FAMOTIDINE- famotidine tablet, film coated FAMOTIDINE tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

McKesson Corporation

INN (Internationale Bezeichnung):

FAMOTIDINE

Zusammensetzung:

FAMOTIDINE 20 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies). Famotidine is also indicated for the short-term treatment of esophagitis

Produktbesonderheiten:

Product: 63739-325 NDC: 63739-325-10 10 TABLET, FILM COATED in a BLISTER PACK / 10 in a BOX, UNIT-DOSE Product: 63739-388

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

FAMOTIDINE- FAMOTIDINE TABLET, FILM COATED
MCKESSON CORPORATION
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FAMOTIDINE TABLETS USP
RX only
Revised: November 2007
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:
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 inhibite