Indication

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, USP 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.

  1. Niacin Extended-Release Tablets, USP are indicated to reduce TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia.
  2. Niacin Extended-Release Tablets USP in combination with simvastatin or lovastatin are indicated for the treatment of primary hyperlipidemia and mixed dyslipidemia when treatment with Niacin Extended-Release Tablets USP, simvastatin or lovastatin monotherapy is considered inadequate.
  3. In patients with a history of myocardial infarction and hyperlipidemia, niacin, USP is indicated to reduce the risk of recurrent nonfatal myocardial infarction.
  4. In patients with a history of coronary artery disease (CAD) and hyperlipidemia, niacin, USP, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
  5. Niacin Extended-Release Tablets USP in combination with a bile acid binding resin are indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia.
  6. Niacin, USP 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.

Important Safety Information

Limitations of Use

No incremental benefit of Niacin Extended-Release Tablets USP co-administered with simvastatin or lovastatin was shown on cardiovascular morbidity and mortality over that of using the single agents. Doses of 1,500-2,000 mg/day in combination with simvastatin did not reduce the incidence of cardiovascular events more than simvastatin alone in a randomized controlled trial.

Niacin extended-release tablets are contraindicated in the following conditions:

  1. Active liver disease or unexplained persistent elevations in hepatic transaminases
  2. Patients with active peptic ulcer disease
  3. Patients with arterial bleeding
  4. Hypersensitivity to niacin or any component of this medication

Niacin extended-release tablets should not be substituted for equivalent doses of immediate-release niacin. For patients switching from immediate-release niacin to extended-release tablets, therapy with niacin extended release tablets should be initiated with low doses and should then be titrated to the desired therapeutic response.

Caution should be used when niacin extended-release tablets are used in patients with unstable angina or in the acute phase of a myocardial infarction (MI), particularly when such patients are also receiving vasoactive drugs such as nitrates, calcium channel blockers or adrenergic blocking agents.

Niacin is rapidly metabolized by the liver and excreted through the kidneys. Niacin extended-release tablets are contraindicated in patients with significant or unexplained hepatic impairment and should be used with caution in patients with renal impairment. Patients with a past history of jaundice, hepatobiliary disease or peptic ulcer disease should be observed closely during niacin extended-release therapy.

Rhabdomyolysis has been associated with concomitant administration of lipid-altering doses (≥ 1 g/day) of niacin and statins. Physicians contemplating combined therapy with statins and niacin extended-release tablets should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness particularly during initial months of therapy and periods of dosage increase of either drug. Periodic serum creatine phosphokinase (CPK) and potassium should be considered in these situations. The risk for myopathy and rhabdomyolysis increases with the co-administration of lovastatin or simvastatin, especially in the elderly and patients with diabetes, renal failure or uncontrolled hypothyroidism.

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. Niacin extended-release tablets should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease.

Niacin preparations have been associated with abnormal liver tests. Liver function tests should be performed on all patients during therapy with niacin extended-release tablets. Serum transaminase levels, including AST and ALT (SGOT and SGPT), should be monitored before treatment begins, every 6 to 12 weeks for the first year and periodically thereafter. Special attention should be paid to patients who develop elevated serum transaminase levels and measurements should be repeated promptly and then performed more frequently. If the transaminase levels show evidence of progression, particularly if they rise to 3 times ULN and are persistent, or if they are associated with symptoms of nausea, fever and/or malaise, the drug should be discontinued.

Niacin extended-release tablets may cause an increase in fasting blood glucose, reduction in platelet count, increase in prothrombin time, increase in uric acid and decrease in phosphorus.

The most common adverse effects reported are flushing, diarrhea, nausea, vomiting, cough, pruritis and rash.

Combination therapy with niacin extended-release tablets and simvastatin or lovastatin should not exceed doses of 2,000 mg niacin extended-release tablets and 40 mg of either simvastatin or lovastatin. Bile-acid resins have high niacin binding capacity; therefore 4-6 hours (or as great an interval as possible) should elapse between ingestion of bile acid-binding resins and niacin extended-release tablets. 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 that contain large doses of niacin or related compounds may potentiate the adverse effects of niacin extended-release tablets.

Niacin extended-release tablets are classified as Pregnancy Category C. It is not known whether niacin at doses typically used for lipid disorders can cause fetal harm when administered to pregnant women or whether it can affect reproductive capacity. If a woman is receiving the drug for primary hyperlipedemia and becomes pregnant, it should be discontinued. If it is being used for hypertriglyceridemia, the benefits and risks should be assessed. Niacin is excreted into human milk and benefits and risks to the nursing mother and infant should be assessed.

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PI Rev. B 2/13