Famotidine

Famotidine Manufacturers

• Remedyrepack Inc.
  

  ×

  Famotidine | Remedyrepack Inc.

  

  ---

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

   

  The recommended adult oral dose is 20 mg once a day at bedtime.

   

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

   

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

   

  See PRECAUTIONS, Pediatric Patients < 1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients< 1 year of age suggest the following starting doses in pediatric patients < 1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients < 3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to < 1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients < 1 year of age with GERD has not been adequately studied.

   

  See PRECAUTIONS, Pediatric Patients1 to 16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients1 to 16 years of age suggest the following starting doses in pediatric patients 1 to 16 years of age:

   

  0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

   

  1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

   

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

   

  Antacids may be given concomitantly if needed.

   

  In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

   

  Close
  No Recall

  More Info
• Remedyrepack Inc.
  

  ×

  Famotidine | Remedyrepack Inc.

  

  ---

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

   

  The recommended adult oral dose is 20 mg once a day at bedtime.

   

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

   

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

   

  See PRECAUTIONS, Pediatric Patients < 1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients< 1 year of age suggest the following starting doses in pediatric patients < 1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients < 3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to < 1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients < 1 year of age with GERD has not been adequately studied.

   

  See PRECAUTIONS, Pediatric Patients1 to 16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients1 to 16 years of age suggest the following starting doses in pediatric patients 1 to 16 years of age:

   

  0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

   

  1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

   

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

   

  Antacids may be given concomitantly if needed.

   

  In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

   

  Close
  No Recall

  More Info
• Blenheim Pharmacal, Inc.
  

  ×

  Famotidine | Blenheim Pharmacal, Inc.

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS , Pediatric Patients 1-16 years of age .

  The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Remedyrepack Inc.
  

  ×

  Famotidine | Remedyrepack Inc.

  

  ---

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

   

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

   

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

   

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

   

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

   

  See PRECAUTIONS , Pediatric Patients 1-16 years of age .

  The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

   

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

   

  Antacids may be given concomitantly if needed.

   

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

   

  Close
  No Recall

  More Info
• Northwind Pharmaceuticals
  

  ×

  Famotidine | Northwind Pharmaceuticals

  

  ---

  Duodenal Ulcer

  Acute Therapy

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients < 1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients < 1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients< 1 year of age suggest the following starting doses in pediatric patients < 1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients < 3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to < 1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients < 1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1 to 16 years of age

  See PRECAUTIONS, Pediatric Patients1 to 16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients1 to 16 years of age suggest the following starting doses in pediatric patients 1 to 16 years of age:

  Peptic Ulcer

  0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease With Or Without Esophagitis Including Erosions And Ulcerations

  1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Mckesson Packaging Services A Business Unit Of Mckesson Corporation
  

  ×

  Famotidine | Mckesson Packaging Services A Business Unit Of Mckesson Corporation

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS , Pediatric Patients 1-16 years of age .

  The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Remedyrepack Inc.
  

  ×

  Famotidine | Uriel Pharmacy Inc.

  

  ---

  Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow.

  Close
  No Recall

  More Info
• St Marys Medical Park Pharmacy
  

  ×

  Famotidine | St Marys Medical Park Pharmacy

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS , Pediatric Patients 1-16 years of age .

  The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Baxter Healthcare Corporation
  

  ×

  Famotidine | Baxter Healthcare Corporation

  

  ---

  In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection may be administered until oral therapy can be instituted.

  The recommended dosage for Famotidine Injection in adult patients is 20 mg intravenously q 12 h.

  The doses and regimen for parenteral administration in patients with GERD have not been established.

  Dosage for Pediatric Patients <1 Year of Age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 Year of Age.

  The studies described in PRECAUTIONS, Pediatric Patients <1 Year of Age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) – 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 Years of Age

  See PRECAUTIONS, Pediatric Patients 1-16 Years of Age.

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 Years of Age suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day.

  While published uncontrolled clinical studies suggest effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h.

  Dosage Adjustments for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of Famotidine Injection may be reduced to half the dose, or the dosing interval may be prolonged to 36-48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult intravenous dose is 20 mg q 12 h. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. In some patients, a higher starting dose may be required. Oral doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  To prepare intravenous solutions, aseptically dilute 2 mL of Famotidine Injection (solution containing 10 mg/mL) with Sodium Chloride Injection 0.9% or other compatible intravenous solution (see Stability) to a total volume of either 5 mL or 10 mL and inject over a period of not less than 2 minutes.

  To prepare intravenous infusion solutions, aseptically dilute 2 mL of Famotidine Injection with 100 mL of Dextrose 5% or other compatible solution (see Stability), and infuse over a 15-30 minute period.

  Concomitant Use of Antacids

  Antacids may be given orally concomitantly if needed.

  Stability

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

  When added to or diluted with most commonly used intravenous solutions, e.g., Water for Injection, Sodium Chloride Injection 0.9%, Dextrose Injection 5% and 10% or Lactated Ringer’s Injection, diluted Famotidine Injection is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature–see HOW SUPPLIED, Storage.

  When added to or diluted with Sodium Bicarbonate Injection 5%, Famotidine Injection at a concentration of 0.2 mg/mL (the recommended concentration of famotidine intravenous infusion solutions) is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature–see HOW SUPPLIED, Storage. However, a precipitate may form at higher concentrations of Famotidine Injection (>0.2 mg/mL) in Sodium Bicarbonate Injection 5%.

  Close
  No Recall

  More Info
• Mckesson Packaging Services Business Unit Of Mckesson Corporation
  

  ×

  Famotidine | Mckesson Packaging Services Business Unit Of Mckesson Corporation

  

  ---

  Duodenal Ulcer Acute Therapy

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS, Pediatric Patients 1-16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age.

  Peptic Ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without Esophagitis Including Erosions and Ulcerations –1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Oral Suspension

  Famotidine for oral suspension may be substituted for famotidine tablets in any of the above indications.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Wockhardt Usa Llc.
  

  ×

  Famotidine |

  

  ---

  Close
  No Recall

  More Info
• Zydus Pharmaceuticals Usa Inc
  

  ×

  Famotidine | Zydus Pharmaceuticals Usa Inc

  

  ---

  
  Duodenal Ulcer
  
  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.
  
  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.
  
  Benign Gastric Ulcer
  
  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.
  
  Gastroesophageal Reflux Disease (GERD)
  
  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
  
  Dosage for Pediatric Patients less than 1 year of age Gastroesophageal Reflux Disease (GERD)
  
  See PRECAUTIONS, Pediatric Patients less than 1 year of age.
  
  The studies described in PRECAUTIONS, Pediatric Patients less than 1 year of age suggest the following starting doses in pediatric patients less than 1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients less than 3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to less than 1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients less than 1 year of age with GERD has not been adequately studied.
  
  Dosage for Pediatric Patients 1 to 16 years of age
  
  See PRECAUTIONS, Pediatric Patients 1 to 16 years of age.
  
