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.

• NIASPAN is 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.
• NIASPAN 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.

Addition of NIASPAN did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial. 

Daily dose should not be increased more than 500 mg in a 4-week period, and doses above 2000 mg daily are not recommended. Women may respond at lower doses than men.

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., 500 mg at bedtime) and the NIASPAN dose should then be titrated to the desired therapeutic response.

Cases of rhabdomyolysis have been associated with concomitant administration of lipid-altering doses (≥1 g/day) of niacin and statins. Elderly patients and patients with diabetes, renal failure,or uncontrolled hypothyroidism are particularly at risk.

Use of NIASPAN in patients with renal or hepatic impairment has not been studied. NIASPAN is contraindicated in patients with significant or unexplained hepatic dysfunction.

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

Caution should also be used when NIASPAN is used in patients with unstable angina or in the acute phase of an MI, particularly when such patients are also receiving vasoactive drugs such as nitrates, calcium channel blockers, or adrenergic blocking agents.

NIASPAN is contraindicated in the following conditions:

• Active liver disease or unexplained persistent elevations in hepatic transaminases 
• Patients with active peptic ulcer disease
• Patients with arterial bleeding

Niacin treatment can increase fasting blood glucose. Frequent monitoring of blood glucose should be performed to ascertain that the drug is producing no adverse effects. Diabetic patients may experience a dose-related increase in glucose intolerance.

Caution should be observed when NIASPAN is administered concomitantly with anticoagulants; platelet counts should be monitored closely in such patients.

Elevated uric acid levels have occurred with niacin therapy, therefore use with caution in patients predisposed to gout.

In placebo-controlled trials, NIASPAN has been associated with small but statistically significant, dose related reductions in phosphorus levels. Although these reductions were transient, phosphorus levels should be monitored periodically in patients at risk for hypophosphatemia.

Bile acid-binding resins have high niacin binding capacity. Therefore, 4 to 6 hours, or as great an interval as possible, should elapse between the ingestion of bile acid-binding resins and the administration of NIASPAN.

Concomitant aspirin may decrease the metabolic clearance of nicotinic acid.

Niacin may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in postural hypotension.

Vitamins or other nutritional supplements containing large doses of niacin or related compounds such as nicotinamide may potentiate the adverse effects of NIASPAN.

Niacin may produce false elevations in some fluorometric determinations of plasma or urinary catecholamines. Niacin may also give false-positive reactions with cupric sulfate solution (Benedict’s reagent) in urine glucose tests.

If a woman receiving niacin for primary hyperlipidemia becomes pregnant, the drug should be discontinued.

Niacin is excreted into human milk but the actual infant dose or infant dose as a percent of the maternal dose is not known. Because of the potential for serious adverse reactions in nursing infants from lipid-altering doses of nicotinic acid, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. No studies have been conducted with NIASPAN in nursing mothers. 

GoToSource 

• Use in patients under the age of 16. GoToSource

• Dosage greater than 2000 mg daily. GoToSource

• Lipid-modifying therapy for patients with diabetes. GoToSource

• Pellagra. GoToSource

• Reduce serum phosphate levels in hemodialysis patients with hyperphosphatemia. GoToSource

Increased glucose levels. GoToSource

New-onset diabetes. GoToSource 

Macular edema (fluid buildup in retina). GoToSource

Liver failure. GoToSource

Increased uric acid and serum aminotransferase levels inducing gout. GoToSource

Hypophosphatemia (low blood phosphate level). GoToSource

Rhabdomyolysis (destruction of skeletal muscle), myopathy (disorder of skeletal muscles) and increased risk of ischemic stroke. GoToSource

Skin irritation including severe itching. GoToSource

Thrombocytopenia (low blood platelet count). GoToSource

Flushing. GoToSource 

Lawsuits filed for strokes.