FAMOTIDINE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Apotheca Inc.

INN (International Name):

FAMOTIDINE

Composition:

FAMOTIDINE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Famotidine tablets USP are indicated in: 1. 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. 2. 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. 3. 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. 4. Short-term treatment of gastroesophageal reflux disease (GERD) Famotidine tablets USP are indicated for short-term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS , Clinical Studies ). Famotidine tablets are also

Product summary:

Famotidine Tablets USP, 20 mg are available as beige, round, unscored, film-coated tablets, debossed with "5728" on one side and "TEVA" on the other side, containing 20 mg famotidine, packaged in bottles of 100, 500 and 1000 tablets. Famotidine Tablets USP, 40 mg are available as tan, round, unscored, film-coated tablets, debossed with "5729" on one side and "TEVA" on the other side, containing 40 mg famotidine, packaged in bottles of 100 and 500 tablets. Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid storage of famotidine tablets at temperatures above 40°C (104°F). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Croatia By: PLIVA HRVATSKA d.o.o. Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. D 2/2014

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FAMOTIDINE- FAMOTIDINE TABLET, FILM COATED
APOTHECA INC.
----------
FAMOTIDINE TABLETS USP
RX ONLY
DESCRIPTION
The active ingredient in famotidine tablets USP is a histamine H
-receptor antagonist. Famotidine, USP
is [1-Amino-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]
propylidene] sulfamide and has
the following structural formula:
C
H
N
O
S
M.W. 337.45
Famotidine, USP 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, USP and has the
following inactive ingredients: colloidal silicon dioxide,
hypromellose, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, pregelatinized corn
starch, sodium starch glycolate,
talc, titanium dioxide, yellow iron oxide. In addition the 20 mg
contains lactose monohydrate, red iron
oxide and triacetin and the 40 mg contains FD&C blue No. 2 aluminum
lake and FD&C yellow No. 6
aluminum lake.
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%,
respecti