Ampicillin

Ampicillin Manufacturers

• Blenheim Pharmacal, Inc.
  

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  Ampicillin | Blenheim Pharmacal, Inc.

  

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  Adults and children weighing over 20 Kg: For genitourinary or gastrointestinal tract infections other than gonorrhea in men and women, the usual dose is 500 mg q.i.d. in equally spaced doses; severe or chronic infections may require larger doses. For the treatment of gonorrhea in both men and women, a single oral dose of 3.5 grams of ampicillin administered simultaneously with 1 gram of probenecid is recommended. Physicians are cautioned to use no less than the above recommended dosage for the treatment of gonorrhea. Follow-up cultures should be obtained from the original site(s) of infection 7 to 14 days after therapy. In women, it is also desirable to obtain culture test-of-cure from both the endocervical and anal canals. Prolonged intensive therapy is needed for complications such as prostatitis and epididymitis. For respiratory tract infections, the usual dose is 250 mg q.i.d. in equally spaced doses.

  Pediatric Patients weighing 20 Kg or less: For genitourinary or gastrointestinal tract infections, the usual dose is 100 mg/kg/day total, q.i.d. in equally divided and spaced doses.

  For respiratory tract infections, the usual dose is 50 mg/kg/day total, in equally divided and spaced doses three to four times daily. Doses for children should not exceed doses recommended for adults.

  All patients, irrespective of age and weight: Larger doses may be required for severe or chronic infections. Although ampicillin is resistant to degradation by gastric acid, it should be administered at least one half-hour before or two hours after meals for maximal absorption. Except for the single dose regimen for gonorrhea referred to above, therapy should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or evidence at bacterial eradication has been obtained. In infections caused by haemolytic strains of streptococci, a minimum of 10 days' treatment is recommended to guard against the risk of rheumatic fever or glomerulonephritis (see PRECAUTIONS, Laboratory Tests). In the treatment of chronic urinary or gastrointestinal infections, frequent bacteriologic and clinical appraisal is necessary during therapy and may be necessary for several months afterwards. Stubborn infections may require treatment for several weeks. Smaller doses than those indicated above should not be used.

  Directions for mixing Oral Suspension

  Prepare suspension at time of dispensing. For ease of preparation, add water to the bottle in two portions and shake well after each addition.

  125 mg/5 mL
  Add a total of 86 mL to the 100 mL package and 170 mL to the 200 mL package. This will provide 100 mL and 200 mL of suspension. Each 5 mL (teaspoonful) will contain ampicillin trihydrate equivalent to 125 mg ampicillin.

  250 mg/5 mL
  Add a total of 70 mL to the 100 mL package and 139 mL to the 200 mL package. This will provide 100 mL and 200 mL of suspension . Each 5 mL (teaspoonful) will contain ampicillin trihydrate equivalent to 250 mg ampicillin.

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• Claris Lifesciences, Inc.
  

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  Ampicillin | Claris Lifesciences, Inc.

  

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  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae.

  Adults – Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months. The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis

  Adults and children – 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia

  Adults and children – 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

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• C.o. Truxton, Inc.
  

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  Ampicillin | C.o. Truxton, Inc.

  

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  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae.

  Adults – Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months. The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis

  Adults and children – 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia

  Adults and children – 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

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• General Injectables & Vaccines, Inc
  

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  Ampicillin | General Injectables & Vaccines, Inc

  

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  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae.

  Adults – Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months. The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis

  Adults and children – 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia

  Adults and children – 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

  DIRECTIONS FOR USE

  Use only freshly prepared solutions. Intramuscular and intravenous injections should be administered within one hour after preparation since the potency may decrease significantly after this period.

  For Intramuscular Use– Dissolve contents of a vial with the amount of Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, listed in the table below:

  NDC 36000
  Label
  Claim Recommended
  Amount of
  Diluent Withdrawable
  Volume Concentration
  (in mg/mL) 070-10 250 mg 1 mL 1 mL 250 mg 071-10 500 mg 1.8 mL 2 mL 250 mg 072-10 1 gram 3.5 mL 4 mL 250 mg 073-10 2 grams 6.8 mL 8 mL 250 mg

  While Ampicillin for Injection, USP, 1 gram and 2 grams, are primarily for intravenous use, they may be administered intramusculary when the 250 mg or 500 mg vials are unavailable. In such instances, dissolve in 3.5 or 6.8 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, respectively. The resulting solution will provide a concentration of 250 mg per mL.

  Ampicillin for Injection, USP 125 mg, is intended primarily for pediatric use. It also serves as a convenient dosage form when small parenteral doses of the antibiotic are required.

  For Direct Intravenous Use– Add 5 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP to the 250, and 500 mg vials and administer slowly over a 3- to 5- minute period. Ampicillin for Injection, USP, 1 gram or 2 grams, may also be given by direct Intravenous administration. Dissolve in 7.4 or 14.8 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, respectively, and administer slowly over at least 10 to 15 minutes. CAUTION: More rapid administration may result in convulsive seizures.

  For Administration by Intravenous Drip– Reconstitute as directed above ( For Direct Intravenous Use) prior to diluting with Intravenous Solution. Stability studies on ampicillin sodium at several concentrations in various intravenous solutions indicate the drug will lose less than 10% activitiy at the temperatures noted for the time periods stated.

  Room Temperature (25° C) Diluent Concentrations Stability
  Periods Sterile Water for Injection up to 30 mg/mL 8 hours 0.9% Sodium Chloride Injection up to 30 mg/mL 8 hours 5% Dextrose in Water 10 to 20 mg/mL 1 hour 5% Dextrose in Water up to 2 mg/mL 2 hours 5% Dextrose in 0.45% NaCl up to 2 mg/mL 2 hours Lactated Ringer's Solution up to 30 mg/mL 8 hours
  
  
  Refrigerated (4° C) Diluent Concentrations Stability
  Periods Sterile Water for Injection 30 mg/mL 48 hours Sterile Water for Injection up to 20 mg/mL 72 hours 0.9% Sodium Chloride Injection 30 mg/mL 24 hours 0.9% Sodium Chloride Injection up to 20 mg/mL 48 hours Lactated Ringer's Solution up to 30 mg/mL 24 hours 5% Dextrose in Water up to 20 mg/mL 1 hour 5% Dextrose and 0.45% NaCl up to 10 mg/mL 1 hour

  Only those solutions listed above should be used for the intravenous infusion of Ampicillin for Injection, USP. The concentrations should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of ampicillin is administered before the drug loses its stability in the solution in use.

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• General Injectables & Vaccines, Inc
  

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  Ampicillin | General Injectables & Vaccines, Inc

  

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  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae.

  Adults – Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months. The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis

  Adults and children – 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia

  Adults and children – 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

  DIRECTIONS FOR USE

  Use only freshly prepared solutions. Intramuscular and intravenous injections should be administered within one hour after preparation since the potency may decrease significantly after this period.

  For Intramuscular Use– Dissolve contents of a vial with the amount of Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, listed in the table below:

  NDC 36000
  Label
  Claim Recommended
  Amount of
  Diluent Withdrawable
  Volume Concentration
  (in mg/mL) 070-10 250 mg 1 mL 1 mL 250 mg 071-10 500 mg 1.8 mL 2 mL 250 mg 072-10 1 gram 3.5 mL 4 mL 250 mg 073-10 2 grams 6.8 mL 8 mL 250 mg

  While Ampicillin for Injection, USP, 1 gram and 2 grams, are primarily for intravenous use, they may be administered intramusculary when the 250 mg or 500 mg vials are unavailable. In such instances, dissolve in 3.5 or 6.8 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, respectively. The resulting solution will provide a concentration of 250 mg per mL.

  Ampicillin for Injection, USP 125 mg, is intended primarily for pediatric use. It also serves as a convenient dosage form when small parenteral doses of the antibiotic are required.

  For Direct Intravenous Use– Add 5 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP to the 250, and 500 mg vials and administer slowly over a 3- to 5- minute period. Ampicillin for Injection, USP, 1 gram or 2 grams, may also be given by direct Intravenous administration. Dissolve in 7.4 or 14.8 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, respectively, and administer slowly over at least 10 to 15 minutes. CAUTION: More rapid administration may result in convulsive seizures.

  For Administration by Intravenous Drip– Reconstitute as directed above ( For Direct Intravenous Use) prior to diluting with Intravenous Solution. Stability studies on ampicillin sodium at several concentrations in various intravenous solutions indicate the drug will lose less than 10% activitiy at the temperatures noted for the time periods stated.

  Room Temperature (25° C) Diluent Concentrations Stability
  Periods Sterile Water for Injection up to 30 mg/mL 8 hours 0.9% Sodium Chloride Injection up to 30 mg/mL 8 hours 5% Dextrose in Water 10 to 20 mg/mL 1 hour 5% Dextrose in Water up to 2 mg/mL 2 hours 5% Dextrose in 0.45% NaCl up to 2 mg/mL 2 hours Lactated Ringer's Solution up to 30 mg/mL 8 hours
  
  
  Refrigerated (4° C) Diluent Concentrations Stability
  Periods Sterile Water for Injection 30 mg/mL 48 hours Sterile Water for Injection up to 20 mg/mL 72 hours 0.9% Sodium Chloride Injection 30 mg/mL 24 hours 0.9% Sodium Chloride Injection up to 20 mg/mL 48 hours Lactated Ringer's Solution up to 30 mg/mL 24 hours 5% Dextrose in Water up to 20 mg/mL 1 hour 5% Dextrose and 0.45% NaCl up to 10 mg/mL 1 hour

  Only those solutions listed above should be used for the intravenous infusion of Ampicillin for Injection, USP. The concentrations should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of ampicillin is administered before the drug loses its stability in the solution in use.

