Famotidine

Famotidine is indicated in-

• Gastric ulcer
• Duodenal ulcer
• Anastomotic ulcer
• Acute stress ulcer
• Reflux esophagitis and
• Zollinger-Ellison syndrome.

Famotidine is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.

Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.

Tablet:

• For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
• For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.

Powder for Suspension: Gastroesophageal Reflux Disease(GERD):

• <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
• Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
• Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
• Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks

Patients 1-16 years of age:

• Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
• Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Maintenance therapy: 40 mg at daily night.
• Reflux esophagitis: 2 mg/kg/day
• Zollinger-Ellison Syndrome: 40 mg 3 times daily.

Intravenous Injection: In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection Premixed or Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection Premixed and 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: Pediatric Patients 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 the 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.

Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.

Known hypersensitivity to any component of the drug.

The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.

No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.