Monograph Details
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Cardiovascular System
> Hyperlipoproteinemias
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NIASPAN |
| Manufacturer |
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Abbott Laboratories |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Nicotinic acid deriv. |
| Generic Name |
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Niacin 500mg, 750mg, 1g; ext-rel tabs. |
| Indications |
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Adjunct to diet in primary hypercholesterolemia and mixed dyslipidemia (Types IIa and IIb) to reduce elevated total-C, LDL-C, apo B, TG and to increase HDL-C; or combined with lovastatin when further reductions in TG or LDL-C or increases in HDL-C are needed; not for initial combination therapy. To reduce risk of recurrent nonfatal MI in patients with a history of MI and hypercholesterolemia. Combined with a bile acid sequestrant to slow progression or promote regression of atherosclerosis in patients with coronary artery disease and hypercholesterolemia. Combined with a bile acid sequestrant to reduce elevated total-C and LDL-C in primary hypercholesterolemia when diet or diet + monotherapy has been inadequate. Adjunct in patients with very high serum TG (Types IV and V hyperlipidemia) who are at risk for pancreatitis, when determined dietary measures are inadequate. |
| Children |
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<21yrs: not recommended. |
| Adults |
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Swallow whole. Take at bedtime with low-fat snack. Avoid concomitant alcohol and hot beverages; may pre-treat with aspirin or another NSAID ½ hour before dosing. >16yrs: initially 500mg once daily for 4 weeks, then 1g once daily for weeks 5–8. May increase by up to 500mg every 4 weeks to usual range of 1–2g daily; max 2g/day. Combined with lovastatin: max 2g niacin and 40mg lovastatin per day. Retitrate if restarting after an extended time. Women may respond at lower doses than men. |
| Contraindications |
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Hepatic dysfunction. Unexplained elevations of serum transaminases. Active peptic ulcer disease. Arterial bleeding. |
| Precautions |
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Do not substitute for equivalent doses of immediate-release or sustained-release niacin (hepatotoxicity may occur). History of jaundice, hepatobiliary disease, peptic ulcer. Substantial alcohol consumption. Monitor serum transaminase levels (before treatment then every 6–12 weeks for 1 year then periodically); discontinue if transaminase levels ≥3xULN persist or if signs of liver disease occur. Renal dysfunction. Cardiovascular disease (eg, unstable angina, acute MI). Gout. Monitor blood glucose and for hypophosphatemia. Surgery. Diabetes or patients at risk for diabetes. Pregnancy (Cat.C), nursing mothers: not recommended (consider discontinuing drug). |
| Interactions |
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Avoid other products with high amounts of niacin or nicotinamide, alcohol. Monitor for rhabdomyolysis with HMG-CoA reductase inhibitors. May potentiate antihypertensives, other vasoactive drugs (eg, ganglionic or adrenergic blockers, nitrates, calcium channel blockers). Caution with anticoagulants (monitor PT and platelet counts). Antidiabetic agents may need adjustment. Separate dosing of bile acid sequestrants by at least 4–6 hours. May cause false (+) Benedict's test. |
| Adverse Reactions |
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Flushing, dizziness, tachycardia, palpitations, shortness of breath, sweating, chills, edema, headache, GI upset, pain, rhinitis, rash, pruritus, glucose intolerance, peptic ulcer, abnormal liver function tests, jaundice. |
| How Supplied |
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Tabs—100 |
| Additional Resources |
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• Related Prescribing Note |
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