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• Dava Pharmaceuticals, Inc.
  

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  Ampicillin | Dava Pharmaceuticals, Inc.

  

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  Adults and children weighing over 20 Kg: For genitourinary or gastrointestinal tract infections other than gonorrhea in men and women, the usual dose is 500 mg q.i.d. in equally spaced doses; severe or chronic infections may require larger doses. For the treatment of gonorrhea in both men and women, a single oral dose of 3.5 grams of ampicillin administered simultaneously with 1 gram of probenecid is recommended. Physicians are cautioned to use no less than the above recommended dosage for the treatment of gonorrhea. Follow-up cultures should be obtained from the original site(s) of infection 7 to 14 days after therapy. In women, it is also desirable to obtain culture test-of-cure from both the endocervical and anal canals. Prolonged intensive therapy is needed for complications such as prostatitis and epididymitis. For respiratory tract infections, the usual dose is 250 mg q.i.d. in equally spaced doses.

  Pediatric Patients weighing 20 Kg or less: For genitourinary or gastrointestinal tract infections, the usual dose is 100 mg/kg/day total, q.i.d. in equally divided and spaced doses.

  For respiratory tract infections, the usual dose is 50 mg/kg/day total, in equally divided and spaced doses three to four times daily. Doses for children should not exceed doses recommended for adults.

  All patients, irrespective of age and weight: Larger doses may be required for severe or chronic infections. Although ampicillin is resistant to degradation by gastric acid, it should be administered at least one half-hour before or two hours after meals for maximal absorption. Except for the single dose regimen for gonorrhea referred to above, therapy should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or evidence at bacterial eradication has been obtained. In infections caused by haemolytic strains of streptococci, a minimum of 10 days' treatment is recommended to guard against the risk of rheumatic fever or glomerulonephritis (see PRECAUTIONS, Laboratory Tests). In the treatment of chronic urinary or gastrointestinal infections, frequent bacteriologic and clinical appraisal is necessary during therapy and may be necessary for several months afterwards. Stubborn infections may require treatment for several weeks. Smaller doses than those indicated above should not be used.

  Directions for mixing Oral Suspension

  Prepare suspension at time of dispensing. For ease of preparation, add water to the bottle in two portions and shake well after each addition.

  125 mg/5 mL
  Add a total of 86 mL to the 100 mL package and 170 mL to the 200 mL package. This will provide 100 mL and 200 mL of suspension. Each 5 mL (teaspoonful) will contain ampicillin trihydrate equivalent to 125 mg ampicillin.

  250 mg/5 mL
  Add a total of 70 mL to the 100 mL package and 139 mL to the 200 mL package. This will provide 100 mL and 200 mL of suspension . Each 5 mL (teaspoonful) will contain ampicillin trihydrate equivalent to 250 mg ampicillin.

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• Sandoz Inc
  

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  The Single Use ADD-Vantage® vials are for intravenous use only.

  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae.

  Adults – Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months. The doses for the preceding infections may be given by intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis

  Adults and children – 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia

  Adults and children – 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

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• Sandoz Inc
  

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  The recommended adult and pediatric dosages and routes of administration are outlined in the following table 10. Cefepime for injection should be administered intravenously over approximately 30 minutes.

  Table 10: Recommended Dosage Schedule for Cefepime for Injection in Patients with CrCL Greater Than 60 mL/min*
  Site and Type of Infection
  Dose
  Frequency Duration
  (days) Adults * Adjust dose in patients with CrCL less than or equal to 60 mL/min † including cases associated with concurrent bacteremia. ‡ For Pseudomonas aeruginosa, use 2 g IV every 8 hours (50 mg per kg per dose in pediatric patients 2 months up to 16 years) § or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re-evaluated frequently. ¶ Intramuscular route of administration is indicated only for mild to moderate, uncomplicated or complicated UTIs due to E. coli when the intramuscular route is considered to be a more appropriate route of drug administration.

  Moderate to Severe Pneumonia due to S. pneumoniae†,
  P. aeruginosa‡, K. pneumoniae, or Enterobacter species

  1 to 2 g IV

  Every 8 to 12 hours

  10

  Empiric therapy for febrile neutropenic patients (See INDICATIONS AND USAGE and CLINICAL STUDIES.)

  2 g IV

  Every 8 hours

  7§

  Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis†

  0.5 to 1 g
  IV/IM¶

  Every 12 hours

  7 to 10

  Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae†

  2 g IV

  Every 12 hours

  10

  Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes

  2 g IV

  Every 12 hours

  10

  Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa‡, K. pneumoniae, Enterobacterspecies, or B. fragilis. (See CLINICAL STUDIES.)

  2 g IV

  Every 8 to 12 hours

  7 to 10

  Pediatric Patients (2 months up to 16 years)

  The maximum dose for pediatric patients should not exceed the recommended adult dose.
  The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg per kg per dose, administered every 12 hours (50 mg per kg per dose, every 8 hours for febrile neutropenic patients), for durations as given above.

  Patients with Hepatic Impairment

  No adjustment is necessary for patients with hepatic impairment.

  Patients with Renal Impairment

  In patients with creatinine clearance less than or equal to 60 mL/min, the dose of cefepime for injection should be adjusted to compensate for the slower rate of renal elimination. The recommended initial dose of cefepime for injection should be the same as in patients with normal renal function except in patients undergoing hemodialysis. The recommended doses of cefepime for injection in patients with renal impairment are presented in Table 11.

  When only serum creatinine is available, the following formula (Cockcroft and Gault equation)4 may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function:

  Males: Creatinine Clearance (mL/min) =

  Weight (kg) × (140-age)

  72 × serum creatinine (mg/dL)

  Females: 0.85 × above value

  Table 11: Recommended Dosing Schedule for Cefepime for Injection in Adult Patients (Normal Renal Function, Renal Impairment, and Hemodialysis) Creatinine
  Clearance
  (mL/min)
  
  Recommended Maintenance Schedule * On hemodialysis days, cefepime should be administered following hemodialysis.
  Whenever possible, cefepime should be administered at the same time each day.

  Greater than 60 Normal recommended dosing schedule

  500 mg every 12 hours

  1 g every 12 hours

  2 g every 12 hours

  2 g every 8 hours

  30 to 60

  500 mg every 24 hours

  1 g every 24 hours

  2 g every 24 hours

  2 g every 12 hours

  11 to 29

  500 mg every 24 hours

  500 mg every 24 hours

  1 g every 24 hours

  2 g every 24 hours

  Less than 11

  250 mg every 24 hours

  250 mg every 24 hours

  500 mg every 24 hours

  1 g every 24 hours

  CAPD

  500 mg every 48 hours

  1 g every 48 hours

  2 g every 48 hours

  2 g every 48 hours

  Hemodialysis*

  1 g on day 1, then 500 mg every 24 hours thereafter

  1 g every 24 hours

  In patients undergoing continuous ambulatory peritoneal dialysis, cefepime for injection may be administered at normally recommended doses at a dosage interval of every 48 hours (see Table 11).

  In patients undergoing hemodialysis, approximately 68% of the total amount of cefepime present in the body at the start of dialysis will be removed during a 3-hour dialysis period. The dosage of cefepime for injection for hemodialysis patients is 1 g on Day 1 followed by 500 mg every 24 hours for the treatment of all infections except febrile neutropenia, which is 1 g every 24 hours.

  Cefepime for injection should be administered at the same time each day and following the completion of hemodialysis on hemodialysis days (see Table 11).

  Data in pediatric patients with impaired renal function are not available; however, since cefepime pharmacokinetics are similar in adults and pediatric patients (see CLINICAL PHARMACOLOGY), changes in the dosing regimen proportional to those in adults (see Tables 10 and 11) are recommended for pediatric patients.

  Administration For Intravenous Infusion

  Dilute with a suitable parenteral vehicle prior to intravenous infusion. Constitute the 1 g, or 2 g vial, and add an appropriate quantity of the resulting solution to an intravenous container with one of the compatible intravenous fluids listed in the Compatibility and Stability subsection. THE RESULTING SOLUTION SHOULD BE ADMINISTERED OVER APPROXIMATELY 30 MINUTES.

  Intermittent intravenous infusion with a Y-type administration set can be accomplished with compatible solutions. However, during infusion of a solution containing cefepime, it is desirable to discontinue the other solution.

  Intramuscular Administration

  For intramuscular administration, cefepime for injection should be constituted with one of the following diluents: Sterile Water for Injection, 0.9% Sodium Chloride, 5% Dextrose Injection, 0.5% or 1% Lidocaine Hydrochloride, or Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol (refer to Table 12).

  Preparation of cefepime for injection solutions is summarized in Table 12.

  Table 12: Preparation of Solutions of Cefepime for Injection Single-Dose Vials for
  Intravenous/Intramuscular
  Administration Amount of Diluent to
  be added (mL) Approximate
  Available
  Volume (mL) Approximate
  Cefepime Concentration
  (mg/mL)

  cefepime vial content

  1 g (IV)

  10

  11.3

  100

  1 g (IM)

  2.4

  3.6

  280

  2 g (IV)

  10

  12.5

  160

  Compatibility and Stability Intravenous

  Cefepime for injection is compatible at concentrations between 1 mg per mL and 40 mg per mL with the following intravenous infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection, Normosol™-R, and Normosol™-M in 5% Dextrose Injection. These solutions may be stored up to 24 hours at controlled room temperature 20° C to 25° C (68° F to 77° F) or 7 days in a refrigerator 2° C to 8° C (36° F to 46° F).

  Cefepime for injection admixture compatibility information is summarized in Table 13.

