FAMOTIDINE tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Carilion Materials Management

INN (nemzetközi neve):

FAMOTIDINE

Összetétel:

FAMOTIDINE 40 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Famotidine tablets are indicated in: 1. . 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. Short term treatment of active duodenal ulcer 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. . 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 active benign gastric ulcer 4. Famotidine is indicated for short term treatment of patients with symptoms of GERD (see ). Short term treatment of gastroesophageal reflux disease (GERD). CLIN

Termék összefoglaló:

NDC:68151-0185-0 in a PACKAGE of 1 TABLET, FILM COATEDS

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

FAMOTIDINE- FAMOTIDINE TABLET, FILM COATED
CARILION MATERIALS MANAGEMENT
----------
FAMOTIDINE TABLETS, USP
RX ONLY
DESCRIPTION
The active ingredient famotidine is a histamine H -receptor
antagonist. Famotidine is -(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:
_N’_
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: hydroxypropyl cellulose, hypromellose, magnesium
stearate, microcrystalline
cellulose, pregelatinized starch, talc, titanium dioxide, polyethylene
glycol. The 20 mg tablets also
contain iron oxides.
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.