FAMOTIDINE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Beli Sekarang

Unduh Karakteristik produk (SPC)
29-12-2017

Bahan aktif:

Famotidine (UNII: 5QZO15J2Z8) (Famotidine - UNII:5QZO15J2Z8)

Tersedia dari:

St Marys Medical Park Pharmacy

INN (Nama Internasional):

Famotidine

Komposisi:

Famotidine 40 mg

Jenis Resep:

PRESCRIPTION DRUG

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

                                FAMOTIDINE- FAMOTIDINE TABLET
ST MARYS MEDICAL PARK PHARMACY
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FAMOTIDINE TABLETS USP
DESCRIPTION
The active ingredient in famotidine, is a histamine H -receptor
antagonist. Famotidine is _N'_-
(aminosulfonyl)-3-[[[2-[(diamino-methylene)amino]-4-
thiazolyl]methyl]thio]propanimidamide. The
empirical 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: hydroxypropyl methylcellulose, magnesium
stearate, microcrystalline cellulose,
polydextrose, polyethylene glycolate, sodium starch glycolate,
modified corn starch (pregelatinized
starch), talc, triacetin, 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 94%,
respectively, for a period of at
least 10 hours. The same doses given in the morning suppressed
food-stimulated acid secretion in all
subjec
                                
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