FAMOTIDINE tablet

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 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Famotidine is 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 is indicated for short-term treatment of patients with symptoms of GERD (see CLINI

Product summary:

Famotidine Tablets, USP, 20 mg, are yellow colored, circular, biconvex film-coated tablets embossed with 'L113'on one side and '20' on the other side. NDC 66267-543-20 bottles of 20. NDC 66267-543-60 bottles of 60. Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Preserve in well-closed, light-resistant containers. Call your doctor for medical advice about side effects. You may report side effects to Alembic Pharmaceuticals Limited at 1-866 210 9797 or FDA at 1-800-FDA-1088. Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA Made in India. Revised: 10/2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FAMOTIDINE- FAMOTIDINE TABLET
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
empirical formula of famotidine is C
H
N
O
S
and its molecular weight is 337.43. 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: colloidal silicon dioxide, yellow iron oxide and
red iron oxide, Lecithin,
macrogel/PEG 3350, magnesium stearate, microcrystalline cellulose,
polyvinyl alcohol, pregelatinized
starch, talc and 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 al