FAMOTIDINE tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Alembic Pharmaceuticals Limited

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 esopha

Огляд продуктів:

Famotidine Tablets, USP, 20 mg, are yellow colored, circular, biconvex film-coated tablets embossed with 'L113'on one side and '20' on the other side. NDC 46708-293-30         bottles of 30 NDC 46708-293-31         bottles of 100 NDC 46708-293-71         bottles of 500 NDC 46708-293-91         bottles of 1000 NDC 46708-293-10         Unit dose tablets of 100 (10 x 10) Famotidine Tablets, USP, 40 mg, are brown colored, circular, biconvex film-coated tablets embossed with 'L114'on one side and '40' on the other side. NDC 46708-294-30         bottles of 30 NDC 46708-294-31         bottles of 100 NDC 46708-294-71         bottles of 500 NDC 46708-294-91         bottles of 1000 NDC 46708-294-10         Unit dose tablets of 100 (10 x 10) Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a USP tight, light-resistant container. Call your doctor for medical advice about side effects. You may report side effects to Alembic Pharmaceuticals Limited at 1-866 210 9797 or FDA at 1-800-FDA-1088. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Village Panelav, P. O. Tajpura, Near Baska, Taluka-Halol, Panchmahal 389350, Gujarat, India. Revised: 10/2015

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

FAMOTIDINE - FAMOTIDINE TABLET
ALEMBIC PHARMACEUTICALS LIMITED
----------
FAMOTIDINE TABLETS, USP
RX ONLY
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 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: colloidal silicon dioxide, yellow iron
oxide and red iron
oxide, Lecithin, macrogel/PEG 3350, magnesium stearate,
microcrystalline cellulose,
polyvinyl alcohol, pregelatinized starch, talc 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% and 94%,
respectively, for a period of at least 10 hours. The same doses given
in the morning
suppressed food-stimulated acid secretion in