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:

Physicians Total Care, Inc.

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 (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker, (3) patients with hypotension (less than 90 mm Hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by X-ray on admission.

Resumen del producto:

Diltiazem hydrochloride tablets, USP are available containing 30 mg, 60 mg, 90 mg or 120 mg of diltiazem hydrochloride. The 30 mg tablets are white with a clear film-coat, unscored, round tablets debossed with M over 23 on one side and blank on the other side. They are available as follows: The 60 mg tablets are white with a clear film-coat, scored, round tablets debossed with M over 45 on the unscored side. They are available as follows: The 90 mg tablets are white with a clear film-coat, scored, capsule-shaped tablets debossed with M135 on the unscored side. They are available as follows: The 120 mg tablets are white with a clear film-coat, scored, capsule-shaped tablets debossed with M525 on the unscored side. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED OCTOBER 2011 DILT:R8AQ Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma      74146

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

DILTIAZEM HYDROCHLORIDE - DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
Diltiazem hydrochloride is a calcium ion 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:
C
H N O S • HCL M.W. 4 50.99
Diltiazem hydrochloride, USP is a white to off-white crystalline
powder with a bitter taste. It is soluble
in water, methanol, and chloroform. 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.
Diltiazem Hydrochloride Tablets, USP 30 mg, 60 mg, 90 mg and 120 mg
meet _USP Dissolution Test 2_.
CLINICAL PHARMACOLOGY
The therapeutic benefits achieved with diltiazem 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 action are still being
delineated, diltiazem is believed to
act in the following ways:
1. Angina Due to Coronary Artery Spasm
Diltiazem has been shown to be a potent dilator of coronary arteries
both epicardial and subendocardial.
Spontaneous and ergonovine-induced coronary artery spasm are inhibited
by diltiazem.
2. Exertional Angina
Diltiazem has been shown to produce increases in exercise tolerance,
probably due to its ability to
reduce myocardial oxygen demand. This is accomplished via reductions
in heart rate and systemic
blood pressure at submaximal and maximal exercise work loads.
22
26
2
4
In animal models, diltiazem interferes with the slow inward
(depolarizing) current in excitable tissue. It
causes excitation-contraction uncoupling