  The studies described in PRECAUTIONS, Pediatric Patients 1 to 16 years of age suggest the following starting doses in pediatric patients 1 to 16 years of age:
  
  Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
  
  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
  
  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.
  
  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)
  
  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.
  
  Oral Suspension
  
  Famotidine for oral suspension may be substituted for famotidine tablets in any of the above indications. Each five mL contains 40 mg of famotidine after constitution of the powder with 46 mL of Purified Water as directed.
  
  Directions for Preparing Famotidine for Oral Suspension
  
  Prepare suspension at time of dispensing. Slowly add 46 mL of Purified Water. Shake vigorously for 5 to 10 seconds immediately after adding the water and immediately before use.
  
  Stability of Famotidine for Oral Suspension
  
  Unused constituted oral suspension should be discarded after 30 days.
  
  Concomitant Use of Antacids
  
  Antacids may be given concomitantly if needed.
  
  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency
  
  In adult patients with moderate (creatinine clearance less than 50 mL/min) or severe (creatinine clearance less than 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.
  
  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.
  

  Close
  No Recall

  More Info
• Dr.reddy’s Laboratories Limited
  

  ×

  Famotidine | Dr.reddy's Laboratories Limited

  

  ---

  Duodenal Ulcer

  Acute Therapy:The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime. 

  Benign Gastric Ulcer 

  Acute Therapy:The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies). 

  Dosage for Pediatric Patients <1 year of ageGastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, PediatricPatients <1 year of age suggest the following startingdoses in pediatric patients <1 year of age:Gastroesophageal Reflux Disease (GERD) - 0.5mg/kg/dose of famotidine oral suspension for thetreatment of GERD for up to 8 weeks once daily inpatients <3 months of age and 0.5 mg/kg/dose twicedaily in patients 3 months to <1 year of age. Patientsshould also be receiving conservative measures (e.g.,thickened feedings). The use of intravenous famotidinein pediatric patients <1 year of age with GERD has notbeen adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS, Pediatric Patients 1-16 years of age. 

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age. 

  Peptic Ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without Esophagitis Including Erosions and Ulcerations – 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d. 

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to    1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations. 

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome. 

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed. 

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient’s clinical response. 

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Paddock Laboratories, Inc.
  

  ×

  Famotidine | Paddock Laboratories, Inc.

  

  ---

  Duodenal Ulcer Acute Therapy:

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy:

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer Acute Therapy:

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS, Pediatric Patients 1-16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Oral Suspension

  Famotidine for oral suspension may be substituted for famotidine tablets in any of the above indications. Each five mL contains 40 mg of famotidine after constitution of the powder with 46 mL of Purified Water as directed.

  Directions for Preparing Famotidine for Oral Suspension

  Prepare suspension at time of dispensing. Slowly add 46 mL of Purified Water. Shake vigorously for 5-10 seconds immediately after adding the water and immediately before use.

  Stability of Famotidine for Oral Suspension

  Unused constituted oral suspension should be discarded after 30 days.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Ipca Laboratories Limited
  

  ×

  Famotidine | Ipca Laboratories Limited

  

  ---

  For 10 mg:

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water.  Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  For 20 mg

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water.  Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Northstar Rxllc
  

  ×

  Famotidine | Northstar Rxllc

  

  ---

  
  

  Duodenal Ulcer
  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.
  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.
  
  Benign Gastric Ulcer
  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.
  
  Gastroesophageal Reflux Disease (GERD)
  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
  
  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)  
  See PRECAUTIONS , Pediatric Patients <1 year of age.
  
  The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.
  
  Dosage for Pediatric Patients 1-16 years of age  
  See PRECAUTIONS, Pediatric Patients 1-16 years of age. 
  
  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:
  Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
  
  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations. 
  
  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas) 
  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.
  
  Concomitant Use of Antacids
  Antacids may be given concomitantly if needed.
  
  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency  
  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.
  
  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Legacy Pharmaceutical Packaging
  

  ×

  Famotidine | Legacy Pharmaceutical Packaging, Llc

  

  ---

  Duodenal Ulcer

  Acute Therapy

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients < 1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients < 1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients < 1 year of age suggest the following starting doses in pediatric patients < 1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients < 3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to < 1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients < 1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1 to 16 years of age

  See PRECAUTIONS, Pediatric Patients 1 to 16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1 to 16 years of age suggest the following starting doses in pediatric patients 1 to 16 years of age:

  Peptic Ulcer

  0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease With Or Without Esophagitis Including Erosions And Ulcerations

  1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Cardinal Health
  

  ×

  Famotidine | Cardinal Health

  

  ---

  Duodenal Ulcer Acute Therapy

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer Acute Therapy

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, ClinicalStudies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients < 1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients<1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1 to 16 years of age

  See PRECAUTIONS, Pediatric Patients1 to 16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients1 to 16 years of age suggest the following starting doses in pediatric patients 1 to 16 years of age:

  Peptic Ulcer

  0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease With Or Without Esophagitis Including Erosions And Ulcerations

  1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Pd-rx Pharmaceuticals, Inc.
  

  ×

  Famotidine | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Duodenal Ulcer Acute Therapy

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer Acute Therapy

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, ClinicalStudies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients < 1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients<1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1 to 16 years of age

  See PRECAUTIONS, Pediatric Patients1 to 16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients1 to 16 years of age suggest the following starting doses in pediatric patients 1 to 16 years of age:

  Peptic Ulcer

  0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease With Or Without Esophagitis Including Erosions And Ulcerations

  1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Pd-rx Pharmaceuticals, Inc.
  

  ×

  Famotidine | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Duodenal Ulcer Acute Therapy

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer Acute Therapy

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, ClinicalStudies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients < 1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients<1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1 to 16 years of age

  See PRECAUTIONS, Pediatric Patients1 to 16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients1 to 16 years of age suggest the following starting doses in pediatric patients 1 to 16 years of age:

  Peptic Ulcer

  0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease With Or Without Esophagitis Including Erosions And Ulcerations

  1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Mckesson Contract Packaging
  

  ×

  Famotidine | Mckesson Contract Packaging

  

  ---

  Duodenal Ulcer Acute Therapy

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer Acute Therapy

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, ClinicalStudies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients < 1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients<1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1 to 16 years of age

  See PRECAUTIONS, Pediatric Patients1 to 16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients1 to 16 years of age suggest the following starting doses in pediatric patients 1 to 16 years of age:

  Peptic Ulcer

  0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease With Or Without Esophagitis Including Erosions And Ulcerations

  1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• App Pharmaceuticals, Llc
  

  ×

  Famotidine | App Pharmaceuticals, Llc

  

  ---

  In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, famotidine injection may be administered until oral therapy can be instituted.

  The recommended dosage for famotidine injection in adult patients is 20 mg intravenously q 12 h.

  The doses and regimen for parenteral administration in patients with GERD have not been established.

