Famoloc

Famotidine

COMPOSITION

• Famoloc 20 mg Tablet: Each film-coated tablet contains Famotidine USP 20 mg.
• Famoloc 40 mg Tablet: Each film-coated tablet contains Famotidine USP 40 mg.
• Famoloc 50 ml PFS: After reconstitution, each 5 ml suspension contains Famotidine USP 40 mg.

INDICATIONS

Gastric ulcer, duodenal ulcer, anastomotic ulcer, acute stress ulcer, reflux esophagitis, and Zollinger-Ellison syndrome. Famoloc (Famotidine) is also indicated for the treatment of acute gastritis, and chronic gastritis in the acute exacerbation stage.

DOSAGE AND ADMINISTRATION

For gastric ulcer, duodenal ulcer anastomotic ulcer, and upper gastrointestinal hemorrhage. reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famoloc 20 twice daily or Famoloc 40 can be administered orally once daily at bedtime.

For the treatment of acute gastritis, chronic gastric in acute exacerbation stage: Usual dosages for adults: Famoloc 20 orally twice a day. Also, Famoloc 40 can be orally administered once a day (before bedtime), dosages should be adjusted according to age & 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.

Dosage and Administration of Powder for Suspension

Gastroesophageal Reflux Disease(GERD):

• 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): 0.5 mg/kg/day p.o. b.i.d. up to 40 mg.

. 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.

. Reflux esophagitis: 2 mg/kg/day

CONTRA-INDICATION

• Known hypersensitivity to any component of the drug.

PRECAUTIONS

I) The drug should be used in the minimum required amount depending upon the conditions of the diseases.

II) The drug should be administered carefully with elderly patients, patients with renal failure, and hepatic disorders.

SIDE EFFECTS

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

USE 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 Famoloc is administered to a nursing woman.

COMMERCIAL PACK

• Famoloc 20 mg Tablet: Box containing 10 X 10 tablets in blister pack.
• Famoloc 40 mg Tablet: Box containing 5 X 10 tablets in blister pack.
• Famoloc 50 ml PFS: Each amber-colored glass bottle contains dry powder to reconstitute 50 ml of suspension.