Imipenem And Cilastatin

Imipenem And Cilastatin Manufacturers

• Fresenius Kabi Usa, Llc
  

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  Imipenem And Cilastatin | Dr. Donna Restivo Dc

  

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  10 drops under the tongue, 3 to 6 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

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• App Pharmaceuticals, Llc
  

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  Imipenem And Cilastatin | Teva Pharmaceuticals Usa Inc

  

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  2.1 General Considerations

  The side effects of irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter [see Adverse Reactions (6)].

  Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

  Irbesartan and hydrochlorothiazide tablets may be administered with or without food.

  Irbesartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

  Renal impairment. The usual regimens of therapy with irbesartan and hydrochlorothiazide tablets may be followed as long as the patient’s creatinine clearance is > 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so irbesartan and hydrochlorothiazide tablets are not recommended.

  Hepatic impairment. No dosage adjustment is necessary in patients with hepatic impairment.

  2.2 Add-On Therapy

  In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of irbesartan and hydrochlorothiazide tablets, in order of increasing mean effect, are (irbesartan-hydrochlorothiazide) 150/12.5 mg, 300/12.5 mg, and 300/25 mg. The largest incremental effect will likely be in the transition from monotherapy to 150/12.5 mg [see Clinical Studies (14.2)].

  2.3 Replacement Therapy

  Irbesartan and hydrochlorothiazide tablets may be substituted for the titrated components.

  2.4 Initial Therapy

  The usual starting dose is irbesartan and hydrochlorothiazide tablets 150/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 300/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Irbesartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].

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• Cardinal Health
  

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  Imipenem And Cilastatin | Cardinal Health

  

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  Adults

  The dosage recommendations for imipenem and cilastatin for injection (I.V.) represent the quantity of imipenem to be administered. An equivalent amount of cilastatin is also present in the solution. Each 125 mg, 250 mg, or 500 mg dose should be given by intravenous administration over 20 to 30 minutes. Each 750 mg or 1000 mg dose should be infused over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed.

  The total daily dosage for imipenem and cilastatin for injection (I.V.) should be based on the type or severity of infection and given in equally divided doses based on consideration of degree of susceptibility of the pathogen(s), renal function, and body weight. Adult patients with impaired renal function, as judged by creatinine clearance ≤ 70 mL/min/1.73 m2, require adjustment of dosage as described in the succeeding section of these guidelines.

  Intravenous Dosage Schedule for Adults with Normal Renal Function and Body Weight ≥ 70 kg

  Doses cited in Table 3 are based on a patient with normal renal function and a body weight of 70 kg. These doses should be used for a patient with a creatinine clearance of ≥ 71 mL/min/1.73 m2 and a body weight of ≥ 70 kg. A reduction in dose must be made for a patient with a creatinine clearance of ≤ 70 mL/min/1.73 m2 and/or a body weight less than 70 kg. (See Tables 4 and 5.)

  Dosage regimens in column A of Table 3 are recommended for infections caused by fully susceptible organisms which represent the majority of pathogenic species. Dosage regimens in column B of Table 3 are recommended for infections caused by organisms with moderate susceptibility to imipenem, primarily some strains of P. aeruginosa.

  TABLE 3 INTRAVENOUS DOSAGE SCHEDULE FOR ADULTS WITH NORMAL RENAL FUNCTION AND BODY WEIGHT ≥ 70 kg Type or
  Severity
  of Infection A
  Fully susceptible organisms including
  gram-positive and gram-negative
  aerobes and anaerobes B
  Moderately susceptible organisms,
  primarily some strains of P. aeruginosa Mild 250 mg q 6 h
  (TOTAL DAILY DOSE = 1 g) 500 mg q 6 h
  (TOTAL DAILY DOSE = 2 g) Moderate 500 mg q 8 h
  (TOTAL DAILY DOSE = 1.5 g)
  or
  500 mg q 6 h
  (TOTAL DAILY DOSE = 2 g)
  500 mg q 6 h
  (TOTAL DAILY DOSE = 2 g)
  or
  1 g q 8 h
  (TOTAL DAILY DOSE = 3 g) Severe, life
      threatening only 500 mg q 6 h
  (TOTAL DAILY DOSE = 2 g) 1 g q 8 h
  (TOTAL DAILY DOSE = 3 g)
  or
  1 g q 6 h
  (TOTAL DAILY DOSE = 4 g)
  Uncomplicated
      urinary tract infection 250 mg q 6 h
  (TOTAL DAILY DOSE = 1 g) 250 mg q 6 h
  (TOTAL DAILY DOSE = 1 g) Complicated
      urinary tract infection
  500 mg q 6 h
  (TOTAL DAILY DOSE = 2 g) 500 mg q 6 h
  (TOTAL DAILY DOSE = 2 g)

