Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)
Mylan Institutional Inc.
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: - Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker - Patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker - Patients with hypotension (less than 90 mm Hg systolic) - Patients who have demonstrated hypersensitivity to the drug - Patients with acute myocardial infarction and pulmonary congestion documented by X-ray on admission
Diltiazem Hydrochloride Tablets, USP are available containing 30 mg, 60 mg, or 90 mg of diltiazem hydrochloride, USP. The 30 mg tablets are white, film-coated, round, unscored tablets debossed with M over 23 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-745-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 60 mg tablets are white, film-coated, round, tablets debossed with M over 45 on one side of the tablet and scored on the other side. They are available as follows: NDC 51079-746-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 90 mg tablets are white, film-coated, capsule-shaped tablets debossed with M135 on one side of the tablet and scored on the other side. They are available as follows: NDC 51079-747-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12180 R1 3/17
Abbreviated New Drug Application
DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED MYLAN INSTITUTIONAL INC. ---------- 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 structural formula is: Diltiazem hydrochloride, USP 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 450.99. Each tablet, for oral administration, contains 30 mg, 60 mg, 90 mg, or 120 mg diltiazem hydrochloride. In addition, each tablet contains the following inactive ingredients: ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, polyethylene glycol, and sodium lauryl sulfate. For oral administration. CLINICAL PHARMACOLOGY The therapeutic benefits achieved with diltiazem hydrochloride tablets 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 is believed to act in the following ways: ANGINA DUE TO CORONARY ARTERY SPASM: Diltiazem hydrochloride tablets have 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. EXERTIONAL ANGINA: Diltiazem hydrochloride tablets have 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 the slow inward (depolarizing) current in excitable tissue. It causes excitation-contraction uncoupling in v Lestu allt skjalið