24 HR Verapamil hydrochloride 200 MG Extended Release Oral Capsule
1 INDICATIONS AND USAGE Verapamil hydrochloride extended-release capsules (PM) for oral use 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 mm Hg 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 is a calcium channel blocker 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. ( 1 )
Mylan Pharmaceuticals Inc.
CAPSULE RED Mylan 6202
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16 HOW SUPPLIED/STORAGE AND HANDLING Verapamil Hydrochloride Extended-Release capsules, USP (PM) are available containing 100 mg, 200 mg or 300 mg of verapamil hydrochloride, USP. The 100 mg capsule is a hard-shell gelatin capsule with a red opaque cap and a white opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 6201 in black ink on both the cap and the body. They are available as follows: NDC 0378-6201-77 bottles of 90 capsules NDC 0378-6201-01 bottles of 100 capsules The 200 mg capsule is a hard-shell gelatin capsule with a red opaque cap and a light orange opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 6202 in black ink on both the cap and the body. They are available as follows: NDC 0378-6202-77 bottles of 90 capsules NDC 0378-6202-01 bottles of 100 capsules NDC 0378-6202-05 bottles of 500 capsules The 300 mg capsule is a hard-shell gelatin capsule with a red opaque cap and a red opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 6203 in black ink on both the cap and the body. They are available as follows: NDC 0378-6203-77 bottles of 90 capsules NDC 0378-6203-01 bottles of 100 capsules NDC 0378-6203-05 bottles of 500 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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