Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29)
Heritage Pharmaceuticals Inc.
VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE 80 mg
ORAL
PRESCRIPTION DRUG
Verapamil hydrochloride tablets USP are indicated for the treatment of the following: Angina 1. Angina at rest including: - Vasospastic (Prinzmetal's variant) angina - Unstable (crescendo, pre-infarction) angina 2. Chronic stable angina (classic effort-associated angina) Arrhythmias 1. In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see WARNINGS: Accessory bypass tract ) 2. Prophylaxis of repetitive paroxysmal supraventricular tachycardia Essential hypertension Verapamil hydrochloride tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive
Verapamil Hydrochloride Tablets, USP 80 mg tablets are round, standard concave, white film-coated, scored, debossed "HP" above and "26" below on one side and plain on the reverse side, supplied as: Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature] and protect from light. Dispense in a tight, light-resistant container using a child-resistant closure. MANUFACTURED FOR: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) 51U000000178US07 Issued: 11/17
Abbreviated New Drug Application
VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET HERITAGE PHARMACEUTICALS INC. ---------- VERAPAMIL HYDROCHLORIDETABLETS, USP 80 MG THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VERAPAMIL HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) TABLET FOR ORAL USE. INITIAL U.S. APPROVAL: DESCRIPTION Verapamil hydrochloride (verapamil HCl) is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) available for oral administration in film-coated tablets containing 80 mg of verapamil hydrochloride. The structural formula of verapamil HCl is: C27H38N2O4• HCl M.W. = 491.08 Benzeneacetonitrile, a-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino]propyl]-3,4-dimethoxy-a-(1- methylethyl) hydrochloride Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil HCl is not chemically related to other cardioactive drugs. Inactive ingredients include colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, light mineral oil, sodium lauryl sulfate, titanium dioxide and hypromellose. CLINICAL PHARMACOLOGY Verapamil hydrochloride is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) that exerts its pharmacologic effects by modulating the influx of ionic calcium across the cell membrane of the arterial smooth muscle as well as in conductile and contractile myocardial cells. MECHANISM OF ACTION Angina: The precise mechanism of action of verapamil hydrochloride as an antianginal agent remains to be fully determined, but includes the following two mechanisms: ARRHYTHMIA: Electrical activity through the AV node depends, to a significant degree, upon calcium influx through the slow channel. By decreasing the influx of calcium, verapamil hydrochloride prolongs the effective refractory per Đọc toàn bộ tài liệu