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:

Glenmark Pharmaceuticals Inc., USA

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 pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Verapamil hydrochloride tablets are contraindicated in:

Product summary:

Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘292’ debossed on one side and plain on the other side. 120 mg: Bottles of 90 - NDC 68462-292-90 Bottles of 100 - NDC 68462-292-01 Bottles of 500 - NDC 68462-292-05 Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘293’ debossed on one side and a break line on the other side. 180 mg: Bottles of 90 - NDC 68462-293-90 Bottles of 100 - NDC 68462-293-01 Bottles of 500 - NDC 68462-293-05 Verapamil Hydrochloride Extended-Release Tablets, USP, 240 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘G74’ debossed on one side and a break line on the other side. 240 mg: Bottles of 30 - NDC 68462-260-30 Bottles of 90 - NDC 68462-260-90 Bottles of 100 - NDC 68462-260-01 Bottles of 500 - NDC 68462-260-05 Bottles of 1000 - NDC 68462-260-10 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture and store in a dry place. Keep tablets in original/pharmacy container. Dispense in a tight, light-resistant container as defined in the USP. You may report side effects to FDA at 1-800-FDA-1088 or Glenmark Pharmaceuticals Inc., USA at 1 [phone]. Manufactured by: Glenmark Pharmaceuticals Limited Plot No. S-7, Colvale Industrial Estate Colvale - Bardez, Goa-403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 [phone] www.glenmarkpharma-us.com February 2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED RELEASE
GLENMARK PHARMACEUTICALS INC., USA
----------
VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP
RX ONLY
DESCRIPTION
Verapamil Hydrochloride Extended-Release Tablets, USP are calcium ion
influx inhibitor
(slow-channel blocker or calcium ion antagonist). Verapamil
Hydrochloride Extended-
Release Tablets, USP are available for oral administration as brown
colored, oval,
biconvex, film-coated tablets containing 120 mg verapamil
hydrochloride, USP
(equivalent to 111.08 mg verapamil free base), as brown colored, oval,
biconvex, film-
coated tablets containing 180 mg verapamil hydrochloride, USP
(equivalent to 166.62
mg verapamil free base), and as brown colored, oval, biconvex,
film-coated tablets
containing 240 mg verapamil hydrochloride, USP (equivalent to 222.16
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 given below:
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, freely soluble in chloroform,
sparingly soluble in alcohol
and practically insoluble in ether. Verapamil HCl, USP is not
chemically related to other
cardio active drugs.
In addition to verapamil HCl, USP, the Verapamil Hydrochloride
Extended-Release
Tablets, USP contain the following inactive ingredients: colloidal
silicon dioxide,
hypromellose, magnesium stearate, microcrystalline cellulose,
polyethylene glycol,
povidone, sodium alginate, and titanium dioxide. The following are the
color additives per
tablet strength:
Strength (mg)
Color Additive(s)
C
H
N O ·HCl M.W. 491.06 g/mol
27
38
2
4
120
Ferric Oxide Yellow, Ferric Oxide Red and Ferric Oxide Black
180