ZANTAC ranitidine hydrochloride tablet film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)

Verfügbar ab:

GlaxoSmithKline LLC

INN (Internationale Bezeichnung):

RANITIDINE HYDROCHLORIDE

Zusammensetzung:

RANITIDINE 150 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

New Drug Application

Fachinformation

ZANTAC- RANITIDINE HYDROCHLORIDE TABLET, FILM COATED
GLAXOSMITHKLINE LLC
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ZANTAC 150
(RANITIDINE HYDROCHLORIDE)
TABLETS, USP
ZANTAC 300
(RANITIDINE HYDROCHLORIDE)
TABLETS, USP
DESCRIPTION
The active ingredient in ZANTAC 150 Tablets and ZANTAC 300 Tablets is
ranitidine hydrochloride
(HCl), USP, a histamine H -receptor antagonist. Chemically it is
N[2-[[[5-[(dimethylamino)methyl]-2-
furanyl]methyl]thio]ethyl]-N′-methyl-2-nitro-1,1-ethenediamine, HCl.
It has the following structure:
The empirical formula is C
H N O S•HCl, representing a molecular weight of 350.87.
Ranitidine HCl is a white to pale yellow granular substance that is
soluble in water. It has a slightly
bitter taste and sulfur-like odor.
Each ZANTAC 150 Tablet for oral administration contains 168 mg of
ranitidine HCl equivalent to 150
mg of ranitidine. Each tablet also contains the inactive ingredients
FD&C Yellow No. 6 Aluminum Lake,
hypromellose, magnesium stearate, microcrystalline cellulose, titanium
dioxide, triacetin, and yellow
iron oxide.
Each ZANTAC 300 Tablet for oral administration contains 336 mg of
ranitidine HCl equivalent to 300
mg of ranitidine. Each tablet also contains the inactive ingredients
croscarmellose sodium, D&C
Yellow No. 10 Aluminum Lake, hypromellose, magnesium stearate,
microcrystalline cellulose, titanium
dioxide, and triacetin.
CLINICAL PHARMACOLOGY
ZANTAC is a competitive, reversible inhibitor of the action of
histamine at the histamine H -receptors,
including receptors on the gastric cells. ZANTAC does not lower serum
Ca++ in hypercalcemic states.
ZANTAC is not an anticholinergic agent.
PHARMACOKINETICS :
_ABSORPTION:_ ZANTAC is 50% absorbed after oral administration,
compared with an intravenous (IV)
injection with mean peak levels of 440 to 545 ng/mL occurring 2 to 3
hours after a 150-mg dose. The
syrup is bioequivalent to the tablets. Absorption is not significantly
impaired by the administration of
food or antacids. Propantheline slightly delays and increases peak
blood levels of ranitidine, probably
b