DILTIAZEM HYDROCHLORIDE capsule, extended release

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Carilion Materials Management

Designación común internacional (DCI):

DILTIAZEM HYDROCHLORIDE

Composición:

DILTIAZEM HYDROCHLORIDE 120 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the treatment of chronic stable angina. 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 severe 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:

NDC:68151-1480-9 in a PACKAGE of 1 CAPSULE, EXTENDED RELEASES Storage conditions: Store at 25°C (77°F); excursions permitted to 15-30°C                               (59-86°F) [see USP Controlled Room Temperature].                               Avoid excessive humidity.

Estado de Autorización:

New Drug Application Authorized Generic

Ficha técnica

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
CARILION MATERIALS MANAGEMENT
----------
DILTIAZEM HYDROCHLORIDE
EXTENDED-RELEASE CAPSULES
USP Drug Release Test 6
DESCRIPTION
Diltiazem hydrochloride is a calcium ion cellular influx inhibitor
(slow channel blocker). Chemically,
diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 )-one,
3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-
dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)- -. The chemical
structure is: _Hcis_
Diltiazem hydrochloride is a white to off-white crystalline powder
with a bitter taste. It is soluble in
water, methanol and chloroform and has a molecular weight of 450.98.
Diltiazem hydrochloride
extended-release capsules contain diltiazem hydrochloride in
extended-release beads at doses of 120,
180, 240, 300, 360 and 420 mg.
Diltiazem Hydrochloride extended-release capsules also contains: black
iron oxide, D&C Red No. 28,
ethyl acrylate and methyl methacrylate copolymer dispersion, FD&C Blue
No. 1, FD&C Green No. 3,
FD&C Red No. 40, gelatin, hypromellose, magnesium stearate,
microcrystalline cellulose, polysorbate,
povidone, simethicone, sucrose stearate, talc, and titanium dioxide.
For oral administration.
CLINICAL PHARMACOLOGY
The therapeutic effects of diltiazem hydrochloride are believed to be
related to its ability to inhibit the
cellular influx of calcium ions during membrane depolarization of
cardiac and vascular smooth muscle.
MECHANISMS OF ACTIONS
Diltiazem produces its antihypertensive effect primarily by relaxation
of vascular smooth muscle and
the resultant decrease in peripheral vascular resistance. The
magnitude of blood pressure reduction is
related to the degree of hypertension: thus hypertensive individuals
experience an antihypertensive
effect, whereas there is only a modest fall in blood pressure in
normotensives. HYPERTENSION:
Diltiazem HCl 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