PEPCID 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:

Marathon Pharmaceuticals, LLC

INN (International Name):

FAMOTIDINE

Composition:

FAMOTIDINE 20 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PEPCID- FAMOTIDINE TABLET, FILM COATED
MARATHON PHARMACEUTICALS, LLC
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PEPCID (FAMOTIDINE) TABLETS
DESCRIPTION
The active ingredient in PEPCID (famotidine) 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: hydroxypropyl cellulose, hypromellose, magnesium
stearate, microcrystalline
cellulose, pre-gelatinized starch, talc, titanium dioxide, and
polyethylene glycol. The 20 mg tablets also
contain iron oxides.
CLINICAL PHARMACOLOGY IN ADULTS
_GI EFFECTS_
PEPCID is a competitive inhibitor of histamine H -receptors. The
primary clinically important
pharmacologic activity of PEPCID is inhibition of gastric secretion.
Both the acid concentration and
volume of gastric secretion are suppressed by PEPCID, while changes in
pepsin secretion are
proportional to volume output.
In normal volunteers and hypersecretors, PEPCID 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 all
subjects. The mean s