In addition, no evidence of damage to genetic material was noted in an in vitro alkaline elution assay using rat or mouse hepatocytes, a V mammalian cell forward mutation study, an in vitro chromosome aberration study in CHO cells, or an in vivo chromosomal aberration assay in mouse bone marrow. Similar findings were seen with another drug in this class. No drug-related effects on fertility were found in studies with lovastatin in rats.
No microscopic changes were observed in the testes from rats of either study. The clinical significance of these findings is unclear. Pregnancy Teratogenic Effects Nursing Mothers It is not known whether lovastatin is excreted in human milk. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Because pediatric patients are not likely to benefit from cholesterol lowering for at least a decade and because experience with this drug is limited no studies in subjects below the age of 20 years , treatment of pediatric patients with lovastatin is not recommended at this time.
The corresponding values for the control agent cholestyramine was 9 percent. Talk to your doctor about whether you should continue breast-feeding. The safety and effectiveness of using this medication have not been established for children.
If you are older than 70 years of age, your doctor will likely monitor you closely for muscle-related side effects. What other drugs could interact with this medication? To be sure this medicine is not causing harmful effects, your blood will need to be tested often. Visit your doctor regularly. Niacin can raise your blood sugar, and may cause unusual results with certain medical tests. Tell any doctor who treats you that you are using lovastatin and niacin.
Lovastatin and niacin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely. Store at room temperature away from moisture and heat. Seek emergency medical attention or call the Poison Help line at Overdose symptoms may include severe dizziness, severe redness or tingling, vomiting, or fainting.
Take the missed dose as soon as you remember. NCEP Classification of Cholesterol Levels in Pediatric Patients with a Familial History of Hypercholesterolemia Children treated with lovastatin in adolescence should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult goals for LDL-C.
Lovastatin should be given with meals. Adult Patients The usual recommended starting dose is 20 mg once a day given with the evening meal.
Doses should be individualized according to the recommended goal of therapy. A starting dose of 10 mg of lovastatin may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more. Cholesterol levels should be monitored periodically and consideration should be given to reducing the dosage of lovastatin if cholesterol levels fall significantly below the targeted range.
Concomitant Lipid-Lowering Therapy Lovastatin is effective alone or when used concomitantly with bile-acid sequestrants. Concomitant administration with strong CYP3A4 inhibitors e. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Moreover, cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes.
Because of the ability of inhibitors of HMG-CoA reductase such as lovastatin to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, lovastatin is contraindicated during pregnancy and in nursing mothers. Lovastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive. The conversion of HMG-CoA to mevalonate is an early step in the biosynthetic pathway for cholesterol.
Safety in pregnant women has not been established. No effect was seen in male rats. Rare clinical reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. They should not be combined with lovastatin. 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. Hepatotoxicity of cardiovascular and antidiabetic medications. Review of hepatotoxicity of lipid lowering agents; asymptomatic elevations in aminotransferases are common in patients receiving statins, but clinically significant hepatotoxicity is rare. Drug therapy for hypercholesterolemia and dyslipidemia.
Textbook of pharmacology and therapeutics: Lovastatin alone and in combination for treatment of primary hypercholesterolemia. Prog Clin Biol Res ; A multicenter comparison of lovastatin and cholestyramine therapy for severe primary hypercholesterolemia. Efficacy and long-term adverse effect pattern of lovastatin. Am J Cardiol ; Extended clinical safety profile of lovastatin.
Long-term clinical tolerance of lovastatin and simvastatin. Cardiology ; 77 Suppl 4: Cholestatic jaundice associated with lovastatin Mevacor therapy. Can Med Assoc J ; Dtsch Med Wochenschr ;
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