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Drug Catalog - Product Detail

VERAPAMIL HCL ER CAPS. CP 240MG 100

NDC Mfr Size Str Form
00378-6440-01 MYLAN 100 240MG CAPSULE
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Generic Name
VERAPAMIL HYDROCHLORIDE
Substance Name
VERAPAMIL HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA075138
Description
DESCRIPTION Verapamil hydrochloride extended-release capsules, USP are a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). Verapamil hydrochloride extended-release capsules are available for oral administration as a 120 mg hard gelatin capsule (bluish green opaque cap and white opaque body), a 180 mg hard gelatin capsule (bluish green opaque cap and light green opaque body) and a 240 mg hard gelatin capsule (bluish green opaque cap and bluish green opaque body). These bead filled capsules provide an extended-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: (±)-5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile monohydrochloride. Verapamil HCl, USP is a white or 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 extended-release capsules contain the following inactive ingredients: ammonium hydroxide, dibutyl sebacate, diethyl phthalate, ethylcellulose, FD&C Green No. 3, gelatin, hypromellose, maltodextrin, methacrylic acid copolymer Type A and B, oleic acid, polyethylene glycol, povidone, silicon dioxide, sodium lauryl sulfate, sugar spheres (which contain cornstarch and sucrose), talc and titanium dioxide, the 180 mg capsules also contain D&C Yellow No. 10. In addition, the black imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Verapamil Hydrochloride Structural Formula
How Supplied
HOW SUPPLIED Verapamil Hydrochloride Extended-Release Capsules, USP are available containing 120 mg, 180 mg or 240 mg of verapamil hydrochloride, USP. The 120 mg capsules are hard-shell gelatin capsules with a bluish green opaque cap and white opaque body filled with white to off-white beads. The capsules are radially printed with MYLAN over 6320 in black ink on both the cap and the body. They are available as follows: NDC 0378-6320-01 bottles of 100 capsules The 180 mg capsules are hard-shell gelatin capsules with a bluish green opaque cap and light green opaque body filled with white to off-white beads. The capsules are radially printed with MYLAN over 6380 in black ink on both the cap and the body. They are available as follows: NDC 0378-6380-01 bottles of 100 capsules The 240 mg capsules are hard-shell gelatin capsules with a bluish green opaque cap and bluish green opaque body filled with white to off-white beads. The capsules are radially printed with MYLAN over 6440 in black ink on both the cap and the body. They are available as follows: NDC 0378-6440-01 bottles of 100 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Brief digressions above 25°C while not detrimental, should be avoided. Avoid excessive heat. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Call your doctor for medical advice about side effects. You may report side effects to Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India 75080580 Revised: 6/2021 MX:CVERER:R1
Indications & Usage
INDICATIONS AND USAGE Verapamil hydrochloride extended-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’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 capsules should be individualized by titration. The usual daily dose of extended-release, verapamil hydrochloride 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 extended-release capsules are evident within the first week of therapy. If adequate response is not obtained with 120 mg of verapamil hydrochloride extended-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 extended-release capsules are for once-a-day administration. When switching from immediate-release verapamil to verapamil hydrochloride extended-release capsules, the same total daily dose of verapamil hydrochloride extended-release capsules can be used. As with immediate-release verapamil, dosages of verapamil hydrochloride extended-release capsules should be individualized and titration may be needed in some patients. Sprinkling the Capsule Contents on Food Verapamil hydrochloride extended-release bead filled capsules may also be administered by carefully opening the capsule and sprinkling the beads 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 beads. The applesauce used should not be hot, and it should be soft enough to be swallowed without chewing. Any bead/applesauce mixture should be used immediately and not stored for future use. Subdividing the contents of a verapamil hydrochloride extended-release capsule is not recommended.