  Table 13: Cefepime Admixture Stability Stability Time for Cefepime for Injection Concentration
  Admixture and
  Concentration
  IV Infusion
  Solutions
  RT/L
  (20° to 25° C)
  Refrigeration
  (2° to 8° C)

  40 mg/mL

  Amikacin 6 mg/mL

  NS or D5W

  24 hours

  7 days

  40 mg/mL

  Ampicillin 1 mg/mL

  D5W

  8 hours

  8 hours

  40 mg/mL

  Ampicillin 10 mg/mL

  D5W

  2 hours

  8 hours

  40 mg/mL

  Ampicillin 1 mg/mL

  NS

  24 hours

  48 hours

  40 mg/mL

  Ampicillin 10 mg/mL

  NS

  8 hours

  48 hours

  4 mg/mL

  Ampicillin 40 mg/mL

  NS

  8 hours

  8 hours

  4 to 40 mg/mL

  Clindamycin Phosphate 0.25 to 6 mg/mL

  NS or D5W

  24 hours

  7 days

  4 mg/mL

  Heparin 10 to 50 units/mL

  NS or D5W

  24 hours

  7 days

  4 mg/mL

  Potassium Chloride 10 to 40 mEq/L

  NS or D5W

  24 hours

  7 days

  4 mg/mL

  Theophylline 0.8 mg/mL

  D5W

  24 hours

  7 days

  1 to 4 mg/mL

  na

  Aminosyn™ II 4.25% with electrolytes and calcium

  8 hours

  3 days

  0.125 to 0.25 mg/mL

  na

  Inpersol™ with 4.25% dextrose

  24 hours

  7 days

  NS = 0.9% Sodium Chloride Injection
  D5W = 5% Dextrose Injection
  na = not applicable
  RT/L = Ambient room temperature and light

  Solutions of cefepime for injection, like those of most beta-lactam antibiotics, should not be added to solutions of ampicillin at a concentration greater than 40 mg per mL, and should not be added to metronidazole, vancomycin, gentamicin, tobramycin, netilmicin sulfate, or aminophylline because of potential interaction. However, if concurrent therapy with cefepime for injection is indicated, each of these antibiotics can be administered separately.

  Intramuscular

  Cefepime for injection constituted as directed is stable for 24 hours at controlled room temperature 20° C to 25° C (68° F to 77° F) or for 7 days in a refrigerator 2° C to 8° C (36° F to 46° F) with the following diluents: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol, or 0.5% or 1% Lidocaine Hydrochloride.

  NOTE: PARENTERAL DRUGS SHOULD BE INSPECTED VISUALLY FOR PARTICULATE MATTER BEFORE ADMINISTRATION. IF PARTICULATE MATTER IS EVIDENT IN RECONSTITUTED FLUIDS, THE DRUG SOLUTION SHOULD BE DISCARDED.

  As with other cephalosporins, the color of cefepime for injection powder, as well as its solutions, tend to darken depending on storage conditions; however, when stored as recommended, the product potency is not adversely affected.

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  The Single Use ADD-Vantage® vials are for intravenous use only.

  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae.

  Adults – Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months. The doses for the preceding infections may be given by intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis

  Adults and children – 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia

  Adults and children – 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

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  Infections of the respiratory tract and soft tissues.
  Patients weighing 40 Kg (88 lbs) or more: 250 to 500 mg every 6 hours.
  Patients weighing less than 40 Kg (88 lbs): 25 to 50 mg/Kg/day in equally divided doses at 6-to 8-hour intervals.
  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).
  Patients weighing 40 Kg (88 lbs) or more: 500 mg every 6 hours.
  Patients weighing less than 40 Kg (88 lbs): 50 mg/Kg/day in equally divided doses at 6-to 8-hour intervals.
  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.
  

  Urethritis in males due to N. gonorrhoeae:
  Adults: Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required. In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months.
  The doses for the preceding infections may be given by intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis.
  Adults and children: 150 to 200 mg/Kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous infusion therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.
  

  Septicemia.
  Adults and children: 150 to 200 mg/Kg/day. Start with intravenous administration for at least three days. Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

  DIRECTIONS FOR USE:
  Use only freshly prepared solutions.  Intramuscular and intravenous injections should be administered within on hour after preparation, since the potency may decrease significantly after this period. 
  
  For Intramuscular Use
  Dissolve contents of vial with the amount of Sterile Water for Injection or Bacteriostatic Water for Injection listed in the table below. 
  
  NDC No.
  Label Claim
  Amount of
  Diluent to be
  Added (mL)
  Approximate
  Available
  Volume (mL)
  Approximate
  Concentration
  (in mg/mL)
  63323-387-10
  250 mg
  0.9
  1
  250
  63323-388-10
  500 mg
  1.7
  2
  250
  63323-389-10
  1 g
  3.4
  4
  250
  63323-399-23
  2 g
  6.8
  8
  250
  While ampicillin for injection 1 g and 2 g vials are primarily for intravenous use, the contents may be administered intramuscularly when the 250 mg or 500 mg vials are unavailable.  In such instances, dissolve in 3.4 or 6.8 mL Sterile Water for Injection or Bacteriostatic Water for Injection respectively.  The resulting solution will provide a concentration of 250 mg per mL.
  
  For Direct Intravenous Use
  Add 5 mL Sterile Water for Injection or Bacteriostatic Water for Injection to the 250 and 500 mg vials and administer slowly over a 3 to 5 minute period.  Ampicillin for Injection, 1 g or 2 g, may also be given by direct intravenous administration.  Dissolve in 7.4 or 14.8 mL Sterile Water for Injection or Bacteriostatic Water for Injection, respectively, and administer slowly over at least 10 to 15 minutes.  CAUTION: More rapid administration may result in convulsive seizures.
  
  For Administration by Intravenous Drip
  Reconstitute as direct above ( For Direct Intravenous Use) prior to diluting with intravenous solution.  Stability studies on ampicillin at several concentrations in various intravenous solutions indicated the drug will lose less than 10% activity at the temperatures noted for the time periods stated. 
  
  Room Temperature (25 C) Diluent Concentrations Stability Periods Sterile Water for Injection
  up to 30 mg/mL
  8 hours
  Sodium Chloride Injection 0.9%
  up to 30 mg/mL
  8 hours
  M/6 Sodium Lactate Injection
  up to 30 mg/mL
  8 hours
  5% Dextrose in Water
  10 to 20 mg/mL
  2 hours
  5% Dextrose in Water
  up to 2 mg/mL
  4 hours
  5% Dextrose and 0.45 NaCl Inj.
  up to 2 mg/mL
  4 hours
  10% Invert Sugar in Water
  up to 2 mg/mL
  4 hours
  Lactated Ringer's Injection
  up to 30 mg/mL
  8 hours
  
  Refrigerated (4 C) Diluent Concentrations Stability Periods Sterile Water for Injection
  30 mg/mL
  48 hours
  Sterile Water for Injection
  up to 20 mg/mL
  72 hours
  Sodium Chloride Injection 0.9%
  30 mg/mL
  48 hours
  Sodium Chloride Injection 0.9%
  up to 20 mg/mL
  72 hours
  Lactated Ringer's Injection
  up to 30 mg/mL
  24 hours
  M/6 Sodium Lactate Injection
  up to 30 mg/mL
  8 hours
  5% Dextrose in Water
  up to 20 mg/mL
  4 hours
  5% Dextrose and 0.45 NaCl Inj.
  up to 10 mg/mL
  4 hours
  10% Invert Sugar
  up to 20 mg/mL
  3 hours
  Only those solutions listed above should be used for the intravenous infusion of Ampicillin for Injection.  The concentrations should fall within the range specified.  The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of ampicillin is administered before the drug loses its stability in the solution in use. 
  
  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 
  
  

  
  

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  ADULTS AND CHILDREN WEIGHING OVER 20 KG:

  For genitourinary or gastrointestinal tract infections other than gonorrhea in men and women, the usual dose is 500 mg qid in equally spaced doses; severe or chronic infections may require larger doses. For the treatment of gonorrhea in both men and women, a single oral dose of 3.5 grams of ampicillin administered simultaneously with 1 gram of probenecid is recommended. Physicians are cautioned to use no less than the above recommended dosage for the treatment of gonorrhea. Follow-up cultures should be obtained from the original site(s) of infection 7 to 14 days after therapy. In women, it is also desirable to obtain culture test-of-cure from both the endocervical and anal canals. Prolonged intensive therapy is needed for complications such as prostatitis and epididymitis.

  For respiratory tract infections, the usual dose is 250 mg qid in equally spaced doses.

  CHILDREN WEIGHING 20 KG OR LESS:

  For genitourinary or gastrointestinal tract infections, the usual dose is 100 mg/kg/day total, qid in equally divided and spaced doses. For respiratory infections, the usual dose is 50 mg/kg/day total, in equally divided and spaced doses three to four times daily. Doses for children should not exceed doses recommended for adults.

  ALL PATIENTS, IRRESPECTIVE OF AGE AND WEIGHT:

  Larger doses may be required for severe or chronic infections. Although ampicillin is resistant to degradation by gastric acid, it should be administered at least one-half hour before or two hours after meals for maximal absorption. Except for the single dose regimen for gonorrhea referred to above, therapy should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. In infections caused by hemolytic strains of streptococci, a minimum of 10 days’ treatment is recommended to guard against the risk of rheumatic fever of glomerulonephritis (see PRECAUTIONS–Laboratory Tests). In the treatment of chronic urinary or gastrointestinal infections, frequent bacteriologic and clinical appraisal is necessary during therapy and may be necessary for several months afterwards. Stubborn infections may require treatment for several weeks. Smaller doses than those indicated above should not be used.

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• Dava Pharmaceuticals, Inc.
  

