Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29)
PD-Rx Pharmaceuticals, Inc.
VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE 180 mg
ORAL
PRESCRIPTION DRUG
Verapamil hydrochloride extended-release tablets USP 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 Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharma
Verapamil hydrochloride extended-release tablets USP, 180 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘293’ debossed on one side and breakline on the other side. 180 mg (brown colored) Bottles of 14 and 30 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP. You may report side effects to FDA at 1-800-FDA-1088 or Glenmark Pharmaceuticals Inc., USA at 1 (888)721-7115.
Abbreviated New Drug Application
VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE PD-RX PHARMACEUTICALS, INC. REFERENCE LABEL SET ID: 59E6790D-A25A-443F-B6F0-110C86467688 ---------- VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP RX ONLY DESCRIPTION Verapamil hydrochloride extended-release tablets USP are calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). Verapamil hydrochloride extended-release tablets USP are available for oral administration as brown colored, oval, biconvex, film-coated tablets containing 120 mg verapamil hydrochloride USP, as brown colored, oval, biconvex, film-coated tablets containing 180 mg verapamil hydrochloride USP, and as brown colored, oval, biconvex, film-coated tablets containing 240 mg verapamil hydrochloride USP. The tablets are designed for sustained release of the drug in the gastrointestinal tract; sustained-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil HCl USP is given below: C H N O ·HCl..........M.W. 491.06 Benzeneacetonitrile, α[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3,4- dimethoxy-α-(1- methylethyl) hydrochloride Verapamil HCl USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl USP is not chemically related to other cardioactive drugs. In addition to verapamil HCl USP, the verapamil hydrochloride extended-release tablets USP contain the following ingredients: colloidal silicon dioxide, sodium alginate, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol and titanium dioxide. The following are the color additives per tablet strength: Strength (mg) Color Additive(s) 120 Ferric Oxide Yellow, Ferric Oxide Red and Ferric Oxide Black 180 Ferric Oxide Yellow, Ferric Oxide Red and Ferric Oxide Black 240 Ferric Oxide Yellow, Ferric Oxide Red and Ferric Oxide Black Verapamil hydrochloride extended-release tablets USP, 120 mg Přečtěte si celý dokument