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nebivolol 20 mg

1. INDICATIONS AND USAGE Nebivolol is a beta-adrenergic blocking agent 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. ( 1.1 ) 1.1 Hypertension Nebivolol tablets are indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies ( 14.1 )] . Nebivolol tablets may be used alone or in combination with other antihypertensive agents [see Drug Interactions ( 7 )] . 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nebivolol tablets. 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.

torrent pharmaceuticals limited


3 years ago ROUND BLUE 1356 nebivolol 20 mg

ROUND BLUE 1356

3 years ago ROUND BLUE 1356 nebivolol 20 mg

1356 ROUND BLUE

16. HOW SUPPLIED/STORAGE AND HANDLING

NEBIVOLOL tablets are available as tablets for oral administration containing

NEBIVOLOL hydrochloride equivalent to 2.5, 5, 10, and 20 mg of

NEBIVOLOL.

NEBIVOLOL tablets have a mosaic appearance, are round, biconvex, uncoated, unscored, differentiated by color and are plain on one side and debossed with the number 53, 1354, 1355 or 1356 on the other side for the 2.5, 5, 10 and 20 mg tablets, respectively.

NEBIVOLOL tablets are supplied in the following strengths and package configurations: 2.5 mg tablets are light blue colored with mosaic appearance, round, biconvex uncoated tablets, debossed with "53" on one side and plain on other side. Bottles of 30 NDC 13668-353-30 Bottles of 90 NDC 13668-353-90 Bottles of 100 NDC 13668-353-01 Bottles of 500 NDC 13668-353-05 5 mg tablets are beige colored with mosaic appearance, round, biconvex uncoated tablets, debossed with "1354" on one side and plain on other side. Bottles of 30 NDC 13668-354-30 Bottles of 90 NDC 13668-354-90 Bottles of 100 NDC 13668-354-01 Bottles of 500 NDC 13668-354-05 10 mg tablets are pinkish purple colored with mosaic appearance, round, biconvex uncoated tablets, debossed with "1355" on one side and plain on other side. Bottles of 30 NDC 13668-355-30 Bottles of 90 NDC 13668-355-90 Bottles of 100 NDC 13668-355-01 Bottles of 500 NDC 13668-355-05 20 mg tablets are light blue colored with mosaic appearance, round, biconvex uncoated tablets, debossed with "1356" on one side and plain on other side. Bottles of 30 NDC 13668-356-30 Bottles of 90 NDC 13668-356-90 Bottles of 100 NDC 13668-356-01 Bottles of 500 NDC 13668-356-05 Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP for Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.


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