24 HR Niacin 500 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Niacin extended-release tablets are indicated to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction. In patients with a history of coronary artery disease (CAD) and hyperlipidemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease. Niacin extended-release tablets in combination with a bile acid binding resin is indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia. Niacin is also indicated as adjunctive therapy for treatment of adult patients with severe hypertriglyceridemia who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Limitations of Use Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH) [see Warnings and Precautions (5.1) ] . Niacin extended-release tablets contain extended-release niacin (nicotinic acid), and is indicated: To reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. ( 1 ) To reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia. ( 1 ) In combination with a bile acid binding resin: Slows progression or promotes regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia. ( 1 ) As an adjunct to diet to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia. ( 1 ) To reduce TG in adult patients with severe hypertriglyceridemia. ( 1 ) Limitations of use: Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial. ( 5.1 )
Aurobindo Pharma Limited
OVAL WHITE T 65
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16 HOW SUPPLIED/STORAGE AND HANDLING
NIACIN Extended-Release Tablets USP are supplied as follows:
NIACIN Extended-Release Tablets USP, 500 mg are white to off-white, film-coated, capsule shaped biconvex tablets debossed with ‘T’ on one side and ‘65’ on other side. Bottles of 90 NDC 59651-018-90 Bottles of 180 NDC 59651-018-18 Bottles of 500 NDC 59651-018-05
NIACIN Extended-Release Tablets USP, 750 mg are white to off-white, film-coated, capsule shaped biconvex tablets debossed with ‘T’ on one side and ‘66’ on other side. Bottles of 90 NDC 59651-019-90 Bottles of 180 NDC 59651-019-18 Bottles of 500 NDC 59651-019-05
NIACIN Extended-Release Tablets USP, 1,000 mg are white to off-white, film-coated, oval shaped biconvex tablets debossed with ‘T’ on one side and ‘67’ on other side. Bottles of 90 NDC 59651-020-90 Bottles of 180 NDC 59651-020-18 Bottles of 500 NDC 59651-020-05 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container with a child-resistant closure.
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