FAMOTIDINE- 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:

NuCare Pharmaceuticals, Inc.

INN (International Name):

FAMOTIDINE

Composition:

FAMOTIDINE 40 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 tablets USP 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 USP

Product summary:

Famotidine Tablets USP, 40 mg are white, rounded square shaped, biconvex, film-coated tablets debossed with ‘CC’ on one side and ‘61’ on the other side. Bottles of 30 NDC 68071-1879-3 Bottles of 60 NDC 68071-1879-6 Bottles of 90 NDC 68071-1879-9 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a USP tight, light-resistant container. Manufactured by: Aurobindo Pharma Limited Unit-VII (SEZ) Mahaboob Nagar (Dt)-509302 India Issued: March 2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FAMOTIDINE- FAMOTIDINE TABLET, FILM COATED
NUCARE PHARMACEUTICALS, INC.
----------
FAMOTIDINE TABLETS USP
RX ONLY
DESCRIPTION
The active ingredient in famotidine tablets USP is a histamine H
-receptor antagonist. Famotidine is _N_′-
(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide.
The
molecular formula of famotidine is C
H
N
O
S
and its molecular weight is 337.43. Its structural
formula is:
Famotidine USP is a white to pale yellowish white crystalline powder
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 the following
inactive ingredients: carnauba wax, corn starch, hydroxypropyl
cellulose, hypromellose, magnesium
stearate, microcrystalline cellulose, sodium starch glycolate, talc,
and titanium dioxide. In addition the
20 mg tablets contain red iron oxide, and yellow iron oxide.
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
2
8
15
7
2
3
2
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 d