  Dosage for Pediatric Patients
  

  See PRECAUTIONS, Pediatric Use.

  The studies described in PRECAUTIONS, Pediatric Use suggest that the starting dose in pediatric patients 1 to 16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15 minute infusion) q 12 h up to 40 mg/day.

  While published uncontrolled clinical studies suggest effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy.  Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy.  Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h.

  No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

  Dosage Adjustments for Patients with Moderate or Severe Renal Insufficiency
  

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased.  For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients.  Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine injection may be reduced to half the dose, or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)
  

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient.  The recommended adult intravenous dose is 20 mg q 12 h. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated.  In some patients, a higher starting dose may be required.  Oral doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Preparation of Intravenous Solutions
  

  To prepare famotidine intravenous solutions, aseptically dilute 2 mL of famotidine injection (solution containing 10 mg/mL) with 0.9% Sodium Chloride Injection or other compatible intravenous solution (see Stability), to a total volume of either 5 mL or 10 mL and inject over a period of not less than 2 minutes.

  To prepare famotidine intravenous infusion solutions, aseptically dilute 2 mL of famotidine injection with 100 mL of 5% dextrose or other compatible solution (see Stability), and infuse over a 15 to 30 minute period.

  Concomitant Use of Antacids
  

  Antacids may be given concomitantly if needed.

  Stability

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

  When added to or diluted with most commonly used intravenous solutions, e.g., Water for Injection, 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, or Lactated Ringer’s Injection, diluted famotidine injection is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature – see HOW SUPPLIED, Storage.

  When added to or diluted with Sodium Bicarbonate Injection, 5%, famotidine injection at a concentration of 0.2 mg/mL (the recommended concentration of famotidine intravenous infusion solutions) is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature – see HOW SUPPLIED, Storage.  However, a precipitate may form at higher concentrations of famotidine injection (>0.2 mg/mL) in Sodium Bicarbonate Injection, 5%.

  Dosage for Pediatric Patients
  

  See PRECAUTIONS, Pediatric Use.

  The studies described in PRECAUTIONS, Pediatric Use suggest that the starting dose in pediatric patients 1 to 16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15 minute infusion) q 12 h up to 40 mg/day.

  While published uncontrolled clinical studies suggest effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy.  Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy.  Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h.

  No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

  Dosage Adjustments for Patients with Moderate or Severe Renal Insufficiency
  

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased.  For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients.  Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine injection may be reduced to half the dose, or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)
  

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient.  The recommended adult intravenous dose is 20 mg q 12 h. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated.  In some patients, a higher starting dose may be required.  Oral doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Preparation of Intravenous Solutions
  

  To prepare famotidine intravenous solutions, aseptically dilute 2 mL of famotidine injection (solution containing 10 mg/mL) with 0.9% Sodium Chloride Injection or other compatible intravenous solution (see Stability), to a total volume of either 5 mL or 10 mL and inject over a period of not less than 2 minutes.

  To prepare famotidine intravenous infusion solutions, aseptically dilute 2 mL of famotidine injection with 100 mL of 5% dextrose or other compatible solution (see Stability), and infuse over a 15 to 30 minute period.

  Concomitant Use of Antacids
  

  Antacids may be given concomitantly if needed.

  Stability

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

  When added to or diluted with most commonly used intravenous solutions, e.g., Water for Injection, 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, or Lactated Ringer’s Injection, diluted famotidine injection is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature – see HOW SUPPLIED, Storage.

  When added to or diluted with Sodium Bicarbonate Injection, 5%, famotidine injection at a concentration of 0.2 mg/mL (the recommended concentration of famotidine intravenous infusion solutions) is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature – see HOW SUPPLIED, Storage.  However, a precipitate may form at higher concentrations of famotidine injection (>0.2 mg/mL) in Sodium Bicarbonate Injection, 5%.

  Close
  No Recall

  More Info
• App Pharmaceuticals, Llc
  

  ×

  Famotidine | App Pharmaceuticals, Llc

  

  ---

  In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, famotidine injection may be administered until oral therapy can be instituted.

  The recommended dosage for famotidine injection in adult patients is 20 mg intravenously q 12 h.

  The doses and regimen for parenteral administration in patients with GERD have not been established.

  Dosage for Pediatric Patients
  

  See PRECAUTIONS, Pediatric Use.

  The studies described in PRECAUTIONS, Pediatric Use suggest that the starting dose in pediatric patients 1 to 16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15 minute infusion) q 12 h up to 40 mg/day.

  While published uncontrolled clinical studies suggest effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy.  Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy.  Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h.

  No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

  Dosage Adjustments for Patients with Moderate or Severe Renal Insufficiency
  

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased.  For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients.  Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine injection may be reduced to half the dose, or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)
  

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient.  The recommended adult intravenous dose is 20 mg q 12 h.  Doses should be adjusted to individual patient needs and should continue as long as clinically indicated.  In some patients, a higher starting dose may be required.  Oral doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Preparation of Intravenous Solutions
  

  To prepare famotidine intravenous solutions, aseptically dilute 2 mL of famotidine injection (solution containing 10 mg/mL) with 0.9% Sodium Chloride Injection or other compatible intravenous solution (see Stability), to a total volume of either 5 mL or 10 mL and inject over a period of not less than 2 minutes.

  To prepare famotidine intravenous infusion solutions, aseptically dilute 2 mL of famotidine injection with 100 mL of 5% dextrose or other compatible solution (see Stability), and infuse over a 15 to 30 minute period.

  Concomitant Use of Antacids
  

  Antacids may be given concomitantly if needed.

  Stability

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

  When added to or diluted with most commonly used intravenous solutions, e.g., Water for Injection, 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, or Lactated Ringer’s Injection, diluted famotidine injection is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature – see HOW SUPPLIED, Storage.

  When added to or diluted with Sodium Bicarbonate Injection, 5%, famotidine injection at a concentration of 0.2 mg/mL (the recommended concentration of famotidine intravenous infusion solutions) is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature – see  HOW SUPPLIED, Storage.  However, a precipitate may form at higher concentrations of famotidine injection (>0.2 mg/mL) in Sodium Bicarbonate Injection, 5%.

  Dosage for Pediatric Patients
  

  See PRECAUTIONS, Pediatric Use.

  The studies described in PRECAUTIONS, Pediatric Use suggest that the starting dose in pediatric patients 1 to 16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15 minute infusion) q 12 h up to 40 mg/day.

  While published uncontrolled clinical studies suggest effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy.  Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy.  Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h.

  No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

  Dosage Adjustments for Patients with Moderate or Severe Renal Insufficiency
  

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased.  For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients.  Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine injection may be reduced to half the dose, or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)
  

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient.  The recommended adult intravenous dose is 20 mg q 12 h.  Doses should be adjusted to individual patient needs and should continue as long as clinically indicated.  In some patients, a higher starting dose may be required.  Oral doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Preparation of Intravenous Solutions
  

  To prepare famotidine intravenous solutions, aseptically dilute 2 mL of famotidine injection (solution containing 10 mg/mL) with 0.9% Sodium Chloride Injection or other compatible intravenous solution (see Stability), to a total volume of either 5 mL or 10 mL and inject over a period of not less than 2 minutes.

