprazole
  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)
   
  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients. Dosing Recommendations for Adults with Impaired Renal FunctionPatients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of less than 30 mL/min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
   
  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
  
  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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• Stat Rx Usa Llc
  

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  Amoxicillin | Stat Rx Usa Llc

  

  ---

  Amoxicillin capsules, chewable tablets, and oral suspensions may be given without regard to meals.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months Infection Severity Usual Adult Dose Usual Dose for Children > 3 Months Ear/Nose/Throat Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose. NOTE:SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis (see PRECAUTIONS, Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days (see INDICATIONS AND USAGE).

  Dual Therapy Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days (see INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults With Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/ min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for Mixing Oral Suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  125 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 62 mL 100 mL 77 mL 150 mL 113 mL

  Each teaspoonful (5 mL) will contain 125 mg amoxicillin (as the trihydrate).

  250 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 47 mL 100 mL 60 mL 150 mL 90 mL

  Each teaspoonful (5 mL) will contain 250 mg amoxicillin (as the trihydrate).

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

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• Altura Pharmaceuticals, Inc.
  

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  Amoxicillin | Altura Pharmaceuticals, Inc.

  

  ---

  Amoxicillin capsules may be given without regard to meals. However, food effect studies have not been performed with the 500 mg formulation.

  Neonates and infants aged ≤ 12 weeks (≤ 3 months):

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and pediatric patients >3 months:

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

   † The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.  Infection  Severity*  Usual  Usual Dose      Adult Dose  for Children        >3 months†  Ear/nose/throat  Mild/Moderate  500 mg  25 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      250 mg  or      every 8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg  or      every 8 hours  40 mg/kg/day        in divided doses        every 8 hours  Lower respiratory  Mild/Moderate  875 mg  45 mg/kg/day  Tract  or Severe  every 12 hours  in divided doses      or  every 12 hours      500 mg every  or      8 hours  40 mg/kg/day        in divided doses        every 8 hours  Skin/Skin  Mild/Moderate  500 mg  25 mg/kg/day  Structure    every 12 hours  in divided doses      or  every 12 hours      250 mg every  or      8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg every  or      8 hours  40 mg/kg/day        in divided doses        every 8 hours  Genitourinary  Mild/Moderate  500 mg  25 mg/kg/day  Tract    every 12 hours  in divided doses      or  every 12 hours      250 mg every  or      8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg  or      every 8 hours  40 mg/kg/day        in divided doses        every 8 hours  Gonorrhea    3 grams  Prepubertal  Acute,    as  children:  uncomplicated    single oral dose  50 mg/kg  ano-genital and      amoxicillin        combined with        25 mg/kg        probenecid  urethral infections      as a single dose.  in males and      NOTE: SINCE  females      PROBENECID IS        CONTRAINDICATED        IN CHILDREN        UNDER 2 YEARS.        DO NOT USE
  THIS REGIMEN        IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS - Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

  General:

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori eradication to reduce the risk of duodenal ulcer recurrence: Triple therapy:

  Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

  Dual therapy:

  Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing recommendations for adults with impaired renal function:

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875-mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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• Blenheim Pharmacal, Inc.
  

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  Amoxicillin | Blenheim Pharmacal, Inc.

  

  ---

  
  Capsules, chewable tablets, and oral suspensions of amoxicillin may be given without regard to meals. The 400 mg suspension, 400 mg chewable tablet, and the 875 mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations. Neonates and Infants Aged ≤12 Weeks (≤3 Months)
  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h. Adults and Pediatric Patients >3 Months
  * Dosing for infections caused by less susceptible organisms should follow the recommendations for
      severe infections.
  †  The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg
     or more should be dosed according to the adult recommendations.
  ‡  Each strength of the suspension of amoxicillin is available as a chewable tablet for use by older children.
     Infection
     Severity*
     Usual Adult Dose
     Usual Dose for Children
     >3 Months†‡
     Ear/Nose/Throat
     Mild/Moderate
     500 mg every 12 hours
     or
     250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Lower Respiratory Tract   
     Mild/Moderate 
     or Severe  
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Skin/Skin Structure
     Mild/Moderate
     500 mg every 12 hours 
     or
     250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Genitourinary Tract    
     Mild/Moderate
     500 mg every 12 hours 
     or
     250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Gonorrhea Acute,
     uncomplicated
     ano-genital and
     urethral infections
     in males and females
  
   
     3 grams as single oral 
     dose   
     Prepubertal children:
     50 mg/kg amoxicillin,    
     combined with 25 mg/kg   
     probenecid as a single   
     dose.
     NOTE: SINCE
     PROBENECID IS
     CONTRAINDICATED
     IN CHILDREN UNDER   
     2 YEARS, DO NOT USE   
     THIS REGIMEN IN
     THESE CASES.
  
  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS: Laboratory Tests.)
   
  Larger doses may be required for stubborn or severe infections. General
  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole
  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.) Dual Therapy Amoxicillin/lansoprazole
  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)
   
  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients. Dosing Recommendations for Adults with Impaired Renal Function
  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of  <30 mL/min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
   
  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
  
  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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• Blenheim Pharmacal, Inc.
  

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  Amoxicillin | Blenheim Pharmacal, Inc.

  

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  Amoxicillin capsules may be given without regard to meals. However, food effect studies have not been performed with the 500 mg formulation.

  Neonates and infants aged ≤ 12 weeks (≤ 3 months):

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and pediatric patients >3 months:

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

   † The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.  Infection  Severity*  Usual  Usual Dose      Adult Dose  for Children        >3 months†  Ear/nose/throat  Mild/Moderate  500 mg  25 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      250 mg  or      every 8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg  or      every 8 hours  40 mg/kg/day        in divided doses        every 8 hours  Lower respiratory  Mild/Moderate  875 mg  45 mg/kg/day  Tract  or Severe  every 12 hours  in divided doses      or  every 12 hours      500 mg every  or      8 hours  40 mg/kg/day        in divided doses        every 8 hours  Skin/Skin  Mild/Moderate  500 mg  25 mg/kg/day  Structure    every 12 hours  in divided doses      or  every 12 hours      250 mg every  or      8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg every  or      8 hours  40 mg/kg/day        in divided doses        every 8 hours  Genitourinary  Mild/Moderate  500 mg  25 mg/kg/day  Tract    every 12 hours  in divided doses      or  every 12 hours      250 mg every  or      8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg  or      every 8 hours  40 mg/kg/day        in divided doses        every 8 hours  Gonorrhea    3 grams  Prepubertal  Acute,    as  children:  uncomplicated    single oral dose  50 mg/kg  ano-genital and      amoxicillin        combined with        25 mg/kg        probenecid  urethral infections      as a single dose.  in males and      NOTE: SINCE  females      PROBENECID IS        CONTRAINDICATED        IN CHILDREN        UNDER 2 YEARS.        DO NOT USE
  THIS REGIMEN        IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS - Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

  General:

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori eradication to reduce the risk of duodenal ulcer recurrence: Triple therapy:

  Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

  Dual therapy:

  Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing recommendations for adults with impaired renal function:

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875-mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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• Rebel Distributors Corp.
  

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  Amoxicillin | Rebel Distributors Corp.

  

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  Amoxicillin capsules, chewable tablets, and oral suspensions may be given without regard to meals.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. ‡ Each strength of amoxicillin for oral suspension is available as a chewable tablet for use by older children. Infection Severity* Usual Adult Dose Usual Dose for Children > 3 Months†‡ Ear/Nose/Throat Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose. NOTE:SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis (see PRECAUTIONS, Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days (see INDICATIONS AND USAGE).

  Dual Therapy Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days (see INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults With Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/ min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for Mixing Oral Suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  125 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 62 mL 100 mL 77 mL 150 mL 113 mL

  Each teaspoonful (5 mL) will contain 125 mg amoxicillin (as the trihydrate).

  250 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 47 mL 100 mL 60 mL 150 mL 90 mL

  Each teaspoonful (5 mL) will contain 250 mg amoxicillin (as the trihydrate).

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

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• Stat Rx Usa Llc
  

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  Amoxicillin | Stat Rx Usa Llc

  

  ---

  Oral suspensions of amoxicillin may be given without regard to meals. The 400 mg suspension has been studied only when administered at the start of a light meal.

  Neonates and Infants Aged ≤12 Weeks (≤3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients >3 Months
    Infection     Severity *     Usual Adult Dose     Usual Dose for Children >3 Months+            Ear/Nose/Throat      Mild/Moderate
      500 mg every 12 hours      25 mg/kg/day in divided        or 250 mg every 8 hours       doses every 12 hours           or
           20 mg/kg/day in divided          doses every 8 hours               Severe
      875 mg every 12 hours      45 mg/kg/day in divided         or 500 mg every 8 hours        doses every 12 hours           or           40 mg/kg/day in divided           doses every 8 hours             Lower Respiratory Tract  
      Mild/Moderate or Severe   
      875 mg every 12 hours      45 mg/kg/day in divided         or 500 mg every 8 hours     doses every 12 hours           or
           40 mg/kg/day in divided           doses every 8 hours             Skin/Skin Structure
      Mild/Moderate
      500 mg every 12 hours     25 mg/kg/day in divided         or 250 mg every 8 hours     doses every 12 hours           or
           20 mg/kg/day in divided           doses every 8 hours               Severe
      875 mg every 12 hours      45 mg/kg/day in divided         or 500 mg every 8 hours     doses every 12 hours           or
           40 mg/kg/day in divided           doses every 8 hours             Genitourinary Tract
      Mild/Moderate
      500 mg every 12 hours      25 mg/kg/day in divided         or 250 mg every 8 hours     doses every 12 hours           or
           20 mg/kg/day in divided           doses every 8 hours       Severe
      875 mg every 12 hours      45 mg/kg/day in divided         or 500 mg every 8 hours     doses every 12 hours           or
           40 mg/kg/day in divided           doses every 8 hours             Gonorrhea Acute,        3 grams as single oral      Prepubertal children:   50     uncomplicated       dose        mg/kg amoxicillin,     ano-genital and         combined with 25 mg/kg     urethral infections         probenecid as a single dose.    in males and         NOTE: SINCE
     females         PROBENECID IS
           CONTRAINDICATED
           IN CHILDREN UNDER           2 YEARS, DO NOT USE   
           THIS REGIMEN IN
           THESE CASES. 

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
  +The children's dosage is intended for individuals whose weight is less that 40 kg or more should be dosed according to the adult recommendations.
  
  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.
   
  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS: Laboratory Tests.)
   
  Larger doses may be required for stubborn or severe infections.
  
  

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole
  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.) Dual Therapy Amoxicillin/lansoprazole
  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)
   
  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients. Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
   
  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
  
  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for Mixing Oral Suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.
  
                                               200 mg/5 mL
                                                                                             Amount of Water
     Bottle Size                                                                  Required for Reconstitution
       50 mL                                                                                       35 mL
       75 mL                                                                                       52 mL
     100 mL                                                                                       69 mL
  
  Each teaspoonful (5 mL) will contain 200 mg amoxicillin.
   
                                              400 mg/5 mL
  
                                                                                            Amount of Water
     Bottle Size                                                                  Required for Reconstitution
       50 mL                                                                                       35 mL
       75 mL                                                                                       52 mL
     100 mL                                                                                       69 mL
  
  Each teaspoonful (5 mL) will contain 400 mg amoxicillin.
  
  NOTE:  SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

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• Rebel Distributors Corp.
  

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  Amoxicillin | Rebel Distributors Corp.

  

  ---

  Capsules, tablets and oral suspensions of amoxicillin may be given without regard to meals. The 400 mg suspension and the 875 mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations.

  Neonates and Infants Aged ≤12 Weeks (≤3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients >3 Months Infection Severity* Usual Adult Dose Usual Dose for Children > 3 months† * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections. † The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Ear/Nose/Throat Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  NOTE: SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological followup for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

  Dual Therapy Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for Mixing Oral Suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  125 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 55 mL 100 mL 68 mL 150 mL 102 mL   Each teaspoonful (5 mL) will contain 125 mg amoxicillin. 200 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL   Each teaspoonful (5 mL) will contain 200 mg amoxicillin. 250 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 55 mL 100 mL 68 mL 150 mL 102 mL   Each teaspoonful (5 mL) will contain 250 mg amoxicillin. 400 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL   Each teaspoonful (5 mL) will contain 400 mg amoxicillin.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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  Amoxicillin capsules may be given without regard to meals.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
  † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity* Usual Adult Dose Usual Dose for Children >3 Months† Ear/Nose/
  Throat Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Lower Respiratory Tract Mild/ Moderate or Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Skin/Skin Structure Mild/ Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Genitourinary Tract Mild/ Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children:
  50 mg/kg Amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  NOTE: SINCE
  PROBENECID IS
  CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS: Laboratory Tests section.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary.  Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

  Triple Therapy

  Amoxicillin/Clarithromycin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE section.)

  Dual Therapy

  Amoxicillin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE section.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS section, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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• Redpharm Drug Inc.
  

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  Amoxicillin | Redpharm Drug Inc.

  

  ---

  
  Capsules, chewable tablets, and oral suspensions of amoxicillin may be given without regard to meals. The 400 mg suspension, 400 mg chewable tablet, and the 875 mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations. Neonates and Infants Aged ≤12 Weeks (≤3 Months)
  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h. Adults and Pediatric Patients >3 Months
  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
  †  The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
  ‡  Each strength of the suspension of amoxicillin is available as a chewable tablet for use by older children.
  Infection
  Severity*
  Usual Adult Dose
  Usual Dose for Children
     >3 Months†‡
     Ear/Nose/Throat
     Mild/Moderate
     500 mg every 12 hours
     or
     250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Lower Respiratory Tract   
     Mild/Moderate 
     or Severe  
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Skin/Skin Structure
     Mild/Moderate
     500 mg every 12 hours 
     or
     250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Genitourinary Tract    
     Mild/Moderate
     500 mg every 12 hours 
     or
     250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Gonorrhea Acute,
     uncomplicated
     ano-genital and
     urethral infections
     in males and females
  
   
     3 grams as single oral 
     dose   
     Prepubertal children:
     50 mg/kg amoxicillin,    
     combined with 25 mg/kg   
     probenecid as a single   
     dose.
     NOTE: SINCE
     PROBENECID IS
     CONTRAINDICATED
     IN CHILDREN UNDER   
     2 YEARS, DO NOT USE   
     THIS REGIMEN IN
     THESE CASES.
  
  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS: Laboratory Tests.)
   
  Larger doses may be required for stubborn or severe infections. General
  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole
  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.) Dual Therapy Amoxicillin/lansoprazole
  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)
   
  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients. Dosing Recommendations for Adults with Impaired Renal Function
  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
   
  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
  
  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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• Redpharm Drug Inc.
  

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  Amoxicillin | Redpharm Drug Inc.

  

  ---

  The 875-mg tablet has been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200-mg and 500-mg formulations.

  Neonates and Infants Aged ≤12 weeks (≤3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of Amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months:

   Infection  Severity  Usual Adult Dosage  Usual Dose for Children > 3 Months  Ear/Nose/ Throat  Mild/ Moderate  500 mg every 12 hours or 250 mg every 8 hours  25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or 500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours  Lower Respiratory Tract  Mild/ Moderate or Severe  875 mg every 12 hours or 500 mg every 8 hours  

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours  Skin/Skin Structure  Mild/ Moderate  500 mg every 12 hours or 250 mg every 8 hours  25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or 500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours  Genitourinary Tract  Mild/ Moderate  500 mg every 12 hours or 250 mg every 8 hours  25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or 500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours  Gonorrhea Acute, Uncomplicated Ano-genital and urethral infections in males and females    3 grams as single oral dose  

  Prepubertal children: 50 mg/kg Amoxicillin combined with 25 mg/kg probenecid as single dose.

  NOTE: SINCE PROBENICID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: Triple therapy: Amoxicillin/clarithromycin/ lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE).

  Dual therapy: Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on the severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on the severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Close
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  More Info
• Redpharm Drug Inc.
  

  ×

  Amoxicillin | Redpharm Drug Inc.

