DILTIAZEM HYDROCHLORIDE- 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 120mg Extended-Release Capsules, USP (Once-a-Day Dosage) Hard gelatin capsules, size ‘2’Light turquoise blue colored cap and body, with “675” imprinted in black ink on cap and body, containing white to off white pellets. Bottles of 30 NDC 68071-1925-3 Storage Condition Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Avoid excessive humidity. Dispense in light-resistant, tight container with child-resistant closure.

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]
DESCRIPTION
Diltiazem hydrochloride is a calcium ion cellular 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 chemical
structure is:
Diltiazem hydrochloride is a white to off-white crystalline powder
with a bitter taste. It is soluble in
water, formic acid, methanol, and chloroform. It has a molecular
weight of 450.98. Diltiazem
hydrochloride extended-release capsule, USP (Once-a-day dosage) is
formulated as a once-a-day
extended-release capsule containing 120 mg, 180 mg, 240 mg, 300 mg and
360 mg diltiazem
hydrochloride, USP. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg
contain: sugar spheres,
hypromellose, talc, ethylcellulose, triethyl citrate, ammonio
methacrylate copolymer dispersion type B,
acetyl tributyl citrate, polysorbate 80, and magnesium stearate. The
capsule shells contain gelatin,
sodium lauryl sulfate, titanium dioxide, FD & C Blue 1 and iron oxide
black (180 mg, 240 mg, 300 mg
and 360 mg).
Imprinting ink contains shellac, dehydrated alcohol, isopropyl
alcohol, butyl alcohol, propylene glycol,
strong ammonia solution, black iron oxide, potassium hydroxide, and
purified water.
For oral administration. USP dissolution test pending.
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 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 hyper