DILTIAZEM HYDROCHLORIDE tablet film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

McKesson Contract Packaging

DCI (Dénomination commune internationale):

DILTIAZEM HYDROCHLORIDE

Composition:

DILTIAZEM HYDROCHLORIDE 30 mg

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED
MCKESSON CONTRACT PACKAGING
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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(5H)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 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 actions 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.
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In animal models, diltiazem interferes with the slow inward
(depolarizing) current in excitable tissue. It
causes excitation-contraction uncoupling in var