  

  ---

  
  Capsules, chewable tablets, and oral suspensions of amoxicillin may be given without regard to meals. The 400 mg suspension, 400 mg chewable tablet, and the 875 mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations. Neonates and Infants Aged ≤12 Weeks (≤3 Months)
  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h. Adults and Pediatric Patients >3 Months
  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
  †  The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
  ‡  Each strength of the suspension of amoxicillin is available as a chewable tablet for use by older children.
     Infection
     Severity*
     Usual Adult Dose
     Usual Dose for Children
     >3 Months†‡
     Ear/Nose/Throat
     Mild/Moderate
     500 mg every 12 hours
     or
     250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Lower Respiratory Tract   
     Mild/Moderate 
     or Severe  
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Skin/Skin Structure
     Mild/Moderate
     500 mg every 12 hours 
     or
     250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Genitourinary Tract    
     Mild/Moderate
     500 mg every 12 hours 
     or
     250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Gonorrhea Acute,
     uncomplicated
     ano-genital and
     urethral infections
     in males and females
  
   
     3 grams as single oral 
     dose   
     Prepubertal children:
     50 mg/kg amoxicillin,    
     combined with 25 mg/kg   
     probenecid as a single   
     dose.
     NOTE: SINCE
     PROBENECID IS
     CONTRAINDICATED
     IN CHILDREN UNDER   
     2 YEARS, DO NOT USE   
     THIS REGIMEN IN
     THESE CASES.
  
  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS: Laboratory Tests.)
   
  Larger doses may be required for stubborn or severe infections. General
  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole
  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.) Dual Therapy Amoxicillin/lansoprazole
  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)
   
  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients. Dosing Recommendations for Adults with Impaired Renal Function
  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of  <30 mL/min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
   
  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
  
  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Close
  No Recall

  More Info
• Redpharm Drug Inc.
  

  ×

  Amoxicillin | Redpharm Drug Inc.

  

  ---

  Capsules, tablets and oral suspensions of amoxicillin may be given without regard to meals. The 400 mg suspension and the 875 mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations.

  Neonates and Infants Aged ≤12 Weeks (≤3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Infection
  Severity*
  Usual Adult Dose
  Usual Dose for children over 3 months† Ear/Nose/Throat
  Mild/Moderate
  500 mg every 12 hours or 250 mg every 8 hours
  25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours
  
  Severe
  875 mg every 12 hours or 500 mg every 8 hours
  45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
  Lover Respiratory Tract
  Mild/Moderate or Severe
  875 mg every 12 hours or 500 mg every 8 hours
  45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
  Skin/Skin Structure
  Mild/Moderate
  500 mg every 12 hours or 250 mg every 8 hours
  25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours
  
  Severe
  875 mg every 12 hours or 500 mg every 8 hours
  45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
  Genitourinary Tract
  Mild/Moderate
  500 mg every 12 hours or 250 mg every 8 hours
  25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours
  
  Severe
  875 mg every 12 hours or 250 mg every 8 hours
  45 mg/kg/day in divided doses every 12 hours
  or
  40mg/kg/day in divided doses every 8 hours
  Gonorrhea Acute, uncomplicated ano-genital and
  urethral infections in males and females
  
  3 grams as single oral dose
  NOTE: SINCE PROBENECID IS
  CONTRAINDICATED IN CHILDREN UNDER
  2 YEARS, DO NOT USE THIS REGIMINE IN
  THESE CASES.
  *Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
  † The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations

  After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological followup for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

  Dual Therapy Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of less than 30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for Mixing Oral Suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  125 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 55 mL 100 mL 68 mL 150 mL 102 mL   Each teaspoonful (5 mL) will contain 125 mg amoxicillin. 200 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL   Each teaspoonful (5 mL) will contain 200 mg amoxicillin. 250 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 55 mL 100 mL 68 mL 150 mL 102 mL   Each teaspoonful (5 mL) will contain 250 mg amoxicillin. 400 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL   Each teaspoonful (5 mL) will contain 400 mg amoxicillin.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

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  More Info
• Redpharm Drug Inc.
  

  ×

  Amoxicillin | Redpharm Drug Inc.

  

  ---

  Amoxicillin capsules, chewable tablets, and oral suspensions may be given without regard to meals.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months Infection Severity Usual Adult Dose Usual Dose for Children > 3 Months Ear/Nose/Throat Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose. NOTE:SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis (see PRECAUTIONS, Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days (see INDICATIONS AND USAGE).

  Dual Therapy Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days (see INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults With Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/ min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for Mixing Oral Suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  125 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 62 mL 100 mL 77 mL 150 mL 113 mL

  Each teaspoonful (5 mL) will contain 125 mg amoxicillin (as the trihydrate).

  250 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 47 mL 100 mL 60 mL 150 mL 90 mL

  Each teaspoonful (5 mL) will contain 250 mg amoxicillin (as the trihydrate).

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

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  Amoxicillin | Pd-rx Pharmaceuticals, Inc.

  

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  Amoxicillin capsules may be given without regard to meals. However, food effect studies have not been performed with the 500 mg formulation.

  Neonates and infants aged ≤ 12 weeks (≤ 3 months):

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and pediatric patients >3 months:

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

   † The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.  Infection  Severity*  Usual  Usual Dose      Adult Dose  for Children        >3 months†  Ear/nose/throat  Mild/Moderate  500 mg  25 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      250 mg  or      every 8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg  or      every 8 hours  40 mg/kg/day        in divided doses        every 8 hours  Lower respiratory  Mild/Moderate  875 mg  45 mg/kg/day  Tract  or Severe  every 12 hours  in divided doses      or  every 12 hours      500 mg every  or      8 hours  40 mg/kg/day        in divided doses        every 8 hours  Skin/Skin  Mild/Moderate  500 mg  25 mg/kg/day  Structure    every 12 hours  in divided doses      or  every 12 hours      250 mg every  or      8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg every  or      8 hours  40 mg/kg/day        in divided doses        every 8 hours  Genitourinary  Mild/Moderate  500 mg  25 mg/kg/day  Tract    every 12 hours  in divided doses      or  every 12 hours      250 mg every  or      8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg  or      every 8 hours  40 mg/kg/day        in divided doses        every 8 hours  Gonorrhea    3 grams  Prepubertal  Acute,    as  children:  uncomplicated    single oral dose  50 mg/kg  ano-genital and      amoxicillin        combined with        25 mg/kg        probenecid  urethral infections      as a single dose.  in males and      NOTE: SINCE  females      PROBENECID IS        CONTRAINDICATED        IN CHILDREN        UNDER 2 YEARS.        DO NOT USE
  THIS REGIMEN        IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS - Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

  General:

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori eradication to reduce the risk of duodenal ulcer recurrence: Triple therapy:

  Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

  Dual therapy:

  Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing recommendations for adults with impaired renal function:

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875-mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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  Amoxicillin | West-ward Pharmaceutical Corp

  

  ---

  Amoxicillin capsules may be given without regard to meals. However, food effect studies have not been performed with the 500 mg formulation.

  Neonates and infants aged ≤ 12 weeks (≤ 3 months):

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and pediatric patients >3 months:

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

   † The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.  Infection  Severity*  Usual  Usual Dose      Adult Dose  for Children        >3 months†  Ear/nose/throat  Mild/Moderate  500 mg  25 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      250 mg  or      every 8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg  or      every 8 hours  40 mg/kg/day        in divided doses        every 8 hours  Lower respiratory  Mild/Moderate  875 mg  45 mg/kg/day  Tract  or Severe  every 12 hours  in divided doses      or  every 12 hours      500 mg every  or      8 hours  40 mg/kg/day        in divided doses        every 8 hours  Skin/Skin  Mild/Moderate  500 mg  25 mg/kg/day  Structure    every 12 hours  in divided doses      or  every 12 hours      250 mg every  or      8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg every  or      8 hours  40 mg/kg/day        in divided doses        every 8 hours  Genitourinary  Mild/Moderate  500 mg  25 mg/kg/day  Tract    every 12 hours  in divided doses      or  every 12 hours      250 mg every  or      8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg  or      every 8 hours  40 mg/kg/day        in divided doses        every 8 hours  Gonorrhea    3 grams  Prepubertal children:  Acute,    as 50 mg/kg amoxicillin combined with uncomplicated    single oral dose  25 mg/kg probenecid as a single dose. ano-genital and    

   NOTE: SINCE PROBENECID IS CONTRA-

  urethral infections in  males and females     INDICATED IN CHILDREN UNDER 2 YEARS. DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS - Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

  General:

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori eradication to reduce the risk of duodenal ulcer recurrence: Triple therapy:

  Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

  Dual therapy:

  Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing recommendations for adults with impaired renal function:

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875-mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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  Amoxicillin | Stat Rx Usa Llc

  

  ---

  
  Capsules, chewable tablets, and oral suspensions of amoxicillin may be given without regard to meals. The 400 mg suspension, 400 mg chewable tablet, and the 875 mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations.
  
  Neonates and Infants Aged ≤12 Weeks (≤3 Months)
   
  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.
  
  Adults and Pediatric Patients >3 Months 
  
      Infection
      Severity *
      Usual Adult Dose Usual Dose for Children
  
  
  
  
     >3 Months†‡
  
  
  
  
  
  Ear/Nose/Throat
  Mild/Moderate
   500 mg every 12 hours 25 mg/kg/day in divided
  
  
  
     or    doses every 12 hours
  
  
  
     250 mg every 8 hours    or
  
  
  
  
     20 mg/kg/day in divided
  
  
  
  
     doses every 8 hours
  
  
  
  
  
  
  
  Severe
  875 mg every 12 hours  45 mg/kg/day in divided
  
  
  
     or    doses every 12 hours
  
  
  
     500 mg every 8 hours    or
  
  
  
  
     40 mg/kg/day in divided
  
  
  
  
     doses every 8 hours
  
  
  
  
  
  Lower Rispiratory Tract
  Mild/Moderate or Severe
  875 mg every 12 hours  45 mg/kg/day in divided
  
  
  
     or    doses every 12 hours
  
  
  
     500 mg every 8 hours    or
  
  
  
  
     40 mg/kg/day in divided
  
  
  
  
     doses every 8 hours
  
  
  
  
  
  Skin/Skin Structure
  Mild/Moderate
  500 mg every 12 hours  25 mg/kg/day in divided
  
  
  
     or    doses every 12 hours
  
  
  
     250 mg every 8 hours    or
  
  
  
  
     20 mg/kg/day in divided
  
  
  
  
     doses every 8 hours
  
  
  
  
  
  
  
  Severe
  875 mg every 12 hours  45 mg/kg/day in divided
  
  
  
     or    doses every 12 hours
  
  
  
     500 mg every 8 hours    or
  
  
  
  
     40 mg/kg/day in divided
  
  
  
  
     doses every 8 hours
  
  
  
  
  
  Genitourinary Tract
  Mild/Moderate
  500 mg every 12 hours  25 mg/kg/day in divided
  
  
  
     or    doses every 12 hours
  
  
  
     250 mg every 8 hours    or
  
  
  
  
     20 mg/kg/day in divided
  
  
  
  
     doses every 8 hours
  
  
  
  
  
  
  
  Severe
  875 mg every 12 hours  45 mg/kg/day in divided
  
  
  
     or    doses every 12 hours
  
  
  
     500 mg every 8 hours    or
  
  
  
  
     40 mg/kg/day in divided
  
  
  
  
     doses every 8 hours
  
  
  
  
  
  Gonorrhea Acute,
  
  
  3 grams as single oral  Prepubertal children:    uncomplicated
  
  
     dose       50 mg/kg amoxicillin,        ano-genital and
  
  
  
     combined with 25 mg/kg       urethral infections
  
  
  
     probenecid as a single       in males and females
  
  
  
     dose.
  
  
  
  
     NOTE: SINCE
  
  
  
  
     PROBENECID IS
  
  
  
  
     CONTRAINDICATED
  
  
  
  
     IN CHILDREN UNDER   
  
  
  
  
     2 YEARS, DO NOT USE   
  
  
  
  
     THIS REGIMEN IN
  
  
  
  
     THESE CASES.  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
  †  The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
  ‡  Each strength of the suspension of amoxicillin is available as a chewable tablet for use by older children.
  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS: Laboratory Tests.)
   
  Larger doses may be required for stubborn or severe infections.
  
  General
   
  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.
  
  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
  
  Triple Therapy
  
  Amoxicillin/clarithromycin/lansoprazole
   
  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)
  
  Dual Therapy
  
  Amoxicillin/lansoprazole
   
  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)
   
  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.
  
  Dosing Recommendations for Adults with Impaired Renal Function
   
  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of less than 30 mL/min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
   
  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
  
  There are currently no dosing recommendations for pediatric patients with impaired renal function.
  
  

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  ---

  The 875-mg tablet has been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200-mg and 500-mg formulations.

  Neonates and Infants Aged ≤12 weeks (≤3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of Amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months:

   Infection  Severity  Usual Adult Dosage  Usual Dose for Children > 3 Months  Ear/Nose/ Throat  Mild/ Moderate  500 mg every 12 hours or 250 mg every 8 hours  25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or 500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours  Lower Respiratory Tract  Mild/ Moderate or Severe  875 mg every 12 hours or 500 mg every 8 hours  

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours  Skin/Skin Structure  Mild/ Moderate  500 mg every 12 hours or 250 mg every 8 hours  25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or 500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours  Genitourinary Tract  Mild/ Moderate  500 mg every 12 hours or 250 mg every 8 hours  25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or 500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours  Gonorrhea Acute, Uncomplicated Ano-genital and urethral infections in males and females    3 grams as single oral dose  

  Prepubertal children: 50 mg/kg Amoxicillin combined with 25 mg/kg probenecid as single dose.

  NOTE: SINCE PROBENICID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: Triple therapy: Amoxicillin/clarithromycin/ lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE).

  Dual therapy: Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on the severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on the severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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• Pd-rx Pharmaceuticals, Inc.
  

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  Amoxicillin | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Amoxicillin capsules, chewable tablets, and oral suspensions may be given without regard to meals.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months Infection Severity Usual Adult Dose Usual Dose for Children > 3 Months Ear/Nose/Throat Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose. NOTE:SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis (see PRECAUTIONS, Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days (see INDICATIONS AND USAGE).

  Dual Therapy Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days (see INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults With Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/ min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for Mixing Oral Suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  125 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 62 mL 100 mL 77 mL 150 mL 113 mL

  Each teaspoonful (5 mL) will contain 125 mg amoxicillin (as the trihydrate).

  250 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 47 mL 100 mL 60 mL 150 mL 90 mL

  Each teaspoonful (5 mL) will contain 250 mg amoxicillin (as the trihydrate).

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

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  Amoxicillin | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Amoxicillin capsules, chewable tablets, and oral suspensions may be given without regard to meals.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months Infection Severity Usual Adult Dose Usual Dose for Children > 3 Months Ear/Nose/Throat Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose. NOTE:SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis (see PRECAUTIONS, Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days (see INDICATIONS AND USAGE).

  Dual Therapy Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days (see INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults With Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/ min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for Mixing Oral Suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  125 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 62 mL 100 mL 77 mL 150 mL 113 mL

  Each teaspoonful (5 mL) will contain 125 mg amoxicillin (as the trihydrate).

  250 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 47 mL 100 mL 60 mL 150 mL 90 mL

  Each teaspoonful (5 mL) will contain 250 mg amoxicillin (as the trihydrate).

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

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• H.j. Harkins Company, Inc.
  

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  Amoxicillin | H.j. Harkins Company, Inc.

  

  ---

  Amoxicillin oral suspensions may be given without regard to meals. The 400 mg suspension has been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg formulation.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months:  Infection  Severitya  Usual Adult Dose  Usual Dose for Children > 3 Monthsb  Ear/Nose/Throat  Mild/Moderate  500 mg every 12 hours or 250 mg every 8 hours  

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses every 8 hours    Severe  875 mg every 12 hours or 500 mg every 8 hours  

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours  Lower Respiratory Tract  Mild/Moderate or Severe  875 mg every 12 hours or 500 mg every 8 hours  

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours  Skin/Skin Structure  Mild/Moderate  500 mg every 12 hours or 250 mg every 8 hours  

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or 500 mg every 8 hours  

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours  Genitourinary Tract  Mild/Moderate  500 mg every 12 hours or 250 mg every 8 hours  

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or 500 mg every 8 hours  

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours  

  Gonorrhea

  Acute, uncomplicated ano-genital and urethral infections in males and females    3 grams as single oral dose  

  Prepubertal children:

  50 mg/kg Amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  NOTE: SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  a  Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

  b  The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS: Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to reduce the risk of Duodenal Ulcer Recurrence Triple Therapy

  Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

  Dual Therapy

  Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for Mixing Oral Suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

   

  125 mg/5 mL

     

  Bottle Size

   Amount of Water
  

  Required for Reconstitution

   80 mL

  100 mL

   66 mL 

  83 mL

   

  150 mL

   

  125 mL

  Each teaspoonful (5 mL) will contain 125 mg amoxicillin.