  Due to the high antimicrobial activity of imipenem and cilastatin for injection (I.V.), it is recommended that the maximum total daily dosage not exceed 50 mg/kg/day or 4 g/day, whichever is lower. There is no evidence that higher doses provide greater efficacy. However, patients over twelve years of age with cystic fibrosis and normal renal function have been treated with imipenem and cilastatin for injection (I.V.) at doses up to 90 mg/kg/day in divided doses, not exceeding 4 g/day.

  Reduced Intravenous Schedule for Adults with Impaired Renal Function and/or Body Weight < 70 kg

  Patients with creatinine clearance of ≤ 70 mL/min/1.73 m2 and/or body weight less than 70 kg require dosage reduction of imipenem and cilastatin for injection (I.V.) as indicated in the tables below. Creatinine clearance may be calculated from serum creatinine concentration by the following equation:

  To determine the dose for adults with impaired renal function and/or reduced body weight:

  Choose a total daily dose from Table 3 based on infection characteristics. a) If the total daily dose is 1 g, 1.5 g, or 2 g, use the appropriate subsection of Table 4 and continue with step 3.
  b) If the total daily dose is 3 g or 4 g, use the appropriate subsection of Table 5 and continue with step 3. From Table 4 or 5:
  a) Select the body weight on the far left which is closest to the patient's body weight (kg).
  b) Select the patient's creatinine clearance category.
  c) Where the row and column intersect is the reduced dosage regimen. TABLE 4 REDUCED INTRAVENOUS DOSAGE OF IMIPENEM AND CILASTATIN FOR INJECTION (I.V.) IN ADULT PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR BODY WEIGHT < 70 kg If TOTAL DAILY DOSE from TABLE 3 is: And Body Weight (kg)
  is: 1 g/day 1.5 g/day 2 g/day and creatinine clearance
  (mL/min/1.73 m2) is:
  and creatinine clearance
  (mL/min/1.73 m2) is: and creatinine clearance
  (mL/min/1.73 m2) is: ≥ 71 41-70 21-40 6-20 ≥ 71 41-70 21-40 6-20 ≥ 71 41-70 21-40 6-20 then the reduced dosage
  regimen (mg) is: then the reduced dosage
  regimen (mg) is: then the reduced dosage
  regimen (mg) is: ≥ 70 250 250 250 250 500 250 250 250 500 500 250 250 q 6 h q 8 h q 12 h q 12 h q 8 h q 6 h q 8 h q 12 h q 6 h q 8 h q 6 h q 12 h 60 250 125 250 125 250 250 250 250 500 250 250 250 q 8 h q 6 h q 12 h q 12 h q 6 h q 8 h q 8 h q 12 h q 8 h q 6 h q 8 h q 12 h 50 125 125 125 125 250 250 250 250 250 250 250 250 q 6 h q 6 h q 8 h q 12 h q 6 h q 8 h q 12 h q 12 h q 6 h q 6 h q 8 h q 12 h 40 125 125 125 125 250 125 125 125 250 250 250 250 q 6 h q 8 h q 12 h q 12 h q 8 h q 6 h q 8 h q 12 h q 6 h q 8 h q 12 h q 12 h 30 125 125 125 125 125 125 125 125 250 125 125 125 q 8 h q 8 h q 12 h q 12 h q 6 h q 8 h q 8 h q 12 h q 8 h q 6 h q 8 h q 12 h TABLE 5 REDUCED INTRAVENOUS DOSAGE OF IMIPENEM AND CILASTATIN FOR INJECTION (I.V.) IN ADULT PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR BODY WEIGHT < 70 kg If TOTAL DAILY DOSE from TABLE 3 is : And
  Body Weight
  (kg)
  is: 3 g/day 4 g/day and creatinine clearance
  (mL/min/1.73 m2) is:
  and creatinine clearance
  (mL/min/1.73 m2) is:
  ≥ 71 41-70 21-40 6-20 ≥ 71 41-70 21-40 6-20 then the reduced dosage regimen (mg) is: then the reduced dosage regimen (mg) is: ≥ 70 1000 500 500 500 1000 750 500 500 q 8 h q 6 h q 8 h q 12 h q 6 h q 8 h q 6 h q 12 h 60 750 500 500 500 1000 750 500 500 q 8 h q 8 h q 8 h q 12 h q 8 h q 8 h q 8 h q 12 h 50 500 500 250 250 750 500 500 500 q 6 h q 8 h q 6 h q 12 h q 8 h q 6 h q 8 h q 12 h 40 500 250 250 250 500 500 250 250 q 8 h q 6 h q 8 h q 12 h q 6 h q 8 h q 6 h q 12 h 30 250 250 250 250 500 250 250 250 q 6 h q 8 h q 8 h q 12 h q 8 h q 6 h q 8 h q 12 h