  To prepare famotidine intravenous infusion solutions, aseptically dilute 2 mL of famotidine injection with 100 mL of 5% dextrose or other compatible solution (see Stability), and infuse over a 15 to 30 minute period.

  Concomitant Use of Antacids
  

  Antacids may be given concomitantly if needed.

  Stability

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

  When added to or diluted with most commonly used intravenous solutions, e.g., Water for Injection, 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, or Lactated Ringer’s Injection, diluted famotidine injection is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature – see HOW SUPPLIED, Storage.

  When added to or diluted with Sodium Bicarbonate Injection, 5%, famotidine injection at a concentration of 0.2 mg/mL (the recommended concentration of famotidine intravenous infusion solutions) is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature – see  HOW SUPPLIED, Storage.  However, a precipitate may form at higher concentrations of famotidine injection (>0.2 mg/mL) in Sodium Bicarbonate Injection, 5%.

  Close
  No Recall

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

  ×

  Famotidine | H.j. Harkins Company, Inc.

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS , Pediatric Patients 1-16 years of age .

  The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Golden State Medical Supply, Inc.
  

  ×

  Famotidine | Golden State Medical Supply, Inc.

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS , Pediatric Patients 1-16 years of age .

  The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

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

  ×

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

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS , Pediatric Patients 1-16 years of age .

  The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Lupin Pharmaceuticals, Inc
  

  ×

  Famotidine | Lupin Pharmaceuticals, Inc

  

  ---

  Duodenal Ulcer:

  Acute Therapy: 

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy:

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer:

  Acute Therapy: 

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD):

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD):

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients <1 year of age  suggest the following starting doses in pediatric patients <1 year of age:

  Gastroesophageal Reflux Disease (GERD):

  0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age:

  See PRECAUTIONS, Pediatric Patients 1-16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age  suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic Ulcer:

  0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease With or Without Esophagitis Including Erosions and Ulcerations:

  1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas):

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Oral Suspension:

  Famotidine for Oral Suspension may be substituted for famotidine tablets in any of the above indications. Each five mL contains 40 mg of famotidine after constitution of the powder with 46 mL of purified water as directed.

  Directions for Preparing Famotidine for Oral Suspension:

  Prepare suspension at time of dispensing. Slowly add 46 mL of purified water. Shake vigorously for 5-10 seconds immediately after adding the water and immediately before use.

  Stability of Famotidine for Oral Suspension:

  Unused constituted oral suspension should be discarded after 30 days.

  Concomitant Use of Antacids:

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency:

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Ncs Healthcare Of Ky, Inc Dba Vangard Labs
  

  ×

  Famotidine | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

  

  ---

  Duodenal Ulcer Acute Therapy

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer Acute Therapy

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, ClinicalStudies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients < 1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients<1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1 to 16 years of age

  See PRECAUTIONS, Pediatric Patients1 to 16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients1 to 16 years of age suggest the following starting doses in pediatric patients 1 to 16 years of age:

  Peptic Ulcer

  0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease With Or Without Esophagitis Including Erosions And Ulcerations

  1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should

  be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Physicians Total Care, Inc.
  

  ×

  Famotidine | Physicians Total Care, Inc.

  

  ---

  Duodenal Ulcer

  Acute Therapy:The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime. 

  Benign Gastric Ulcer 

  Acute Therapy:The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies). 

  Dosage for Pediatric Patients <1 year of ageGastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, PediatricPatients <1 year of age suggest the following startingdoses in pediatric patients <1 year of age:Gastroesophageal Reflux Disease (GERD) - 0.5mg/kg/dose of famotidine oral suspension for thetreatment of GERD for up to 8 weeks once daily inpatients <3 months of age and 0.5 mg/kg/dose twicedaily in patients 3 months to <1 year of age. Patientsshould also be receiving conservative measures (e.g.,thickened feedings). The use of intravenous famotidinein pediatric patients <1 year of age with GERD has notbeen adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS, Pediatric Patients 1-16 years of age. 

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age. 

  Peptic Ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without Esophagitis Including Erosions and Ulcerations – 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d. 

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to    1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations. 

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome. 

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed. 

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient’s clinical response. 

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Ncs Healthcare Of Ky, Inc Dba Vangard Labs
  

  ×

  Famotidine | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

  

  ---

  Duodenal Ulcer Acute Therapy

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer Acute Therapy

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, ClinicalStudies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients < 1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients<1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1 to 16 years of age

  See PRECAUTIONS, Pediatric Patients1 to 16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients1 to 16 years of age suggest the following starting doses in pediatric patients 1 to 16 years of age:

  Peptic Ulcer

  0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease With Or Without Esophagitis Including Erosions And Ulcerations

  1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Dr.reddys Laboratories Limited
  

  ×

  Famotidine | Dr.reddys Laboratories Limited

  

  ---

  For Famotidine 10 mg: adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor For Famotidine 20 mg: adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• West-ward Pharmaceutical Corp.
  

  ×

  Famotidine | West-ward Pharmaceutical Corp.

  

  ---

  In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection may be administered until oral therapy can be instituted.
  
  The recommended dosage for Famotidine Injection in adult patients is 20 mg intravenously q 12 h.
  
  The doses and regimen for parenteral administration in patients with GERD have not been established.

  Dosage for Pediatric Patients <1 Year of Age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 Year of Age.
  
  The studies described in PRECAUTIONS, Pediatric Patients <1 Year of Age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) – 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 Years of Age

  See PRECAUTIONS, Pediatric Patients 1-16 Years of Age.
  
  The studies described in PRECAUTIONS, Pediatric Patients 1-16 Years of Age suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day.
  
  While published uncontrolled clinical studies suggest effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients 1-16 years of age have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h.

  Dosage Adjustments for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of Famotidine Injection may be reduced to half the dose, or the dosing interval may be prolonged to 36-48 hours as indicated by the patient’s clinical response.
  
  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult intravenous dose is 20 mg q 12 h. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. In some patients, a higher starting dose may be required. Oral doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.
  
  To prepare intravenous solutions, aseptically dilute 2 mL of Famotidine Injection (solution containing 10 mg/mL) with Sodium Chloride Injection 0.9% or other compatible intravenous solution (see Stability) to a total volume of either 5 mL or 10 mL and inject over a period of not less than 2 minutes.
  
  To prepare intravenous infusion solutions, aseptically dilute 2 mL of Famotidine Injection with 100 mL of Dextrose 5% or other compatible solution (see Stability), and infuse over a 15-30 minute period.

  Concomitant Use of Antacids

  Antacids may be given orally concomitantly if needed.