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  Adults and children weighing over 20 Kg: For genitourinary or gastrointestinal tract infections other than gonorrhea in men and women, the usual dose is 500 mg q.i.d. in equally spaced doses; severe or chronic infections may require larger doses. For the treatment of gonorrhea in both men and women, a single oral dose of 3.5 grams of ampicillin administered simultaneously with 1 gram of probenecid is recommended. Physicians are cautioned to use no less than the above recommended dosage for the treatment of gonorrhea. Follow-up cultures should be obtained from the original site(s) of infection 7 to 14 days after therapy. In women, it is also desirable to obtain culture test-of-cure from both the endocervical and anal canals. Prolonged intensive therapy is needed for complications such as prostatitis and epididymitis. For respiratory tract infections, the usual dose is 250 mg q.i.d. in equally spaced doses.

  Pediatric Patients weighing 20 Kg or less: For genitourinary or gastrointestinal tract infections, the usual dose is 100 mg/kg/day total, q.i.d. in equally divided and spaced doses.

  For respiratory tract infections, the usual dose is 50 mg/kg/day total, in equally divided and spaced doses three to four times daily. Doses for children should not exceed doses recommended for adults.

  All patients, irrespective of age and weight: Larger doses may be required for severe or chronic infections. Although ampicillin is resistant to degradation by gastric acid, it should be administered at least one half-hour before or two hours after meals for maximal absorption. Except for the single dose regimen for gonorrhea referred to above, therapy should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or evidence that bacterial eradication has been obtained. In infections caused by hemolytic strains of streptococci, a minimum of 10 days' treatment is recommended to guard against the risk of rheumatic fever or glomerulonephritis (see PRECAUTIONS, Laboratory Tests). In the treatment of chronic urinary or gastrointestinal infections, frequent bacteriologic and clinical appraisal is necessary during therapy and may be necessary for several months afterwards. Stubborn infections may require treatment for several weeks. Smaller doses than those indicated above should not be used.

  Directions for mixing Oral Suspension

  Prepare suspension at time of dispensing. For ease of preparation, add water to the bottle in two portions and shake well after each addition.

  125 mg/5 mL
  Add a total of 86 mL to the 100 mL package and 170 mL to the 200 mL package. This will provide 100 mL and 200 mL of suspension, respectively. Each 5 mL (teaspoonful) will contain ampicillin trihydrate equivalent to 125 mg ampicillin.

  250 mg/5 mL
  Add a total of 70 mL to the 100 mL package and 139 mL to the 200 mL package. This will provide 100 mL and 200 mL of suspension, respectively. Each 5 mL (teaspoonful) will contain ampicillin trihydrate equivalent to 250 mg ampicillin.

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  ADULTS AND CHILDREN WEIGHING OVER 20 KG:

  For genitourinary or gastrointestinal tract infections other than gonorrhea in men and women, the usual dose is 500 mg qid in equally spaced doses; severe or chronic infections may require larger doses. For the treatment of gonorrhea in both men and women, a single oral dose of 3.5 grams of ampicillin administered simultaneously with 1 gram of probenecid is recommended. Physicians are cautioned to use no less than the above recommended dosage for the treatment of gonorrhea. Follow-up cultures should be obtained from the original site(s) of infection 7 to 14 days after therapy. In women, it is also desirable to obtain culture test-of-cure from both the endocervical and anal canals. Prolonged intensive therapy is needed for complications such as prostatitis and epididymitis.

  For respiratory tract infections, the usual dose is 250 mg qid in equally spaced doses.

  CHILDREN WEIGHING 20 KG OR LESS:

  For genitourinary or gastrointestinal tract infections, the usual dose is 100 mg/kg/day total, qid in equally divided and spaced doses. For respiratory infections, the usual dose is 50 mg/kg/day total, in equally divided and spaced doses three to four times daily. Doses for children should not exceed doses recommended for adults.

  ALL PATIENTS, IRRESPECTIVE OF AGE AND WEIGHT:

  Larger doses may be required for severe or chronic infections. Although ampicillin is resistant to degradation by gastric acid, it should be administered at least one-half hour before or two hours after meals for maximal absorption. Except for the single dose regimen for gonorrhea referred to above, therapy should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. In infections caused by hemolytic strains of streptococci, a minimum of 10 days’ treatment is recommended to guard against the risk of rheumatic fever of glomerulonephritis (see PRECAUTIONS–Laboratory Tests). In the treatment of chronic urinary or gastrointestinal infections, frequent bacteriologic and clinical appraisal is necessary during therapy and may be necessary for several months afterwards. Stubborn infections may require treatment for several weeks. Smaller doses than those indicated above should not be used.

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  Adults and children weighing over 20 Kg: For genitourinary or gastrointestinal tract infections other than gonorrhea in men and women, the usual dose is 500 mg q.i.d. in equally spaced doses; severe or chronic infections may require larger doses. For the treatment of gonorrhea in both men and women, a single oral dose of 3.5 grams of ampicillin administered simultaneously with 1 gram of probenecid is recommended. Physicians are cautioned to use no less than the above recommended dosage for the treatment of gonorrhea. Follow-up cultures should be obtained from the original site(s) of infection 7 to 14 days after therapy. In women, it is also desirable to obtain culture test-of-cure from both the endocervical and anal canals. Prolonged intensive therapy is needed for complications such as prostatitis and epididymitis. For respiratory tract infections, the usual dose is 250 mg q.i.d. in equally spaced doses.

  Pediatric Patients weighing 20 Kg or less: For genitourinary or gastrointestinal tract infections, the usual dose is 100 mg/kg/day total, q.i.d. in equally divided and spaced doses.

  For respiratory tract infections, the usual dose is 50 mg/kg/day total, in equally divided and spaced doses three to four times daily. Doses for children should not exceed doses recommended for adults.

  All patients, irrespective of age and weight: Larger doses may be required for severe or chronic infections. Although ampicillin is resistant to degradation by gastric acid, it should be administered at least one half-hour before or two hours after meals for maximal absorption. Except for the single dose regimen for gonorrhea referred to above, therapy should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or evidence at bacterial eradication has been obtained. In infections caused by haemolytic strains of streptococci, a minimum of 10 days' treatment is recommended to guard against the risk of rheumatic fever or glomerulonephritis (see PRECAUTIONS, Laboratory Tests). In the treatment of chronic urinary or gastrointestinal infections, frequent bacteriologic and clinical appraisal is necessary during therapy and may be necessary for several months afterwards. Stubborn infections may require treatment for several weeks. Smaller doses than those indicated above should not be used.

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• Cardinal Health
  

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  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae.

  Adults – Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months. The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis

  Adults and children – 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia

  Adults and children – 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

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  ---

  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6 to 8 hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6 to 8 hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae.

  Adults: Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months.

  The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis

  Adults and children: 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous infusion therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia

  Adults and children: 150 to 200 mg/kg/day. Start with intravenous administration for at least 3 days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

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• General Injectables & Vaccines, Inc
  

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  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 Kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 Kg (88 lbs): 25 to 50 mg/Kg/day in equally divided doses at 6-to 8-hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 Kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 Kg (88 lbs): 50 mg/Kg/day in equally divided doses at 6-to 8-hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae:

  Adults: Two doses of 500 mg each at an interval of 8 to 12 hours.

  Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months.

  The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis.

  Adults and children: 150 to 200 mg/Kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous infusion therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia.

  Adults and children: 150 to 200 mg/Kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

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  Ampicillin | General Injectables & Vaccines, Inc

  

  ---

  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 Kg (88 lbs) or more:  250 to 500 mg every 6 hours.

  Patients weighing less than 40 Kg (88 lbs):  25 to 50 mg/Kg/day in equally divided doses at 6-to 8-hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 Kg (88 lbs) or more:  500 mg every 6 hours.

  Patients weighing less than 40 Kg (88 lbs):  50 mg/Kg/day in equally divided doses at 6-to 8-hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae:

  Adults:  Two doses of 500 mg each at an interval of 8 to 12 hours.

  Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months.

  The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis.

  Adults and children:  150 to 200 mg/Kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous infusion therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia.

  Adults and children:  150 to 200 mg/Kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

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  More Info
• Cardinal Health
  

  ×

  Ampicillin | Cardinal Health

  

  ---

  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6 to 8 hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6 to 8 hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae.

  Adults: Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months.

  The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis

  Adults and children: 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous infusion therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia

  Adults and children: 150 to 200 mg/kg/day. Start with intravenous administration for at least 3 days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

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  More Info
• A-s Medication Solutions Llc
  

  ×

  Ampicillin | A-s Medication Solutions Llc

  

  ---

  Adults and children weighing over 20 Kg: For genitourinary or gastrointestinal tract infections other than gonorrhea in men and women, the usual dose is 500 mg q.i.d. in equally spaced doses; severe or chronic infections may require larger doses. For the treatment of gonorrhea in both men and women, a single oral dose of 3.5 grams of ampicillin administered simultaneously with 1 gram of probenecid is recommended. Physicians are cautioned to use no less than the above recommended dosage for the treatment of gonorrhea. Follow-up cultures should be obtained from the original site(s) of infection 7 to 14 days after therapy. In women, it is also desirable to obtain culture test-of-cure from both the endocervical and anal canals. Prolonged intensive therapy is needed for complications such as prostatitis and epididymitis. For respiratory tract infections, the usual dose is 250 mg q.i.d. in equally spaced doses.

  Pediatric Patients weighing 20 Kg or less: For genitourinary or gastrointestinal tract infections, the usual dose is 100 mg/kg/day total, q.i.d. in equally divided and spaced doses.

  For respiratory tract infections, the usual dose is 50 mg/kg/day total, in equally divided and spaced doses three to four times daily. Doses for children should not exceed doses recommended for adults.

