Felodipine 24 HR Felodipine 5 MG Extended Release Oral Tablet
INDICATIONS AND USAGE Felodipine tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 felodipine. 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 1 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 Programβs 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 (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Felodipine tablets may be administered with other antihypertensive agents.
Glenmark Generics, Inc. USA
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HOW SUPPLIED
FELODIPINE extended-release tablets USP, 2.5 mg are green colored film coated, circular shaped, biconvex tablets engraved with βG19β on one side of the tablet and plain on the other side. They are supplied as follows: Bottles of 90 NDC 68462-233-90 Bottles of 100 NDC 68462-233-01 Bottles of 1000 NDC 68462-233-10 Unit dose packages of 100 (10 x 10) NDC 68462-233-11
FELODIPINE extended-release tablets USP 5 mg are light pink colored film coated, circular shaped, biconvex tablets engraved with βG19β on one side of the tablet and β5β on the other side. They are supplied as follows: Bottles of 90 NDC 68462-234-90 Bottles of 100 NDC 68462-234-01 Bottles of 1000 NDC 68462-234-10 Unit dose packages of 100 (10 x 10) NDC 68462-234-11
FELODIPINE extended-release tablets USP 10 mg are brown colored film coated, circular shaped, biconvex tablets engraved with βG19β on one side of the tablet and β10β on the other side. They are supplied as follow: Bottles of 90 NDC 68462-235-90 Bottles of 100 NDC 68462-235-01 Bottles of 1000 NDC 68462-235-10 Unit dose packages of 100 (10 x 10) NDC 68462-235-11 Storage: Store at 20 o -25 o C (68 o -77 o F); excursions permitted to 15 o -30 o C (59 o -86 o F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.
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