Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29)
PD-Rx Pharmaceuticals, Inc.
VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE 120 mg
ORAL
PRESCRIPTION DRUG
Verapamil hydrochloride tablets are indicated for the treatment of the following: Angina - Angina at rest including: Vasospastic (Prinzmetal's variant) angina Unstable (crescendo, pre-infarction) angina - Vasospastic (Prinzmetal's variant) angina - Unstable (crescendo, pre-infarction) angina - Chronic stable angina (classic effort-associated angina) Arrhythmias - 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) - Prophylaxis of repetitive paroxysmal supraventricular tachycardia 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 thi
Verapamil Hydrochloride Tablets, USP are available containing 120 mg of verapamil hydrochloride, USP. The 120 mg tablets are white, film-coated, round tablets debossed with MYLAN above the score and 772 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 55289-481-30 bottles of 30 tablets NDC 55289-481-60 bottles of 60 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Abbreviated New Drug Application
VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED PD-RX PHARMACEUTICALS, INC. ---------- 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 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, USP 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 calcium sulfate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, talc and titanium dioxide. CLINICAL PHARMACOLOGY Verapamil hydrochloride tablets are 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 tablets as an antianginal agent remains to be fully determined, but includes the following two mechanisms: 1. _ Relaxation and prevention of coronary artery spasm:_ Verapamil hydrochloride tablets dilate 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 oxygen delivery in patients with coronary artery spasm and is responsible for the effectiveness of verapamil hydrochloride tablets in vasospastic (Prinzmetal Lire le document complet