  Stability

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
  
  When added to or diluted with most commonly used intravenous solutions, e.g., Water for Injection, Sodium Chloride Injection 0.9%, Dextrose Injection 5% and 10% or Lactated Ringer’s Injection, diluted Famotidine Injection is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature–see HOW SUPPLIED, Storage.
  
  When added to or diluted with Sodium Bicarbonate Injection 5%, Famotidine Injection at a concentration of 0.2 mg/mL (the recommended concentration of famotidine intravenous infusion solutions) is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature–see HOW SUPPLIED, Storage.  However, a precipitate may form at higher concentrations of Famotidine Injection (>0.2 mg/mL) in Sodium Bicarbonate Injection 5%.

  Close
  No Recall

  More Info
• Cardinal Health
  

  ×

  Famotidine | Cardinal Health

  

  ---

  Duodenal Ulcer Acute Therapy

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS, Pediatric Patients 1-16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age.

  Peptic Ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without Esophagitis Including Erosions and Ulcerations –1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Oral Suspension

  Famotidine for oral suspension may be substituted for famotidine tablets in any of the above indications.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Cardinal Health
  

  ×

  Famotidine | Cardinal Health

  

  ---

  Duodenal Ulcer Acute Therapy

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer Acute Therapy

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, ClinicalStudies).

  Dosage for Pediatric Patients < 1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients < 1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients< 1 year of age suggest the following starting doses in pediatric patients < 1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients < 3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to < 1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients < 1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1 to 16 years of age

  See PRECAUTIONS, Pediatric Patients1 to 16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients1 to 16 years of age suggest the following starting doses in pediatric patients 1 to 16 years of age:

  Peptic Ulcer

  0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease With Or Without Esophagitis Including Erosions And Ulcerations

  1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Wockhardt Limited
  

  ×

  Famotidine | Wockhardt Limited

  

  ---

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Wockhardt Usa Llc.
  

  ×

  Famotidine | Wockhardt Usa Llc.

  

  ---

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Stat Rx Usa Llc
  

  ×

  Famotidine | Stat Rx Usa Llc

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) -0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS, Pediatric Patients 1-16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Wockhardt Usa Llc.
  

  ×

  Famotidine | Wockhardt Usa Llc.

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) -0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS, Pediatric Patients 1-16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Wockhardt Limited
  

  ×

  Famotidine | Wockhardt Limited

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) -0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS, Pediatric Patients 1-16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Chain Drug Marketing Association Inc.
  

  ×

  Famotidine | Chain Drug Marketing Association Inc.

  

  ---

  Famotidine USP, 10 mg

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Famotidine USP, 20 mg

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Bryant Ranch Prepack
  

  ×

  Famotidine | Bryant Ranch Prepack

  

  ---

  adults and children 12 years and over: to symptoms, swallow 1 tablet with a glass of water. Do not chew. relieve to symptoms, swallow 1 tablet with a glass of water at any time from eating food or drinking beverages that cause heartburn prevent10 to 60 minutes before do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Carlsbad Technology, Inc
  

  ×

  Famotidine | Carlsbad Technology, Inc

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS , Pediatric Patients 1-16 years of age .

  The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Mylan Institutional Inc.
  

  ×

  Famotidine | Target Corporation

  

  ---

  • take only as directed – see overdose warning • do not exceed 4 doses per 24 hrs

  adults & children 12 yrs & over

  2 softgels with water every 4 hrs

  children 4 to under 12 yrs

  ask a doctor

  children under 4 yrs

  do not use

  Close
  No Recall

  More Info
• Bryant Ranch Prepack
  

  ×

  Famotidine | Bryant Ranch Prepack

  

  ---

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Fred’s Inc.
  

  ×

  Famotidine | Fred's Inc.

  

  ---

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Valu Merchandisers Company
  

  ×

  Famotidine | Valu Merchandisers Company

  

  ---

  Famotidine USP, 10 mg

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Famotidine USP, 20 mg

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Amerisource Bergen
  

  ×

  Famotidine | Amerisource Bergen

  

  ---

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Remedyrepack Inc.
  

  ×

  Famotidine | Remedyrepack Inc.

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) -0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS, Pediatric Patients 1-16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

   

  Close
  No Recall

  More Info
• Remedyrepack Inc.
  

  ×

  Famotidine | Remedyrepack Inc.

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) -0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS, Pediatric Patients 1-16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

   

  Close
  No Recall

  More Info
• Remedyrepack Inc.
  

  ×

  Famotidine | Remedyrepack Inc.

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) -0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS, Pediatric Patients 1-16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

   

  Close
  No Recall

  More Info
• Shopko Stores Operating Co., Llc
  

  ×

  Famotidine | Shopko Stores Operating Co., Llc

  

  ---

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Cardinal Health
  

  ×

  Famotidine | Walgreen Co.

  

  ---

  do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor 

  Close
  No Recall

  More Info
• Unit Dose Services
  

  ×

  Famotidine | Unit Dose Services

  

  ---

  Duodenal Ulcer

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective. Acute Therapy:

  The recommended adult oral dose is 20 mg once a day at bedtime. Maintenance Therapy:

  Benign Gastric Ulcer

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime. Acute Therapy:

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see , ). CLINICAL PHARMACOLOGY IN ADULTSClinical Studies

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See , PRECAUTIONS. Pediatric Patients <1 year of age

  The studies described in , suggest the following starting doses in pediatric patients <1 year of age: - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied. PRECAUTIONSPediatric Patients <1 year of ageGastroesophageal Reflux Disease (GERD)

  Dosage for Pediatric Patients 1-16 years of age

  See , . PRECAUTIONSPediatric Patients 1-16 years of age

  The studies described in , suggest the following starting doses in pediatric patients 1-16 years of age: PRECAUTIONSPediatric Patients 1-16 years of age

  — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day. Peptic ulcer

  — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d. Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Unit Dose Services
  

  ×

  Famotidine | Unit Dose Services

  

  ---

  Duodenal Ulcer

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective. Acute Therapy:

  The recommended adult oral dose is 20 mg once a day at bedtime. Maintenance Therapy:

  Benign Gastric Ulcer

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime. Acute Therapy:

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see , ). CLINICAL PHARMACOLOGY IN ADULTSClinical Studies

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See , PRECAUTIONS. Pediatric Patients <1 year of age

  The studies described in , suggest the following starting doses in pediatric patients <1 year of age: - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied. PRECAUTIONSPediatric Patients <1 year of ageGastroesophageal Reflux Disease (GERD)

  Dosage for Pediatric Patients 1-16 years of age

  See , . PRECAUTIONSPediatric Patients 1-16 years of age

  The studies described in , suggest the following starting doses in pediatric patients 1-16 years of age: PRECAUTIONSPediatric Patients 1-16 years of age

  — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day. Peptic ulcer

  — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d. Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Kinray
  

  ×

  Famotidine | Kinray

  

  ---

  Famotidine USP, 10 mg

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Famotidine USP, 20 mg

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Remedyrepack Inc.
  

