VERAPAMIL HYDROCHLORIDE tablet

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

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Verapamil hydrochloride extended-release tablets is 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 pharmacolog

Product summary:

NDC: 71335-1258-1: 30 Tablets in a BOTTLE NDC: 71335-1258-2: 90 Tablets in a BOTTLE NDC: 71335-1258-3: 10 Tablets in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET
BRYANT RANCH PREPACK
----------
VERAPAMIL HYDROCHLORIDE
EXTENDED-RELEASE TABLETS USP
EXTENDED RELEASE
FILM COATED TABLETS
DESCRIPTION
Verapamil hydrochloride extended-release tablets, USP is a calcium ion
influx inhibitor
(slow-channel blocker or calcium ion antagonist). Verapamil
hydrochloride extended-
release tablets, USP is available for oral administration as light
blue, oval shaped, scored,
film coated tablets containing 240 mg of verapamil hydrochloride USP;
as light blue,
capsule shaped, bevelled edged, scored, film coated tablets containing
180 mg of
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:
C
H
N O ∙ HCl
M.W.=491.08
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.
Inactive ingredients include colloidal silicon dioxide, hypromellose,
magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone,
sodium alginate, and
film coating contains FD&C Blue No. 1 Brilliant Blue FCF aluminum
lake, hypromellose,
iron oxide yellow, titanium dioxide and triacetin.
Verapamil hydrochloride extended-release tablets USP, 180 mg and 240
mg meet USP
Dissolution Test 3.
CLINICAL PHARMACOLOGY
Verapamil HCl is a calcium ion influx inhibitor (slow-channel blocker
or calcium ion
antagonist) that exerts its pharmacologic effects by modulating the
influx of ionic
27
38
2
4
calcium across the cell membrane of the arterial smooth muscle as well
as in conductile
and contractile myocardial cells.
MECHANISM OF ACTION
Essential hypertension
V