VERAPAMIL HYDROCHLORIDE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cadila Pharmaceuticals Limited

INN (International Name):

VERAPAMIL HYDROCHLORIDE

Composition:

VERAPAMIL HYDROCHLORIDE 180 mg

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:

Verapamil hydrochloride extended-release tablets, USP 120 mg are supplied as light blue, oval shaped, film coated tablets debossed with “V12” on one side and plain on other side. NDC Number                         Size NDC 71209-104-05              bottle of 100 NDC 71209-104-10              bottle of 500 Verapamil hydrochloride extended-release tablets, USP 180 mg are supplied as light blue, oval shaped, scored, film coated tablets debossed with C 75 on one side and plain on other side. NDC Number                                      Size   NDC 71209-047-05                            bottle of 100  NDC 71209-047-40                        bottle of 500 Verapamil hydrochloride extended-release tablets, USP 240 mg are supplied as light blue, capsule shaped, bevelled edged, scored, film coated tablets debossed with C 77 on one side and plain on other side. NDC Number                                      Size NDC 71209-048-05                          bottle of 100 NDC 71209-048-10                          bottle of 500 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] and protect from light and moisture. Dispense in tight, light-resistant containers.    Manufactured by: Cadila Pharmaceuticals Limited 1389, Dholka, District - Ahmedabad, Gujarat State, INDIA  Revised May, 2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VERAPAMIL HYDROCHLORIDE - VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
CADILA PHARMACEUTICALS LIMITED
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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, capsule shaped,
bevelled edged, scored, film coated tablets containing 240 mg of
verapamil
hydrochloride USP; as light blue, oval shaped, scored, film coated
tablets containing 180
mg of verapamil hydrochloride USP; and light blue, oval shaped, film
coated tablets
containing 120 mg of verapamil hydrochloride USP (equivalent to 111.08
mg verapamil
free base). 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:
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, 120 mg, 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
calcium across the cell membrane of the arterial smooth muscle as well
as in conductile
and contractile myocardial