  ×

  Famotidine | Remedyrepack Inc.

  

  ---

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

   

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

   

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

   

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

   

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

   

  See PRECAUTIONS , Pediatric Patients 1-16 years of age .

  The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

   

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

   

  Antacids may be given concomitantly if needed.

   

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

   

  Close
  No Recall

  More Info
• American Health Packaging
  

  ×

  Famotidine | American Health Packaging

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) -0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS, Pediatric Patients 1-16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Select Brand
  

  ×

  Famotidine | Select Brand

  

  ---

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Pfizer Laboratories Div Pfizer Inc
  

  ×

  Famotidine | Pfizer Laboratories Div Pfizer Inc

  

  ---

  In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, famotidine injection, USP may be administered until oral therapy can be instituted.

  The recommended dosage for famotidine injection, USP in adult patients is 20 mg intravenously q 12 h.

  The doses and regimen for parenteral administration in patients with GERD have not been established.

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1–16 years of age

  See PRECAUTIONS, Pediatric Patients 1 to 16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1 to 16 years of age suggest that the starting dose in pediatric patients 1 to 16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day.

  While published uncontrolled clinical studies suggest effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients 1 to 16 years of age have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h.

  Dosage Adjustments for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine injection, USP may be reduced to half the dose, or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult intravenous dose is 20 mg q 12 h. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. In some patients, a higher starting dose may be required. Oral doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  To prepare famotidine intravenous solutions, aseptically dilute 2 mL of famotidine injection, USP (solution containing 10 mg/mL) with 0.9% Sodium Chloride Injection or other compatible intravenous solution (see Stability, Famotidine Injection, USP) to a total volume of either 5 mL or 10 mL and inject over a period of not less than 2 minutes.

  To prepare famotidine intravenous infusion solutions, aseptically dilute 2 mL of famotidine injection, USP with 100 mL of 5% dextrose or other compatible solution (see Stability, Famotidine Injection, USP), and infuse over a 15 to 30 minute period.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Stability

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

  Famotidine Injection, USP

  When added to or diluted with most commonly used intravenous solutions, e.g., Water for Injection, 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, or Lactated Ringer's Injection, diluted famotidine injection, USP is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature—see HOW SUPPLIED, Storage.

  When added to or diluted with Sodium Bicarbonate Injection, 5%, famotidine injection, USP at a concentration of 0.2 mg/mL (the recommended concentration of famotidine intravenous infusion solutions) is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature—see HOW SUPPLIED, Storage. However, a precipitate may form at higher concentrations of famotidine injection, USP (>0.2 mg/mL) in Sodium Bicarbonate Injection, 5%.

  Close
  No Recall

  More Info
• Lake Erie Medical Dba Quality Care Products Llc
  

  ×

  Famotidine | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) -0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS, Pediatric Patients 1-16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Ivax Pharmaceuticals, Inc.
  

  ×

  Famotidine | Ivax Pharmaceuticals, Inc.

  

  ---

  • adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of
  water. Do not chew. • to prevent symptoms, swallow 1 tablet with a glass of
  water at any time from 15 to 60 minutes before eating
  food or drinking beverages that cause heartburn • do not use more than 2 tablets in 24 hours • children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Spirit Pharmaceuticals,llc
  

  ×

  Famotidine | Spirit Pharmaceuticals,llc

  

  ---

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Avkare, Inc.
  

  ×

  Famotidine | Avkare, Inc.

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS , Pediatric Patients 1-16 years of age .

  The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Cardinal Health
  

  ×

  Famotidine | Cardinal Health

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) -0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS, Pediatric Patients 1-16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Our Family (Nash Finch Company)
  

  ×

  Famotidine | Our Family (nash Finch Company)

  

  ---

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water 15 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Dispensing Solutions, Inc.
  

  ×

  Famotidine | Dispensing Solutions, Inc.

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS , Pediatric Patients 1-16 years of age .

  The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Walgreen Company
  

  ×

  Famotidine | Walgreen Company

  

  ---

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Preferred Pharmaceuticals, Inc
  

  ×

  Famotidine | Preferred Pharmaceuticals, Inc.

  

  ---

  Duodenal Ulcer

  Acute Therapy:The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime. 

  Benign Gastric Ulcer 

  Acute Therapy:The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies). 

  Dosage for Pediatric Patients <1 year of ageGastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, PediatricPatients <1 year of age suggest the following startingdoses in pediatric patients <1 year of age:Gastroesophageal Reflux Disease (GERD) - 0.5mg/kg/dose of famotidine oral suspension for thetreatment of GERD for up to 8 weeks once daily inpatients <3 months of age and 0.5 mg/kg/dose twicedaily in patients 3 months to <1 year of age. Patientsshould also be receiving conservative measures (e.g.,thickened feedings). The use of intravenous famotidinein pediatric patients <1 year of age with GERD has notbeen adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS, Pediatric Patients 1-16 years of age. 

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age. 

  Peptic Ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without Esophagitis Including Erosions and Ulcerations – 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d. 

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to    1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations. 

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome. 

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed. 

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient’s clinical response. 

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Preferred Pharmaceuticals, Inc.
  

  ×

  Famotidine | Preferred Pharmaceuticals, Inc.

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) -0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS, Pediatric Patients 1-16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Aidarex Pharmaceuticals Llc
  

  ×

  Famotidine | Aidarex Pharmaceuticals Llc

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS , Pediatric Patients 1-16 years of age .

  The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Aidarex Pharmaceuticals Llc
  

  ×

  Famotidine | Aidarex Pharmaceuticals Llc

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) -0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS, Pediatric Patients 1-16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Mckesson Packaging Services A Business Unit Of Mckesson Corporation
  

  ×

  Famotidine | Mckesson Packaging Services A Business Unit Of Mckesson Corporation

  

  ---

  
  DuodenalUlcer
  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.
  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.
  
  Benign Gastric Ulcer
  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.
  
  Gastroesophageal Reflux Disease (GERD)
  
  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
  
  Dosage for Pediatric Patients <1 year of age 
  Gastroesophageal Reflux Disease (GERD)  
  See PRECAUTIONS , Pediatric Patients <1 year of age.
  
  The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age:
  Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.
  
  Dosage for Pediatric Patients 1-16 years of age  
  See PRECAUTIONS, Pediatric Patients 1-16 years of age. 
  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:
  Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations. 
  
  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas) 
  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.
  
  Concomitant Use of Antacids
  Antacids may be given concomitantly if needed.
  
  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency  
  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response. Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Cardinal Health
  

  ×

  Famotidine | Cardinal Health

  

  ---

  Duodenal Ulcer

  Acute Therapy:

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy:

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy:

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age 

  Gastroesophageal Reflux Disease (GERD) 

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age:

  Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age 

  See PRECAUTIONS, Pediatric Patients 1-16 years of age. 

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer

  - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations

  - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations. 

