Niacin

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.

The mechanism by which niacin alters lipid profiles has not been well defined. It may involve several actions including partial inhibition of release of free fatty acids from adipose tissue, and increased lipoprotein lipase activity, which may increase the rate of chylomicron triglyceride removal from plasma. Niacin decreases the rate of hepatic synthesis of VLDL and LDL, and does not appear to affect fecal excretion of fats, sterols, or bile acids.

Niacin extended-release tablets should be taken at bedtime with a low-fat snack. Dose range: 500 mg to 2,000 mg once daily. Therapy with niacin extended-release tablets 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 4-week period. Maintenance dose: 1,000 to 2,000 mg once daily. Doses greater than 2,000 mg daily are not recommended.

Niacin extended-release tablets are 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 Hypersensitivity to niacin or any component of this medication Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels. Active peptic ulcer disease. Arterial bleeding. Known hypersensitivity to product components.

Niacin extended-release preparations should not be substituted for equivalent doses of immediate-release (crystalline) niacin. For patients switching from immediate-release niacin to niacin extended-release, therapy with niacin extended-release should be initiated with low doses (i.e. 500 mg at bedtime) and the niacin extended-release dose should then be titrated to the desired therapeutic response. Caution should also be used when niacin extended-release 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. Niacin is rapidly metabolized by the liver, and excreted through the kidneys.

The following adverse reactions are discussed in greater detail in other sections of the labeling: Mortality and Coronary Heart Disease Morbidity Skeletal Muscle (rhabdomyolysis) Liver Dysfunction Laboratory Abnormalities Most common adverse reactions (incidence > 5% and greater than placebo) are flushing, diarrhea, nausea, vomiting, increased cough, and pruritus. Flushing of the skin may be reduced in frequency or severity by pretreatment with aspirin (up to the recommended dose of 325 mg taken 30 minutes prior to niacin extended-release dose).

Statins: Caution should be used when prescribing niacin with statins as these agents can increase risk of myopathy/rhabdomyolysis. Bile Acid Sequestrants: Bile acid sequestrants have a high niacin-binding capacity and should be taken at least 4 to 6 hours before niacin extended-release administration.

Store at 20° to 25°C (68° to 77°F).