  Patients with creatinine clearances of 6 to 20 mL/min/1.73 m2 should be treated with imipenem and cilastatin for injection (I.V.) 125 mg or 250 mg every 12 hours for most pathogens. There may be an increased risk of seizures when doses of 500 mg every 12 hours are administered to these patients.

  Patients with creatinine clearance ≤ 5 mL/min/1.73 m2 should not receive imipenem and cilastatin for injection (I.V.) unless hemodialysis is instituted within 48 hours. There is inadequate information to recommend usage of imipenem and cilastatin for injection (I.V.) for patients undergoing peritoneal dialysis.

  Hemodialysis

  When treating patients with creatinine clearances of ≤ 5 mL/min/1.73 m2who are undergoing hemodialysis, use the dosage recommendations for patients with creatinine clearances of 6-20 mL/min/1.73 m2. (See Reduced Intravenous Dosage Schedule for Adults with Impaired Renal Function and/or Body Weight < 70 kg.) Both imipenem and cilastatin are cleared from the circulation during hemodialysis. The patient should receive imipenem and cilastatin for injection (I.V.) after hemodialysis and at 12 hour intervals timed from the end of that hemodialysis session.

  Dialysis patients, especially those with background CNS disease, should be carefully monitored; for patients on hemodialysis, imipenem and cilastatin for injection (I.V.) is recommended only when the benefit outweighs the potential risk of seizures. (See PRECAUTIONS)

  Pediatric Patients

  See PRECAUTIONS, Pediatric Patients.

  For pediatric patients ≥ 3 months of age, the recommended dose for non-CNS infections is 15-25 mg/kg/dose administered every six hours. Based on studies in adults, the maximum daily dose for treatment of infections with fully susceptible organisms is 2 g per day, and of infections with moderately susceptible organisms (primarily some strains of P. aeruginosa) is 4 g/day. Higher doses (up to 90 mg/kg/day in older children) have been used in patients with cystic fibrosis.

  For pediatric patients ≤ 3 months of age (weighing ≥ 1,500 g), the following dosage schedule is recommended for non-CNS infections:

    < 1 wk of age: 25 mg/kg every 12 hrs   1-4 wks of age: 25 mg/kg every 8 hrs   4 wks-3 mos. of age: 25 mg/kg every 6 hrs.

  Doses less than or equal to 500 mg should be given by intravenous infusion over 15 to 30 minutes. Doses greater than 500 mg should be given by intravenous infusion over 40 to 60 minutes.

  Imipenem and cilastatin for injection (I.V.) is not recommended in pediatric patients with CNS infections because of the risk of seizures.

  Imipenem and cilastatin for injection (I.V.) is not recommended in pediatric patients < 30 kg with impaired renal function, as no data are available.

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• Hospira, Inc.
  

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  Imipenem And Cilastatin | Hospira, Inc.

  

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  Adults
  The dosage recommendations for Imipenem and Cilastatin for Injection (I.V.) represent the quantity of imipenem to be administered. An equivalent amount of cilastatin is also present in the solution. Each 125 mg, 250 mg, or 500 mg dose should be given by intravenous administration over 20 to 30 minutes. Each 750 mg or 1000 mg dose should be infused over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed.

