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:

Bryant Ranch Prepack

INN (International Name):

VERAPAMIL HYDROCHLORIDE

Composition:

VERAPAMIL HYDROCHLORIDE 240 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:

Product: 71335-0029 NDC: 71335-0029-1 30 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-0029-2 90 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-0029-3 60 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE Product: 71335-0638 NDC: 71335-0638-1 30 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-0638-2 90 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-0638-3 10 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE Product: 71335-0927 NDC: 71335-0927-1 30 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-0927-2 90 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-0927-3 100 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-0927-4 60 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED RELEASE
BRYANT RANCH PREPACK
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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:
C
H
N O • HCL M.W. = 491.06
(±)-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