DILTIAZEM HYDROCHLORIDE- diltiazem hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

DILTIAZEM HYDROCHLORIDE

Composition:

DILTIAZEM HYDROCHLORIDE 60 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Diltiazem hydrochloride 60 mg scored tablets are supplied in bottles of 30 NDC 68071-3290-3 bottles od 60 NDC 68071-3290-6 Each light yellow, round tablet is engraved with MARION on one side and 1772 on the other. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid excessive humidity. ©Valeant Pharmaceuticals North America LLC Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA By: Valeant Pharmaceuticals International, Inc. Laval, Quebec H7L 4A8, Canada Rev. 07/2016 9467801

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET
NUCARE PHARMACEUTICALS, INC.
----------
DILTIAZEM HYDROCHLORIDE
DIRECT COMPRESSION TABLETS
RX ONLY
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 chemical
structure is:
Diltiazem hydrochloride 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 450.98.
Each tablet contains 30 mg, 60
mg, 90 mg, or 120 mg diltiazem hydrochloride.
Also contains: colloidal silicon dioxide, D&C Yellow #10 Aluminum
Lake, FD&C Blue #1 Aluminum
Lake (30 mg and 90 mg), FD&C Yellow #6 Aluminum Lake (60 mg and 120
mg), hydroxypropyl
cellulose, hypromellose, lactose, magnesium stearate, methylparaben,
microcrystalline cellulose, and
polyethylene glycol.
For oral administration.
CLINICAL PHARMACOLOGY
The therapeutic benefits achieved with diltiazem hydrochloride 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
hydrochloride is believed to act in the following ways:
1. ANGINA DUE TO CORONARY ARTERY SPASM. Diltiazem hydrochloride has
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
hydrochloride.
2. EXERTIONAL ANGINA. Diltiazem hydrochloride 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, diltia