  The total daily dosage for Imipenem and Cilastatin for Injection (I.V.) should be based on the type or severity of infection and given in equally divided doses based on consideration of degree of susceptibility of the pathogen(s), renal function, and body weight. Adult patients with impaired renal function, as judged by creatinine clearance ≤70 mL/min/1.73 m2, require adjustment of dosage as described in the succeeding section of these guidelines.

  Intravenous Dosage Schedule for Adults with Normal Renal Function and Body Weight ≥70 kg
  Doses cited in Table 3 are based on a patient with normal renal function and a body weight of 70 kg. These doses should be used for a patient with a creatinine clearance of ≥71 mL/min/1.73 m2 and a body weight of ≥70 kg. A reduction in dose must be made for a patient with a creatinine clearance of ≤70 mL/min/1.73 m2 and/or a body weight less than 70 kg. (See Tables 4 and 5.)

  Dosage regimens in column A of Table 3 are recommended for infections caused by fully susceptible organisms which represent the majority of pathogenic species. Dosage regimens in column B of Table 3 are recommended for infections caused by organisms with moderate susceptibility to imipenem, primarily some strains of P. aeruginosa.

  TABLE 3: INTRAVENOUS DOSAGE SCHEDULE FOR ADULTS WITH NORMAL RENAL FUNCTION AND BODY WEIGHT ≥70 kg

  Type or
  Severity
  of Infection

  A
  Fully susceptible organisms including gram-positive and gram-negative aerobes and anaerobes

  B
  Moderately susceptible organisms, primarily some strains of P. aeruginosa

  Mild

   

  250 mg q6h
  (TOTAL DAILY DOSE = 1g)

  500 mg q6h
  (TOTAL DAILY DOSE = 2g)

  Moderate

   

  500 mg q8h
  (TOTAL DAILY DOSE = 1.5g)
  or
  500 mg q6h
  (TOTAL DAILY DOSE = 2g)

  500 mg q6h
  (TOTAL DAILY DOSE = 2g)
  or
  1 g q8h
  (TOTAL DAILY DOSE = 3g)

  Severe, life
     threatening
     only

   

  500 mg q6h
  (TOTAL DAILY DOSE = 2g)

   

  1 g q8h
  (TOTAL DAILY DOSE = 3g)
  or
  1 g q6h
  (TOTAL DAILY DOSE = 4g)

  Uncomplicated
     urinary tract
        infection

  250 mg q6h
  (TOTAL DAILY DOSE = 1g)

  250 mg q6h
  (TOTAL DAILY DOSE = 1g)

  Complicated
     urinary tract
        infection

  500 mg q6h
  (TOTAL DAILY DOSE = 2g)

  500 mg q6h
  (TOTAL DAILY DOSE = 2g) 

  Due to the high antimicrobial activity of Imipenem and Cilastatin for Injection (I.V.), it is recommended that the maximum total daily dosage not exceed 50 mg/kg/day or 4 g/day, whichever is lower. There is no evidence that higher doses provide greater efficacy. However, patients over twelve years of age with cystic fibrosis and normal renal function have been treated with Imipenem and Cilastatin for Injection (I.V.) at doses up to 90 mg/kg/day in divided doses, not exceeding 4 g/day.

  Reduced Intravenous Schedule for Adults with Impaired Renal Function and/or Body Weight <70 kg

  Patients with creatinine clearance of ≤70 mL/min/1.73 m2 and/or body weight less than 70 kg require dosage reduction of Imipenem and Cilastatin for Injection (I.V.) as indicated in the tables below. Creatinine clearance may be calculated from serum creatinine concentration by the following equation:

  Tcc (Males) =    (wt. in kg) (140 – age)        
     (72) (creatinine in mg/dL)  Tcc (Females) = 0.85 × above value

  To determine the dose for adults with impaired renal function and/or reduced body weight:
  1. Choose a total daily dose from Table 3 based on infection characteristics.
  2. a) If the total daily dose is 1 g, 1.5 g, or 2 g, use the appropriate subsection of Table 4 and continue with step 3.
      b) If the total daily dose is 3 g or 4 g, use the appropriate subsection of Table 5 and continue with step 3.
  3. From Table 4 or 5:
      a) Select the body weight on the far left which is closest to the patient's body weight (kg).
      b) Select the patient's creatinine clearance category.
      c) Where the row and column intersect is the reduced dosage regimen.

