FAMOTIDINE tablet, film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Clinical Solutions Wholesale, LLC

INN (nume internaţional):

FAMOTIDINE

Compoziție:

FAMOTIDINE 20 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Famotidine tablets USP 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 tablets USP 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. Stu

Rezumat produs:

Famotidine Tablets USP, 20 mg are yellow, rounded square shaped, biconvex, film-coated tablets debossed with ‘CC’ on one side and ‘60’ on the other side. Bottles of 30                              NDC 65862-859-30 Bottles of 100                            NDC 65862-859-01 Bottles of 500                            NDC 65862-859-05 Bottles of 1,000                         NDC 65862-859-99 10  x 10 Unit-dose Tablets         NDC 65862-859-78 Famotidine Tablets USP, 40 mg are white, rounded square shaped, biconvex, film-coated tablets debossed with ‘CC’ on one side and ‘61’ on the other side. Bottles of 30                             NDC 65862-860-30 Bottles of 100                           NDC 65862-860-01 Bottles of 500                           NDC 65862-860-05 Bottles of 1,000                        NDC 65862-860-99 10  x 10 Unit-dose Tablets        NDC 65862-860-78 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a USP tight, light-resistant container. Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Unit-VII (SEZ) Mahaboob Nagar (Dt)-509302 India Issued: March 2015 Repackaged by: Clinical Solutions Wholesale Franklin, TN 37067

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

FAMOTIDINE- FAMOTIDINE TABLET, FILM COATED
CLINICAL SOLUTIONS WHOLESALE, LLC
----------
FAMOTIDINE TABLETS USP
RX ONLY
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 337.43. Its structural
formula is:
Famotidine USP is a white to pale yellowish white crystalline powder
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 the following
inactive ingredients: carnauba wax, corn starch, hydroxypropyl
cellulose, hypromellose, magnesium
stearate, microcrystalline cellulose, sodium starch glycolate, talc,
and titanium dioxide. In addition the
20 mg tablets contain red iron oxide, and yellow iron oxide.
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.
2
8
15
7
2
3
2
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 s