  All patients, irrespective of age and weight: Larger doses may be required for severe or chronic infections. Although ampicillin is resistant to degradation by gastric acid, it should be administered at least one half-hour before or two hours after meals for maximal absorption. Except for the single dose regimen for gonorrhea referred to above, therapy should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or evidence at bacterial eradication has been obtained. In infections caused by haemolytic strains of streptococci, a minimum of 10 days' treatment is recommended to guard against the risk of rheumatic fever or glomerulonephritis (see PRECAUTIONS, Laboratory Tests). In the treatment of chronic urinary or gastrointestinal infections, frequent bacteriologic and clinical appraisal is necessary during therapy and may be necessary for several months afterwards. Stubborn infections may require treatment for several weeks. Smaller doses than those indicated above should not be used.

  Directions for mixing Oral Suspension

  Prepare suspension at time of dispensing. For ease of preparation, add water to the bottle in two portions and shake well after each addition.

  125 mg/5 mL
  Add a total of 86 mL to the 100 mL package and 170 mL to the 200 mL package. This will provide 100 mL and 200 mL of suspension. Each 5 mL (teaspoonful) will contain ampicillin trihydrate equivalent to 125 mg ampicillin.

  250 mg/5 mL
  Add a total of 70 mL to the 100 mL package and 139 mL to the 200 mL package. This will provide 100 mL and 200 mL of suspension . Each 5 mL (teaspoonful) will contain ampicillin trihydrate equivalent to 250 mg ampicillin.

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  No Recall

  More Info
• Gc Hanford Manufacturing Company
  

  ×

  Ampicillin | Gc Hanford Manufacturing Company

  

  ---

  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8-hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more:500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8-hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae.

  Adults: Two doses of 500 mg each at an interval of 8 to 12 hours.

  Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months.

  The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis.

  Adults and children: 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia.

  Adults and children: 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

  Close
  No Recall

  More Info
• Gc Hanford Manufacturing Company
  

  ×

  Ampicillin | Gc Hanford Manufacturing Company

  

  ---

  This insert is for the Pharmacy Bulk Package and is intended for preparing IV admixtures only. Dosage recommendations for intramuscular or direct intravenous injection are for informational purposes only.

  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8-hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8-hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae:

  Adults: Two doses of 500 mg each at an interval of 8 to 12 hours.

  Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months.

  The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis.

  Adults and children: 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia.

  Adults and children: 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.
  
  

  For Administration by Intravenous Infusion: Reconstitute as directed below (Directions for Proper Use of Pharmacy Bulk Package) prior to diluting with an intravenous solution.

  IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Stability studies on ampicillin sodium at several concentrations in various intravenous solutions indicate the drug will lose less than 10% activity at the temperatures noted for the time periods stated.

  Room Temperature (25°C)

  Diluent

  Concentrations

  Stability Periods

  Sterile Water for Injection

  up to 30 mg/mL

  8 hours

  Sodium Chloride Injection, USP 0.9%

  up to 30 mg/mL

  8 hours

  5% Dextrose in Water

  10 to 20 mg/mL

  1 hour

  5% Dextrose in Water

  up to 2 mg/mL

  2 hours

  5% Dextrose in 0.45% NaCl Inj.

  up to 2 mg/mL

  2 hours

  Lactated Ringer’s Solution

  up to 30 mg/mL

  8 hours

  Refrigerated (4°C)

  Sterile Water for Injection

  30 mg/mL

  48 hours

  Sterile Water for Injection

  up to 20 mg/mL

  72 hours

  Sodium Chloride Injection, USP, 0.9%

  30 mg/mL

  24 hours

  Sodium Chloride Injection, USP, 0.9%

  up to 20 mg/mL

  48 hours

  Lactated Ringer’s Solution

  up to 30 mg/mL

  24 hours

  5% Dextrose in Water

  up to 20 mg/mL

  1 hour

  5% Dextrose in 0.45% NaCl Inj.

  up to 10 mg/mL

  1 hour

  Only those solutions listed above should be used for the intravenous infusion of Ampicillin for Injection, USP. The concentrations should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of Ampicillin is administered before the drug loses its stability in the solution in use.

  Directions for Proper Use of Pharmacy Bulk Package

  This glass Pharmacy Bulk Package bottle contains 10 grams Ampicillin and is designed for use in the pharmacy in preparing IV admixtures.

  a) Add 94 mL Sterile Water for Injection, USP. The resulting solution will contain 100 milligrams ampicillin activity per mL, and is stable up to one hour at room temperature. b) Dilute further within ONE HOUR to a concentration of 5 mg to 10 mg per mL. See TABLE for suitable fluid. Use promptly. This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible. c) Using aseptic technique under a laminar flow hood, the closure should be penetrated only one time after reconstitution using a suitable sterile dispensing set which allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage. d) After entry, use entire contents of Pharmacy Bulk Package bottle promptly. The entire contents of the Pharmacy Bulk Package bottle must be dispensed within ONE HOUR of reconstitution. This time limit should begin with the introduction of solvent in the Pharmacy Bulk Package bottle. e) A plastic bail band attached to the Pharmacy Bulk Package provides a suitable hanging device while dispensing contents.

  Use of this product is restricted to a suitable work area, such as a laminar flow hood. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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  More Info
• Pd-rx Pharmaceuticals, Inc.
  

  ×

  Ampicillin | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Adults and children weighing over 20 Kg: For genitourinary or gastrointestinal tract infections other than gonorrhea in men and women, the usual dose is 500 mg q.i.d. in equally spaced doses; severe or chronic infections may require larger doses. For the treatment of gonorrhea in both men and women, a single oral dose of 3.5 grams of ampicillin administered simultaneously with 1 gram of probenecid is recommended. Physicians are cautioned to use no less than the above recommended dosage for the treatment of gonorrhea. Follow-up cultures should be obtained from the original site(s) of infection 7 to 14 days after therapy. In women, it is also desirable to obtain culture test-of-cure from both the endocervical and anal canals. Prolonged intensive therapy is needed for complications such as prostatitis and epididymitis. For respiratory tract infections, the usual dose is 250 mg q.i.d. in equally spaced doses.

  Pediatric Patients weighing 20 Kg or less: For genitourinary or gastrointestinal tract infections, the usual dose is 100 mg/kg/day total, q.i.d. in equally divided and spaced doses.

  For respiratory tract infections, the usual dose is 50 mg/kg/day total, in equally divided and spaced doses three to four times daily. Doses for children should not exceed doses recommended for adults.

  All patients, irrespective of age and weight: Larger doses may be required for severe or chronic infections. Although ampicillin is resistant to degradation by gastric acid, it should be administered at least one half-hour before or two hours after meals for maximal absorption. Except for the single dose regimen for gonorrhea referred to above, therapy should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or evidence at bacterial eradication has been obtained. In infections caused by haemolytic strains of streptococci, a minimum of 10 days' treatment is recommended to guard against the risk of rheumatic fever or glomerulonephritis (see PRECAUTIONS, Laboratory Tests). In the treatment of chronic urinary or gastrointestinal infections, frequent bacteriologic and clinical appraisal is necessary during therapy and may be necessary for several months afterwards. Stubborn infections may require treatment for several weeks. Smaller doses than those indicated above should not be used.

  Directions for mixing Oral Suspension

  Prepare suspension at time of dispensing. For ease of preparation, add water to the bottle in two portions and shake well after each addition.

  125 mg/5 mL
  Add a total of 86 mL to the 100 mL package and 170 mL to the 200 mL package. This will provide 100 mL and 200 mL of suspension. Each 5 mL (teaspoonful) will contain ampicillin trihydrate equivalent to 125 mg ampicillin.

  250 mg/5 mL
  Add a total of 70 mL to the 100 mL package and 139 mL to the 200 mL package. This will provide 100 mL and 200 mL of suspension . Each 5 mL (teaspoonful) will contain ampicillin trihydrate equivalent to 250 mg ampicillin.

  Close
  No Recall

  More Info
• Sandoz Inc
  

  ×

  Ampicillin | Sandoz Inc

  

  ---

  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae.

  Adults – Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months. The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis

  Adults and children – 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia

  Adults and children – 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

  Close
  No Recall

  More Info
• Sandoz Inc
  

  ×

  Ampicillin | Sandoz Inc

  

  ---

  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae.

  Adults – Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months. The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis

  Adults and children – 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia

  Adults and children – 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

  Close
  No Recall

  More Info
• Sandoz Inc
  

  ×

  Ampicillin | Sandoz Inc

  

  ---

  This insert is for a Pharmacy Bulk Package and is intended for preparing IV admixtures only. Dosage recommendations for intramuscular injection are for informational purposes only.

  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae.

  Adults – Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months.

  The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis

  Adults and children – 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia

  Adults and children – 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

  For Administration by Intravenous Infusion – Reconstitute as directed below (Directions for Proper Use of Pharmacy Bulk Package) prior to diluting with an intravenous solution.

  IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Stability studies on ampicillin sodium at several concentrations in various intravenous solutions indicate the drug will lose less than 10% activity at the temperatures noted for the time periods stated.