  TABLE 4: REDUCED INTRAVENOUS DOSAGE OF IMIPENEM AND CILASTATIN FOR INJECTION (I.V.) IN ADULT PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR BODY WEIGHT <70 kg

  And
  Body
  Weight
  (kg)
  is:

  If  TOTAL DAILY DOSE from TABLE 3 is:

  1 g/day

  1.5 g/day

  2 g/day

  and creatinine clearance
  (mL/min/1.73 m2) is:

  and creatinine clearance
  (mL/min/1.73 m2) is:

  and creatinine clearance
  (mL/min/1.73 m2) is:

  ≥71

  41 to 70

  21 to 40

  6 to 20

  ≥71

  41 to 70

  21 to 40

  6 to 20

  ≥71

  41 to 70

  21 to 40

  6 to 20

   

  then the reduced dosage regimen (mg) is:

  then the reduced dosage regimen (mg) is:

  then the reduced dosage regimen (mg) is:

  ≥70

  250

  q6h

  250

  q8h

  250

  q12h

  250

  q12h

  500

  q8h

  250

  q6h

  250

  q8h

  250

  q12h

  500

  q6h

  500

  q8h

  250

  q6h

  250

  q12h

  60

   

  250

  q8h

  125

  q6h

  250

  q12h

  125

  q12h

  250

  q6h

  250

  q8h

  250

  q8h

  250

  q12h

  500

  q8h

  250

  q6h

  250

  q8h

  250

  q12h

  50

   

  125

  q6h

  125

  q6h

  125

  q8h

  125

  q12h

  250

  q6h

  250

  q8h

  250

  q12h

  250

  q12h

  250

  q6h

  250

  q6h

  250

  q8h

  250

  q12h

  40

   

  125

  q6h

  125

  q8h

  125

  q12h

  125

  q12h

  250

  q8h

  125

  q6h

  125

  q8h

  125

  q12h

  250

  q6h

  250

  q8h

  250

  q12h

  250

  q12h

  30

   

  125

  q8h

  125

  q8h

  125

  q12h

  125

  q12h

  125

  q6h

  125

  q8h

  125

  q8h

  125

  q12h

  250

  q8h

  125

  q6h

  125

  q8h

  125

  q12h

  TABLE 5: REDUCED INTRAVENOUS DOSAGE OF IMIPENEM AND CILASTATIN FOR INJECTION (I.V.) IN ADULT PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR BODY WEIGHT <70 kg

  And
  Body
  Weight
  (kg)
  is:

  If  TOTAL DAILY DOSE from TABLE 3 is:

  3 g/day

  4 g/day

  and creatinine clearance
  (mL/min/1.73 m2) is:

  and creatinine clearance
  (mL/min/1.73 m2) is:

  ≥71

  41 to 70

  21 to 40

  6 to 20

  ≥71

  41 to 70

  21 to 40

  6 to 20

   

  then the reduced dosage regimen (mg) is:

  then the reduced dosage regimen (mg) is:

  ≥70

   

  1000

  q8h

  500

  q6h

  500

  q8h

  500

  q12h

  1000

  q6h

  750

  q8h

  500

  q6h

  500

  q12h

  60

   

  750

  q8h

  500

  q8h

  500

  q8h

  500

  q12h

  1000

  q8h

  750

  q8h

  500

  q8h

  500

  q12h

  50

   

  500

  q6h

  500

  q8h

  250

  q6h

  250

  q12h

  750

  q8h

  500

  q6h

  500

  q8h

  500

  q12h

  40

   

  500

  q8h

  250

  q6h

  250

  q8h

  250

  q12h

  500

  q6h

  500

  q8h

  250

  q6h

  250

  q12h

  30

   

  250

  q6h

  250

  q8h

  250

  q8h

  250

  q12h

  500

  q8h

  250

  q6h

  250

  q8h

  250

  q12h

  Patients with creatinine clearances of 6 to 20 mL/min/1.73 m2 should be treated with Imipenem and Cilastatin for Injection (I.V.) 125 mg or 250 mg every 12 hours for most pathogens. There may be an increased risk of seizures when doses of 500 mg every 12 hours are administered to these patients.

  Patients with creatinine clearance ≤5 mL/min/1.73 m2 should not receive Imipenem and Cilastatin for Injection (I.V.) unless hemodialysis is instituted within 48 hours. There is inadequate information to recommend usage of Imipenem and Cilastatin for Injection (I.V.) for patients undergoing peritoneal dialysis.

