Niaspan (niacin extended-release)
NIASPAN (niacin extended-release) – a controlled release niacin product commonly used to treat lipid disorders and certain types of cardiovascular disease. The mechanism by which niacin extended-release influences serum 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 also decreases the rate of hepatic synthesis of VLDL and LDL.
FDA approved uses: Niaspan is indicated –
• To reduce elevated TC, LDL-C, Apo B and TG, and to increase HDLC in patients with primary hyperlipidemia and mixed dyslipidemia.
• In combination with simvastatin or lovastatin: to treat primary hyperlipidemia and mixed dyslipidemia when treatment with NIASPAN, simvastatin, or lovastatin monotherapy is considered inadequate.
• To reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia.
• In combination with a bile acid binding resin:
o Slows progression or promotes regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia.
o As an adjunct to diet to reduce elevated TC and LDLC in adult patients with primary hyperlipidemia.
• To reduce TG in adult patients with severe hypertriglyceridemia.
Important 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.
Available dosage forms: Unscored film coated tablets for oral administration – 500, 750 and 1000 mg extended-release.
Usual dosage: 500 mg to 2000 mg once daily. Initiate at 500 mg at bedtime in order to reduce the incidence and severity of side effects. Do not increase by more than 500 mg in any four week period. Usual maintenance dose is 1000 mg to 2000 mg daily. Doses greater than 2000 mg are not recommended. If used concomitantly with lovastatin or simvastatin, the dosage should not exceed 2000 mg of Niaspan along with 40 mg of either lovastatin or simvastatin.
Contraindications: Do not administer to patients with hypersensitivity to any component of this product. Also do not use in active liver disease, active peptic ulcer disease, or arterial bleeding.
Special Warnings: Severe hepatic toxicity has occurred in patients substituting sustained-release niacin for immediate release niacin at equivalent doses. Myopathy has been reported in patients taking Niaspan. Risk for is increased when lovastatin or simvastatin is used with Niaspan, particularly in elderly patients and diabetics. Use with caution in patients with unstable angina or in the acute phase of a myocardial infarct.
Adverse reactions (side effects) of these medications: The most common side effects of Niaspan include upper flushing, diarrhea, nausea, vomiting, increased cough, and pruritus. Other adverse reactions seen in clinical trials or post-marketing include: Hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, flushing, dyspnea, tongue edema, larynx edema, face edema, peripheral edema, laryngismus, and vesiculobullous rash; maculopapular rash; dry skin; tachycardia; palpitations; atrial fibrillation; other cardiac arrhythmias; syncope; hypotension; postural hypotension; blurred vision; macular edema; peptic ulcers; eructation; flatulence; hepatitis; jaundice; decreased glucose tolerance; gout; myalgia; myopathy; dizziness; insomnia; asthenia; nervousness; paresthesia; dyspnea; sweating; burning sensation/skin burning sensation; skin discoloration, and migraine.
Common drug interactions: Statins can increase the risk of myopathy and rhabdomyopathy when coadministered with Niaspan. Bile-acid sequestrants have high the ability to bind niacin, and therefore should be given 4 to 6 hours (or as great an interval as possible) before or after Niaspan.
Special instructions for patients: Take Niaspan daily as prescribed. Do not crush or chew. Call physician if you experience any unexplained muscle pain, tenderness, or weakness. Notify doctor about all medication, both prescription and over the counter, that you take. Flushing including redness, itching, and/or tingling of the skin, is a common side effect, which can be lessened by taking one aspirin 325 mg tablet 30 minutes for taking Niaspan.
Full prescribing information may be found at the manufacturer‘s official website Niaspan.com or at the U.S. Food and Drug Administration’s website at Niaspan Info at Drugs@FDA