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nebivolol 5 mg

1 INDICATIONS AND USAGE Nebivolol tablet 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.

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3 years ago TRIANGLE ORANGE J 9 nebivolol 5 mg

TRIANGLE ORANGE J 9

3 years ago TRIANGLE ORANGE J 9 nebivolol 5 mg

J 9 TRIANGLE ORANGE

16 HOW SUPPLIED/STORAGE AND HANDLING

NEBIVOLOL is available as tablets for oral administration containing

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

NEBIVOLOL.

NEBIVOLOL tablets are supplied in the following strengths and package configurations:

NEBIVOLOL tablets, 2.5 mg are white to off-white, triangular biconvex tablets debossed with ‘J’ on one side and ‘8’ on other side. Bottle of 30 tablets NDC 31722-585-30 Bottle of 100 tablets NDC 31722-585-01 Blister card of 10 Unit dose tablets (PVC/PVdC) NDC 31722-585-31 Blister pack of 120 (12 x 10) Unit dose tablets (PVC/PVdC) NDC 31722-585-32 Blister card of 10 Unit dose tablets (Alu-Alu) NDC 31722-585-33 Blister pack of 150 (15 x 10) Unit dose tablets (Alu-Alu) NDC 31722-585-34

NEBIVOLOL tablets, 5 mg are light orange, triangular biconvex tablets debossed with ‘J’ on one side and ‘9’ on other side. Bottle of 30 tablets NDC 31722-586-30 Bottle of 90 tablets NDC 31722-586-90 Bottle of 100 tablets NDC 31722-586-01 Blister card of 10 Unit dose tablets (PVC/PVdC) NDC 31722-586-31 Blister pack of 100 (10 x 10) Unit dose tablets (PVC/PVdC) NDC 31722-586-32 Blister card of 7 Unit dose tablets (Alu-Alu) NDC 31722-586-33 Blister pack of 126 (18 x 7) Unit dose tablets (Alu-Alu) NDC 31722-586-34

NEBIVOLOL tablets, 10 mg are light peach color, triangular shaped biconvex tablets debossed with ‘J’ on one side and ‘10’ on other side. Bottle of 30 tablets NDC 31722-587-30 Bottle of 90 tablets NDC 31722-587-90 Bottle of 100 tablets NDC 31722-587-01 Blister card of 10 Unit dose tablets (PVC/PVdC) NDC 31722-587-31 Blister pack of 100 (10 x 10) Unit dose tablets (PVC/PVdC) NDC 31722-587-32 Blister card of 7 Unit dose tablets (Alu-Alu) NDC 31722-587-33 Blister pack of 126 (18 x 7) Unit dose tablets (Alu-Alu) NDC 31722-587-34

NEBIVOLOL tablets, 20 mg are white to off-white, triangular biconvex tablets debossed with ‘J’ on one side and ‘11’ on other side. Bottle of 30 tablets NDC 31722-588-30 Bottle of 90 tablets NDC 31722-588-90 Bottle of 100 tablets NDC 31722-588-01 Blister card of 10 Unit dose tablets (PVC/PVdC) NDC 31722-588-31 Blister pack of 100 (10 x 10) Unit dose tablets (PVC/PVdC) NDC 31722-588-32 Blister card of 7 Unit dose tablets (Alu-Alu) NDC 31722-588-33 Blister pack of 126 (18 x 7) Unit dose tablets (Alu-Alu) NDC 31722-588-34 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.


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