Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29)
Major Pharmaceuticals
VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE 80 mg
ORAL
PRESCRIPTION DRUG
Verapamil Hydrochloride Tablets 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 is 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 cardiovascular
Verapamil Hydrochloride Tablets USP, 80 mg white, scored film-coated tablets, debossed with WATSON 343 are available in Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-2920-61. Verapamil Hydrochloride Tablets USP, 120 mg white, scored film-coated tablets, debossed with WATSON 345 are available in Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-2924-61. Dispense in a tight, light-resistant container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Distributed by: MAJOR® PHARMACEUTICALS 31778 Enterprise Drive Livonia, MI 48150 Revised: November 2014
Abbreviated New Drug Application
VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED MAJOR PHARMACEUTICALS ---------- VERAPAMIL HYDROCHLORIDE TABLETS USP REVISED: NOVEMBER 2014 RX ONLY DESCRIPTION Verapamil hydrochloride is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) available for oral administration in film-coated tablets containing 40 mg, 80 mg, or 120 mg of verapamil hydrochloride. The structural formula of verapamil hydrochloride is: Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3,4- dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil hydrochloride is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil hydrochloride is not chemically related to other cardioactive drugs. Inactive ingredients include anhydrous lactose, corn starch, hypromellose 2910, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and polyethylene glycol 400. In addition the following coloring agents are used: FD&C Yellow No. 6 Aluminum Lake, hydroxypropyl cellulose and titanium dioxide (40 mg light peach); hydroxypropyl cellulose and titanium dioxide (80 mg white and 120 mg white). 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: 1_. Relaxation and prevention of coronary artery spasm:_ Verapamil dilates the main coronary arteries and coronary arterioles, both in normal and ischemic regions, and is a potent inhibitor of coronary artery spasm, whether spontaneous or ergonovine-induced. This property increases myocardial oxyge Przeczytaj cały dokument