   

  200 mg/5 mL

     

  Bottle Size

   

  Amount of Water

  Required for Reconstitution

    50 mL

    75 mL

  39 mL 

  59 mL

   

  100 mL

   

  78 mL

  Each teaspoonful (5 mL) will contain 200 mg amoxicillin.

   

  250 mg/5 mL

     

  Bottle Size

   

  Amount of Water

  Required for Reconstitution

    80 mL

  100 mL

   59 mL 

  73 mL

   

  150 mL

   

  110 mL

  Each teaspoonful (5 mL) will contain 250 mg amoxicillin.

   

  400 mg/5 mL

     

  Bottle Size

   

  Amount of Water

  Required for Reconstitution

    50 mL

    75 mL

  100 mL

  34 mL

  51 mL 

  65 mL

  Each teaspoonful (5 mL) will contain 400 mg amoxicillin.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

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• Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
  

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  Amoxicillin | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

  

  ---

  Capsules, tablets and oral suspensions of amoxicillin may be given without regard to meals. The 400 mg suspension and the 875 mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations.

  Neonates and Infants Aged ≤12 Weeks (≤3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Infection
  Severity*
  Usual Adult Dose
  Usual Dose for children over 3 months† Ear/Nose/Throat
  Mild/Moderate
  500 mg every 12 hours or 250 mg every 8 hours
  25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours
  
  Severe
  875 mg every 12 hours or 500 mg every 8 hours
  45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
  Lover Respiratory Tract
  Mild/Moderate or Severe
  875 mg every 12 hours or 500 mg every 8 hours
  45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
  Skin/Skin Structure
  Mild/Moderate
  500 mg every 12 hours or 250 mg every 8 hours
  25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours
  
  Severe
  875 mg every 12 hours or 500 mg every 8 hours
  45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
  Genitourinary Tract
  Mild/Moderate
  500 mg every 12 hours or 250 mg every 8 hours
  25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours
  
  Severe
  875 mg every 12 hours or 250 mg every 8 hours
  45 mg/kg/day in divided doses every 12 hours
  or
  40mg/kg/day in divided doses every 8 hours
  Gonorrhea Acute, uncomplicated ano-genital and
  urethral infections in males and females
  
  3 grams as single oral dose
  NOTE: SINCE PROBENECID IS
  CONTRAINDICATED IN CHILDREN UNDER
  2 YEARS, DO NOT USE THIS REGIMINE IN
  THESE CASES.
  *Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
  † The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations

  After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological followup for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

  Dual Therapy Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of less than 30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for Mixing Oral Suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  125 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 55 mL 100 mL 68 mL 150 mL 102 mL   Each teaspoonful (5 mL) will contain 125 mg amoxicillin. 200 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL   Each teaspoonful (5 mL) will contain 200 mg amoxicillin. 250 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 55 mL 100 mL 68 mL 150 mL 102 mL   Each teaspoonful (5 mL) will contain 250 mg amoxicillin. 400 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL   Each teaspoonful (5 mL) will contain 400 mg amoxicillin.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

  Close
  No Recall

  More Info
• Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
  

  ×

  Amoxicillin | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

  

  ---

  Capsules, tablets and oral suspensions of amoxicillin may be given without regard to meals. The 400 mg suspension and the 875 mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations.

  Neonates and Infants Aged ≤12 Weeks (≤3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients >3 Months Infection Severity Usual Adult Dose Usual Dose for Children > 3 months Ear/Nose/Throat Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  NOTE: SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological followup for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

  Dual Therapy Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for Mixing Oral Suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  125 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 55 mL 100 mL 68 mL 150 mL 102 mL   Each teaspoonful (5 mL) will contain 125 mg amoxicillin. 200 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL   Each teaspoonful (5 mL) will contain 200 mg amoxicillin. 250 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 55 mL 100 mL 68 mL 150 mL 102 mL   Each teaspoonful (5 mL) will contain 250 mg amoxicillin. 400 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL   Each teaspoonful (5 mL) will contain 400 mg amoxicillin.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

  Close
  No Recall

  More Info
• H.j. Harkins Company, Inc.
  

  ×

  Amoxicillin | H.j. Harkins Company, Inc.

  

  ---

  
  Oral suspensions of amoxicillin may be given without regard to meals. The 400 mg suspension has been studied only when administered at the start of a light meal. Neonates and Infants Aged ≤12 Weeks (≤3 Months)
  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h. Adults and Pediatric Patients >3 Months
  
  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
  † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed
     according to the adult recommendations.
     Infection
     Severity *
     Usual Adult Dose
     Usual Dose for Children >3
     Months†
     Ear/Nose/Throat
     Mild/Moderate
     500 mg every 12 hours
     or 250 mg every 8 hours   
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
     875 mg every 12 hours
     or 500 mg every 8 hours   
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Lower Respiratory Tract    
     Mild/Moderate or Severe    
     875 mg every 12 hours
     or 500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Skin/Skin Structure
     Mild/Moderate
     500 mg every 12 hours
     or 250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
     875 mg every 12 hours
     or 500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Genitourinary Tract
     Mild/Moderate
     500 mg every 12 hours
     or 250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
     875 mg every 12 hours
     or 500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Gonorrhea Acute,
     uncomplicated
     ano-genital and
     urethral infections
     in males and
     females
   
     3 grams as single oral
     dose    
     Prepubertal children:   50
     mg/kg amoxicillin,
     combined with 25 mg/kg
     probenecid as a single dose.
     NOTE: SINCE
     PROBENECID IS
     CONTRAINDICATED
     IN CHILDREN UNDER
     2 YEARS, DO NOT USE    
     THIS REGIMEN IN
     THESE CASES.
  
  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.
   
  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS: Laboratory Tests.)
   
  Larger doses may be required for stubborn or severe infections. General
  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole
  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.) Dual Therapy Amoxicillin/lansoprazole
  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)
   
  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients. Dosing Recommendations for Adults with Impaired Renal Function
  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
   
  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
  
  There are currently no dosing recommendations for pediatric patients with impaired renal function. Directions for Mixing Oral Suspension
  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.
  
                                                200 mg/5 mL
                                                                                              Amount of Water
      Bottle Size                                                                   Required for Reconstitution
       50 mL                                                                                       35 mL
       75 mL                                                                                       52 mL
     100 mL                                                                                       69 mL
  
  Each teaspoonful (5 mL) will contain 200 mg amoxicillin.
   
                                               400 mg/5 mL
  
                                                                                             Amount of Water
      Bottle Size                                                                   Required for Reconstitution
       50 mL                                                                                       35 mL
       75 mL                                                                                       52 mL
     100 mL                                                                                       69 mL
  
  Each teaspoonful (5 mL) will contain 400 mg amoxicillin.
  
  NOTE:  SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

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• Pd-rx Pharmaceuticals, Inc.
  

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  Amoxicillin | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Amoxicillin capsules, chewable tablets, and oral suspensions may be given without regard to meals.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months Infection Severity Usual Adult Dose Usual Dose for Children > 3 Months Ear/Nose/Throat Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose. NOTE:SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis (see PRECAUTIONS, Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days (see INDICATIONS AND USAGE).

  Dual Therapy Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days (see INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults With Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/ min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for Mixing Oral Suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  125 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 62 mL 100 mL 77 mL 150 mL 113 mL

  Each teaspoonful (5 mL) will contain 125 mg amoxicillin (as the trihydrate).

  250 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 47 mL 100 mL 60 mL 150 mL 90 mL

  Each teaspoonful (5 mL) will contain 250 mg amoxicillin (as the trihydrate).

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

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• H.j. Harkins Company, Inc.
  

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  Amoxicillin | H.j. Harkins Company, Inc.

  

  ---

  
  Capsules, chewable tablets, and oral suspensions of amoxicillin may be given without regard to meals. The 400 mg suspension, 400 mg chewable tablet, and the 875 mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations. Neonates and Infants Aged ≤12 Weeks (≤3 Months)
  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h. Adults and Pediatric Patients >3 Months
  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
  †  The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
  ‡  Each strength of the suspension of amoxicillin is available as a chewable tablet for use by older children.
     Infection
     Severity*
     Usual Adult Dose
     Usual Dose for Children
     >3 Months†‡
     Ear/Nose/Throat
     Mild/Moderate
     500 mg every 12 hours
     or
     250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Lower Respiratory Tract   
     Mild/Moderate 
     or Severe  
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Skin/Skin Structure
     Mild/Moderate
     500 mg every 12 hours 
     or
     250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Genitourinary Tract    
     Mild/Moderate
     500 mg every 12 hours 
     or
     250 mg every 8 hours
     25 mg/kg/day in divided
     doses every 12 hours
     or
     20 mg/kg/day in divided
     doses every 8 hours
     Severe
     875 mg every 12 hours 
     or
     500 mg every 8 hours
     45 mg/kg/day in divided
     doses every 12 hours
     or
     40 mg/kg/day in divided
     doses every 8 hours
     Gonorrhea Acute,
     uncomplicated
     ano-genital and
     urethral infections
     in males and females
  
   
     3 grams as single oral 
     dose   
     Prepubertal children:
     50 mg/kg amoxicillin,    
     combined with 25 mg/kg   
     probenecid as a single   
     dose.
     NOTE: SINCE
     PROBENECID IS
     CONTRAINDICATED
     IN CHILDREN UNDER   
     2 YEARS, DO NOT USE   
     THIS REGIMEN IN
     THESE CASES.
  
  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS: Laboratory Tests.)
   
  Larger doses may be required for stubborn or severe infections. General
  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole
  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.) Dual Therapy Amoxicillin/lansoprazole
  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)
   
  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients. Dosing Recommendations for Adults with Impaired Renal Function
  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of  <30 mL/min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
   
  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
  
  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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• Virtus Pharmaceuticals, Llc
  

  ×

  Amoxicillin | Virtus Pharmaceuticals, Llc

  

  ---

  Amoxicillin capsules may be given without regard to meals.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
  † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity* Usual Adult Dose Usual Dose for Children >3 Months† Ear/Nose/
  Throat Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Lower Respiratory Tract Mild/ Moderate or Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Skin/Skin Structure Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Genitourinary Tract Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children:
  50 mg/kg Amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  NOTE: SINCE
  PROBENECID ISCONTRAINDICATED N CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS:Laboratory Tests section.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary.  Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pyloriEradication to Reduce the Risk of Duodenal Ulcer Recurrence

  Triple Therapy

  Amoxicillin/Clarithromycin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE section.)

  Dual Therapy

  Amoxicillin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE section.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS section, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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• Rebel Distributors Corp
  

  ×

  Amoxicillin | Rebel Distributors Corp

  

  ---

  Amoxicillin oral suspensions may be given without regard to meals. The 400 mg suspension has been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg formulation.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months:  Infection  Severitya  Usual Adult Dose  Usual Dose for Children > 3 Monthsb  Ear/Nose/Throat  Mild/Moderate  500 mg every 12 hours or 250 mg every 8 hours  

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses every 8 hours    Severe  875 mg every 12 hours or 500 mg every 8 hours  

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours  Lower Respiratory Tract  Mild/Moderate or Severe  875 mg every 12 hours or 500 mg every 8 hours  

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours  Skin/Skin Structure  Mild/Moderate  500 mg every 12 hours or 250 mg every 8 hours  

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or 500 mg every 8 hours  

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours  Genitourinary Tract  Mild/Moderate  500 mg every 12 hours or 250 mg every 8 hours  

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or 500 mg every 8 hours  

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours  

  Gonorrhea

  Acute, uncomplicated ano-genital and urethral infections in males and females    3 grams as single oral dose  

  Prepubertal children:

  50 mg/kg Amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  NOTE: SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  a  Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

  b  The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS: Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to reduce the risk of Duodenal Ulcer Recurrence Triple Therapy

  Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

  Dual Therapy

  Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for Mixing Oral Suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

   

  125 mg/5 mL

     

  Bottle Size

   Amount of Water
  

  Required for Reconstitution

   80 mL

  100 mL

   66 mL 

  83 mL

   

  150 mL

   

  125 mL

  Each teaspoonful (5 mL) will contain 125 mg amoxicillin.

   

  200 mg/5 mL

     

  Bottle Size

   

  Amount of Water

  Required for Reconstitution

    50 mL

    75 mL

  39 mL 

  59 mL

   

  100 mL

   

  78 mL

  Each teaspoonful (5 mL) will contain 200 mg amoxicillin.

   

  250 mg/5 mL

     

  Bottle Size

   

  Amount of Water

  Required for Reconstitution

    80 mL

  100 mL

   59 mL 

  73 mL

   

  150 mL

   

  110 mL

  Each teaspoonful (5 mL) will contain 250 mg amoxicillin.

   

  400 mg/5 mL

     

  Bottle Size

   

  Amount of Water

  Required for Reconstitution

    50 mL

    75 mL

  100 mL

  34 mL

  51 mL 

  65 mL

  Each teaspoonful (5 mL) will contain 400 mg amoxicillin.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

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• Unit Dose Services
  

  ×

  Amoxicillin | Unit Dose Services

  

  ---

  Amoxicillin capsules may be given without regard to meals. However, food effect studies have not been performed with the 500 mg formulation.

  Neonates and infants aged ≤ 12 weeks (≤ 3 months):

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and pediatric patients >3 months:

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

   † The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.   Infection   Severity*   Usual   Usual Dose       Adult Dose   for Children         >3 months†  Ear/nose/throat  Mild/Moderate  500 mg  25 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      250 mg  or      every 8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg  or      every 8 hours  40 mg/kg/day        in divided doses        every 8 hours  Lower respiratory  Mild/Moderate  875 mg  45 mg/kg/day  Tract  or Severe  every 12 hours  in divided doses      or  every 12 hours      500 mg every  or      8 hours  40 mg/kg/day        in divided doses        every 8 hours  Skin/Skin  Mild/Moderate  500 mg  25 mg/kg/day  Structure    every 12 hours  in divided doses      or  every 12 hours      250 mg every  or      8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg every  or      8 hours  40 mg/kg/day        in divided doses        every 8 hours  Genitourinary  Mild/Moderate  500 mg  25 mg/kg/day  Tract    every 12 hours  in divided doses      or  every 12 hours      250 mg every  or      8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg  or      every 8 hours  40 mg/kg/day        in divided doses        every 8 hours  Gonorrhea    3 grams  Prepubertal children:  Acute,    as 50 mg/kg amoxicillin combined with uncomplicated    single oral dose  25 mg/kg probenecid as a single dose. ano-genital and    

    NOTE: SINCE PROBENECID IS CONTRA-

  urethral infections in  males and females     INDICATED IN CHILDREN UNDER 2 YEARS. DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See ) . PRECAUTIONS - Laboratory Tests

  Larger doses may be required for stubborn or severe infections.

  General:

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  eradication to reduce the risk of duodenal ulcer recurrence: H. pylori Triple therapy:

  Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See ) . INDICATIONS AND USAGE

  Dual therapy:

  Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See ) . INDICATIONS AND USAGE

  Please refer to clarithromycin and lansoprazole full prescribing information for and , and for information regarding dosing in elderly and renally impaired patients. CONTRAINDICATIONSWARNINGS

  Dosing recommendations for adults with impaired renal function:

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875-mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
  

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by

  Streptococcus pyogenes

  to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.  