  Room Temperature (25° C)

  Diluent

  Concentrations

  Stability Periods

  Sterile Water for Injection USP

  up to 30 mg/mL

  8 hours

  0.9% Sodium Chloride Injection USP

  up to 30 mg/mL

  8 hours

  5% Dextrose Injection USP

  10 to 20 mg/mL

  1 hour

  5% Dextrose Injection USP

  up to   2 mg/mL

  2 hours

  5% Dextrose and 0.45% NaCl Injection USP

  up to   2 mg/mL

  2 hours

  Lactated Ringer’s Injection USP

  up to 30 mg/mL

  8 hours

  Refrigerated (4° C)

  Sterile Water for Injection USP

  30 mg/mL

  48 hours

  Sterile Water for Injection USP

  up to 20 mg/mL

  72 hours

  0.9% Sodium Chloride Injection USP

  30 mg/mL

  24 hours

  0.9% Sodium Chloride Injection USP

  up to 20 mg/mL

  48 hours

  Lactated Ringer’s Injection USP

  up to 30 mg/mL

  24 hours

  5% Dextrose Injection USP

  up to 20 mg/mL

  1 hour

  5% Dextrose and 0.45% NaCl Injection USP

  up to 10 mg/mL

  1 hour

  Only those solutions listed above should be used for the intravenous infusion of Ampicillin for Injection, USP. The concentrations should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of ampicillin is administered before the drug loses its stability in the solution in use.

  Directions For Proper Use Of Pharmacy Bulk Package

  This glass Pharmacy Bulk Package bottle contains 10 grams ampicillin and is designed for use in the pharmacy in preparing IV admixtures.

  a) Add 94 mL Sterile Water for Injection USP. The resulting solution will contain 100 milligrams ampicillin activity per mL, and is stable up to one hour at room temperature.

  b) Dilute further within ONE HOUR to a concentration of 5 mg to 10 mg per mL. See Table for suitable fluid. Use promptly. This chemical stability information in no way indicates that it would be acceptable practice to use this product well after preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  c) Using aseptic technique under a laminar flow hood, the closure should be penetrated only one time after reconstitution using a suitable sterile dispensing set; which allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage.

  d) After entry, use entire contents of Pharmacy Bulk Package bottle promptly. The entire contents of the Pharmacy Bulk Package bottle must be dispensed within ONE HOUR of reconstitution. This time limit should begin with the introduction of solvent in the Pharmacy Bulk Package bottle.

  e) A plastic ball attached to the pharmacy bulk package provides a suitable hanging device while dispensing contents.

  Use of this product is restricted to a suitable work area, such as a laminar flow hood. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Close
  No Recall

  More Info
• Sandoz Inc
  

  ×

  Ampicillin | Sandoz Inc

  

  ---

  This insert is for a Pharmacy Bulk Package and is intended for preparing IV admixtures only. Dosage recommendations for intramuscular injection are for informational purposes only.

  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae.

  Adults – Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months.

  The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis

  Adults and children – 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia

  Adults and children – 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

  For Administration by Intravenous Infusion – Reconstitute as directed below (Directions for Proper Use of Pharmacy Bulk Package) prior to diluting with an intravenous solution.

  IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Stability studies on ampicillin sodium at several concentrations in various intravenous solutions indicate the drug will lose less than 10% activity at the temperatures noted for the time periods stated.

  Room Temperature (25° C)

  Diluent

  Concentrations

  Stability Periods

  Sterile Water for Injection USP

  up to 30 mg/mL

  8 hours

  0.9% Sodium Chloride Injection USP

  up to 30 mg/mL

  8 hours

  5% Dextrose Injection USP

  10 to 20 mg/mL

  1 hour

  5% Dextrose Injection USP

  up to   2 mg/mL

  2 hours

  5% Dextrose and 0.45% NaCl Injection USP

  up to   2 mg/mL

  2 hours

  Lactated Ringer’s Injection USP

  up to 30 mg/mL

  8 hours

  Refrigerated (4° C)

  Sterile Water for Injection USP

  30 mg/mL

  48 hours

  Sterile Water for Injection USP

  up to 20 mg/mL

  72 hours

  0.9% Sodium Chloride Injection USP

  30 mg/mL

  24 hours

  0.9% Sodium Chloride Injection USP

  up to 20 mg/mL

  48 hours

  Lactated Ringer’s Injection USP

  up to 30 mg/mL

  24 hours

  5% Dextrose Injection USP

  up to 20 mg/mL

  1 hour

  5% Dextrose and 0.45% NaCl Injection USP

  up to 10 mg/mL

  1 hour

  Only those solutions listed above should be used for the intravenous infusion of Ampicillin for Injection, USP. The concentrations should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of ampicillin is administered before the drug loses its stability in the solution in use.

  Directions For Proper Use Of Pharmacy Bulk Package

  This glass Pharmacy Bulk Package bottle contains 10 grams ampicillin and is designed for use in the pharmacy in preparing IV admixtures.

  a) Add 94 mL Sterile Water for Injection USP. The resulting solution will contain 100 milligrams ampicillin activity per mL, and is stable up to one hour at room temperature.

  b) Dilute further within ONE HOUR to a concentration of 5 mg to 10 mg per mL. See Table for suitable fluid. Use promptly. This chemical stability information in no way indicates that it would be acceptable practice to use this product well after preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  c) Using aseptic technique under a laminar flow hood, the closure should be penetrated only one time after reconstitution using a suitable sterile dispensing set; which allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage.

  d) After entry, use entire contents of Pharmacy Bulk Package bottle promptly. The entire contents of the Pharmacy Bulk Package bottle must be dispensed within ONE HOUR of reconstitution. This time limit should begin with the introduction of solvent in the Pharmacy Bulk Package bottle.

  e) A plastic ball attached to the pharmacy bulk package provides a suitable hanging device while dispensing contents.

  Use of this product is restricted to a suitable work area, such as a laminar flow hood. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• Auromedics Pharma Llc
  

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  Ampicillin | American Health Packaging

  

  ---

  In elderly patients, the pharmacokinetics of metronidazole may be altered, and, therefore, monitoring of serum levels may be necessary to adjust the metronidazole dosage accordingly.

  Trichomoniasis
  In the Female
  One-day treatment — two grams of metronidazole tablets, given either as a single dose or in two divided doses of one gram each given in the same day. Seven-day course of treatment — 250 mg three times daily for seven consecutive days. There is some indication from controlled comparative studies that cure rates as determined by vaginal smears, signs and symptoms, may be higher after a seven-day course of treatment than after a one day treatment regimen.

  The dosage regimen should be individualized. Single-dose treatment can assure compliance, especially if administered under supervision, in those patients who cannot be relied on to continue the seven-day regimen. A seven-day course of treatment may minimize reinfection by protecting the patient long enough for the sexual contacts to obtain appropriate treatment. Further, some patients may tolerate one treatment regimen better than the other.

  Pregnant patients should not be treated during the first trimester. (See CONTRAINDICATIONS.) In pregnant patients in whom alternative treatment has been inadequate, the one-day course of therapy should not be used, as it results in higher serum levels which can reach the fetal circulation (see PRECAUTIONS, Pregnancy).

  When repeat courses of the drug are required, it is recommended that an interval of four to six weeks elapse between courses and that the presence of the trichomonad be reconfirmed by appropriate laboratory measures. Total and differential leukocyte counts should be made before and after re-treatment.

  In the Male
  Treatment should be individualized as for the female.

  Amebiasis
  Adults
  For acute intestinal amebiasis (acute amebic dysentery): 750 mg orally three times daily for 5 to 10 days.
  For amebic liver abscess: 500 mg or 750 mg orally three times daily for 5 to 10 days.

  Pediatric Patients
  35 to 50 mg/kg/24 hours, divided into three doses, orally for 10 days.

  Anaerobic Bacterial Infections
  In the treatment of most serious anaerobic infections, the intravenous form of metronidazole is usually administered initially.

  The usual adult oral dosage is 7.5 mg/kg every six hours (approx. 500 mg for a 70 kg adult). A maximum of 4 g should not be exceeded during a 24-hour period.

  The usual duration of therapy is 7 to 10 days; however, infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment.

  Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in the plasma. Accordingly, for such patients, doses below those usually recommended should be administered cautiously. Close monitoring of plasma metronidazole levels 2 and toxicity is recommended.

  The dose of metronidazole tablets should not be specifically reduced in anuric patients since accumulated metabolites may be rapidly removed by dialysis.

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• App Pharmaceuticals, Llc
  

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  Ampicillin | App Pharmaceuticals, Llc

  

  ---

  This insert is for a Pharmacy Bulk Package and is intended for preparing IV admixtures only.  Dosage recommendations for intravenous injection are for informational purposes only.

  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used.  Higher doses should be used for stubborn or severe infections.  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.

  Urethritis in males due to N. gonorrhoeae.

  Adults - Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required.  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment.  In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months.

  The doses for the preceding infections may be given by either the intramuscular or intravenous route.  A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis
  

  Adults and children – 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours.  (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia

  Adults and children – 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours. 

  Treatment of all infections 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.  A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

  For Administration by Intravenous Infusion

  Reconstitute as directed below (Directions for Proper Use of Pharmacy Bulk Package) prior to diluting with an intravenous solution.

  IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time.  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Stability studies on ampicillin sodium at several concentrations in various intravenous solutions indicate the drug will lose less than 10% activity at the temperatures noted for the time periods stated.

   

  Room Temperature (25°C)

   

  Diluent

   

  Concentrations

   

  Stability Periods

   

  Sterile Water for Injection

   

  up to 30 mg/mL

   

  8 hours

   

  Sodium Chloride Injection USP, 0.9%

   

  up to 30 mg/mL

   

  8 hours

   

  5% Dextrose in Water

   

  10 to 20 mg/mL

   

  1 hour

   

  5% Dextrose in Water

   

  up to 2 mg/mL

   

  2 hours

   

  5% Dextrose in 0.45% NaCl Inj.

   

  up to 2 mg/mL

   

  2 hours

   

  Lactated Ringer’s Solution

   

  up to 30 mg/mL

   

  8 hours

   

  Refrigerated (4°C)

   

  Sterile Water for Injection

   

  30 mg/mL

   

  48 hours

   

  Sterile Water for Injection

   

  up to 20 mg/mL

   

  72 hours

   

  Sodium Chloride Injection USP, 0.9%

   

  30 mg/mL

   

  24 hours

   

  Sodium Chloride Injection USP, 0.9%

   

  up to 20 mg/mL

   

  48 hours

   

  Lactated Ringer’s Solution

   

  up to 30 mg/mL

   

  24 hours

   

  5% Dextrose in Water

   

  up to 20 mg/mL

   

  1 hour

   

  5% Dextrose and 0.45% NaCl Inj.

