FAMOTIDINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)

Available from:

Direct Rx

INN (International Name):

FAMOTIDINE

Composition:

FAMOTIDINE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Famotidine is indicated in: - Short term treatment of active duodenal ulcer . Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks. - Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer . Controlled studies in adults have not extended beyond one year. - Short term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks. - Short term treatment of gastroesophageal reflux disease (GERD). Famotidine is indicated for short term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies). Famotidine is also indica

Product summary:

Famotidine Tablets USP (white round tablets) containing 20mg of famotidine and engraved with . Bottle of 30 (NDC 61442-121-30) Bottle of 100 (NDC 61442-121-01) Bottle of 500 (NDC 61442-121-05) Bottle of 1,000 (NDC 61442-121-10) Famotidine Tablets USP (white round tablets) containing 40mg of famotidine and engraved with . Bottle of 30 (NDC 61442-122-30) Bottle of 100 (NDC 61442-122-01) Bottle of 500 (NDC 61442-122-05) Bottle of 1,000 (NDC 61442-122-10) STORAGE Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad Technology, Inc. Carlsbad, CA 92008 Revised: 06/12 CTI-12 Rev. C Principal Display Panel – Bottle Label NDC 61442-121-30 Famotidine Tablets USP 20 mg Rx Only Carlsbad Technology, Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FAMOTIDINE- FAMOTIDINE TABLET
DIRECT RX
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FAMOTIDINE
DESCRIPTION
The active ingredient in famotidine, is a histamine H2 -receptor
antagonist. Famotidine is N'-
(aminosulfonyl)-3-[[[2-[(diamino-methylene)amino]-4-
thiazolyl]methyl]thio]propanimidamide. The
empirical formula of famotidine is C8H15N7O2S3 and its molecular
weight is 337.45. Its structural
formula is:
Famotidine is a white to pale yellow crystalline compound that is
freely soluble in glacial acetic acid,
slightly soluble in methanol, very slightly soluble in water, and
practically insoluble in ethanol.
Each tablet for oral administration contains either 20 mg or 40 mg of
famotidine and the following
inactive ingredients: hydroxypropyl methylcellulose, magnesium
stearate, microcrystalline cellulose,
polydextrose, polyethylene glycolate, sodium starch glycolate,
modified corn starch (pregelatinized
starch), talc, triacetin, titanium dioxide.
CLINICAL PHARMACOLOGY
GI EFFECTS
Famotidine is a competitive inhibitor of histamine H2 -receptors. The
primary clinically important
pharmacologic activity of famotidine is inhibition of gastric
secretion. Both the acid concentration and
volume of gastric secretion are suppressed by famotidine, while
changes in pepsin secretion are
proportional to volume output.
In normal volunteers and hypersecretors, famotidine inhibited basal
and nocturnal gastric secretion, as
well as secretion stimulated by food and pentagastrin. After oral
administration, the onset of the
antisecretory effect occurred within one hour; the maximum effect was
dose-dependent, occurring
within one to three hours. Duration of inhibition of secretion by
doses of 20 and 40 mg was 10 to 12
hours.
Single evening oral doses of 20 and 40 mg inhibited basal and
nocturnal acid secretion in all subjects;
mean nocturnal gastric acid secretion was inhibited by 86% and 94%,
respectively, for a period of at
least 10 hours. The same doses given in the morning suppressed
food-stimulated acid secretion in all
subjects. The mean suppression was 76% and 84%,