Famotack Powder for Suspension

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.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products need stomach acid so that the body can absorb them properly. Famotidine decreases stomach acid, so it may change how well these products work. Some affected products include atazanavir, dasatinib, delavirdine, certain azole antifungals (such as itraconazole, ketoconazole), levoketoconazole, pazopanib, among others.

Do not take this medication with other products that contain famotidine or other H2 blockers (cimetidine, nizatidine, ranitidine).

Known hypersensitivity to any component of the drug.

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

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.

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.

N/A

H2 Receptor Antagonist

N/A

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