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:

Mylan Institutional Inc.

INN (International Name):

FAMOTIDINE

Composition:

FAMOTIDINE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Famotidine tablets are indicated in: - Short-Term Treatment of Active Duodenal Ulcer: Most adult patients heal within 4 weeks; there is rarely reason to use famotidine tablets at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine tablets in uncomplicated active duodenal ulcer for periods of more than 8 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 tablets in uncomplicated active benign gastric ulcer for periods of more than 8 weeks. - Short-Term Treatment of Gastroesophageal Reflux Disease (GERD): Famotidine tablets are indicated for short-term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS: Clinical Studies). - Fa

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FAMOTIDINE- FAMOTIDINE TABLET, FILM COATED
MYLAN INSTITUTIONAL INC.
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DESCRIPTION
Famotidine 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 337.45. Its structural formula is:
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. Each tablet also
contains the following inactive ingredients: D&C Yellow No. 10
Aluminum Lake, FD&C Yellow No. 6
Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
polydextrose, polyethylene glycol, povidone, pregelatinized starch
(corn), sodium lauryl sulfate,
sodium starch glycolate and titanium dioxide. In addition the 20 mg
tablet contains FD&C Blue No. 2
Aluminum Lake and triacetin and the 40 mg tablet contains FD&C Blue
No. 1 Aluminum Lake and
glyceryl triacetate.
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 1 to 3 hours. Duration of inhibition of secretion by doses of
20 mg and 40 mg was 10 to 12
hours.
Single evening oral doses of 20 mg and 40 mg inhibited basal and
nocturnal acid secretion in a