INDICATIONS AND USAGE Angina Pectoris Nadolol tablets are indicated for the long-term management of patients with angina pectoris. hypertension Nadolol tablets 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol. 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. Nadolol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
zydus pharmaceuticals (usa) inc.
HOW SUPPLIED 20 mg tablets: white to off-white colored, round shaped, flat faced, beveled edge uncoated tablets, debossed with ''N" on upper half of the breakline and "20" on lower half of the breakline on one side and plain on other sideand are supplied as : NDC 68382-732-16 in bottle of 90 tablets NDC 68382-732-01 in bottle of 100 tablets NDC 68382-732-10 in bottle of 1000 tablets NDC 68382-732-77 in cartons of 100 tablets (10 x 10 unit-dose) 40 mg tablets: Light yellow colored, round shaped, flat faced, beveled edge uncoated tablets, debossed with "N" on upper half of the breakline and "40" on lower half of the breakline on one side and plain on the other side and are supplied as : NDC 68382-733-16 in bottle of 90 tablets NDC 68382-733-01 in bottle of 100 tablets NDC 68382-733-10 in bottle of 1000 tablets NDC 68382-733-77 in cartons of 100 tablets (10 x 10 unit-dose) 80 mg tablets: Light blue colored, spotted, round shaped, flat faced, beveled edge uncoated tablets debossed with "N" on upper half of the breakline and "80" on lower half of the breakline on one side and plain on the other side and are supplied as : NDC 68382-734-16 in bottle of 90 tablets NDC 68382-734-01 in bottle of 100 tablets NDC 68382-734-10 in bottle of 1000 tablets NDC 68382-734-77 in cartons of 100 tablets (10 x 10 unit-dose) STORAGE Store at 20Â° to 25Â°C (68Â° to 77Â°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from light. Keep bottle tightly closed. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.com Manufactured by: Cadila Healthcare Limited Matoda, Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 08/17
Lupin Pharmaceuticals, Inc.
Watson Laboratories, Inc.
Lupin Pharmaceuticals, Inc.
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