DILTIAZEM HYDROCHLORIDE- diltiazem hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx 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: - Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker - Patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker - Patients with hypotension (less than 90 mm Hg systolic) - Patients who have demonstrated hypersensitivity to the drug - Patients with acute myocardial infarction and pulmonary congestion documented by X-ray on admission

Product summary:

Diltiazem Hydrochloride Tablets, USP are available containing 60 mgof 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: bottles of 30 and 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
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:
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 have 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 excitable tissue. It
causes excitation-contraction uncoupling i