FAMOTIDINE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Blenheim Pharmacal, Inc.

INN (International Name):

FAMOTIDINE

Sammensetning:

FAMOTIDINE 20 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Famotidine is indicated in: - 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. - 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. - 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. - 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 i

Produkt oppsummering:

Famotidine Tablets USP (white round tablets) containing 20mg of famotidine and engraved with . Bottle of 30 (NDC 61442-121-30) Bottle of 100 (NDC 61442-121-01) Bottle of 500 (NDC 61442-121-05) Bottle of 1,000 (NDC 61442-121-10) Famotidine Tablets USP (white round tablets) containing 40mg of famotidine and engraved with . Bottle of 30 (NDC 61442-122-30) Bottle of 100 (NDC 61442-122-01) Bottle of 500 (NDC 61442-122-05) Bottle of 1,000 (NDC 61442-122-10) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad Technology, Inc. Carlsbad, CA 92008 Revised: 06/12 CTI-12 Rev. C

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

FAMOTIDINE- FAMOTIDINE TABLET
BLENHEIM PHARMACAL, INC.
----------
FAMOTIDINE TABLETS USP
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 all
subjects. The mean suppression was 76% and 84%, respectively 3 to 5
hours after administration, and
25% and 30%, respectively 8 to 10 hours after administration. In some
subjects who received the 20 mg
dose, however, the antisecretory effect was dissipated within 6-8
hours. There was no cumulative
effect with repeated doses. The nocturnal intragastric pH was raised
by evening doses of 20 and 40 mg
of famotidine to mean values of 5.0 and 6.4, respectively. When
famotidine was given after breakfast,
the basal daytime interdigestive pH at 3 and 8 hours after 20 or 40 mg
of famotidine was raised to about
5.
Famotidine had little or no effect on fasting or postprandial serum
gastrin levels. Gastric emptying and
exocrine pancreatic function were not affected by famotidine.
OTHER EFFECTS
Systemic effects of famotidine in the CNS, cardiovascular, respiratory
or endocri