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Drug Catalog - Product Detail

VERAPAMIL HCL ER TB 120MG 100

NDC Mfr Size Str Form
57664-0116-88 SUN PHARMACEUTICALS 100 120MG TABLET
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Generic Name
VERAPAMIL HYDROCHLORIDE
Substance Name
VERAPAMIL HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA090529
Description
DESCRIPTION Verapamil hydrochloride is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). 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 given below: C 27 H 38 N 2 O 4 •HCl M.W.491.06 The chemical name is: Benzeneacetronitrile, α[3-[[2-(3,4-dimethoxyphenyl) ethyl]methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride Verapamil hydrochloride 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. Each film-coated extended-release tablet for oral administration contains 120 mg, 180 mg, or 240 mg of verapamil hydrochloride, USP. Each tablet contains the following inactive ingredients: carnauba wax, D&C yellow #10 aluminum lake, hypromellose, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol 8000, povidone, sodium alginate, titanium dioxide and triacetin. USP Dissolution Test Pending. chemical structure
How Supplied
HOW SUPPLIED Each film-coated extended-release tablet for oral administration contains 120 mg, 180 mg, or 240 mg of verapamil hydrochloride, USP. 120 mg: Yellow, oval-shaped, biconvex, film-coated tablets, debossed with “116” on one side and plain on the other side. NDC 57664-116-83 Bottles of 30 CRC NDC 57664-116-88 Bottles of 100 CRC NDC 57664-116-08 Bottles of 100 NDC 57664-116-13 Bottles of 500 NDC 57664-116-18 Bottles of 1000 180 mg : Yellow, oval-shaped, biconvex, film-coated tablets, debossed with “117” on one side and scored on the other side. NDC 57664-117-83 Bottles of 30 CRC NDC 57664-117-88 Bottles of 100 CRC NDC 57664-117-08 Bottles of 100 NDC 57664-117-13 Bottles of 500 NDC 57664-117-18 Bottles of 1000 240 mg : Yellow, capsule-shaped, biconvex, film-coated tablets, debossed with “118” on one side and scored on the other side. NDC 57664-118-83 Bottles of 30 CRC NDC 57664-118-88 Bottles of 100 CRC NDC 57664-118-08 Bottles of 100 NDC 57664-118-13 Bottles of 500 NDC 57664-118-18 Bottles of 1000 Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 6428T04 Rev. 08/2014
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Essential Hypertension: The dose of verapamil hydrochloride extended-release tablets should be individualized by titration and the drug should be administered with food. Initiate therapy with 180 mg of extended-release verapamil hydrochloride, given in the morning. Lower initial doses of 120 mg a day may be warranted in patients who may have an increased response to verapamil (eg, the elderly or small people). Upward titration should be based on therapeutic efficacy and safety evaluated weekly and approximately 24 hours after the previous dose. The antihypertensive effects of verapamil hydrochloride extended-release tablets are evident within the first week of therapy. If adequate response is not obtained with 180 mg of verapamil hydrochloride extended-release tablets, the dose may be titrated upward in the following manner: a) 240 mg each morning, b) 180 mg each morning plus 180 mg each evening; or 240 mg each morning plus 120 mg each evening, c) 240 mg every 12 hours. When switching from verapamil hydrochloride immediate-release tablets to verapamil hydrochloride extended-release tablets, the total daily dose in milligrams may remain the same.