   

  up to 10 mg/mL

   

  1 hour

   

  Only those solutions listed above should be used for the intravenous infusion of Ampicillin for Injection, USP.  The concentrations should fall within the range specified.  The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of ampicillin is administered before the drug loses its stability in the solution in use.

  Directions For Proper Use Of Pharmacy Bulk Package

  This glass Pharmacy Bulk Package bottle contains 10 grams ampicillin and is designed for use in the pharmacy in preparing IV admixtures.

  a) Add 94 mL Sterile Water for Injection USP.  The resulting solution will contain 100 milligrams ampicillin activity per mL, and is stable up to ONE HOUR at room temperature.

  b) Dilute further within ONE HOUR to a concentration of 5 mg to 10 mg per mL.  See Table for suitable fluid.  Use promptly.  This chemical stability information in no way indicates that it would be acceptable practice to use this product well after preparation time.  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  c) Using aseptic technique under a laminar flow hood, the closure should be penetrated only one time after reconstitution using a suitable sterile dispensing set; which allows measured dispensing of the contents.  Use of a syringe and needle is not recommended as it may cause leakage.

  d) After entry, use entire contents of Pharmacy Bulk Package bottle promptly.  The entire contents of the Pharmacy Bulk Package bottle must be dispensed within ONE HOUR of reconstitution.  This time limit should begin with the introduction of solvent or diluent into the Pharmacy Bulk Package bottle.

  e) A plastic ball attached to the pharmacy bulk package provides a suitable hanging device while dispensing contents. 

  Use of this product is restricted to a suitable work area, such as a laminar flow hood.  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used.  Higher doses should be used for stubborn or severe infections.  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.

  Urethritis in males due to N. gonorrhoeae.

  Adults - Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required.  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment.  In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months.

  The doses for the preceding infections may be given by either the intramuscular or intravenous route.  A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis
  

  Adults and children – 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours.  (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia

  Adults and children – 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours. 

  Treatment of all infections 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.  A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

  For Administration by Intravenous Infusion

  Reconstitute as directed below (Directions for Proper Use of Pharmacy Bulk Package) prior to diluting with an intravenous solution.

  IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time.  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Stability studies on ampicillin sodium at several concentrations in various intravenous solutions indicate the drug will lose less than 10% activity at the temperatures noted for the time periods stated.

   

  Room Temperature (25°C)

   

  Diluent

   

  Concentrations

   

  Stability Periods

   

  Sterile Water for Injection

   

  up to 30 mg/mL

   

  8 hours

   

  Sodium Chloride Injection USP, 0.9%

   

  up to 30 mg/mL

   

  8 hours

   

  5% Dextrose in Water

   

  10 to 20 mg/mL

   

  1 hour

   

  5% Dextrose in Water

   

  up to 2 mg/mL

   

  2 hours

   

  5% Dextrose in 0.45% NaCl Inj.

   

  up to 2 mg/mL

   

  2 hours

   

  Lactated Ringer’s Solution

   

  up to 30 mg/mL

   

  8 hours

   

  Refrigerated (4°C)

   

  Sterile Water for Injection

   

  30 mg/mL

   

  48 hours

   

  Sterile Water for Injection

   

  up to 20 mg/mL

   

  72 hours

   

  Sodium Chloride Injection USP, 0.9%

   

  30 mg/mL

   

  24 hours

   

  Sodium Chloride Injection USP, 0.9%

   

  up to 20 mg/mL

   

  48 hours

   

  Lactated Ringer’s Solution

   

  up to 30 mg/mL

   

  24 hours

   

  5% Dextrose in Water

   

  up to 20 mg/mL

   

  1 hour

   

  5% Dextrose and 0.45% NaCl Inj.

   

  up to 10 mg/mL

   

  1 hour

   

  Only those solutions listed above should be used for the intravenous infusion of Ampicillin for Injection, USP.  The concentrations should fall within the range specified.  The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of ampicillin is administered before the drug loses its stability in the solution in use.

  Directions For Proper Use Of Pharmacy Bulk Package

  This glass Pharmacy Bulk Package bottle contains 10 grams ampicillin and is designed for use in the pharmacy in preparing IV admixtures.

  a) Add 94 mL Sterile Water for Injection USP.  The resulting solution will contain 100 milligrams ampicillin activity per mL, and is stable up to ONE HOUR at room temperature.

  b) Dilute further within ONE HOUR to a concentration of 5 mg to 10 mg per mL.  See Table for suitable fluid.  Use promptly.  This chemical stability information in no way indicates that it would be acceptable practice to use this product well after preparation time.  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  c) Using aseptic technique under a laminar flow hood, the closure should be penetrated only one time after reconstitution using a suitable sterile dispensing set; which allows measured dispensing of the contents.  Use of a syringe and needle is not recommended as it may cause leakage.

  d) After entry, use entire contents of Pharmacy Bulk Package bottle promptly.  The entire contents of the Pharmacy Bulk Package bottle must be dispensed within ONE HOUR of reconstitution.  This time limit should begin with the introduction of solvent or diluent into the Pharmacy Bulk Package bottle.

  e) A plastic ball attached to the pharmacy bulk package provides a suitable hanging device while dispensing contents. 

  Use of this product is restricted to a suitable work area, such as a laminar flow hood.  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• Agila Specialties Private Limited
  

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  Ampicillin | Agila Specialties Private Limited

  

  ---

  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 mg to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 mg to 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae.

  Adults – Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required. In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months.

  The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis

  Adults and children – 150 mg to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia

  Adults and children – 150 mg to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10 days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

  DIRECTIONS FOR USE

  Use only freshly prepared solutions. Intramuscular and intravenous injections should be administered within one hour after preparation since the potency may decrease significantly after this period.

  For Intramuscular Use – Dissolve contents of a vial with the amount of Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, listed in the table below:

  
  

  
  

  
  
  Recommended
  Withdrawable
  Concentration
  NDC
  Label Claim
  Amount of Diluent
  volume
  (in mg/mL)
  76126-026-10
  250 mg
  1 mL
  1 mL
  250 mg
  76126-027-10
  500 mg
  1.8 mL
  2 mL
  250 mg
  76126-028-10
  1 gram
  3.5 mL
  4 mL
  250 mg
  76126-047-04
  2 grams
  6.8 mL
  8 mL
  250 mg
  

  While Ampicillin for Injection, USP, 1 g and 2 g, are primarily for intravenous use, they may be administered intramuscularly when the 250 mg or 500 mg vials are unavailable. In such instances, dissolve in 3.5 or 6.8 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP respectively. The resulting solution will provide a concentration of 250 mg per mL.

  Ampicillin for Injection USP, 125 mg is intended primarily for pediatric use. It also serves as a convenient dosage form when small parenteral doses of the antibiotic are required.

  For Direct Intravenous Use – Add 5 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP to the 250 mg, and 500 mg vials and administer slowly over a 3- to 5- minute period. Ampicillin for Injection, USP 1 g or 2 g, may also be given by direct Intravenous administration. Dissolve in 7.4 or 14.8 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, respectively, and administer slowly over at least 10 to 15 minutes. CAUTION: More rapid administration may result in convulsive seizures.

  For Administration by Intravenous Drip – Reconstitute as directed above (For Direct Intravenous Use) prior to diluting with Intravenous Solution. Stability studies on ampicillin sodium at several concentrations in various intravenous solutions indicate the drug will lose less than 10% activity at the temperatures noted for the time periods stated.

  
  

  
  Room Temperature
  
  
  (25ºC)
  
  Diluent
  Concentrations
  Stability Periods
  Sterile Water for Injection USP
  up to 30 mg/mL
  8 hours
  Sodium Chloride Injection USP, 0.9%
  up to 30 mg/mL
  8 hours
  5% Dextrose in Water
  10 to 20 mg/mL
  1 hour
  5% Dextrose in Water
  up to 2 mg/mL
  2 hours
  5% Dextrose in 0.45% Sodium Chloride
  up to 2 mg/mL
  2 hours
  Lactated Ringer’s Solution
  up to 30 mg/mL
  8 hours
  
  Refrigerated (4°C)
  
  Diluent
  Concentrations
  Stability Periods
  Sterile Water for Injection USP
  30 mg/mL
  48 hours
  Sterile Water for Injection USP
  up to 20 mg/mL
  72 hours
  Sodium Chloride Injection USP, 0.9%
  30 mg/mL
  24 hours
  Sodium Chloride Injection USP, 0.9%
  up to 20 mg/mL
  48 hours
  Lactated Ringer’s Solution
  up to 30 mg/mL
  24 hours
  5% Dextrose in Water
  up to 20 mg/mL
  1 hour
  5% Dextrose and 0.45% Sodium Chloride
  up to 10 mg/mL
  1 hour
  

  Only those solutions listed above should be used for the intravenous infusion of Ampicillin for injection, USP. The concentrations should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of ampicillin is administered before the drug loses its stability in the solution in use.

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• Putney Inc
  

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  Ampicillin | Bristol Myers Squibb & Gilead Sciences, Llc

  

  ---

  Adults and pediatric patients 12 years of age and older with body weight at least 40 kg (at least 88 lbs): The dose of ATRIPLA is one tablet once daily taken orally on an empty stomach. Dosing at bedtime may improve the tolerability of nervous system symptoms.

