VERAPAMIL HYDROCHLORIDE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29)

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

VERAPAMIL HYDROCHLORIDE

Composition:

VERAPAMIL HYDROCHLORIDE 180 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Verapamil hydrochloride extended-release 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 Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacolo

Product summary:

Verapamil Hydrochloride Extended-Release Tablets, USP are available containing 180 mg of verapamil hydrochloride, USP. The 180 mg tablets are blue film-coated, oval tablets debossed with M to the left of the score and 312 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 66267-211-30 Bottles of 30 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED NOVEMBER 2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
NUCARE PHARMACEUTICALS, INC.
----------
DESCRIPTION
Verapamil hydrochloride is a calcium ion influx inhibitor (slow
channel blocker or calcium ion
antagonist). The tablets are designed for extended-release of the drug
in the gastrointestinal tract;
extended-release characteristics are not altered when the tablet is
divided in half.
The structural formula of verapamil hydrochloride is given below:
(±)-5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile
monohydrochloride
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.
Each extended-release tablet, for oral administration, contains 120
mg, 180 mg or 240 mg of verapamil
hydrochloride. In addition, each tablet contains the following
inactive ingredients: FD&C Blue No. 1
Aluminum Lake, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polyvinyl
alcohol, povidone, sodium alginate, sodium lauryl sulfate, talc, and
titanium dioxide.
Verapamil Hydrochloride Extended-release Tablets USP, 120 mg meet _USP
Dissolution Test 1_.
Verapamil Hydrochloride Extended-release Tablets USP, 180 mg and 240
mg meet _USP Dissolution_
_Test 3_.
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
_ESSENTIAL HYPERTENSION_
Verapamil exerts antihypertensive effects by decreasing systemic
vascular resistance, usually without
orthostatic decreases in blood pressure or reflex tachycardia;
bradycardia (rate less than 50 beats/min)
is uncommon (1.4%). During isometric or dynamic