HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use NIASPAN ® safely and effectively. See full prescribing information for NIASPAN.
NIASPAN (niacin extended-release) tablet, film coated, extended release for oral use.
Initial U.S. Approval: 1997
INDICATIONS AND USAGE
NIASPAN contains extended-release niacin (nicotinic acid), and is indicated:
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To reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia.(1)
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In combination with simvastatin or lovastatin: to treat primary hyperlipidemia and mixed dyslipidemia when treatment with NIASPAN, simvastatin, or lovastatin monotherapy is considered inadequate.(1)
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To reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia.(1)
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In combination with a bile acid binding resin:
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Slows progression or promotes regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia. (1)
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As an adjunct to diet to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia. (1)
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To reduce TG in adult patients with severe hypertriglyceridemia.(1)
Limitations of use:
No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin and lovastatin monotherapy, has been established.
DOSAGE AND ADMINISTRATION
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NIASPAN should be taken at bedtime with a low-fat snack. (2)
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Dose range: 500 mg to 2000 mg once daily. (2)
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Therapy with NIASPAN must be initiated at 500 mg at bedtime in order to reduce the incidence and severity of side effects which may occur during early therapy and should not be increased by more than 500 mg in any four week period. (2)
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Maintenance dose: 1000 to 2000 mg once daily. (2)
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Doses greater than 2000 mg daily are not recommended. (2)
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Concomitant therapy with lovastatin: Initial dose of lovastatin is 20 mg once a day; combination therapy with NIASPAN and lovastatin should not exceed doses of 2000 mg and 40 mg daily, respectively. (2)
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Concomitant therapy with simvastatin: Initial dose of simvastatin is 20 mg once a day; combination therapy with NIASPAN and simvastatin should not exceed doses of 2000 mg and 40 mg daily, respectively. (2)
DOSAGE FORMS AND STRENGTHS
Unscored film-coated tablets for oral administration: 500, 750 and 1000 mg niacin extended-release. (3)
CONTRAINDICATIONS
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Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels. (4, 5.2)
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Active peptic ulcer disease. (4)
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Arterial bleeding. (4)
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Known hypersensitivity to product components. (4, 6.1)
WARNINGS AND PRECAUTIONS
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Severe hepatic toxicity has occurred in patients substituting sustained-release niacin for immediate-release niacin at equivalent doses. (5.2)
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Myopathy has been reported in patients taking NIASPAN. The risk for myopathy and rhabdomyolysis are increased when lovastatin or simvastatin are coadministered with NIASPAN, particularly in elderly patients and patients with diabetes, renal failure, or uncontrolled hypothyroidism. (5.1)
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Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminase can occur. Monitor liver enzymes before and during treatment. (5.2)
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Use with caution in patients with unstable angina or in the acute phase of an MI. (5)
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NIASPAN can increase serum glucose levels. Glucose levels should be closely monitored in diab
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