FAMOTIDINE- famotidine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

famotidine (UNII: 5QZO15J2Z8) (famotidine - UNII:5QZO15J2Z8)

Available from:

Physicians Total Care, Inc.

INN (International Name):

famotidine

Composition:

famotidine 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Famotidine tablets, USP 20 mg are yellow, film coated, round shaped tablet with ‘C’                                                                                                                                                                         119                                                                                                                on one side and plain on other side and are supplied in bottles of 30’s, 100’s and 1000’s counts.  Famotidine tablets, USP 40 mg are yellow, film coated, round shaped tablet with ‘C’                                                                                                                                                                          120                                                                                                                            on one side and plain on other side and are supplied in bottles of 30’s, 100’s and 1000’s counts.                   Storage   Preserve in well-closed, light-resistant containers.   Store at 20 ° -25 ° C (68 ° -77 ° F) [see USP C ontrolled Room Temperature ].  Rx only  Manufactured by:Dr.Reddy's Laboratories Limited Bachepalli - 502 325, INDIA   Revised: 0410                                            Relabeing and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma        74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FAMOTIDINE - FAMOTIDINE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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FAMOTIDINE TABLETS 20 AND 40 MG
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 inhibited by 86% and 9