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas) 

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency 

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Wal-mart Stores Inc
  

  ×

  Famotidine | Wal-mart Stores Inc

  

  ---

  For Famotidine 10 mg: adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor For Famotidine 20 mg: adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Walmart Stores Inc.
  

  ×

  Famotidine | Walmart Stores Inc.

  

  ---

  For Famotidine 10 mg: adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor For Famotidine 20 mg: adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Mylan Institutional Llc
  

  ×

  Famotidine | Mylan Institutional Llc

  

  ---

  In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, famotidine injection, USP may be administered until oral therapy can be instituted.

  The recommended dosage for famotidine injection, USP in adult patients is 20 mg intravenously q 12 h.

  The doses and regimen for parenteral administration in patients with GERD have not been established.

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS, Pediatric Patients 1 to 16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1 to 16 years of age suggest that the starting dose in pediatric patients 1 to 16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day.

  While published uncontrolled clinical studies suggest effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients 1 to 16 years of age have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h.

  Dosage Adjustments for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine injection, USP may be reduced to half the dose, or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult intravenous dose is 20 mg q 12 h. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. In some patients, a higher starting dose may be required. Oral doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  To prepare famotidine intravenous solutions, aseptically dilute 2 mL of famotidine injection, USP (solution containing 10 mg/mL) with 0.9% Sodium Chloride Injection or other compatible intravenous solution (see Stability, Famotidine Injection, USP) to a total volume of either 5 mL or 10 mL and inject over a period of not less than 2 minutes.

  To prepare famotidine intravenous infusion solutions, aseptically dilute 2 mL of famotidine injection, USP with 100 mL of 5% dextrose or other compatible solution (see Stability, Famotidine Injection, USP), and infuse over a 15 to 30 minute period.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Stability

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

  Famotidine Injection, USP

  When added to or diluted with most commonly used intravenous solutions, e.g., Water for Injection, 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, or Lactated Ringer’s Injection, diluted famotidine injection, USP is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature — see HOW SUPPLIED, Storage.

  When added to or diluted with Sodium Bicarbonate Injection, 5%, famotidine injection, USP at a concentration of 0.2 mg/mL (the recommended concentration of famotidine intravenous infusion solutions) is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature — see HOW SUPPLIED, Storage. However, a precipitate may form at higher concentrations of famotidine injection, USP (>0.2 mg/mL) in Sodium Bicarbonate Injection, 5%.

  Close
  No Recall

  More Info
• Kaiser Foundation Hospitals
  

  ×

  Famotidine | Kaiser Foundation Hospitals

  

  ---

  Duodenal Ulcer Acute Therapy

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer Acute Therapy

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, ClinicalStudies).

  Dosage for Pediatric Patients < 1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients < 1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients< 1 year of age suggest the following starting doses in pediatric patients < 1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients < 3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to < 1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients < 1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1 to 16 years of age

  See PRECAUTIONS, Pediatric Patients1 to 16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients1 to 16 years of age suggest the following starting doses in pediatric patients 1 to 16 years of age:

  Peptic Ulcer

  0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease With Or Without Esophagitis Including Erosions And Ulcerations

  1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Heb
  

  ×

  Famotidine | Heb

  

  ---

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Ivax Pharmaceuticals, Inc.
  

  ×

  Famotidine | Ivax Pharmaceuticals, Inc.

  

  ---

  Duodenal Ulcer Acute Therapy

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer Acute Therapy

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients < 1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients < 1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients< 1 year of age suggest the following starting doses in pediatric patients < 1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients < 3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to < 1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients < 1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1 to 16 years of age

  See PRECAUTIONS, Pediatric Patients1 to 16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients1 to 16 years of age suggest the following starting doses in pediatric patients 1 to 16 years of age:

  Peptic Ulcer

  0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease With Or Without Esophagitis Including Erosions And Ulcerations

  1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Bluepoint Laboratories
  

  ×

  Famotidine | Aplicare, Inc.

  

  ---

  Directions apply locally as needed

  Close
  No Recall

  More Info
• St Marys Medical Park Pharmacy
  

  ×

  Famotidine | St Marys Medical Park Pharmacy

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS , Pediatric Patients 1-16 years of age .

  The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Teva Pharmaceuticals Usa Inc
  

  ×

  Famotidine | Teva Pharmaceuticals Usa Inc

  

  ---

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of
  water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of
  water at any time from 15 to 60 minutes before eating
  food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Cantrell Drug Company
  

  ×

  Famotidine | Cantrell Drug Company

  

  ---

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

  Close
  No Recall

  More Info
• Baxter Healthcare Corporation
  

  ×

  Famotidine | Baxter Healthcare Corporation

  

  ---

  In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection may be administered until oral therapy can be instituted.

  The recommended dosage for Famotidine Injection in adult patients is 20 mg intravenously q 12 h.

  The doses and regimen for parenteral administration in patients with GERD have not been established.

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1–16 years of age

  See PRECAUTIONS, Pediatric Patients 1-16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1–16 years of age suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day.

  While published uncontrolled clinical studies suggest effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients 1-16 years of age have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h.

  Dosage Adjustments for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of Famotidine Injection may be reduced to half the dose, or the dosing interval may be prolonged to 36-48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult intravenous dose is 20 mg q 12 h. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. In some patients, a higher starting dose may be required. Oral doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Famotidine Injection

  Famotidine Injection, supplied in GALAXY containers (PL 2501 Plastic), is a 50 mL iso-osmotic solution premixed with 0.9% sodium chloride for administration as an infusion over a 15-30 minute period.

  This premixed solution is for intravenous use only using sterile equipment.

  Close
  No Recall

  More Info
• Carilion Materials Management
  

  ×

  Famotidine | Carilion Materials Management

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.  

    Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see ) Gastroesophageal Reflux Disease (GERD)CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies. 

  Dosage for Pediatric Patients <1 year of ageGastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, PediatricPatients <1 year of age suggest the following startingdoses in pediatric patients <1 year of age:Gastroesophageal Reflux Disease (GERD) - 0.5mg/kg/dose of famotidine oral suspension for thetreatment of GERD for up to 8 weeks once daily inpatients <3 months of age and 0.5 mg/kg/dose twicedaily in patients 3 months to <1 year of age. Patientsshould also be receiving conservative measures (e.g.,thickened feedings). The use of intravenous famotidinein pediatric patients <1 year of age with GERD has notbeen adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See   PRECAUTIONS, Pediatric Patients 1-16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age. 

  Peptic Ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without Esophagitis Including Erosions and Ulcerations – 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d. 

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to    1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.  

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.  

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed. 

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient’s clinical response. 

