Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)
NuCare Pharmaceuticals, Inc.
DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE 60 mg
ORAL
PRESCRIPTION DRUG
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 (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.
Diltiazem hydrochloride 60 mg scored tablets are supplied in bottles of 30 NDC 68071-3290-3 bottles od 60 NDC 68071-3290-6 Each light yellow, round tablet is engraved with MARION on one side and 1772 on the other. 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. ©Valeant Pharmaceuticals North America LLC Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA By: Valeant Pharmaceuticals International, Inc. Laval, Quebec H7L 4A8, Canada Rev. 07/2016 9467801
New Drug Application Authorized Generic
DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET NUCARE PHARMACEUTICALS, INC. ---------- DILTIAZEM HYDROCHLORIDE DIRECT COMPRESSION TABLETS RX 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. Each tablet contains 30 mg, 60 mg, 90 mg, or 120 mg diltiazem hydrochloride. Also contains: colloidal silicon dioxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake (30 mg and 90 mg), FD&C Yellow #6 Aluminum Lake (60 mg and 120 mg), hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, and polyethylene glycol. For oral administration. CLINICAL PHARMACOLOGY The therapeutic benefits achieved with diltiazem hydrochloride 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 hydrochloride is believed to act in the following ways: 1. ANGINA DUE TO CORONARY ARTERY SPASM. Diltiazem hydrochloride has 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 hydrochloride. 2. EXERTIONAL ANGINA. Diltiazem hydrochloride 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 workloads. In animal models, diltia Lire le document complet