Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
Diltiazem hydrochloride (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)
Oceanside Pharmaceuticals
Diltiazem hydrochloride
Diltiazem hydrochloride 30 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:
Diltiazem hydrochloride 30 mg tablets are supplied in bottles of 100 (NDC 68682-006-10) and 500 (NDC 68682-006-50). Each light green, round tablet is engraved with MARION on one side and 1771 on the other. Diltiazem hydrochloride 60 mg scored tablets are supplied in bottles of 100 (NDC 68682-007-10) and 500 (NDC 68682-007-50). Each light yellow, round tablet is engraved with MARION on one side and 1772 on the other. Diltiazem hydrochloride 90 mg scored tablets are supplied in bottles of 100 (NDC 68682-008-10) and 500 (NDC 68682-008-50). Each light green, capsule-shaped tablet is engraved with CARDIZEM on one side and 90 mg on the other. Diltiazem hydrochloride 120 mg scored tablets are supplied in bottles of 100 (NDC 68682-009-10). Each yellow, capsule-shaped tablet is engraved with CARDIZEM on one side and 120 mg 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. Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada CARDIZEM is a trademark of Bausch Health Companies Inc. or its affiliates. © 2020 Bausch Health Companies Inc. or its affiliates Rev. 06/2020 9467803
New Drug Application Authorized Generic
DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET OCEANSIDE PHARMACEUTICALS ---------- DILTIAZEM HYDROCHLORIDE 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: • • 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. 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, diltiazem interferes with th Прочетете целия документ