  
  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children
  > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
   Mild/Moderate
   500 mg every 12 hours or
   250 mg every 8 hours
   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
   Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Lower Respiratory
   Tract
   Mild/Moderate or Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Gonorrhea Acute,
   uncomplicated ano
   -genital and urethral
   infections in males
   and females
   
   3 grams as single oral dose
   Prepubertal children: 50 mg/kg amoxicillin capsules, combined with 25 mg/kg probenecid as a single dose.
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)
  

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by

  Streptococcus pyogenes

  to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin capsules is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection
  

  Triple Therapy:

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 

  
  

   

  
  

  Dual Therapy:

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 

  
  

   

  
  

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity* Usual Adult Dose Usual Dose for Children > 3 Months†

  Ear/Nose/Throat

  Skin/Skin Structure

  Genitourinary Tract Mild/Moderate

  500 mg every 12 hours or

  250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses

  every 8 hours Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Lower Respiratory

  Tract

  Mild/Moderate or

  Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses

  every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, uncomplicated ano-genital and urethral infections in males and females

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid iscontraindicated in childrenunder 2 years, do not use thisregimen in children under 2

  years of age. 2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (seeTable 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size

  Amount of Water

  Required for Reconstitution Oral Suspension 125 mg/5 mL 80 mL 62 mL 100 mL 77 mL 150 mL 113 mL Each teaspoonful (5 mL) will contain 200 mg amoxicillin (as the trihydrate). Oral Suspension 250 mg/5 mL 80 mL 47 mL 100 mL 60 mL 150 mL 90 mL Each teaspoonful (5 mL) will contain 400 mg amoxicillin (as the trihydrate).

   After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.  
  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children
  > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
   Mild/Moderate
   500 mg every 12 hours or
   250 mg every 8 hours
   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
   Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Lower Respiratory
   Tract
   Mild/Moderate or Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Gonorrhea Acute,
   uncomplicated ano
   -genital and urethral
   infections in males
   and females
   
   3 grams as single oral dose
   Prepubertal children: 50 mg/kg amoxicillin capsules, combined with 25 mg/kg probenecid as a single dose.
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)
  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin capsules is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function. 2.3 Dosing for H. pylori Infection
  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
   
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
   
  Please refer to clarithromycin and lansoprazole full prescribing information. 2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.  
  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children
  > 3 Monthsb  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
    Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
    Mild/Moderate
    500 mg every 12 hours or
   250 mg every 8 hours
    25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
    Severe
    875 mg every 12 hours or
   500 mg every 8 hours
    45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
    Lower Respiratory
   Tract
    Mild/Moderate or Severe
    875 mg every 12 hours or
   500 mg every 8 hours
    45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
    Gonorrhea Acute,
   uncomplicated ano
   -genital and urethral
   infections in males
   and females
    
    3 grams as single oral dose
    Prepubertal children: 50 mg/kg amoxicillin capsules, combined with 25 mg/kg probenecid as a single dose.
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)
  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin capsules is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function. 2.3 Dosing for H. pylori Infection
  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
   
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
   
  Please refer to clarithromycin and lansoprazole full prescribing information. 2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children > 3 Monthsb Ear/Nose/Throat
  Skin/Skin Structure
  Genitourinary Tract Mild/Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided doses
  every 12 hours
  or
  20 mg/kg/day in divided doses
  every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided doses
  every 12 hours
  or
  40 mg/kg/day in divided doses
  every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided doses
  every 12 hours
  or
  40 mg/kg/day in divided doses
  every 8 hours Gonorrhea
  Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children:
  50 mg/kg amoxicillin, combined with
  25 mg/kg probenecid as a single dose.
  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  
  

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  
  

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  
  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water
  Required for Reconstitution Oral Suspension 125 mg/5 mL 80 mL 62 mL 100 mL 78 mL 150 mL 116 mL Oral Suspension 200 mg/5 mL 50 mL 39 mL 75 mL 57 mL 100 mL 76 mL Oral Suspension 250 mg/5 mL 80 mL 59 mL 100 mL 74 mL 150 mL 111 mL Oral Suspension 400 mg/5 mL 50 mL 36 mL 75 mL 54 mL 100 mL 71 mL
  

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  
  

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  The 875-mg tablet has been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200-mg and 500-mg formulations.

  Neonates and Infants Aged ≤12 weeks (≤3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of Amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months:

   Infection  Severity  Usual Adult Dosage  Usual Dose for Children > 3 Months  Ear/Nose/ Throat  Mild/ Moderate  500 mg every 12 hours or 250 mg every 8 hours  25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or 500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours  Lower Respiratory Tract  Mild/ Moderate or Severe  875 mg every 12 hours or 500 mg every 8 hours  

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours  Skin/Skin Structure  Mild/ Moderate  500 mg every 12 hours or 250 mg every 8 hours  25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or 500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours  Genitourinary Tract  Mild/ Moderate  500 mg every 12 hours or 250 mg every 8 hours  25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or 500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours  Gonorrhea Acute, Uncomplicated Ano-genital and urethral infections in males and females    3 grams as single oral dose  

  Prepubertal children: 50 mg/kg Amoxicillin combined with 25 mg/kg probenecid as single dose.

  NOTE: SINCE PROBENICID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: Triple therapy: Amoxicillin/clarithromycin/ lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE).

  Dual therapy: Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on the severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on the severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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  Capsules, tablets, and oral suspensions of amoxicillin may be given without regard to meals. The 875-mg tablet has been studied only when administered at the start of a light meal. However, food effect studies have not been performed with 500-mg formulations.

  Neonates and Infants Aged ≤12 weeks (≤3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months:

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity* Usual Adult Dosage Usual Dose for
  Children > 3 Months† Ear/Nose/ Throat Mild/ Moderate 500 mg every
  12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every
  12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/ Moderate or Severe 875 mg every
  12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/ Moderate 500 mg every
  12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every
  12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/ Moderate 500 mg every
  12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every
  12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin combined with 25 mg/kg probenecid as single dose. NOTE: SINCE PROBENICID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: Triple therapy: Amoxicillin/clarithromycin/ lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q 12h) for 14 days. (See INDICATIONS AND USAGE).

  Dual therapy: Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q 8h) for 14 days. (See INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Storage

  Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

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  Capsules, tablets, and oral suspensions of amoxicillin may be given without regard to meals. The 875-mg tablet has been studied only when administered at the start of a light meal. However, food effect studies hove not been performed with the 500-mg formulation.

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q 12h (Neonates and Infants Aged ≤ 12 weeks (≤ 3 months):

  : Adults and Pediatric Patients > 3 Months

  Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections. ‡

  The children’s dosage is intended for individuals whose weight is less then 40 kg or more should be dosed according to adult recommendations. §

  After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See - ). PRECAUTIONSLaboratory Tests

  Larger doses may be required for stubborn or severe infections.

  : It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. General

  Eradication to Reduce the Risk of Duodenal Ulcer Recurrence H. pylori:

  Amoxicillin/clarithromycin/lansoprazole : Triple therapy

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q 12h) for 14 days. (See ). INDICATIONS AND USAGE

  Amoxicillin/lansoprazole Dual therapy:

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q 8h) for 14 days. (See ). INDICATIONS AND USAGE

  Please refer to clarithromycin and lansoprazole full prescribing information for and , and for information regarding dosing in elderly and renally impaired patients. CONTRAINDICATIONSWARNINGS

  : Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Dosing Recommendation for Adults with Impaired Renal Function

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive on additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for mixing oral suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately ½, of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously. Each teaspoonful (5 mL) will contain 125 mg or 250 mg amoxicillin.

  Product Bottle Size Amount of water required for reconstitution 125 mg/5 mL 80 mL 69 mL 100 mL

  86 mL

  150 mL 128 mL 250 mg/5 mL 80 mL 56 mL 100 mL 70 mL 150 mL 104 mL

  NOTE: SHAKE THE ORAL SUSPENSION WELL BEFORE USING.

  Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable but not required.

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  Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac tromethamine. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days. In adults, the use of oral ketorolac tromethamine is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine. See package insert for ketorolac tromethamine tablets for transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose oral ketorolac tromethamine.

  Note: Oral formulation should not be given as an initial dose.

  Use minimum effective dose for the individual patient.

  Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity Usual Adult Dose Usual Dose for Children > 3 Months

  Ear/Nose/Throat

  Skin/Skin Structure

  Genitourinary Tract Mild/Moderate

  500 mg every 12 hours or

  250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses

  every 8 hours Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Lower Respiratory

  Tract

  Mild/Moderate or

  Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses

  every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, Uncomplicated Ano-Genital and Urethral Infections

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (seeTable 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size

  Amount of Water

  Required for Reconstitution Oral Suspension 125 mg/5 mL 80 mL 62 mL 100 mL 77 mL 150 mL 113 mL Oral Suspension 250 mg/5 mL 80 mL 47 mL 100 mL 60 mL 150 mL 90 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  ---

  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity Usual Adult Dose Usual Dose for Children > 3 Months

  Ear/Nose/Throat

  Skin/Skin Structure

  Genitourinary Tract Mild/Moderate

  500 mg every 12 hours or

  250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses

  every 8 hours Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Lower Respiratory

  Tract

  Mild/Moderate or

  Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses

  every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, Uncomplicated Ano-Genital and Urethral Infections

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (seeTable 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size

  Amount of Water

  Required for Reconstitution Oral Suspension 125 mg/5 mL 80 mL 62 mL 100 mL 77 mL 150 mL 113 mL Oral Suspension 250 mg/5 mL 80 mL 47 mL 100 mL 60 mL 150 mL 90 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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• Cardinal Health
  

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity* Usual Adult Dose Usual Dose for Children > 3 Months†

  Ear/Nose/Throat

  Skin/Skin Structure

  Genitourinary Tract Mild/Moderate

  500 mg every 12 hours or

  250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses

  every 8 hours Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Lower Respiratory

  Tract

  Mild/Moderate or

  Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses

  every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, uncomplicated ano-genital and urethral infections in males and females

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid iscontraindicated in childrenunder 2 years, do not use thisregimen in children under 2

  years of age. 2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (seeTable 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size

  Amount of Water

  Required for Reconstitution Oral Suspension 125 mg/5 mL 80 mL 62 mL 100 mL 77 mL 150 mL 113 mL Each teaspoonful (5 mL) will contain 200 mg amoxicillin (as the trihydrate). Oral Suspension 250 mg/5 mL 80 mL 47 mL 100 mL 60 mL 150 mL 90 mL Each teaspoonful (5 mL) will contain 400 mg amoxicillin (as the trihydrate).

   After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  Amoxicillin capsules may be given without regard to meals.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
  † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity* Usual Adult Dose Usual Dose for Children >3 Months† Ear/Nose/
  Throat Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Lower Respiratory Tract Mild/ Moderate or Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Skin/Skin Structure Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Genitourinary Tract Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children:
  50 mg/kg Amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  NOTE: SINCE
  PROBENECID ISCONTRAINDICATED N CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS:Laboratory Tests section.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary.  Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pyloriEradication to Reduce the Risk of Duodenal Ulcer Recurrence

  Triple Therapy

  Amoxicillin/Clarithromycin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE section.)

  Dual Therapy

  Amoxicillin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE section.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS section, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children
  > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.  Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract Mild/Moderate  500 mg every 12 hours or
   250 mg every 8 hours  25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or
   500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours  Lower Respiratory Tract  Mild/Moderate
   or Severe  875 mg every 12 hours or
   500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours  Gonorrhea
   Acute, uncomplicated
   ano-genital and
   urethral infections in
   males and females  3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin tablets, combined with 25 mg/kg probenecid as a single dose.
  
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age. 2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin tablets is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
  
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
  
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  Capsules, tablets and oral suspensions of amoxicillin may be given without regard to meals. The 400 mg suspension and the 875 mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations.

  Neonates and Infants Aged ≤12 Weeks (≤3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  
  Adults and Pediatric Patients >3 Months Infection Severity* Usual Adult Dose Usual Dose for Children > 3 months† * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections. † The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Ear/Nose/
  Throat Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  NOTE: SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological followup for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

  Dual Therapy Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for Mixing Oral Suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  125 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 55 mL 100 mL 68 mL 150 mL 102 mL Each teaspoonful (5 mL) will contain 125 mg amoxicillin. 200 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL Each teaspoonful (5 mL) will contain 200 mg amoxicillin. 250 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 55 mL 100 mL 68 mL 150 mL 102 mL Each teaspoonful (5 mL) will contain 250 mg amoxicillin.
  400 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL Each teaspoonful (5 mL) will contain 400 mg amoxicillin.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.  

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children
  > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.  Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract  Mild/Moderate  500 mg every 12 hours or
   250 mg every 8 hours  25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or
   500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours  Lower Respiratory
   Tract  Mild/Moderate or Severe  875 mg every 12 hours or
   500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours  Gonorrhea Acute,
   uncomplicated ano
   -genital and urethral
   infections in males
   and females  3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin capsules, combined with 25 mg/kg probenecid as a single dose.
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age. 2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin capsules is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
  
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
  
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  Capsules, tablets, and oral suspensions of amoxicillin may be given without regard to meals. The 875-mg tablet has been studied only when administered at the start of a light meal. However, food effect studies hove not been performed with the 500-mg formulation.

  (Neonates and Infants Aged ≤ 12 weeks (≤ 3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q 12h

  Adults and Pediatric Patients > 3 Months:

  ‡ Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

  § The children’s dosage is intended for individuals whose weight is less then 40 kg or more should be dosed according to adult recommendations.

  After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS- Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence:

  Triple therapy: Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q 12h) for 14 days. (See INDICATIONS AND USAGE).

  Dual therapy: Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q 8h) for 14 days. (See INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendation for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive on additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for mixing oral suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately ½, of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously. Each teaspoonful (5 mL) will contain 125 mg or 250 mg amoxicillin.

  Product Bottle Size Amount of water required for reconstitution 125 mg/5 mL 80 mL 69 mL 100 mL

  86 mL

  150 mL 128 mL 250 mg/5 mL 80 mL 56 mL 100 mL 70 mL 150 mL 104 mL

  NOTE: SHAKE THE ORAL SUSPENSION WELL BEFORE USING.

  Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable but not required.

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  Capsules, tablets and oral suspensions of amoxicillin may be given without regard to meals. The 400 mg suspension and the 875 mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations.

  Neonates and Infants Aged ≤12 Weeks (≤3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  
  Adults and Pediatric Patients >3 Months Infection Severity* Usual Adult Dose Usual Dose for Children > 3 months† * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections. † The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Ear/Nose/
  Throat Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  NOTE: SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological followup for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

  Dual Therapy Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for Mixing Oral Suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  125 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 55 mL 100 mL 68 mL 150 mL 102 mL Each teaspoonful (5 mL) will contain 125 mg amoxicillin. 200 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL Each teaspoonful (5 mL) will contain 200 mg amoxicillin. 250 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 80 mL 55 mL 100 mL 68 mL 150 mL 102 mL Each teaspoonful (5 mL) will contain 250 mg amoxicillin.
  400 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL Each teaspoonful (5 mL) will contain 400 mg amoxicillin.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity* Usual Adult Dose Usual Dose for Children > 3 Months†

  Ear/Nose/Throat

  Skin/Skin Structure

  Genitourinary Tract Mild/Moderate

  500 mg every 12 hours or

  250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses

  every 8 hours Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Lower Respiratory

  Tract

  Mild/Moderate or

  Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses

  every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, Uncomplicated Ano-Genital and Urethral Infections

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (seeTable 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size

  Amount of Water

  Required for Reconstitution Oral Suspension 125 mg/5 mL 80 mL 62 mL 100 mL 77 mL 150 mL 113 mL Oral Suspension 250 mg/5 mL 80 mL 47 mL 100 mL 60 mL 150 mL 90 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  ---

  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity a Usual Adult Dose Usual Dose for Children > 3 Monthsb  Ear/Nose/Throat
  Skin/ Skin Structure
  Genitourinary Tract Mild/
  Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours
  Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
  Lower Respiratory Tract
  Mild/
  Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
  Gonorrhea
  Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children:
  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  Note: since probenecid is contraindicated in children under 2 years. Do not use this regimen in children under 2 years of age.  

  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least

  10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this

  age group, the recommended upper dose of amoxicillin 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

        Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.
  Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose.
  Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.
  Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water
  Required for Reconstitution Oral Suspension 125 mg /5 mL 80 mL 66 mL 100 mL 83 mL 150 mL 125 mL Oral Suspension 200 mg /5 mL 50 mL 39 mL 75 mL 59 mL 100 mL 78 mL Oral Suspension 250 mg /5 mL 80 mL 59 mL 100 mL 73 ml 150 mL 110 mL Oral Suspension 400 mg /5 mL 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  Amoxicillin capsules may be given without regard to meals.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
  † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity* Usual Adult Dose Usual Dose for Children >3 Months† Ear/Nose/
  Throat Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Lower Respiratory Tract Mild/ Moderate or Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Skin/Skin Structure Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Genitourinary Tract Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children:
  50 mg/kg Amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  NOTE: SINCE
  PROBENECID ISCONTRAINDICATED N CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS:Laboratory Tests section.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary.  Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pyloriEradication to Reduce the Risk of Duodenal Ulcer Recurrence

  Triple Therapy

  Amoxicillin/Clarithromycin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE section.)

