FAMOTIDINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvPAK

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 indicated for the short term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies ). - Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies ). Hypersensitivity to any component of these products. Cross sensitivity in this class of compounds has been observed. Therefore, famotidine should not be administered to patients with a history of hypersensitivity to other H 2 -receptor antagonists.

Product summary:

Famotidine Tablets USP (white round tablets) containing 20mg of famotidine and engraved with . NDC 50268-303-15   10 Tablets per card, 5 cards per carton Famotidine Tablets USP (white round tablets) containing 40mg of famotidine and engraved with . NDC 50268-304-15   10 Tablets per card, 5 cards per carton Dispensed in Blister Punch Material.  For Institutional Use Only. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 06/12            AV 09/14 (P) CTI-12 Rev. C

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FAMOTIDINE- FAMOTIDINE TABLET
AVPAK
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FAMOTIDINE TABLETS USP
DESCRIPTION
The active ingredient in famotidine, is a histamine H
-receptor antagonist. Famotidine is
_N'_-(aminosulfonyl)-3-[[[2-[(diamino-methylene)amino]-4-
thiazolyl]methyl]thio]propanimidamide. The empirical formula of
famotidine is C
H
N
O
S
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 IN ADULTS
GI EFFECTS
Famotidine is a competitive inhibitor of histamine H
-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 w