  Hemodialysis
  When treating patients with creatinine clearances of ≤5 mL/min/1.73 m2 who are undergoing hemodialysis, use the dosage recommendations for patients with creatinine clearances of 6 to 20 mL/min/1.73 m2. (See Reduced Intravenous Dosage Schedule for Adults with Impaired Renal Function and/or Body Weight <70 kg.) Both imipenem and cilastatin are cleared from the circulation during hemodialysis. The patient should receive Imipenem and Cilastatin for Injection (I.V.) after hemodialysis and at 12 hour intervals timed from the end of that hemodialysis session. Dialysis patients, especially those with background CNS disease, should be carefully monitored; for patients on hemodialysis, Imipenem and Cilastatin for Injection (I.V.) is recommended only when the benefit outweighs the potential risk of seizures. (See PRECAUTIONS.)

  Pediatric Patients
  See PRECAUTIONS, Pediatric Patients.

  For pediatric patients ≥3 months of age, the recommended dose for non-CNS infections is 15 to 25 mg/kg/dose administered every six hours. Based on studies in adults, the maximum daily dose for treatment of infections with fully susceptible organisms is 2 g per day, and of infections with moderately susceptible organisms (primarily some strains of P. aeruginosa) is 4 g/day. Higher doses (up to 90 mg/kg/day in older children) have been used in patients with cystic fibrosis.

  For pediatric patients ≤3 months of age (weighing ≥1,500 g), the following dosage schedule is recommended for non-CNS infections:
       <1 wk of age: 25 mg/kg every 12 hrs
      1 to 4 wks of age: 25 mg/kg every 8 hrs
      4 wks to 3 mos. of age: 25 mg/kg every 6 hrs.

  Doses less than or equal to 500 mg should be given by intravenous infusion over 15 to 30 minutes. Doses greater than 500 mg should be given by intravenous infusion over 40 to 60 minutes.

  Imipenem and Cilastatin for Injection (I.V.) is not recommended in pediatric patients with CNS infections because of the risk of seizures.

  Imipenem and Cilastatin for Injection (I.V.) is not recommended in pediatric patients <30 kg with impaired renal function, as no data are available.  

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• Hospira, Inc.
  

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  Imipenem And Cilastatin | Supervalu Inc

  

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  • if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you. • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the lozenge on your quit day • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule:

  Weeks 1 to 6

  Weeks 7 to 9

  Weeks 10 to 12

  1 lozenge every

  1 to 2 hours

  1 lozenge every

  2 to 4 hours

  1 lozenge every

  4 to 8 hours

  • nicotine lozenge is a medicine and must be used a certain way to get the best results • place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge. • you may feel a warm or tingling sensation • occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes) • do not eat or drink 15 minutes before using or while the lozenge is in your mouth • to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks • do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects • do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. • it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

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• Hospira, Inc.
  

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  Imipenem And Cilastatin | Merck Sharp & Dohme Corp.

  

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  2.1 Recommended Dosing

  The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food.

  2.2 Patients with Renal Insufficiency

  For patients with mild renal insufficiency (creatinine clearance [CrCl] greater than or equal to 50 mL/min, approximately corresponding to serum creatinine levels of less than or equal to 1.7 mg/dL in men and less than or equal to 1.5 mg/dL in women), no dosage adjustment for JANUVIA is required.

  For patients with moderate renal insufficiency (CrCl greater than or equal to 30 to less than 50 mL/min, approximately corresponding to serum creatinine levels of greater than 1.7 to less than or equal to 3.0 mg/dL in men and greater than 1.5 to less than or equal to 2.5 mg/dL in women), the dose of JANUVIA is 50 mg once daily.

  For patients with severe renal insufficiency (CrCl less than 30 mL/min, approximately corresponding to serum creatinine levels of greater than 3.0 mg/dL in men and greater than 2.5 mg/dL in women) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of JANUVIA is 25 mg once daily. JANUVIA may be administered without regard to the timing of dialysis.

  Because there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of JANUVIA and periodically thereafter. Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula. [See Clinical Pharmacology (12.3).] There have been postmarketing reports of worsening renal function in patients with renal insufficiency, some of whom were prescribed inappropriate doses of sitagliptin.

  2.3 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin

  When JANUVIA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia. [See Warnings and Precautions (5.3).]

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