  Dual Therapy

  Amoxicillin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE section.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS section, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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  Amoxicillin capsules may be given without regard to meals.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
  † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity* Usual Adult Dose Usual Dose for Children >3 Months† Ear/Nose/
  Throat Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Lower Respiratory Tract Mild/ Moderate or Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Skin/Skin Structure Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Genitourinary Tract Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children:
  50 mg/kg Amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  NOTE: SINCE
  PROBENECID ISCONTRAINDICATED N CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS:Laboratory Tests section.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary.  Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pyloriEradication to Reduce the Risk of Duodenal Ulcer Recurrence

  Triple Therapy

  Amoxicillin/Clarithromycin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE section.)

  Dual Therapy

  Amoxicillin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE section.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS section, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity a Usual Adult Dose Usual Dose for Children > 3 Monthsb  Ear/Nose/Throat
  Skin/ Skin Structure
  Genitourinary Tract Mild/
  Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours
  Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
  Lower Respiratory Tract
  Mild/
  Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
  Gonorrhea
  Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children:
  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  Note: since probenecid is contraindicated in children under 2 years. Do not use this regimen in children under 2 years of age.  

  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least

  10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this

  age group, the recommended upper dose of amoxicillin 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

        Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.
  Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose.
  Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.
  Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water
  Required for Reconstitution Oral Suspension 125 mg /5 mL 80 mL 66 mL 100 mL 83 mL 150 mL 125 mL Oral Suspension 200 mg /5 mL 50 mL 39 mL 75 mL 59 mL 100 mL 78 mL Oral Suspension 250 mg /5 mL 80 mL 59 mL 100 mL 73 ml 150 mL 110 mL Oral Suspension 400 mg /5 mL 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  
  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.  
  

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children
  > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
   Mild/Moderate
   500 mg every 12 hours or
   250 mg every 8 hours
   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
   Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Lower Respiratory
   Tract
   Mild/Moderate or Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Gonorrhea Acute,
   uncomplicated ano
   -genital and urethral
   infections in males
   and females
   
   3 grams as single oral dose
   Prepubertal children: 50 mg/kg amoxicillin capsules, combined with 25 mg/kg probenecid as a single dose.
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  
  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin capsules is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  
  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
   
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
   
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity* Usual Adult Dose Usual Dose for Children > 3 Months†

  Ear/Nose/Throat

  Skin/Skin Structure

  Genitourinary Tract Mild/Moderate

  500 mg every 12 hours or

  250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses

  every 8 hours Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Lower Respiratory

  Tract

  Mild/Moderate or

  Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses

  every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, Uncomplicated Ano-Genital and Urethral Infections

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (seeTable 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size

  Amount of Water

  Required for Reconstitution Oral Suspension 125 mg/5 mL 80 mL 62 mL 100 mL 77 mL 150 mL 113 mL Oral Suspension 250 mg/5 mL 80 mL 47 mL 100 mL 60 mL 150 mL 90 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  Amoxicillin capsules may be given without regard to meals.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
  † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity* Usual Adult Dose Usual Dose for Children >3 Months† Ear/Nose/
  Throat Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Lower Respiratory Tract Mild/ Moderate or Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Skin/Skin Structure Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Genitourinary Tract Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children:
  50 mg/kg Amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  NOTE: SINCE
  PROBENECID ISCONTRAINDICATED N CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS:Laboratory Tests section.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary.  Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pyloriEradication to Reduce the Risk of Duodenal Ulcer Recurrence

  Triple Therapy

  Amoxicillin/Clarithromycin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE section.)

  Dual Therapy

  Amoxicillin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE section.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS section, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity* Usual Adult Dose Usual Dose for Children > 3 Months†

  Ear/Nose/Throat

  Skin/Skin Structure

  Genitourinary Tract Mild/Moderate

  500 mg every 12 hours or

  250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses

  every 8 hours Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Lower Respiratory

  Tract

  Mild/Moderate or

  Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses

  every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, Uncomplicated Ano-Genital and Urethral Infections

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (seeTable 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size

  Amount of Water

  Required for Reconstitution Oral Suspension 125 mg/5 mL 80 mL 62 mL 100 mL 77 mL 150 mL 113 mL Oral Suspension 250 mg/5 mL 80 mL 47 mL 100 mL 60 mL 150 mL 90 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  
  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.
  

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children
  > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
  Mild/Moderate
   500 mg every 12 hours or
   250 mg every 8 hours
   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
   Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Lower Respiratory Tract
   Mild/Moderate
   or Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Gonorrhea
   Acute, uncomplicated
   ano-genital and
   urethral infections in
   males and females
   
   3 grams as single oral dose
   Prepubertal children: 50 mg/kg amoxicillin tablets, combined with 25 mg/kg probenecid as a single dose.
   
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  
  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin tablets is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  
  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
   
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
   
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity* Usual Adult Dose Usual Dose for Children > 3 Months†

  Ear/Nose/Throat

  Skin/Skin Structure

  Genitourinary Tract Mild/Moderate

  500 mg every 12 hours or

  250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses

  every 8 hours Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Lower Respiratory

  Tract

  Mild/Moderate or

  Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses

  every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, Uncomplicated Ano-Genital and Urethral Infections

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg Amoxicillin for Oral Suspension, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid iscontraindicated in childrenunder 2 years, do not use thisregimen in children under 2

  years of age. 2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of Amoxicillin for Oral Suspension is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram Amoxicillin for Oral Suspension, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual Therapy: The recommended adult oral dose is 1 gram Amoxicillin for Oral Suspension and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size

  Amount of Water

  Required for Reconstitution Oral Suspension 200 mg/5 mL 50 mL 39 mL 75 mL 57 mL 100 mL 75 mL Each teaspoonful (5 mL) will contain 200 mg amoxicillin. Oral Suspension 400 mg/5 mL 50 mL 35 mL 75 mL 51 mL 100 mL 67 mL Each teaspoonful (5 mL) will contain 400 mg amoxicillin.

   After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
  

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  
  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children
  > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
  Mild/Moderate
   500 mg every 12 hours or
   250 mg every 8 hours
   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
   Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Lower Respiratory Tract
   Mild/Moderate
   or Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Gonorrhea
   Acute, uncomplicated
   ano-genital and
   urethral infections in
   males and females
   
   3 grams as single oral dose
   Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
   
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  
  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin tablets is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  
  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
   
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
   
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  The 875-mg tablet has been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200-mg and 500-mg formulations.

  Neonates and Infants Aged ≤12 weeks (≤3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of Amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months:

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.  Infection  Severity*  Usual Adult Dosage  Usual Dose for Children > 3 Months†  Ear/Nose/ Throat  Mild/ Moderate  500 mg every 12 hours or 250 mg every 8 hours  25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or 500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours  Lower Respiratory Tract  Mild/ Moderate or Severe  875 mg every 12 hours or 500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours  Skin/Skin Structure  Mild/ Moderate  500 mg every 12 hours or 250 mg every 8 hours  25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or 500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours  Genitourinary Tract  Mild/ Moderate  500 mg every 12 hours or 250 mg every 8 hours  25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or 500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours  Gonorrhea Acute, Uncomplicated Ano-genital and urethral infections in males and females  3 grams as single oral dose

  Prepubertal children: 50 mg/kg Amoxicillin combined with 25 mg/kg probenecid as single dose.

  NOTE: SINCE PROBENICID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: Triple therapy: Amoxicillin/clarithromycin/ lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE).

  Dual therapy: Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on the severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on the severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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  Amoxicillin capsules may be given without regard to meals.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
  † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity* Usual Adult Dose Usual Dose for Children >3 Months† Ear/Nose/
  Throat Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Lower Respiratory Tract Mild/ Moderate or Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Skin/Skin Structure Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Genitourinary Tract Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children:
  50 mg/kg Amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  NOTE: SINCE
  PROBENECID ISCONTRAINDICATED N CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS:Laboratory Tests section.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary.  Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pyloriEradication to Reduce the Risk of Duodenal Ulcer Recurrence

  Triple Therapy

  Amoxicillin/Clarithromycin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE section.)

  Dual Therapy

  Amoxicillin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE section.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS section, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenesto prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity* Usual Adult Dose Usual Dose for Children
  > 3 Months† * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.   Ear/Nose/Throat   Skin/Skin Structure   Genitourinary Tract

  Mild/Moderate

    500 mg every 12 hours or   250 mg every 8 hours   25 mg/kg/day in divided doses   every 12 hours   or   20 mg/kg/day in divided doses   every 8 hours

  Severe

    875 mg every 12 hours or   500 mg every 8 hours   45 mg/kg/day in divided doses   every 12 hours   or   40 mg/kg/day in divided doses   every 8 hours   Lower Respiratory   Tract   Mild/Moderate or   Severe   875 mg every 12 hours or   500 mg every 8 hours   45 mg/kg/day in divided doses   every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, uncomplicated

  ano-genital and urethral infections in males and females

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenesto prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  The 875-mg tablet has been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200-mg and 500-mg formulations.

  Neonates and Infants Aged ≤12 weeks (≤3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of Amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months:

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.  Infection  Severity*  Usual Adult Dosage  Usual Dose for Children > 3 Months†  Ear/Nose/ Throat  Mild/ Moderate  500 mg every 12 hours or 250 mg every 8 hours  25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or 500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours  Lower Respiratory Tract  Mild/ Moderate or Severe  875 mg every 12 hours or 500 mg every 8 hours  

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours  Skin/Skin Structure  Mild/ Moderate  500 mg every 12 hours or 250 mg every 8 hours  25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or 500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours  Genitourinary Tract  Mild/ Moderate  500 mg every 12 hours or 250 mg every 8 hours  25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours  Severe  875 mg every 12 hours or 500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours  Gonorrhea Acute, Uncomplicated Ano-genital and urethral infections in males and females    3 grams as single oral dose  

  Prepubertal children: 50 mg/kg Amoxicillin combined with 25 mg/kg probenecid as single dose.

  NOTE: SINCE PROBENICID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: Triple therapy: Amoxicillin/clarithromycin/ lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE).

  Dual therapy: Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on the severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on the severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  Infection

  Severity*

  Usual Adult Dose

  Usual Dose for Children > 3 Months†

  Ear/Nose/Throat

  Skin/Skin Structure

  Genitourinary Tract

  Mild/Moderate

  500 mg every 12 hours or

  250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses every 8 hours

  Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours

  Lower Respiratory

  Tract

  Mild/Moderate or

  Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours

  Gonorrhea,

  Acute, Uncomplicated

  (Ano-Genital and Urethral Infections)

  3 grams as single oral dose

  Prepubertal Children:

  50 mg/kg Amoxicillin Tablets, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2

  years of age.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875 mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
  

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by

  Streptococcus pyogenes

  to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  
  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
  Mild/Moderate
  500 mg every 12 hours
  or
  250 mg every 8 hours
   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
  Severe
  875 mg every 12 hours
  or
  500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Lower Respiratory Tract
  Mild/Moderate or Severe
  875 mg every 12 hours
  or
  500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Gonorrhea
   Acute, uncomplicated ano-genital and urethral infections in males and females
  3 grams as single oral dose
   Prepubertal children: 50 mg/kg amoxicillin for oral suspension, combined with 25 mg/kg probenecid as a single dose.
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  2.2 Dosing in Neonates and Infants Aged12 Weeks ( 3 Months)
  

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by

  Streptococcus pyogenes

  to prevent the occurrence of acute rheumatic fever.  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin for oral suspension is

   

  30 mg/kg/day divided every 12 hours.  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection
  

  Triple Therapy:

  The recommended adult oral dose is 1 gram amoxicillin for oral suspension, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  
  

   

  
  

  Dual Therapy:

  The recommended adult oral dose is 1 gram amoxicillin for oral suspension and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

   

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension
  

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  
  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water
  Required for
  Reconstitution Oral Suspension 200 mg/5 mL
  50 mL
  35 mL
  75 mL
  52 mL
  100 mL
  69 mL
  Oral Suspension 400 mg/5 mL
  50 mL
  35 mL
  75 mL
  52 mL
  100 mL
  69 mL
  

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  
  

  
  NOTE:

  SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children
  > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
  

   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
  

  Mild/Moderate
  

   500 mg every 12 hours or
   250 mg every 8 hours
  

   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
  

   Severe
  

   875 mg every 12 hours or
   500 mg every 8 hours
  

   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
  

   Lower Respiratory Tract
  

   Mild/Moderate
   or Severe
  

   875 mg every 12 hours or
   500 mg every 8 hours
  

   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
  

   Gonorrhea
   Acute, uncomplicated
   ano-genital and
   urethral infections in
   males and females
  

   
  

   3 grams as single oral dose
  

   Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
   
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  
  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin tablets is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  
  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
   
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
   
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  Infection

  Severity*

  Usual Adult Dose

  Usual Dose for Children > 3 Months†

  Ear/Nose/Throat

  Skin/Skin Structure

  Genitourinary Tract

  Mild/Moderate

  500 mg every 12 hours or

  250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses

  every 8 hours

  Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Lower Respiratory

  Tract

  Mild/Moderate or

  Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses

  every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, Uncomplicated Ano-Genital and Urethral Infections

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (seeTable 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension

  Strength

  Bottle Size

  Amount of Water

  Required for Reconstitution

  Oral Suspension 125 mg/5 mL

  80 mL

  62 mL

  100 mL

  77 mL

  150 mL

  113 mL

  Oral Suspension 250 mg/5 mL

  80 mL

  47 mL

  100 mL

  60 mL

  150 mL

  90 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  Infection

  Severity*

  Usual Adult Dose

  Usual Dose for Children > 3 Months†

  Ear/Nose/Throat

  Skin/Skin Structure

  Genitourinary Tract

  Mild/Moderate

  500 mg every 12 hours or

  250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses

  every 8 hours

  Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Lower Respiratory

  Tract

  Mild/Moderate or

  Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses

  every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, Uncomplicated Ano-Genital and Urethral Infections

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (seeTable 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension

  Strength

  Bottle Size

  Amount of Water

  Required for Reconstitution

  Oral Suspension 125 mg/5 mL

  80 mL

  62 mL

  100 mL

  77 mL

  150 mL

  113 mL

  Oral Suspension 250 mg/5 mL

  80 mL

  47 mL

  100 mL

  60 mL

  150 mL

  90 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  
  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.  

  
  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children
  > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
   Mild/Moderate
   500 mg every 12 hours or
   250 mg every 8 hours
   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
   Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Lower Respiratory
   Tract
   Mild/Moderate or Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Gonorrhea Acute,
   uncomplicated ano
   -genital and urethral
   infections in males
   and females
  
   3 grams as single oral dose
  Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  2.2 Dosing in Neonates and Infants Aged ≤12 Weeks ( ≤3 Months)

  
  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin capsules is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  
  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
  
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
  
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  Capsules, tablets, and oral suspensions of amoxicillin may be given without regard to meals. The 875-mg tablet has been studied only when administered at the start of a light meal. However, food effect studies hove not been performed with the 500-mg formulation.

  (Neonates and Infants Aged ≤ 12 weeks (≤ 3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q 12h

  Adults and Pediatric Patients > 3 Months:

  ‡ Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

  § The children’s dosage is intended for individuals whose weight is less then 40 kg or more should be dosed according to adult recommendations.

  After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS- Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence:

  Triple therapy: Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q 12h) for 14 days. (See INDICATIONS AND USAGE).

  Dual therapy: Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q 8h) for 14 days. (See INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendation for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive on additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for mixing oral suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately ½, of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously. Each teaspoonful (5 mL) will contain 125 mg or 250 mg amoxicillin.

   Product  Bottle Size  Amount of water required for reconstitution   125 mg/5 mL  80 mL  69 mL    100 mL  

  86 mL

     150 mL  128 mL  250 mg/5 mL  80 mL  56 mL    100 mL   70 mL    150 mL   104 mL

  NOTE: SHAKE THE ORAL SUSPENSION WELL BEFORE USING.

  Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  Infection

  Severity*

  Usual Adult Dose

  Usual Dose for Children > 3 Months†

  Ear/Nose/Throat

  Skin/Skin Structure

  Genitourinary Tract

  Mild/Moderate

  500 mg every 12 hours or

  250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses

  every 8 hours

  Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Lower Respiratory

  Tract

  Mild/Moderate or

  Severe

  875 mg every 12 hours or

  500 mg every 8 hours

  45 mg/kg/day in divided doses

  every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, Uncomplicated Ano-Genital and Urethral Infections

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg Amoxicillin For Oral Suspension, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2

  years of age.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of Amoxicillin for Oral Suspension is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram Amoxicillin for Oral Suspension, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual Therapy: The recommended adult oral dose is 1 gram Amoxicillin for Oral Suspension and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875 mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension

  Strength

  Bottle Size

  Amount of Water

  Required for Reconstitution

  Oral Suspension 200 mg/5 mL

  50 mL

  39 mL

  75 mL

  57 mL

  100 mL

  75 mL

  Each teaspoonful (5 mL) will contain 200 mg amoxicillin.

  Oral Suspension 400 mg/5 mL

  50 mL

  35 mL

  75 mL

  51 mL

  100 mL

  67 mL

  Each teaspoonful (5 mL) will contain 400 mg amoxicillin.

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  Amoxicillin capsules, chewable tablets, and oral suspensions may be given without regard to meals. The 400 mg suspension, 400 mg chewable tablet and the 875 mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations.

  Amoxicillin tablets, chewable should be chewed before swallowing

  Neonates and Infants aged ≤ 12 weeks (≤ 3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 months

  Infection Severity‡ Usual Adult Dose Usual Dose for Children >3 months§ π Ear/Nose/Throat Mild/Moderate 500 mg every12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours   Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/Moderate 500 mg every12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours   Severe 875 mg every12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/Moderate 500 mg every12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours   Severe 875 mg every12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females   3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.NOTE: SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  ‡ Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

  § The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  π Each strength of the suspension of amoxicillin is available as a chewable tablet for use by older children.

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

  General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: Triple Therapy: Amoxicillin/clarithromycin/ lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

  Dual Therapy:Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of less than 30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for Mixing Oral Suspension: Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  200 mg/5 mL

  Bottle Size Amount of Water Required for Reconstitution     50 mL 33 mL 75 mL 49 mL 100 mL 66 mL

  Each teaspoonful (5 mL) will contain 200 mg amoxicillin

  400 mg/5 mL

  Bottle Size Amount of Water Required for Reconstitution 50 mL 33 mL 75 mL 49 mL 100 mL 66 mL

  Each teaspoonful (5 mL) will contain 400 mg amoxicillin.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children > 3 Monthsb

  Ear/Nose/Throat
  Skin/Skin Structure
  Genitourinary Tract

  Mild/Moderate

  500 mg every 12 hours or
  250 mg every 8 hours

  25 mg/kg/day in divided doses
  every 12 hours
  or
  20 mg/kg/day in divided doses
  every 8 hours

  Severe

  875 mg every 12 hours or
  500 mg every 8 hours

  45 mg/kg/day in divided doses
  every 12 hours
  or
  40 mg/kg/day in divided doses
  every 8 hours

  Lower Respiratory Tract

  Mild/Moderate or Severe

  875 mg every 12 hours or
  500 mg every 8 hours

  45 mg/kg/day in divided doses
  every 12 hours
  or
  40 mg/kg/day in divided doses
  every 8 hours

  Gonorrhea
  Acute, uncomplicated ano-genital and urethral infections in males and females

  3 grams as single oral dose

  Prepubertal children:
  50 mg/kg amoxicillin, combined with
  25 mg/kg probenecid as a single dose.
  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water
  Required for Reconstitution

  Oral Suspension 125 mg/5 mL

  80 mL

  62 mL

  100 mL

  78 mL

  150 mL

  116 mL

  Oral Suspension 200 mg/5 mL

  50 mL

  39 mL

  75 mL

  57 mL

  100 mL

  76 mL

  Oral Suspension 250 mg/5 mL

  80 mL

  59 mL

  100 mL

  74 mL

  150 mL

  111 mL

  Oral Suspension 400 mg/5 mL

  50 mL

  36 mL

  75 mL

  54 mL

  100 mL

  71 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  Use the lowest effective dose for the patient.

  2.1 Dosage in Adults

  The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In some patients, the higher morning blood levels of LUNESTA following use of the 2 mg or 3 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of LUNESTA should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.2 Geriatric or Debilitated Patients

  The total dose of LUNESTA should not exceed 2 mg in elderly or debilitated patients.

  2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors

  In patients with severe hepatic impairment, or in patients coadministered LUNESTA with potent CYP3A4 inhibitors, the total dose of LUNESTA should not exceed 2 mg [see Warning and Precautions (5.7)].

  2.4 Use with CNS Depressants

  Dosage adjustments may be necessary when LUNESTA is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.5 Administration with Food

  Taking LUNESTA with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of LUNESTA on sleep latency [see Clinical Pharmacology (12.3)].

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
  

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  
  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children
  > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
  Mild/Moderate
   500 mg every 12 hours or
   250 mg every 8 hours
   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
   Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Lower Respiratory Tract
   Mild/Moderate
   or Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Gonorrhea
   Acute, uncomplicated
   ano-genital and
   urethral infections in
   males and females
   
   3 grams as single oral dose
   Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
   
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)
  

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin tablets is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection
  

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
  
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
  
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
  

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.  

  
  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children
  > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
   Mild/Moderate
   500 mg every 12 hours or
   250 mg every 8 hours
   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
   Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Lower Respiratory
   Tract
   Mild/Moderate or Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Gonorrhea Acute,
   uncomplicated ano
   -genital and urethral
   infections in males
   and females
   
   3 grams as single oral dose
   Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  2.2 Dosing in Neonates and Infants Aged 12 Weeks ( 3 Months)
  

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin capsules is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection
  

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
  
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
  
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
  

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  
  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
  Mild/Moderate
  500 mg every 12 hours
  or
  250 mg every 8 hours
   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
  Severe
  875 mg every 12 hours
  or
  500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Lower Respiratory Tract
  Mild/Moderate or Severe
  875 mg every 12 hours
  or
  500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Gonorrhea
   Acute, uncomplicated ano-genital and urethral infections in males and females
  3 grams as single oral dose
   Prepubertal children: 50 mg/kg amoxicillin for oral suspension, combined with 25 mg/kg probenecid as a single dose.
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks ( ≤ 3 Months)
  

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin for oral suspension is

  30 mg/kg/day divided every 12 hours.  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection
  

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin for oral suspension, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.
  
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin for oral suspension and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.
  
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension
  

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  
  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water
  Required for
  Reconstitution Oral Suspension 200 mg/5 mL
  50 mL
  35 mL
  75 mL
  52 mL
  100 mL
  69 mL
  Oral Suspension 400 mg/5 mL
  50 mL
  35 mL
  75 mL
  52 mL
  100 mL
  69 mL
  

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.
  
  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.  

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
  Infection
  Severitya
  Usual Adult Dose
  Usual Dose for Children
  > 3 Monthsb
   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
   Mild/Moderate
   500 mg every 12 hours or
   250 mg every 8 hours
   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
   Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Lower Respiratory Tract
   Mild/Moderate or Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin capsules is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.
  
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.
  
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
  

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.  

  
  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children
  > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
   Mild/Moderate
   500 mg every 12 hours or
   250 mg every 8 hours
   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
   Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Lower Respiratory
   Tract
   Mild/Moderate or Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Gonorrhea Acute,
   uncomplicated ano
   -genital and urethral
   infections in males
   and females
   
   3 grams as single oral dose
   Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks ( ≤ 3 Months)
  

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin capsules is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection
  

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
  
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.  
  
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment
  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children > 3 Monthsb

  Ear/Nose/Throat
  Skin/Skin Structure
  Genitourinary Tract

  Mild/Moderate

  500 mg every 12 hours or
  250 mg every 8 hours

  25 mg/kg/day in divided doses
  every 12 hours
  or
  20 mg/kg/day in divided doses
  every 8 hours

  Severe

  875 mg every 12 hours or
  500 mg every 8 hours

  45 mg/kg/day in divided doses
  every 12 hours
  or
  40 mg/kg/day in divided doses
  every 8 hours

  Lower Respiratory Tract

  Mild/Moderate or Severe

  875 mg every 12 hours or
  500 mg every 8 hours

  45 mg/kg/day in divided doses
  every 12 hours
  or
  40 mg/kg/day in divided doses
  every 8 hours

  Gonorrhea
  Acute, uncomplicated ano-genital and urethral infections in males and females

  3 grams as single oral dose

  Prepubertal children:
  50 mg/kg amoxicillin, combined with
  25 mg/kg probenecid as a single dose.
  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water
  Required for Reconstitution

  Oral Suspension 125 mg/5 mL

  80 mL

  62 mL

  100 mL

  78 mL

  150 mL

  116 mL

  Oral Suspension 200 mg/5 mL

  50 mL

  39 mL

  75 mL

  57 mL

  100 mL

  76 mL

  Oral Suspension 250 mg/5 mL

  80 mL

  59 mL

  100 mL

  74 mL

  150 mL

  111 mL

  Oral Suspension 400 mg/5 mL

  50 mL

  36 mL

  75 mL

  54 mL

  100 mL

  71 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  Amoxicillin capsules may be given without regard to meals. However, food effect studies have not been performed with the 500 mg formulation.

  Neonates and infants aged ≤ 12 weeks (≤ 3 months):

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and pediatric patients >3 months:

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

   † The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.  Infection  Severity*  Usual  Usual Dose      Adult Dose  for Children        >3 months†  Ear/nose/throat  Mild/Moderate  500 mg  25 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      250 mg  or      every 8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg  or      every 8 hours  40 mg/kg/day        in divided doses        every 8 hours  Lower respiratory  Mild/Moderate  875 mg  45 mg/kg/day  Tract  or Severe  every 12 hours  in divided doses      or  every 12 hours      500 mg every  or      8 hours  40 mg/kg/day        in divided doses        every 8 hours  Skin/Skin  Mild/Moderate  500 mg  25 mg/kg/day  Structure    every 12 hours  in divided doses      or  every 12 hours      250 mg every  or      8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg every  or      8 hours  40 mg/kg/day        in divided doses        every 8 hours  Genitourinary  Mild/Moderate  500 mg  25 mg/kg/day  Tract    every 12 hours  in divided doses      or  every 12 hours      250 mg every  or      8 hours  20 mg/kg/day        in divided doses        every 8 hours    Severe  875 mg  45 mg/kg/day      every 12 hours  in divided doses      or  every 12 hours      500 mg  or      every 8 hours  40 mg/kg/day        in divided doses        every 8 hours  Gonorrhea    3 grams  Prepubertal children:  Acute,    as 50 mg/kg amoxicillin combined with uncomplicated    single oral dose  25 mg/kg probenecid as a single dose. ano-genital and    

   NOTE: SINCE PROBENECID IS CONTRA-

  urethral infections in  males and females     INDICATED IN CHILDREN UNDER 2 YEARS. DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS - Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

  General:

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori eradication to reduce the risk of duodenal ulcer recurrence: Triple therapy:

  Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

  Dual therapy:

  Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing recommendations for adults with impaired renal function:

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875-mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
  

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  
  
  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children
  > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
  Mild/Moderate
   500 mg every 12 hours or
   250 mg every 8 hours
   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
   Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Lower Respiratory Tract
   Mild/Moderate
   or Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Gonorrhea
   Acute, uncomplicated
   ano-genital and
   urethral infections in
   males and females
   
   3 grams as single oral dose
   Prepubertal children: 50 mg/kg amoxicillin tablets, combined with 25 mg/kg probenecid as a single dose.
   
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)
  

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin tablets is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection
  

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
  
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.  
  
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment
  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
  

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  
  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
  Mild/Moderate
  500 mg every 12 hours
  or
  250 mg every 8 hours
   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
  Severe
  875 mg every 12 hours
  or
  500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Lower Respiratory Tract
  Mild/Moderate or Severe
  875 mg every 12 hours
  or
  500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Gonorrhea
   Acute, uncomplicated ano-genital and urethral infections in males and females
   
  3 grams as single oral dose
   Prepubertal children: 50 mg/kg amoxicillin for oral suspension, combined with 25 mg/kg probenecid as a single dose.
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  2.2 Dosing in Neonates and Infants Aged 12 Weeks (3 Months)
  

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin for oral suspension is

  30 mg/kg/day divided every 12 hours.  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection
  

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin for oral suspension, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.
  
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin for oral suspension and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
  
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment
  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension
  

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  
  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water
  Required for
  Reconstitution Oral Suspension 200 mg/5 mL
  50 mL
  35 mL
  75 mL
  52 mL
  100 mL
  69 mL
  Oral Suspension 400 mg/5 mL
  50 mL
  35 mL
  75 mL
  52 mL
  100 mL
  69 mL
  

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.
  
  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
  

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
  

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  
  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children
  > 3 Monthsb  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
    Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
   Mild/Moderate
    500 mg every 12 hours or
   250 mg every 8 hours
    25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
    Severe
    875 mg every 12 hours or
   500 mg every 8 hours
    45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
    Lower Respiratory Tract
    Mild/Moderate
   or Severe
    875 mg every 12 hours or
   500 mg every 8 hours
    45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
    Gonorrhea
   Acute, uncomplicated
   ano-genital and
   urethral infections in
   males and females
    
    3 grams as single oral dose
    Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
   
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  
  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin tablets is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  
  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
   
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
   
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  Amoxicillin oral suspensions may be given without regard to meals. The 400 mg suspension has been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg formulation.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months:   Infection   Severitya   Usual Adult Dose   Usual Dose for Children > 3 Monthsb   Ear/Nose/Throat   Mild/Moderate   500 mg every 12 hours or 250 mg every 8 hours   

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses every 8 hours      Severe   875 mg every 12 hours or 500 mg every 8 hours   

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours   Lower Respiratory Tract   Mild/Moderate or Severe   875 mg every 12 hours or 500 mg every 8 hours   

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours   Skin/Skin Structure   Mild/Moderate   500 mg every 12 hours or 250 mg every 8 hours   

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses every 8 hours   Severe   875 mg every 12 hours or 500 mg every 8 hours   

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours   Genitourinary Tract   Mild/Moderate   500 mg every 12 hours or 250 mg every 8 hours   

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses every 8 hours   Severe   875 mg every 12 hours or 500 mg every 8 hours   

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours   

  Gonorrhea

  Acute, uncomplicated ano-genital and urethral infections in males and females      3 grams as single oral dose   

  Prepubertal children:

  50 mg/kg Amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  NOTE: SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  a  Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

  b  The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS: Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to reduce the risk of Duodenal Ulcer Recurrence Triple Therapy

  Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

  Dual Therapy

  Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for Mixing Oral Suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

    

  125 mg/5 mL

       

  Bottle Size

    Amount of Water
  

  Required for Reconstitution

   

   80 mL

  100 mL

    66 mL 

  83 mL

    

  150 mL

    

  125 mL

  Each teaspoonful (5 mL) will contain 125 mg amoxicillin.

    

  200 mg/5 mL

       

  Bottle Size

    

  Amount of Water

  Required for Reconstitution

     50 mL

    75 mL

   39 mL 

  59 mL

    

  100 mL

    

  78 mL

  Each teaspoonful (5 mL) will contain 200 mg amoxicillin.

    

  250 mg/5 mL

       

  Bottle Size

    

  Amount of Water

  Required for Reconstitution

     80 mL

  100 mL

    59 mL 

  73 mL

    

  150 mL

    

  110 mL

  Each teaspoonful (5 mL) will contain 250 mg amoxicillin.

    

  400 mg/5 mL

       

  Bottle Size

    

  Amount of Water

  Required for Reconstitution

   

    50 mL

    75 mL

  100 mL

   

  34 mL

  51 mL 

  65 mL

  Each teaspoonful (5 mL) will contain 400 mg amoxicillin.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children > 3 Monthsb  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
    Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
   Mild/Moderate
   500 mg every 12 hours
  or
  250 mg every 8 hours
    25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
   Severe
   875 mg every 12 hours
  or
  500 mg every 8 hours
    45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
    Lower Respiratory Tract
   Mild/Moderate or Severe
   875 mg every 12 hours
  or
  500 mg every 8 hours
    45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
    Gonorrhea
   Acute, uncomplicated ano-genital and urethral infections in males and females
     3 grams as single oral dose
    Prepubertal children: 50 mg/kg amoxicillin for oral suspension, combined with 25 mg/kg probenecid as a single dose.
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  2.2 Dosing in Neonates and Infants Aged12 Weeks ( 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin for oral suspension is 30 mg/kg/day divided every 12 hours.  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin for oral suspension, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.
   
