FAMOTIDINE tablet film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Major Pharmaceuticals

INN (International namn):

FAMOTIDINE

Sammansättning:

FAMOTIDINE 20 mg

Receptbelagda typ:

PRESCRIPTION DRUG

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

FAMOTIDINE- FAMOTIDINE TABLET, FILM COATED
MAJOR PHARMACEUTICALS
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FAMOTIDINE TABLETS USP
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 337.45. Its structural
formula is:
STRUCTURAL FORMULA
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, magnesium stearate,
microcrystalline cellulose, Opadry
OY 52945 Yellow, pregelatinized starch and talc. The composition of
Opadry OY 52945 Yellow, used
for film coating of famotidine tablets, is as follows: hydroxypropyl
methylcellulose, polyethylene
glycol 400, synthetic yellow iron oxide 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% an