DILTIAZEM HYDROCHLORIDE capsule, extended release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

NuCare Pharmaceuticals,Inc.

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Diltiazem Hydrochloride Extended-Release Capsules (Once-a-Day Dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem Hydrochloride Extended-Release Capsules (Once-a-Day Dosage) 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.

Descriptif du produit:

Diltiazem Hydrochloride Extended-Release Capsules, USP Light green opaque capsule NDC 68071-4371-9 BOTTLES OF 90 Storage Conditions: 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.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
NUCARE PHARMACEUTICALS,INC.
----------
DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP
(ONCE-A-DAY DOSAGE)
R 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.
Diltiazem Hydrochloride Extended-Release Capsule (Once-a-Day Dosage),
is formulated
as a once-a-day extended-release capsule containing 120 mg, 180 mg,
240 mg, or 300
mg diltiazem hydrochloride.
Also contains: D&C Yellow #10, FD&C Green #3, gelatin, hypromellose,
magnesium
stearate, microcrystalline cellulose, ethyl acrylate and methyl
methacrylate copolymer,
polysorbate, povidone, simethicone emulsion, sucrose stearate, talc,
and titanium
dioxide.
Diltiazem Hydrochloride Extended-Release Capsule meets USP Dissolution
Test 12.
For oral administration.
CLINICAL PHARMACOLOGY
The therapeutic effects of Diltiazem Hydrochloride Extended-Release
Capsules (Once-a-
Day Dosage) 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.
X
MECHANISMS OF ACTION
HYPERTENSION: 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.
ANGINA: Diltiazem has been shown to produce increases in exercise
tolerance, probably
d