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin for oral suspension and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.
   
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water
  Required for
  Reconstitution  Oral Suspension 200 mg/5 mL
   50 mL
   35 mL
     75 mL
   52 mL
     100 mL
   69 mL
   Oral Suspension 400 mg/5 mL
   50 mL
   35 mL
     75 mL
   52 mL
     100 mL
   69 mL
  

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.
  
  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age   Infection   Severity a   Usual Adult Dose   Usual Dose for Children > 3 Monthsb   Ear/Nose/Throat
  Skin/ Skin Structure
  Genitourinary Tract  Mild/
  Moderate  500 mg every 12 hours or 250 mg every 8 hours  25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours
      Severe  875 mg every 12 hours or 500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
    Lower Respiratory Tract
   Mild/
  Moderate or Severe  875 mg every 12 hours or 500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
   Gonorrhea
  Acute, uncomplicated ano-genital and urethral infections in males and females     3 grams as single oral dose  Prepubertal children:
  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  Note: since probenecid is contraindicated in children under 2 years. Do not use this regimen in children under 2 years of age.  

  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.
  Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose.
  Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.
  Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension   Strength   Bottle Size   Amount of Water
  Required for Reconstitution   Oral Suspension 125 mg /5 mL   80 mL   66 mL      100 mL   83 mL      150 mL   125 mL   Oral Suspension 200 mg /5 mL   50 mL   39 mL      75 mL   59 mL      100 mL   78 mL   Oral Suspension 250 mg /5 mL   80 mL   59 mL      100 mL   73 ml      150 mL   110 mL   Oral Suspension 400 mg /5 mL   50 mL   34 mL      75 mL   51 mL      100 mL   68 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Streptococcus pyogenes

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity a Usual Adult Dose Usual Dose for Children > 3 Months b Ear/Nose/Throat Skin/Skin Structure Genitourinary Tract
  
  Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours
  25 mg/kg/day in divided doses every 12 hours 20 mg/kg/day in divided doses every 8 hours
  
  or
  
  Severe 875 mg every 12 hours or 500 mg every 8 hours
  45 mg/kg/day in divided doses every 12 hours 40 mg/kg/day in divided doses every 8 hours
  
  or
  
  Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours
  45 mg/kg/day in divided doses every 12 hours 40 mg/kg/day in divided doses every 8 hours
  
  or
  
  Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females
  3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  
  
  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. a
  b

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function. Streptococcus pyogenes

  2.3 Dosing for Infection H. pylori

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Triple therapy:

  
  

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. Dual therapy:

  
  

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  
  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water Required for Reconstitution
  Oral Suspension 125 mg/5 mL 80 mL 62 mL 100 mL 78 mL 150 mL 116 mL Oral Suspension 200 mg/5 mL 50 mL 39 mL 75 mL 57 mL 100 mL 76 mL Oral Suspension 250 mg/5 mL 80 mL 59 mL 100 mL 74 mL 150 mL 111 mL Oral Suspension 400 mg/5 mL 50 mL 36 mL 75 mL 54 mL 100 mL 71 mL
  

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  
  

  SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required. NOTE:

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  Amoxicillin | Aidarex Pharmaceuticals Llc

  

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age   Infection   Severity a   Usual Adult Dose   Usual Dose for Children > 3 Monthsb   Ear/Nose/Throat
  Skin/ Skin Structure
  Genitourinary Tract  Mild/
  Moderate  500 mg every 12 hours or 250 mg every 8 hours  25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours
      Severe  875 mg every 12 hours or 500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
    Lower Respiratory Tract
   Mild/
  Moderate or Severe  875 mg every 12 hours or 500 mg every 8 hours  45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
   Gonorrhea
  Acute, uncomplicated ano-genital and urethral infections in males and females     3 grams as single oral dose  Prepubertal children:
  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  Note: since probenecid is contraindicated in children under 2 years. Do not use this regimen in children under 2 years of age.  

  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.
  Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose.
  Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.
  Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension   Strength   Bottle Size   Amount of Water
  Required for Reconstitution   Oral Suspension 125 mg /5 mL   80 mL   66 mL      100 mL   83 mL      150 mL   125 mL   Oral Suspension 200 mg /5 mL   50 mL   39 mL      75 mL   59 mL      100 mL   78 mL   Oral Suspension 250 mg /5 mL   80 mL   59 mL      100 mL   73 ml      150 mL   110 mL   Oral Suspension 400 mg /5 mL   50 mL   34 mL      75 mL   51 mL      100 mL   68 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  Capsules, tablets, and oral suspensions of amoxicillin may be given without regard to meals. The 875-mg tablet has been studied only when administered at the start of a light meal. However, food effect studies have not been performed with 500-mg formulations.

  Neonates and Infants Aged ≤12 weeks (≤3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months:

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity * Usual Adult Dosage Usual Dose for
  Children > 3 Months † Ear/Nose/ Throat Mild/ Moderate 500 mg every
  12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every
  12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/ Moderate or Severe 875 mg every
  12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/ Moderate 500 mg every
  12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every
  12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/ Moderate 500 mg every
  12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every
  12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin combined with 25 mg/kg probenecid as single dose. NOTE: SINCE PROBENICID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: Triple therapy: Amoxicillin/clarithromycin/ lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q 12h) for 14 days. (See INDICATIONS AND USAGE).

  Dual therapy: Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q 8h) for 14 days. (See INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Storage

  Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age  Infection  Severity a  Usual Adult Dose  Usual Dose for Children > 3 Monthsb  Ear/Nose/Throat
  Skin/ Skin Structure
  Genitourinary Tract Mild/
  Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours  Lower Respiratory Tract Mild/
  Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours Gonorrhea
  Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children:
  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  Note: since probenecid is contraindicated in children under 2 years. Do not use this regimen in children under 2 years of age.  

  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.

  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension  Strength  Bottle Size  Amount of Water
  Required for Reconstitution  Oral Suspension 125 mg /5 mL  80 mL  66 mL  100 mL  83 mL  150 mL  125 mL  Oral Suspension 200 mg /5 mL  50 mL  39 mL  75 mL  59 mL  100 mL  78 mL  Oral Suspension 250 mg /5 mL  80 mL  59 mL  100 mL  73 ml  150 mL  110 mL  Oral Suspension 400 mg /5 mL  50 mL  34 mL  75 mL  51 mL  100 mL  68 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  Usual adult dose is 1 tablet daily, or as directed by a physician.

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  do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

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  Amoxicillin | Camber Pharmaceuticals

  

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  Citalopram tablets, USP should be administered once daily, in the morning or evening, with or without food.

  Initial Treatment

  Citalopram tablets, USP should be administered at an initial dose of 20 mg once daily, with an increase to a maximum dose of 40 mg/day at an interval of no less than one week. Doses above 40 mg/day are not recommended due to the risk of QT prolongation. Additionally, the only study pertinent to dose response for effectiveness did not demonstrate an advantage for the 60 mg/day dose over the 40 mg/day dose.

  Special Populations

  20 mg/day is the maximum recommended dose for patients who are greater than 60 years of age, patients with hepatic impairment, and for CYP2C19 poor metabolizers or those patients taking cimetidine or another CYP2C19 inhibitor. (see WARNINGS)

  No dosage adjustment is necessary for patients with mild or moderate renal impairment. Citalopram should be used with caution in patients with severe renal impairment.

  Treatment of Pregnant Women During the Third Trimester

  Neonates exposed to citalopram and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with citalopram tablets, USP during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering citalopram tablets, USP in the third trimester.

  Maintenance Treatment

  It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Systematic evaluation of citalopram in two studies has shown that its antidepressant efficacy is maintained for periods of up to 24 weeks following 6 or 8 weeks of initial treatment (32 weeks total). In one study, patients were assigned randomly to placebo or to the same dose of citalopram (20 to 60 mg/day) during maintenance treatment as they had received during the acute stabilization phase, while in the other study, patients were assigned randomly to continuation of citalopram 20 or 40 mg/day, or placebo, for maintenance treatment. In the latter study, the rates of relapse to depression were similar for the two dose groups (see Clinical Trials under CLINICAL PHARMACOLOGY). Based on these limited data, it is not known whether the dose of citalopram needed to maintain euthymia is identical to the dose needed to induce remission. If adverse reactions are bothersome, a decrease in dose to 20 mg/day can be considered.

  Discontinuation of Treatment with Citalopram tablets, USP

  Symptoms associated with discontinuation of citalopram and other SSRIs and SNRIs have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

  Switching Patients To or From a Monoamine Oxidase Inhibitor

  At least 14 days should elapse between discontinuation of an MAOI and initiation of Citalopram therapy. Similarly, at least 14 days should be allowed after stopping Citalopram before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).

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  Capsules, tablets, and oral suspensions of amoxicillin may be given without regard to meals. The 875-mg tablet has been studied only when administered at the start of a light meal. However, food effect studies hove not been performed with the 500-mg formulation.

  (Neonates and Infants Aged ≤ 12 weeks (≤ 3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q 12h

  Adults and Pediatric Patients > 3 Months:

  ‡ Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

  § The children’s dosage is intended for individuals whose weight is less then 40 kg or more should be dosed according to adult recommendations.

  After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS- Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence:

  Triple therapy: Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q 12h) for 14 days. (See INDICATIONS AND USAGE).

  Dual therapy: Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q 8h) for 14 days. (See INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendation for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive on additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

  Directions for mixing oral suspension

  Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately ½, of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously. Each teaspoonful (5 mL) will contain 125 mg or 250 mg amoxicillin.

  Product

  Bottle Size

  Amount of water required for reconstitution

  125 mg/5 mL

  80 mL

  69 mL

  100 mL

  86 mL

  150 mL

  128 mL

  250 mg/5 mL

  80 mL

  56 mL

  100 mL

  70 mL

  150 mL

  104 mL

  NOTE: SHAKE THE ORAL SUSPENSION WELL BEFORE USING.

  Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age *Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.†The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  Infection

  Severity*

  Usual Adult Dose

  Usual Dose for Children > 3 Months†

  Ear/Nose/Throat

  Skin/Skin Structure

  Genitourinary Tract

  Mild/Moderate

  500 mg every 12 hours
  or

  250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses

  every 8 hours

  Severe

  875 mg every 12 hours
  or

  500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Lower Respiratory

  Tract

  Mild/Moderate or

  Severe

  875 mg every 12 hours
  or

  500 mg every 8 hours

  45 mg/kg/day in divided doses

  every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, Uncomplicated Ano-Genital and Urethral Infections in Males and Females

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment•Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.•Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose.•Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.•Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.•Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension

  Strength

  Bottle Size

  Amount of Water

  Required for Reconstitution

  Oral Suspension 125 mg/5 mL

  80 mL

  62 mL

  100 mL

  77 mL

  150 mL

  113 mL

  Oral Suspension 250 mg/5 mL

  80 mL

  47 mL

  100 mL

  60 mL

  150 mL

  90 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  do not take more than directed the smallest effective dose should be used adults and children 12 years and older: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age   Infection   Severitya   Usual Adult Dose   Usual Dose for Children > 3 Monthsb  Ear/Nose/Throat
  Skin/ Skin Structure
  Genitourinary Tract Mild/
  Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours
     Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
  Lower Respiratory Tract
  Mild/
  Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
  Gonorrhea
  Acute, uncomplicated ano-genital and urethral infections in males and females    3 grams as single oral dose Prepubertal children:
  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  Note: since probenecid is contraindicated in children under 2 years. Do not use this regimen in children under 2 years of age.  

  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.
  Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose.
  Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.
  Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension   Strength Bottle Size Amount of Water
  Required for Reconstitution   Oral Suspension 125 mg /5 mL   80 mL   66 mL      100 mL   83 mL      150 mL   125 mL   Oral Suspension 200 mg /5 mL   50 mL   39 mL      75 mL   59 mL      100 mL   78 mL   Oral Suspension 250 mg /5 mL   80 mL   59 mL      100 mL   73 ml      150 mL   110 mL   Oral Suspension 400 mg /5 mL   50 mL   34 mL      75 mL   51 mL      100 mL   68 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.  

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children
  > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
  

   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
  

   Mild/Moderate
  

   500 mg every 12 hours or
   250 mg every 8 hours
  

   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
  

   Severe
  

   875 mg every 12 hours or
   500 mg every 8 hours
  

   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
  

   Lower Respiratory
   Tract
  

   Mild/Moderate or Severe
  

   875 mg every 12 hours or
   500 mg every 8 hours
  

   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
  

   Gonorrhea Acute,
   uncomplicated ano
   -genital and urethral
   infections in males
   and females
  

   
  

   3 grams as single oral dose
  

   Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks ( ≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin capsules is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
  
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
  
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.  

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children
  > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
  

   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
  

   Mild/Moderate
  

   500 mg every 12 hours or
   250 mg every 8 hours
  

   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
  

   Severe
  

   875 mg every 12 hours or
   500 mg every 8 hours
  

   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
  

   Lower Respiratory
   Tract
  

   Mild/Moderate or Severe
  

   875 mg every 12 hours or
   500 mg every 8 hours
  

   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
  

   Gonorrhea Acute,
   uncomplicated ano
   -genital and urethral
   infections in males
   and females
  

   
  

   3 grams as single oral dose
  

   Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks ( ≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin capsules is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
  
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
  
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age

   Infection

   Severity a

   Usual Adult Dose

   Usual Dose for Children > 3 Monthsb 

  Ear/Nose/Throat
  Skin/ Skin Structure
  Genitourinary Tract

  Mild/
  Moderate

  500 mg every 12 hours or 250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours
  

   

  Severe

  875 mg every 12 hours or 500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
  

   Lower Respiratory Tract
  

  Mild/
  Moderate or Severe

  875 mg every 12 hours or 500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
  

  Gonorrhea
  Acute, uncomplicated ano-genital and urethral infections in males and females

   

  3 grams as single oral dose

  Prepubertal children:
  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  Note: since probenecid is contraindicated in children under 2 years. Do not use this regimen in children under 2 years of age.  

  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.
  • Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose.
  • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.
  • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
  • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension

   Strength

   Bottle Size

   Amount of Water
  Required for Reconstitution

   Oral Suspension 125 mg /5 mL

   80 mL

   66 mL

   

   100 mL

   83 mL

   

   150 mL

   125 mL

   Oral Suspension 200 mg /5 mL

   50 mL

   39 mL

   

   75 mL

   59 mL

   

   100 mL

   78 mL

   Oral Suspension 250 mg /5 mL

   80 mL

   59 mL

   

   100 mL

   73 ml

   

   150 mL

   110 mL

   Oral Suspension 400 mg /5 mL

   50 mL

   34 mL

   

   75 mL

   51 mL

   

   100 mL

   68 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  Amoxicillin capsules may be given without regard to meals.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
  † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity* Usual Adult Dose Usual Dose for Children >3 Months† Ear/Nose/
  Throat Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Lower Respiratory Tract Mild/ Moderate or Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Skin/Skin Structure Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Genitourinary Tract Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children:
  50 mg/kg Amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  NOTE: SINCE
  PROBENECID ISCONTRAINDICATED N CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS:Laboratory Tests section.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary.  Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pyloriEradication to Reduce the Risk of Duodenal Ulcer Recurrence

  Triple Therapy

  Amoxicillin/Clarithromycin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE section.)

