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:

NuCare Pharmaceuticals,Inc.

INN (International Name):

FAMOTIDINE

Composition:

FAMOTIDINE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Famotidine tablets are 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 tablets are indicated for short-term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS , Clinical Studies ). Famotidine tablets are also indicate

Product summary:

Famotidine Tablets USP, 20 mg are available as beige, round, unscored, film-coated tablets, debossed with 5728 on one side and “TEVA” on the other side, containing 20 mg famotidine. NDC 68071-3181-2 BOTTLES OF 20 NDC 68071-3181-3 BOTTLES OF 30 NDC 68071-3181-6 BOTTLES OF 60 NDC 68071-3181-9 BOTTLES OF 90 NDC 68071-3181-8 BOTTLES OF 180 Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid storage of famotidine tablets at temperatures above 40°C (104°F). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Croatia By: PLIVA HRVATSKA d.o.o. Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. E 5/2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FAMOTIDINE- FAMOTIDINE TABLET, FILM COATED
NUCARE PHARMACEUTICALS,INC.
----------
FAMOTIDINE TABLETS USP
5728
5729
RX ONLY
DESCRIPTION
The active ingredient in famotidine tablets USP is a histamine H
-receptor antagonist.
Famotidine, USP is
[1-Amino-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]
propylidene] sulfamide and has the following structural formula:
C
H
N
O
S
M.W. 337.45
Famotidine, USP 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, USP
and has the following inactive ingredients: colloidal silicon dioxide,
hypromellose,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
pregelatinized corn
starch, sodium starch glycolate, talc, titanium dioxide, yellow iron
oxide. In addition the
20 mg contains lactose monohydrate, red iron oxide and triacetin and
the 40 mg
contains FD&C blue No. 2 aluminum lake and FD&C yellow No. 6 aluminum
lake.
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
2
8
15
7
2
3
2
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