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:

NuCare Pharmaceuticals, Inc.

Designación común internacional (DCI):

DILTIAZEM HYDROCHLORIDE

Composición:

DILTIAZEM HYDROCHLORIDE 60 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Diltiazem hydrochloride tablets USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm. Diltiazem is 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 as: 60 mg – orange, round, film-coated, biconvex tablets, scored in half on one side, debossed with "93" and "319" on each side of the score and plain on the other side. Available in bottles of 100 and 500. NDC 66267-588-30– Bottle of 100 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive humidity. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. N 12/2014

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED
NUCARE PHARMACEUTICALS, INC.
----------
DILTIAZEM HYDROCHLORIDE TABLETS USP
0318
0319
0320
0321
RX ONLY
DESCRIPTION
Diltiazem hydrochloride tablets USP are a calcium ion cellular influx
inhibitor (slow channel blocker
or calcium antagonist). Chemically, diltiazem hydrochloride, USP 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. 450.98
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 of diltiazem hydrochloride,
USP. Each tablet also contains the following inactive ingredients:
hypromellose, lactose monohydrate,
magnesium stearate, polyethylene glycol, polysorbate 80, povidone,
titanium dioxide and FD&C yellow
#6 aluminum lake.
Diltiazem hydrochloride tablets meet USP Dissolution Test 1.
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 actions are still being
delineated, diltiazem is believed
to act in the following ways:
ANGINA DUE TO CORONARY ARTERY SPASM. Diltiazem has been shown to be a
potent dilator of
22
26
2
4
coronary arteries both epicardial and subendocardial. Spontaneous and
ergonovine-induced
coronary artery spasms are inhibited by diltiazem.
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
workloads.
In animal models, diltiazem interferes with the slow inward
(depolarizing) current in