  Dual Therapy

  Amoxicillin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE section.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS section, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children > 3 Monthsb Ear/Nose/Throat
  Skin/Skin Structure
  Genitourinary Tract Mild/Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided doses
  every 12 hours
  or
  20 mg/kg/day in divided doses
  every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided doses
  every 12 hours
  or
  40 mg/kg/day in divided doses
  every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided doses
  every 12 hours
  or
  40 mg/kg/day in divided doses
  every 8 hours Gonorrhea
  Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children:
  50 mg/kg amoxicillin, combined with
  25 mg/kg probenecid as a single dose.
  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  
  

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  
  

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  
  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water
  Required for Reconstitution Oral Suspension 125 mg/5 mL 80 mL 62 mL 100 mL 78 mL 150 mL 116 mL Oral Suspension 200 mg/5 mL 50 mL 39 mL 75 mL 57 mL 100 mL 76 mL Oral Suspension 250 mg/5 mL 80 mL 59 mL 100 mL 74 mL 150 mL 111 mL Oral Suspension 400 mg/5 mL 50 mL 36 mL 75 mL 54 mL 100 mL 71 mL
  

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  
  

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  Amoxicillin | Hikma Pharmaceutical

  

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children
  > 3 Monthsb  Ear/Nose/Throat
  Skin/Skin Structure
  Genitourinary Tract
   Mild/Moderate
   

  500 mg every 12 hours or 250 mg every 8 hours

    25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
   Severe
   875 mg every 12 hours or
  500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
  40 mg/kg/day in divided doses every 8 hours
   Lower Respiratory Tract
   Mild/Moderate
   or Severe
   875 mg every 12 hours or
  500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
  40 mg/kg/day in divided doses every 8 hours
   Gonorrhea
  Acute, uncomplicated
  ano-genital and
  urethral infections in
   males and females
     
   3 grams as single oral dose
   Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
   
  Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin tablets is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
  
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
  
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  Amoxicillin capsules may be given without regard to meals. However, food effect studies have not been performed with the 500 mg formulation.

  Neonates and infants aged ≤ 12 weeks (≤ 3 months):

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and pediatric patients >3 months: * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.  † The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

   Infection

   Severity*

   Usual

   Usual Dose

   

   

   Adult Dose

   for Children

   

   

   

   >3 months†

   Ear/nose/throat

   Mild/Moderate

   500 mg

   25 mg/kg/day

   

   

   every 12 hours

   in divided doses

   

   

   or

   every 12 hours

   

   

   250 mg

   or

   

   

   every 8 hours

   20 mg/kg/day

   

   

   

   in divided doses

   

   

   

   every 8 hours

   

   Severe

   875 mg

   45 mg/kg/day

   

   

   every 12 hours

   in divided doses

   

   

   or

   every 12 hours

   

   

   500 mg

   or

   

   

   every 8 hours

   40 mg/kg/day

   

   

   

   in divided doses

   

   

   

   every 8 hours

   Lower respiratory

   Mild/Moderate

   875 mg

   45 mg/kg/day

   Tract

   or Severe

   every 12 hours

   in divided doses

   

   

   or

   every 12 hours

   

   

   500 mg every

   or

   

   

   8 hours

   40 mg/kg/day

   

   

   

   in divided doses

   

   

   

   every 8 hours

   Skin/Skin

   Mild/Moderate

   500 mg

   25 mg/kg/day

   Structure

   

   every 12 hours

   in divided doses

   

   

   or

   every 12 hours

   

   

   250 mg every

   or

   

   

   8 hours

   20 mg/kg/day

   

   

   

   in divided doses

   

   

   

   every 8 hours

   

   Severe

   875 mg

   45 mg/kg/day

   

   

   every 12 hours

   in divided doses

   

   

   or

   every 12 hours

   

   

   500 mg every

   or

   

   

   8 hours

   40 mg/kg/day

   

   

   

   in divided doses

   

   

   

   every 8 hours

   Genitourinary

   Mild/Moderate

   500 mg

   25 mg/kg/day

   Tract

   

   every 12 hours

   in divided doses

   

   

   or

   every 12 hours

   

   

   250 mg every

   or

   

   

   8 hours

   20 mg/kg/day

   

   

   

   in divided doses

   

   

   

   every 8 hours

   

   Severe

   875 mg

   45 mg/kg/day

   

   

   every 12 hours

   in divided doses

   

   

   or

   every 12 hours

   

   

   500 mg

   or

   

   

   every 8 hours

   40 mg/kg/day

   

   

   

   in divided doses

   

   

   

   every 8 hours

   Gonorrhea

   

   3 grams

   Prepubertal children:

   Acute,

   

   as

  50 mg/kg amoxicillin combined with

  uncomplicated

   

   single oral dose

   25 mg/kg probenecid as a single dose.

  ano-genital and

   

   

   NOTE: SINCE PROBENECID IS CONTRA-

  urethral infections in  males and females

   

   

  INDICATED IN CHILDREN UNDER 2 YEARS. DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS - Laboratory Tests.)

  Larger doses may be required for stubborn or severe infections.

  General:

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori eradication to reduce the risk of duodenal ulcer recurrence: Triple therapy:

  Amoxicillin/clarithromycin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

  Dual therapy:

  Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing recommendations for adults with impaired renal function:

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875-mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenesto prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity* Usual Adult Dose Usual Dose for Children
  > 3 Months† * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.   Ear/Nose/Throat   Skin/Skin Structure   Genitourinary Tract

  Mild/Moderate

    500 mg every 12 hours or   250 mg every 8 hours   25 mg/kg/day in divided doses   every 12 hours   or   20 mg/kg/day in divided doses   every 8 hours

  Severe

    875 mg every 12 hours or   500 mg every 8 hours   45 mg/kg/day in divided doses   every 12 hours   or   40 mg/kg/day in divided doses   every 8 hours   Lower Respiratory   Tract   Mild/Moderate or   Severe   875 mg every 12 hours or   500 mg every 8 hours   45 mg/kg/day in divided doses   every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, uncomplicated

  ano-genital and urethral infections in males and females

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenesto prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water Required for Reconstitution

  Oral Suspension 125 mg/5 mL

  80 mL

  55 mL

  100 mL

  68 mL

  150 mL

  102 mL

  Oral Suspension 200 mg/5 mL

  50 mL

  34 mL

  75 mL

  51 mL

  100 mL

  68 mL

  Oral Suspension 250 mg/5 mL

  80 mL

  55 mL

  100 mL

  68 mL

  150 mL

  102 mL

  Oral Suspension 400 mg/5 mL

  50 mL

  34 mL

  75 mL

  51 mL

  100 mL

  68 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  Amoxicillin capsules may be given without regard to meals.

  Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
  † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity* Usual Adult Dose Usual Dose for Children >3 Months† Ear/Nose/
  Throat Mild/ Moderate 500 mg every 12 hours or
  250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Lower Respiratory Tract Mild/ Moderate or Severe 875 mg every 12 hours or
  500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Skin/Skin Structure Mild/ Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Genitourinary Tract Mild/ Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided
  doses every 12 hours
  or
  20 mg/kg/day in divided
  doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided
  doses every 12 hours
  or
  40 mg/kg/day in divided
  doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children:
  50 mg/kg Amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  NOTE: SINCE
  PROBENECID IS
  CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS: Laboratory Tests section.)

  Larger doses may be required for stubborn or severe infections.

  General

  It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary.  Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

  Triple Therapy

  Amoxicillin/Clarithromycin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE section.)

  Dual Therapy

  Amoxicillin/Lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE section.)

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS section, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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  The 875-mg tablet has been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200-mg and 500-mg formulations.

  Neonates and Infants Aged ≤12 weeks (≤3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of Amoxicillin is 30 mg/kg/day divided q12h.

  Adults and Pediatric Patients > 3 Months:

  * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

   Infection

   Severity*

   Usual Adult Dosage

   Usual Dose for Children > 3 Months†

   Ear/Nose/ Throat

   Mild/ Moderate

   500 mg every 12 hours or 250 mg every 8 hours

   25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours

   Severe

   875 mg every 12 hours or 500 mg every 8 hours

   45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours

   Lower Respiratory Tract

   Mild/ Moderate or Severe

   875 mg every 12 hours or 500 mg every 8 hours

   

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses every 8 hours

   Skin/Skin Structure

   Mild/ Moderate

   500 mg every 12 hours or 250 mg every 8 hours

   25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours

   Severe

   875 mg every 12 hours or 500 mg every 8 hours

   45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours

   Genitourinary Tract

   Mild/ Moderate

   500 mg every 12 hours or 250 mg every 8 hours

   25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours

   Severe

   875 mg every 12 hours or 500 mg every 8 hours

   45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours

   Gonorrhea Acute, Uncomplicated Ano-genital and urethral infections in males and females

   

   3 grams as single oral dose

   

  Prepubertal children: 50 mg/kg Amoxicillin combined with 25 mg/kg probenecid as single dose.

  NOTE: SINCE PROBENICID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

  All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests).

  Larger doses may be required for stubborn or severe infections.

  General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: Triple therapy: Amoxicillin/clarithromycin/ lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE).

  Dual therapy: Amoxicillin/lansoprazole

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE).

  Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

  Dosing Recommendations for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on the severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on the severity of the infection. They should receive an additional dose both during and at the end of dialysis.

  There are currently no dosing recommendations for pediatric patients with impaired renal function.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
  

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.   Streptococcus pyogenes

  
  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity a Usual Adult Dose Usual Dose for Children > 3 Months
  b Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. a
  b
   Ear/Nose/Throat  Skin/Skin Structure  Genitourinary Tract
  
  
   Mild/Moderate
   500 mg every 12 hours or  250 mg every 8 hours
  
   25 mg/kg/day in divided doses every 12 hours  20 mg/kg/day in divided doses every 8 hours
   or
  
   Severe
   875 mg every 12 hours or  500 mg every 8 hours
  
   45 mg/kg/day in divided doses every 12 hours  40 mg/kg/day in divided doses every 8 hours
   or
  
   Lower Respiratory  Tract
  
   Mild/Moderate or Severe
   875 mg every 12 hours or  500 mg every 8 hours
  
   45 mg/kg/day in divided doses every 12 hours  40 mg/kg/day in divided doses every 8 hours
   or
  
   Gonorrhea Acute,  uncomplicated ano  -genital and urethral  infections in males  and females
  
  
  
  
   
   3 grams as single oral dose
    children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose. Prepubertal
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks ( ≤ 3 Months)
  

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin capsules is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function. Streptococcus pyogenes

  2.3 Dosing for H. pylori Infection
  

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.  Please refer to clarithromycin and lansoprazole full prescribing information. Triple Therapy:
  
  Dual Therapy:
  
  

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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  Amoxicillin | Rxhomeo Private Limited D.b.a. Rxhomeo, Inc

  

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  Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  Infection

  Severity*

  Usual Adult Dose

  Usual Dose for Children > 3 Months†

  Ear/Nose/Throat

  Skin/Skin Structure

  Genitourinary Tract

  Mild/Moderate

  500 mg every 12 hours
  or

  250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours

  or

  20 mg/kg/day in divided doses

  every 8 hours

  Severe

  875 mg every 12 hours
  or

  500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Lower Respiratory

  Tract

  Mild/Moderate or

  Severe

  875 mg every 12 hours
  or

  500 mg every 8 hours

  45 mg/kg/day in divided doses

  every 12 hours

  or

  40 mg/kg/day in divided doses

  every 8 hours

  Gonorrhea

  Acute, Uncomplicated Ano-Genital and Urethral Infections in Males and Females

  3 grams as single oral dose

  Prepubertal children:

  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.

  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension

  Strength

  Bottle Size

  Amount of Water

  Required for Reconstitution

  Oral Suspension 125 mg/5 mL

  80 mL

  62 mL

  100 mL

  77 mL

  150 mL

  113 mL

  Oral Suspension 250 mg/5 mL

  80 mL

  47 mL

  100 mL

  60 mL

  150 mL

  90 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age

   Infection

   Severity a

   Usual Adult Dose

   Usual Dose for Children > 3 Monthsb 

  Ear/Nose/Throat
  Skin/ Skin Structure
  Genitourinary Tract

  Mild/
  Moderate

  500 mg every 12 hours or 250 mg every 8 hours

  25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours
  

   

  Severe

  875 mg every 12 hours or 500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
  

   Lower Respiratory Tract
  

  Mild/
  Moderate or Severe

  875 mg every 12 hours or 500 mg every 8 hours

  45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
  

  Gonorrhea
  Acute, uncomplicated ano-genital and urethral infections in males and females

   

  3 grams as single oral dose

  Prepubertal children:
  50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  Note: since probenecid is contraindicated in children under 2 years. Do not use this regimen in children under 2 years of age.  

  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection

  Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment • Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.
  • Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose.
  • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.
  • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
  • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension

   Strength

   Bottle Size

   Amount of Water
  Required for Reconstitution

   Oral Suspension 125 mg /5 mL

   80 mL

   66 mL

   

   100 mL

   83 mL

   

   150 mL

   125 mL

   Oral Suspension 200 mg /5 mL

   50 mL

   39 mL

   

   75 mL

   59 mL

   

   100 mL

   78 mL

   Oral Suspension 250 mg /5 mL

   80 mL

   59 mL

   

   100 mL

   73 ml

   

   150 mL

   110 mL

   Oral Suspension 400 mg /5 mL

   50 mL

   34 mL

   

   75 mL

   51 mL

   

   100 mL

   68 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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  Amoxicillin | Remedyrepack Inc.

  

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  In adults, 750-1750 mg/day in divided doses every 8-12 hours. In Pediatric Patients > 3 Months of Age, 20-45 mg/kg/day in divided doses every 8-12 hours. Refer to full prescribing information for specific dosing regimens. (2.1, 2.2, 2.3) Treatment of gonorrhea is 3 grams as a single oral dose. (2.1) The upper dose for neonates and infants ≤ 3 months is 30 mg/kg/day divided every 12 hours. (2.2) Dosing for H. pylori Infection: Triple therapy: 1 gram Amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: 1 gram Amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. (2.3) Reduce the dose in patients with severe renal impairment (GFR <30 mL/min). (2.4)

   

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age  Infection  Severity a  Usual Adult Dose  Usual Dose for Children > 3 Monthsb  Ear/Nose/Throat
  Skin/ Skin Structure
  Genitourinary Tract Mild/
  Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
  or
  20 mg/kg/day in divided doses every 8 hours
    Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
   Lower Respiratory Tract
  Mild/
  Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
  or
  40 mg/kg/day in divided doses every 8 hours
  Gonorrhea
  Acute, uncomplicated ano-genital and urethral infections in males and females   3 grams as single oral dose Prepubertal children:
  50 mg/kg Amoxicillin, combined with 25 mg/kg probenecid as a single dose.
  Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.  

  a Dosing for infections caused by bacteria that are intermediate in their susceptibility to Amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

   

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of Amoxicillin in this age group, the recommended upper dose of Amoxicillin 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

   

  Triple therapy: The recommended adult oral dose is 1 gram Amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  Dual therapy: The recommended adult oral dose is 1 gram Amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  Please refer to clarithromycin and lansoprazole full prescribing information.

   

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.
  Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose.
  Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.
  Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
  Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

   

  Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

  Table 2. Amount of Water for Mixing Oral Suspension  Strength  Bottle Size  Amount of Water
  Required for Reconstitution  Oral Suspension 125 mg /5 mL  80 mL  66 mL    100 mL  83 mL    150 mL  125 mL  Oral Suspension 200 mg /5 mL  50 mL  39 mL    75 mL  59 mL    100 mL  78 mL  Oral Suspension 250 mg /5 mL  80 mL  59 mL    100 mL  73 ml    150 mL  110 mL  Oral Suspension 400 mg /5 mL  50 mL  34 mL    75 mL  51 mL    100 mL  68 mL

  After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

  NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

   

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  2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
  

  Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  
  Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity a Usual Adult Dose Usual Dose for Children
  > 3 Months b a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
   Ear/Nose/Throat
   Skin/Skin Structure
   Genitourinary Tract
  Mild/Moderate
   500 mg every 12 hours or
   250 mg every 8 hours
   25 mg/kg/day in divided doses every 12 hours
   or
   20 mg/kg/day in divided doses every 8 hours
   Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Lower Respiratory Tract
   Mild/Moderate
   or Severe
   875 mg every 12 hours or
   500 mg every 8 hours
   45 mg/kg/day in divided doses every 12 hours
   or
   40 mg/kg/day in divided doses every 8 hours
   Gonorrhea
   Acute, uncomplicated
   ano-genital and
   urethral infections in
   males and females
   
   3 grams as single oral dose
    Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
   
   Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
  2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)
  

  Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin tablets is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

  2.3 Dosing for H. pylori Infection
  

  Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. 
  
  Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 
  
  Please refer to clarithromycin and lansoprazole full prescribing information.

  2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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