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Drug Catalog - Product Detail

VERAPAMIL HCL ER CAPS. CP 180MG 100

NDC Mfr Size Str Form
00591-2882-01 ACTAVIS PHARMA 100 MG CAPSULE
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Generic Name
VERAPAMIL HYDROCHLORIDE
Substance Name
VERAPAMIL HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
NDA019614
Description
DESCRIPTION Verapamil hydrochloride sustained-release capsules are calcium ion influx inhibitors (slow channel blockers or calcium ion antagonists). Verapamil hydrochloride sustained-release capsules are available for oral administration as a 360 mg hard gelatin capsule (lavender cap/yellow body), a 240 mg hard gelatin capsule (dark blue cap/yellow body), a 180 mg hard gelatin capsule (light grey cap/yellow body), and a 120 mg hard gelatin capsule (yellow cap/yellow body). These pellet-filled capsules provide a sustained-release of the drug in the gastrointestinal tract. The structural formula of verapamil HCl is given below: C 27 H 38 N 2 O 4 •HCl M.W. 491.07 Chemical name: Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) monohydrochloride. Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not structurally related to other cardioactive drugs. In addition to verapamil HCl the verapamil hydrochloride sustained-release capsules contain the following inactive ingredients: fumaric acid, talc, sugar spheres, povidone, shellac, gelatin, FD&C red #40, yellow iron oxide, titanium dioxide, methylparaben, propylparaben, silicon dioxide, and sodium lauryl sulfate. In addition, the verapamil hydrochloride sustained-release capsules 240 mg and 360 mg capsules contain FD&C blue #1 and D&C red #28; and the verapamil hydrochloride sustained-release capsules 180 mg contain black iron oxide. verapamil hydrochloride structural formula
How Supplied
HOW SUPPLIED Verapamil hydrochloride sustained-release capsules are supplied in four dosage strengths: 120 mg - Two-piece, size 2 hard gelatin capsule (yellow cap/yellow body), printed with 60274 and 120 mg in black ink, supplied as follows: NDC 0591-2880-01 - Bottle of 100s 180 mg - Two-piece, size 1 elongated hard gelatin capsule (light grey cap/yellow body), printed with 60274 and 180 mg in black ink, supplied as follows: NDC 0591-2882-01 - Bottle of 100s 240 mg - Two-piece, size 0 hard gelatin capsule (dark blue cap/yellow body), printed with 60274 and 240 mg in black ink, supplied as follows: NDC 0591-2884-01 - Bottle of 100s 360 mg - Two-piece, size 00 hard gelatin capsule (lavender cap/yellow body), printed with 60274 and 360 mg in black ink, supplied as follows: NDC 0591-2886-01 - Bottle of 100s Store at Controlled Room Temperature 20° to 25°C (68° to 77°F). [See USP]. Avoid excessive heat. Brief digressions above 25°C, while not detrimental, should be avoided. Protect from moisture. Dispense in tight, light-resistant container as defined in USP.
Indications & Usage
INDICATIONS AND USAGE Verapamil hydrochloride sustained-release capsules 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 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 sustained-release capsules should be individualized by titration. The usual daily dose of sustained-release verapamil, verapamil hydrochloride sustained-release capsules, in clinical trials has been 240 mg given by mouth once daily in the morning. However, initial doses of 120 mg a day may be warranted in patients who may have an increased response to verapamil (e.g., elderly, small people, etc.). Upward titration should be based on therapeutic efficacy and safety evaluated approximately 24 hours after dosing. The antihypertensive effects of verapamil hydrochloride sustained-release capsules are evident within the first week of therapy. If adequate response is not obtained with 120 mg of verapamil hydrochloride sustained-release capsules, the dose may be titrated upward in the following manner: (a) 180 mg in the morning. (b) 240 mg in the morning. (c) 360 mg in the morning. (d) 480 mg in the morning. Verapamil hydrochloride sustained-release capsules are for once-a-day administration. When switching from immediate-release verapamil to verapamil hydrochloride sustained-release capsules, the same total daily dose of verapamil hydrochloride sustained-release capsules can be used. As with immediate-release verapamil, dosages of verapamil hydrochloride sustained-release capsules should be individualized and titration may be needed in some patients. Sprinkling the Capsule Contents on Food Verapamil hydrochloride sustained-release capsules may also be administered by carefully opening the capsule and sprinkling the pellets on a spoonful of applesauce. The applesauce should be swallowed immediately without chewing and followed with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot, and it should be soft enough to be swallowed without chewing. Any pellet/applesauce mixture should be used immediately and not stored for future use. Subdividing the contents of a verapamil hydrochloride sustained-release capsule is not recommended.