  Renal Impairment: Because ATRIPLA is a fixed-dose combination, it should not be prescribed for patients requiring dosage adjustment such as those with moderate or severe renal impairment (estimated creatinine clearance below 50 mL/min).

  Rifampin Coadministration: When ATRIPLA is administered with rifampin to patients weighing 50 kg or more, an additional 200 mg/day of efavirenz is recommended [See Drug Interactions (7.3), Table 4, and Clinical Pharmacology (12.3), Table 5].

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• Sagent Pharmaceuticals
  

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  Ampicillin | Teva Pharmaceuticals Usa Inc

  

  ---

  2.1 Recommended Dosage

  The recommended dosage of cilostazol tablets is 100 mg twice daily taken at least half an hour before or two hours after breakfast and dinner.

  
  Patients may respond as early as 2 to 4 weeks after the initiation of therapy, but treatment for up to 12 weeks may be

  needed before a beneficial effect is experienced. If symptoms are unimproved after 3 months, discontinue cilostazol tablets.

  2.2 Dose Reduction With CYP3A4 and CYP2C19 Inhibitors

  Reduce dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP3A4 (e.g.,

  ketoconazole, itraconazole, erythromycin, and diltiazem) or inhibitors of CYP2C19 (e.g., ticlopidine, fluconazole, and

  omeprazole) [see Drug Interactions (7.1)].

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• Sagent Pharmaceuticals
  

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  Ampicillin | Sagent Pharmaceuticals

  

  ---

  This insert is for the Pharmacy Bulk Package and is intended for preparing IV admixtures only. Dosage recommendations for intramuscular or direct intravenous injection are for informational purposes only.

  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6 - to 8-hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6 - to 8-hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae:

  Adults: Two doses of 500 mg each at an interval of 8 to 12 hours.

  Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months.

  The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis.

  Adults and children: 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia.

  Adults and children: 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

  For Administration by Intravenous Infusion: Reconstitute as directed below (Directions for Proper Use of Pharmacy Bulk Package) prior to diluting with an intravenous solution.

  IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible. Protect the constituted solution from freezing.

  Stability studies on ampicillin sodium at several concentrations in various intravenous solutions indicate the drug will lose less than 10% activity at the temperatures noted for the time periods stated.

  Room Temperature (25°C) Diluent Concentrations Stability Periods Sterile Water for Injection up to 30 mg/mL 8 hours Sodium Chloride Injection, USP 0.9% up to 30 mg/mL 8 hours 5% Dextrose in Water 10 to 20 mg/mL 1 hour 5% Dextrose in Water up to 2 mg/mL 2 hours 5% Dextrose in 0.45% NaCl Inj. up to 2 mg/mL 2 hours Lactated Ringer's Solution up to 30 mg/mL 8 hours Refrigerated (4°C) Sterile Water for Injection 30 mg/mL 48 hours Sterile Water for Injection up to 20 mg/mL 72 hours Sodium Chloride Injection, USP, 0.9% 30 mg/mL 24 hours Sodium Chloride Injection, USP, 0.9% up to 20 mg/mL 48 hours Lactated Ringer's Solution up to 30 mg/mL 24 hours 5% Dextrose in Water up to 20 mg/mL 1 hour 5% Dextrose in 0.45% NaCl Inj. up to 10 mg/mL 1 hour

  Only those solutions listed above should be used for the intravenous infusion of Ampicillin for Injection, USP. The concentrations should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of Ampicillin is administered before the drug loses its stability in the solution in use.

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• Wg Critical Care, Llc
  

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  Ampicillin | Blenheim Pharmacal, Inc.

  

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  Carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets, USP and other treatment options before deciding to use diclofenac sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

  After observing the response to initial therapy with diclofenac sodium extended-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.

  For the relief of osteoarthritis, the recommended dosage is 100 mg q.d.

  For the relief of rheumatoid arthritis, the recommended dosage is 100 mg q.d. In the rare patient where diclofenac sodium extended-release tablets 100 mg/day are unsatisfactory, the dose may be increased to 100 mg b.i.d. if the benefits outweigh the clinical risks of increased side effects.

  Different formulations of diclofenac (diclofenac sodium enteric-coated tablets; diclofenac sodium extended-release tablets, USP, diclofenac potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.

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• Wg Critical Care, Llc
  

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  Ampicillin | Wg Critical Care, Llc

  

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  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8-hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8-hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. 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.

  Urethritis in males due to N. gonorrhoeae:

  Adults: Two doses of 500 mg each at an interval of 8 to 12 hours.

  Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months.

  The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis.

  Adults and children: 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia.

  Adults and children: 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections 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. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

  DIRECTIONS FOR USE

  Use only freshly prepared solutions. Intramuscular and intravenous injections should be administered within one hour after preparation, since the potency may decrease significantly after this period.

  For Intramuscular Use: Dissolve contents of a vial with the amount of Sterile Water for Injection, USP or Bacteriostatic Water for Injection, USP, listed in the table below:

  Vial Label Claim

  Recommended Amount of Diluent

  Withdrawable Volume

  Concentration (in mg/mL)

  125 mg

  1.2 mL

  1 mL

  125 mg

  250 mg

  1 mL

  1 mL

  250 mg

  500 mg

  1.8 mL

  2 mL

  250 mg

  1 gram

  3.5 mL

  4 mL

  250 mg

  2 grams

  6.8 mL

  8 mL

  250 mg

  While Ampicillin for Injection, USP 1 g and 2 g, are primarily for intravenous use, they may be administered intramuscularly when the 250 mg or 500 mg vials are unavailable. In such instances, dissolve in 3.5 or 6.8 mL Sterile Water for Injection, USP or Bacteriostatic Water for Injection, USP, respectively. The resulting solution will provide a concentration of 250 mg per mL.

  Ampicillin for Injection, USP 125 mg, is intended primarily for pediatric use. It also serves as a convenient dosage form when small parenteral doses of the antibiotic are required.

  Note: Bacteriostatic Water for Injection, USP is not to be used as a diluent when the product will be used in newborns.

  For Direct Intravenous Use

  Add 5 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP to the 125, 250, and 500 mg vials and administer slowly over a 3 to 5 minute period. Ampicillin for Injection, USP 1 g or 2 g, may also be given by direct intravenous administration. Dissolve in 7.4 or 14.8 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, respectively, and administer slowly over at least 10 to 15 minutes. CAUTION: More rapid administration may result in convulsive seizures.

  For Administration by Intravenous Drip:

  Reconstitute as directed above (For Direct Intravenous Use) prior to diluting with Intravenous Solution. Stability studies on ampicillin sodium at several concentrations in various intravenous solutions indicate the drug will lose less than 10% activity at the temperatures noted for the time periods stated.

  Room Temperature (25°C)

  Diluent

  Concentrations

  Stability Periods

  Sterile Water for Injection

  up to 30 mg/mL

  8 hours

  0.9% Sodium Chloride Injection

  up to 30 mg/mL

  8 hours

  5% Dextrose in Water

  10 to 20 mg/mL

  1 hour

  5% Dextrose in Water

  up to 2 mg/mL

  2 hours

  5% Dextrose in 0.45% NaCl

  up to 2 mg/mL

  2 hours

  Lactated Ringer’s Solution

  up to 30 mg/mL

  8 hours

  Refrigerated (4°C)

  Sterile Water for Injection

  30 mg/mL

  48 hours

  Sterile Water for Injection

  up to 20 mg/mL

  72 hours

  0.9% Sodium Chloride Injection

  30 mg/mL

  24 hours

  0.9% Sodium Chloride Injection

  up to 20 mg/mL

  48 hours

  Lactated Ringer’s Solution

  up to 30 mg/mL

  24 hours

  5% Dextrose in Water

  up to 20 mg/mL

  1 hour

  5% Dextrose in 0.45% NaCl

  up to 10 mg/mL

  1 hour

  Only those solutions listed above should be used for the intravenous infusion of Ampicillin for Injection, USP. The concentrations should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of ampicillin is administered before the drug loses its stability in the solution in use.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Piggyback IV Package: These glass vials contain the labeled quantity of Ampicillin for Injection and are intended for intravenous administration. The diluent and volume are specified on the label of each package.

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• Auromedics Pharma Llc
  

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  Ampicillin | Cardinal Health

  

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  ■ take preferably at bedtime or as directed by a doctor

  age

  starting dose

  maximum dosage

  adults and children

  12 years of age and older

  2 tablets once a day

  4 tablets twice a day

  Children 6 to under

  12 years of age

  1 tablets once a day

  2 tablets twice a day

  Children 2 to under

  6 years of age

  1/2 tablet once a day

  1 tablet twice a day

  Children under 2 years of age

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• Gc Hanford Manufacturing Company
  

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  Ampicillin | Gc Hanford Manufacturing Company

  

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  The dosage of ampicillin for injectable suspension will vary according to the animal being treated, the severity of the infection and the animal’s response.

  Dogs and Cats - The recommended dose for dogs or cats is 3 mg/lb of body weight administered twice daily by subcutaneous or intramuscular injection.

  Cattle and Calves Including Non-Ruminating (Veal Calves) - From 2 mg to 5 mg/lb of body weight once daily by intramuscular injection. Do not treat for more than 7 days.

  In all species, 3 days treatment is usually adequate, but treatment should be continued for 48 to 72 hours after the animal has become afebrile or asymptomatic.

  DIRECTIONS FOR USE

  The multi-dose dry-filled vials should be reconstituted to the desired concentration by adding the required amount of Sterile Water for Injection, USP, according to label directions. SHAKE WELL.

  After reconstitution this product is stable for 3 months under refrigeration and will be white to pale yellow in color.

  At the time of reconstitution the vial should be dated and the concentration noted on the label.

  CAUTION

  Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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