Famotidine USP
Composition : Each 5 ml reconstituted suspension contains Famotidine USP 40 mg.
Indication : Famotidine is indicated in Duodenal ulcer, gastric ulcer, gastroesophageal reflux disease, acute stress ulcer and Zollinger-Ellison syndrome. It is also indicated in acute gastritis, chronic gastritis in acute exacerbation stage.
Dosage and administration:
Gastroesophageal reflux disease (GERD):
‹1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8weeks once daily in patients.
Age 3 to 11 months : 0.5 mg/kg/dose twice daily up to 8weeks
Age 1 to 2 months : 0.5 mg/kg/dose once daily up to 8weeks
Neonates : 0.5 mg/kg/dose maximum once daily up to 8weeks
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.
Duodenal Ulcer: 0.5 mg/kg/day p.o. at bed time or divided b.i.d. up to 40 mg/day.
Peptic ulcer: 0.5 mg/kg/day p.o. at bed time 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.
Or, as directed by a registered physician.
Use in pregnancy and lactation : 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 famotidine is administered to a nursing woman.
Packing: Famotid Suspension: Each bottle contains dry powder for preparation of 50 ml suspension.