niacin and lovastatin, Advicor (cont.)
Omudhome Ogbru, PharmD
Omudhome Ogbru, PharmD
Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.
Medical and Pharmacy Editor:
Large quantities of grape fruit juice (>1 quart daily) also will increase blood levels of lovastatin and should be avoided.
Amiodarone (Cordarone), verapamil (Calan, Verelan, Isoptin), diltiazem (Cardizem), danazol (Danocrine), niacin (Niacor, Niaspan, Slo-Niacin), colchicine, ranolazine (Ranexa), gemfibrozil (Lopid), and fenofibrate (Tricor) also may increase the risk of muscle toxicity when combined with lovastatin. Cyclosporine or gemfibrozil should not be combined with lovastatin. Patients taking amiodarone (Cordarone) should not exceed 40 mg daily of lovastatin. Patients taking verapamil, diltiazem, or danazol should start with 10 mg and should not exceed 20 mg of lovastatin daily. Patients taking niacin (greater than or equal to 1 g/day), fenofibrate (Tricor) or cyclosporine (Gengraf, Neoral) should not take more than 20 mg of lovastatin.
Lovastatin may increase the effect of warfarin (Coumadin), a blood thinner. Patients taking lovastatin and warfarin (Coumadin) should be monitored carefully for toxic effects of warfarin.
Niacin may increase blood glucose levels in individuals with diabetes. Therefore, medications for controlling blood glucose may need to be adjusted when niacin is taken by those with diabetes.
Bile acid sequestrants (for example, cholestyramine [Questran]) bind and prevent absorption of niacin. Administration of bile acid sequestrants and niacin should be separated by 4-6 hours. Alcohol or hot drinks may increase flushing and itching caused by niacin and should not be used when Advicor is ingested. Vitamins and nutritional supplements containing niacin or related compounds (for example, nicotinamide) will increase adverse effects of niacin and should not be combined with Advicor.
PREGNANCY: Advicor should not be administered to pregnant women because lovastatin can be harmful to the fetus. Niacin has not been evaluated in pregnant women at doses used for treating levels of cholesterol and triglycerides.
NURSING MOTHERS: Niacin in Advicor is excreted in breast milk and may cause side effects if ingested by the infant.
SIDE EFFECTS: The most common side effects are flushing, redness, warm sensation, rash, itching, headache, stomach upset, nausea, vomiting, muscle pain, and tingling in extremities. Flushing may be reduced by taking 325 mg of aspirin 30 minutes before the niacin and by increasing the dose of niacin slowly.
Drinking hot liquids or alcohol shortly before or after niacin is taken may increase the occurrence of flushing.
Lovastatin shares side effects, such as liver and muscle damage associated with all statins. Serious liver damage caused by statins is rare. More often, statins cause abnormalities of liver tests. Abnormal tests usually return to normal even if a statin is continued, but if the abnormal test value is greater than three times the upper limit of normal, the statin usually is stopped. Liver function tests should be performed at the beginning of treatment then as needed thereafter.
Inflammation of the muscles caused by statins can lead to a serious breakdown of muscle cells called rhabdomyolysis. Rhabdomyolysis causes the release of muscle protein (myoglobin) into the blood. Myoglobin can cause kidney failure and even death. When used alone, statins cause rhabdomyolysis in less than one percent of patients. To prevent the development of rhabdomyolysis, patients taking lovastatin should contact their health care professional immediately if they develop unexplained muscle pain, weakness, or muscle tenderness.
Statins have been associated with increases in HbA1c and fasting serum glucose levels as are seen in diabetes.
There are also post-marketing reports of memory loss, forgetfulness, amnesia, confusion, and memory impairment. Symptoms may start 1 day to years after starting treatment and resolve within a median of 3 weeks after stopping the statin.
Reference: FDA Prescribing Information
Last Editorial Review: 7/23/2012
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