VERAPAMIL HYDROCHLORIDE- 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:

Mylan Institutional Inc.

INN (International Name):

VERAPAMIL HYDROCHLORIDE

Composition:

VERAPAMIL HYDROCHLORIDE 120 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 120 mg, 180 mg or 240 mg of verapamil hydrochloride, USP. The 120 mg tablets are blue, film-coated, oval, unscored tablets debossed with MYLAN on one side of the tablet and 244 on the other side. They are available as follows: NDC 51079-894-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 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 51079-899-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 240 mg tablets are blue, film-coated, modified capsule-shaped tablets debossed with M to the left of the score and 411 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-869-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12441 R1 4/18

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
MYLAN INSTITUTIONAL INC.
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DESCRIPTION
Verapamil hydrochloride extended-release tablets, USP are a calcium
ion influx inhibitor (slow-channel
blocker or calcium ion antagonist). Verapamil hydrochloride
extended-release tablets are available for
oral administration as blue, film-coated, oval, unscored tablets
debossed with MYLAN on one side of
the tablet and 244 on the other side containing 120 mg of verapamil
hydrochloride; as 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 containing 180 mg of verapamil
hydrochloride; and as blue, film-
coated, modified capsule-shaped tablets debossed with M to the left of
the score and 411 to the right of
the score on one side of the tablet and blank on the other side
containing 240 mg of verapamil
hydrochloride. 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:
(±)-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.
Inactive ingredients include 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 tablets are a calcium ion