Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29)
Mylan Pharmaceuticals Inc.
VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE 80 mg
ORAL
PRESCRIPTION DRUG
Verapamil hydrochloride tablets are indicated for the treatment of the following: Angina Arrhythmias 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 cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High
Verapamil Hydrochloride Tablets, USP are available containing 80 mg or 120 mg of verapamil hydrochloride, USP. The 80 mg tablets are white, film-coated, round tablets debossed with MYLAN above the score and 512 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0512-77 bottles of 90 tablets NDC 0378-0512-01 bottles of 100 tablets 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 0378-0772-77 bottles of 90 tablets NDC 0378-0772-01 bottles of 100 tablets NDC 0378-0772-05 bottles of 500 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. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 9/2017 VER:R10
Abbreviated New Drug Application
VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED MYLAN 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: C H N O •HCL M.W. 4 91.07 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. 27 38 2 4 _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 2. _ARRHYTHMIA_ Electrical activity through the AV node dep Baca dokumen lengkapnya