INDICATIONS

Niaspan® (niacin extended-release tablets) 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, to reduce elevated TC, LDL-C, Apo B, and TG levels, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb). In patients with a history of: myocardial infarction and hypercholesterolemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction or; coronary artery disease and hypercholesterolemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.

NIASPAN in combination with lovastatin is indicated for the treatment of primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb) in patients treated with: lovastatin who require further TG lowering or HDL-C raising who may benefit from having niacin added to their regimen or; niacin who require further LDL-C lowering who may benefit from having lovastatin added to their regimen.

Combination therapy is not indicated for initial therapy.

IMPORTANT SAFETY INFORMATION

NIASPAN is contraindicated in patients with a known hypersensitivity to niacin or any component of this medication, significant or unexplained hepatic dysfunction, active peptic ulcer disease, or arterial bleeding.

NIASPAN preparations should not be substituted for equivalent doses of immediate-release (crystalline) niacin. For patients switching from immediate-release niacin to NIASPAN, therapy with NIASPAN® should be initiated with low doses (i.e., 500mg qhs) and the NIASPAN dose should then be titrated to the desired therapeutic response.

Cases of severe hepatic toxicity, including fulminant hepatic necrosis, have occurred in patients who have substituted sustained-release (modified-release, timed-release) niacin products for immediate-release (crystalline) niacin at equivalent doses.

Active liver diseases or unexplained transaminase elevations are contraindications to the use of NIASPAN. NIASPAN should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease.

Liver tests should be performed on all patients during therapy with NIASPAN. Serum transaminase levels should be monitored before treatment begins, every 6 to 12 weeks for the first year, and periodically thereafter.

Rare cases of rhabdomyolysis have been associated with concomitant administration of lipid-altering doses (≥1 g/day) of niacin and HMG-CoA reductase inhibitors. Patients on combined therapy with HMG-CoA reductase inhibitors and NIASPAN should be monitored carefully for any signs and symptoms of muscle pain, tenderness, or weakness particularly during the initial months of therapy and during any periods of upward dosage titration of either drug. Periodic serum creatine phosphokinase (CPK) and potassium determinations should be considered in such situations, but there is no assurance that such monitoring will prevent the occurrence of severe myopathy.

Diabetic patients may experience a dose-related rise in glucose intolerance, the clinical significance of which is unclear. Diabetic or potentially diabetic patients should be observed closely. Adjustment of diet and/or hypoglycemic therapy may be necessary.

The most common adverse event with NIASPAN is flushing (up to 88% in placebo-controlled trials; <6% of patients discontinued). Flushing is a redness, warmth, itching, and/or tingling sensation on the face, neck, chest, and/or back. Spontaneous reports suggest that flushing may also be accompanied by dizziness, tachycardia, palpitations, shortness of breath, sweating, chills, and/or edema, which in rare cases may lead to syncope. Other common adverse events (≥5% patients) include: headache, pain, diarrhea, dyspepsia, nausea, vomiting, abdominal pain, rhinitis, rash, and itching.