FAMOTIDINE for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lupin Pharmaceuticals,Inc.

INN (International Name):

FAMOTIDINE

Composition:

FAMOTIDINE 40 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Famotidine for Oral Suspension 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 indicated for the short-term treatment of

Product summary:

Famotidine for Oral Suspension is a white to off-white powder containing 400 mg of famotidine for constitution. When constituted to 50 mL as directed, Famotidine for Oral Suspension is a smooth, mobile, off-white, homogeneous suspension with a cherry-banana-mint flavor, containing 40 mg of famotidine per 5 mL. NDC 43386-500-11, bottles containing 400 mg famotidine. Storage Preserve in well-closed, light resistant containers. Store at controlled room temperature. Store Famotidine for Oral Suspension dry powder and suspension at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Suspension: Protect from freezing. Discard unused suspension after 30 days. Manufactured by: Novel Laboratories, Inc Somerset, NJ USA Manufactured for: GAVIS Pharmaceuticals, LLC Somerset, NJ 08873 PI5001100202 Rev. 07/2013

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FAMOTIDINE- FAMOTIDINE FOR SUSPENSION
LUPIN PHARMACEUTICALS,INC.
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FAMOTIDINE FOR ORAL SUSPENSION, USP
DESCRIPTION
The active ingredient in Famotidine for Oral Suspension 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 5 mL of the oral suspension when prepared as directed contains 40
mg of famotidine and the
following inactive ingredients: anhydrous citric acid, flavors
(cherry, banana, and mint),
microcrystalline cellulose and carboxymethylcellulose sodium,
confectioner's sugar, corn starch,
colloidal silicon-dioxide and xanthan gum. Added as preservatives are
sodium benzoate and sodium
methylparaben.
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 sa