Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)
Lake Erie Medical DBA Quality Care Products LLC
DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE 30 mg
ORAL
PRESCRIPTION DRUG
Diltiazem hydrochloride tablets USP 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.
Diltiazem hydrochloride tablets USP are available as: 30 mg - faint orange, round, film-coated, biconvex, unscored tablets, debossed with "93" and "318" on one side and plain on the other side. 60 mg – orange, round, film-coated, biconvex tablets, scored in half on one side, debossed with "93" and "319" on each side of the score and plain on the other side. 90 mg - faint orange, oblong, film-coated tablets, scored in half on one side, debossed with "93" and "320" on each side of the score and plain on the other side. 120 mg - orange, oblong, film-coated tablets, scored in half on one side, debossed with "93" and "321" on each side of the score and plain on the other side. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In India By: PIRAMAL ENTERPRISES LIMITED Pithampur, Madhya Pradesh, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. M 8/2012
Abbreviated New Drug Application
DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- DILTIAZEM HYDROCHLORIDE TABLETS USP 0318 0319 0320 0321 RX ONLY DESCRIPTION Diltiazem hydrochloride tablets USP are a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP 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: C H N O S•HCl M.W. 450.98 Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. Each tablet for oral administration contains 30 mg, 60 mg, 90 mg, or 120 mg of diltiazem hydrochloride, USP. Each tablet also contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, titanium dioxide and FD&C yellow #6 aluminum lake. Diltiazem hydrochloride tablets meet USP Dissolution Test 1. CLINICAL PHARMACOLOGY The therapeutic benefits achieved with diltiazem 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: 1. ANGINA DUE TO CORONARY ARTERY SPASM. Diltiazem has been shown to be a potent dilator of coronary arteries both epicardial and subendocardial. Spontaneous and ergonovine-induced coronary artery spasm are inhibited by diltiazem. 2. EXERTIONAL ANGINA. Diltiazem 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. 22 26 2 4 In animal models, diltiazem interferes with the slow inward (d Prečítajte si celý dokument