DILTIAZEM HYDROCHLORIDE tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)

Disponible desde:

Cardinal Health

Designación común internacional (DCI):

DILTIAZEM HYDROCHLORIDE

Composición:

DILTIAZEM HYDROCHLORIDE 30 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm. Diltiazem hydrochloride tablets are contraindicated in:

Resumen del producto:

Diltiazem Hydrochloride Tablets, USP are available containing 30 mg, 60 mg, or 90 mg of diltiazem hydrochloride, USP. The 60 mg tablets are white, film-coated, round, tablets debossed with M over 45 on one side of the tablet and scored on the other side. They are available as follows: NDC 55154-5523-0 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. Distributed by: Cardinal Health Dublin, OH 43017 L29066750119 S-12180 R1 3/17

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED
CARDINAL HEALTH
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DESCRIPTION
Diltiazem hydrochloride is a calcium ion cellular influx inhibitor
(slow channel blocker or calcium
antagonist). Chemically, diltiazem hydrochloride is
1,5-Benzothiazepin-4(5 _H_)one, 3-(acetyloxy)-5-[2-
(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl),
monohydrochloride, (+) _-cis-_. The structural
formula is:
Diltiazem hydrochloride, USP is a white to off-white crystalline
powder with a bitter taste. It is soluble
in water, methanol, and chloroform. It has a molecular weight of
450.99. Each tablet, for oral
administration, contains 30 mg, 60 mg, 90 mg, or 120 mg diltiazem
hydrochloride. In addition, each
tablet contains the following inactive ingredients: ethylcellulose,
hypromellose, lactose monohydrate,
magnesium stearate, maltodextrin, polyethylene glycol, and sodium
lauryl sulfate.
For oral administration.
CLINICAL PHARMACOLOGY
The therapeutic benefits achieved with diltiazem hydrochloride tablets
are believed to be related to its
ability to inhibit the influx of calcium ions during membrane
depolarization of cardiac and vascular
smooth muscle.
MECHANISMS OF ACTION
Although precise mechanisms of its antianginal actions are still being
delineated, diltiazem is believed
to act in the following ways:
•
•
In animal models, diltiazem interferes with the slow inward
(depolarizing) current in excitable tissue. It
causes excitation-contraction uncoupling in various myocardial tissues
without changes in the
configuration of the action potential. Diltiazem produces relaxation
of coronary vascular smooth
muscle and dilation of both large and small coronary arteries at drug
levels which cause little or no
ANGINA DUE TO CORONARY ARTERY SPASM: Diltiazem hydrochloride tablets
have been shown to be
a potent dilator of coronary arteries both epicardial and
subendocardial. Spontaneous and
ergonovine-induced coronary artery spasms are inhibited by diltiazem.
EXERTIONAL ANGINA: Diltiazem hydrochloride tablets ha