FAMOTIDINE tablet film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

McKesson Contract Packaging

INN (Διεθνής Όνομα):

FAMOTIDINE

Σύνθεση:

FAMOTIDINE 20 mg

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

FAMOTIDINE- FAMOTIDINE TABLET, FILM COATED
MCKESSON CONTRACT PACKAGING
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FAMOTIDINE TABLETS USP
RX ONLY
DESCRIPTION
The active ingredient in famotidine is a histamine H -receptor
antagonist. Famotidine is [1-Amino-3-
[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio] propylidene]
sulfamide and has the following
structural formula:
C H N O S M.W. 337.45
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 has the following
inactive ingredients: colloidal silicon dioxide, hypromellose,
magnesium stearate, microcrystalline
cellulose, polyethylene glycol, pregelatinized starch, sodium starch
glycolate, talc, titanium dioxide,
yellow iron oxide. In addition the 20 mg contains lactose monohydrate,
red iron oxide and triacetin and
the 40 mg contains FD&C blue #2 aluminum lake and FD&C yellow #6
aluminum lake.
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 a