FAMOTIDINE tablet, film coated

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Међународно име):

FAMOTIDINE

Састав:

FAMOTIDINE 40 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Famotidine tablets are 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 tablets are indicated for short-term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS , Clinical Studies ). Famotidine tablets are also indicated for the short-term treat

Резиме производа:

Famotidine Tablets USP, 40 mg are available as tan, round, unscored, film-coated tablets, debossed with either and the figure “40” on one side and “5729” on the other side or "5729" on one side and "TEVA" on the other side, containing 40 mg famotidine, packaged in blistercards of 30. Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid storage of famotidine tablets at temperatures above 40°C (104°F). Manufactured In Croatia By: PLIVA HRVATSKA d.o.o. Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. A 3/2010

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

FAMOTIDINE- FAMOTIDINE TABLET, FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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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, fo