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Carilion Materials Management
  

  ×

  Famotidine | Carilion Materials Management

  

  ---

  Duodenal Ulcer

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective. Acute Therapy:

  The recommended adult oral dose is 20 mg once a day at bedtime. Maintenance Therapy:

  Benign Gastric Ulcer

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime. Acute Therapy:

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see ). CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See . PRECAUTIONS, Pediatric Patients <1 year of age

  The studies described in PRECAUTIONS, suggest the following starting doses in pediatric patients <1 year of age: -0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied. Pediatric Patients <1 year of ageGastroesophageal Reflux Disease (GERD)

  Dosage for Pediatric Patients 1-16 years of age

  See . PRECAUTIONS, Pediatric Patients 1-16 years of age

  The studies described in PRECAUTIONS, suggest the following starting doses in pediatric patients 1-16 years of age: Pediatric Patients 1-16 years of age

  - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day. Peptic ulcer

  - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d. Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Mylan Pharmaceuticals Inc.
  

  ×

  Famotidine | Mylan Pharmaceuticals Inc.

  

  ---

  Duodenal Ulcer Acute Therapy

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine tablets at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer Acute Therapy

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 mg or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS: Clinical Studies).

  Dosage for Pediatric Patients < 1 Year of Age Gastroesophageal Reflux Disease (GERD)

  (See PRECAUTIONS: Pediatric Patients < 1 Year of Age.)

  The studies described in PRECAUTIONS: Pediatric Patients < 1 Year of Age suggest the following starting doses in pediatric patients < 1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients < 3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to < 1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients < 1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1 to 16 Years of Age

  (See PRECAUTIONS: Pediatric Patients 1 to 16 Years of Age.)

  The studies described in PRECAUTIONS: Pediatric Patients 1 to 16 Years of Age suggest the following starting doses in pediatric patients 1 to 16 years of age:

    Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.   Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine tablets in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q6h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q6h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine tablets may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine tablets in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  HOW SUPPLIED

  Famotidine Tablets, USP are available containing either 20 mg or 40 mg of famotidine, USP.

  The 20 mg tablets are yellow film-coated, round, unscored tablets debossed with M over F1 on one side of the tablet and blank on the other side. They are available as follows:

  NDC 0378-3020-01
  bottles of 100 tablets

  NDC 0378-3020-05
  bottles of 500 tablets

  The 40 mg tablets are green film-coated, round, unscored tablets debossed with M over F2 on one side of the tablet and blank on the other side. They are available as follows:

  NDC 0378-3040-01
  bottles of 100 tablets

  Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

  Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

  Mylan Pharmaceuticals Inc.
  Morgantown, WV 26505 U.S.A.

  REVISED MAY 2014
  FAMO:R10

  Close
  No Recall

  More Info
• Pd-rx Pharmaceuticals, Inc.
  

  ×

  Famotidine | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Duodenal Ulcer Acute Therapy

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer Acute Therapy

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients < 1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients < 1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients< 1 year of age suggest the following starting doses in pediatric patients < 1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients < 3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to < 1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients < 1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1 to 16 years of age

  See PRECAUTIONS, Pediatric Patients1 to 16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients1 to 16 years of age suggest the following starting doses in pediatric patients 1 to 16 years of age:

  Peptic Ulcer

  0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease With Or Without Esophagitis Including Erosions And Ulcerations

  1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Bryant Ranch Prepack
  

  ×

  Famotidine | Bryant Ranch Prepack

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS , Pediatric Patients 1-16 years of age .

  The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Northwind Pharmaceuticals,llc
  

  ×

  Famotidine | Northwind Pharmaceuticals,llc

  

  ---

  Duodenal Ulcer

  Acute Therapy

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients < 1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients < 1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients< 1 year of age suggest the following starting doses in pediatric patients < 1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients < 3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to < 1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients < 1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1 to 16 years of age

  See PRECAUTIONS, Pediatric Patients1 to 16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients1 to 16 years of age suggest the following starting doses in pediatric patients 1 to 16 years of age:

  Peptic Ulcer

  0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease With Or Without Esophagitis Including Erosions And Ulcerations

  1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Remedyrepack Inc.
  

  ×

  Famotidine | Remedyrepack Inc.

  

  ---

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

   

  The recommended adult oral dose is 20 mg once a day at bedtime.

   

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

   

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

   

  See PRECAUTIONS, Pediatric Patients < 1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients< 1 year of age suggest the following starting doses in pediatric patients < 1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients < 3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to < 1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients < 1 year of age with GERD has not been adequately studied.

   

  See PRECAUTIONS, Pediatric Patients1 to 16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients1 to 16 years of age suggest the following starting doses in pediatric patients 1 to 16 years of age:

   

  0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

   

  1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

   

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

   

  Antacids may be given concomitantly if needed.

   

  In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

   

  Close
  No Recall

  More Info
• Direct Rx
  

  ×

  Famotidine | Direct Rx

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS , Pediatric Patients 1-16 years of age .

  The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Safecor Health, Llc
  

  ×

  Famotidine | Safecor Health, Llc

  

  ---

  • adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. • to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn • do not use more than 2 tablets in 24 hours • children under 12 years: ask a doctor

  Close
  No Recall

  More Info
• Medsource Pharmaceuticals
  

  ×

  Famotidine | Medsource Pharmaceuticals

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS , Pediatric Patients 1-16 years of age .

  The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Preferred Pharmaceuticals Inc.
  

  ×

  Famotidine | Preferred Pharmaceuticals Inc.

  

  ---

  Duodenal Ulcer

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age

  See PRECAUTIONS , Pediatric Patients 1-16 years of age .

  The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Avera Mckennan Hospital
  

  ×

  Famotidine | Avera Mckennan Hospital

  

  ---

  Duodenal Ulcer Acute Therapy

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer Acute Therapy

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients < 1 year of age Gastroesophageal Reflux Disease (GERD)

  See PRECAUTIONS, Pediatric Patients < 1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients< 1 year of age suggest the following starting doses in pediatric patients < 1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients < 3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to < 1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients < 1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1 to 16 years of age

  See PRECAUTIONS, Pediatric Patients1 to 16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients1 to 16 years of age suggest the following starting doses in pediatric patients 1 to 16 years of age:

  Peptic Ulcer

  0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease With Or Without Esophagitis Including Erosions And Ulcerations

  1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Concomitant Use of Antacids

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

  In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient’s clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

  Close
  No Recall

  More Info
• Remedyrepack Inc.
  

  ×

  Famotidine | Remedyrepack Inc.

  

  ---

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

   

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

   

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

   

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

   

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

   

  See PRECAUTIONS , Pediatric Patients 1-16 years of age .

  The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

   

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

   

  Antacids may be given concomitantly if needed.

   

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

   

  Close
  No Recall

  More Info
• Remedyrepack Inc.
  

  ×

  Famotidine | Remedyrepack Inc.

  

  ---

  Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

   

  Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

   

  Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

   

  Gastroesophageal Reflux Disease (GERD)

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

   

  See PRECAUTIONS , Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

   

  See PRECAUTIONS , Pediatric Patients 1-16 years of age .

  The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

   

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

   

  Antacids may be given concomitantly if needed.

   

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

   

  Close
  No Recall

  More Info