Composition
Each 5ml reconstituted suspension contains Famotidine USP 40 mg.
Pharmacology
Famotidine is a H2-receptor antagonist. By inhibiting H2 receptor it inhibits the secretion of gastric acid, reducing both the volume of the acid and the pepsin content of the secretion. Famotidine has a relatively long duration of action and a single 40 mg/ 5 ml dose effectively suppresses gastric acid secretion for twelve hours.
Indication
Famotidine is indicated in duodenal ulcers, gastric ulcers, gastroesophageal reflux disease, acute stress ulcers, and zollinger-ellison Syndrome. It is also indicated in Acute Gastritis, Chronic Gastritis in Acute Exacerbation Stage.
Dosage and Administration
Gastroesophageal Reflux Disease (GERD)
Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks.
Less than 3 months: 0.5 mg/kg/dose once daily up to 8 weeks.
3 months to less than 1 year: 0.5 mg/kg/dose twice 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.
Duodenal 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.
Or, as directed by a registered physician.
To Prepare 50 ml Suspension
First, shake the bottle to loosen the powder, then add 35 ml or 7 teaspoonfuls (with supplied measuring cup) of boiled and cooled water into the bottle & shake well to make 50 ml suspension.
The reconstituted suspension should be kept at room temperature & must be used within 30 days.
Contraindication
Famotidine is contraindicated for patients who have hypersensitivity to the drug or any other ingredients.
Precaution
The drug should be used in the minimum required amount depending upon the conditions of the disease. The drug should be administered carefully with elderly patients, patients with renal failure, and hepatic disorders.
Side Effects
Adverse effects of Famotidine are generally infrequent and minor. Eruption, constipation, diarrhea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness, or insomnia may rarely occur.
Pregnancy and Lactation
Pregnancy category B. There are no adequate and well-controlled studies on pregnant women. This drug should be used during pregnancy only if needed. Caution should be exercised when Famotidine is administered to a nursing woman.
Drug Interaction
No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.
Overdose
There is no data available.
Storage
Store below 30⁰C, protect from light & moisture. Keep out of the reach of children.
Packaging
Each amber bottle contains dry powder for preparation of 50 ml suspension with a measuring cup & dropper.
