Indicated for:

Primary Prevention of Coronary Heart Disease:  

In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, Mevacor is indicated to reduce the risk of:

• Myocardial infarction
• Unstable angina
• Coronary revascularization procedures

Coronary Heart Disease: 

To slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels.

Hypercholesterolemia: 

As an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb), when the response to diet restricted in saturated fat and cholesterol and to other non-pharmacological measures alone has been inadequate.

Adolescent Patients with Heterozygous Familial Hypercholesterolemia: 

As an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present:

• LDL-C remains >189 mg/dL or  
• LDL-C remains >160 mg/dL and
• there is a positive family history of premature cardiovascular disease or
• two or more other CVD risk factors are present in the adolescent patient

Prior to initiating therapy with lovastatin, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total-C, HDL-C, and TG.

Lovastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above ten times the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. The risk of myopathy is increased by high levels of HMG-CoA reductase inhibitory activity in plasma.The risk of myopathy/rhabdomyolysis is dose related.

Lovastatin produced optic nerve degeneration.

MEVACOR is contraindicated with:

• Patients with active liver disease or unexplained persistent elevations of serum transaminases
• Pregnancy and lactation
• Concomitant administration with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, and cobicistat-containing products)

The combined use of lovastatin with gemfibrozil should be avoided, unless the benefits are likely to outweigh the increased risks of this drug combination.

Lovastatin, like several other inhibitors of HMG-CoA reductase, is a substrate of cytochrome P450 3A4 (CYP3A4). Certain drugs which inhibit this metabolic pathway can raise the plasma levels of lovastatin and may increase the risk of myopathy. These include itraconazole, ketoconazole, posaconazole, voriconazole, the macrolide antibiotics erythromycin and clarithromycin, the ketolide antibiotic telithromycin, HIV protease inhibitors, boceprevir, telaprevir, the antidepressant nefazodone, or cobicistat-containing products. Combination of these drugs with lovastatin is contraindicated. If short-term treatment with strong CYP3A4 inhibitors is unavoidable, therapy with lovastatin should be suspended during the course of treatment.

Caution should be used when prescribing other fibrates or lipid-lowering doses (greater than or equal to 1 g/day) of niacin with lovastatin, as these agents can cause myopathy when given alone. The benefit of further alterations in lipid levels by the combined use of lovastatin with other fibrates or niacin should be carefully weighed against the potential risks of these combinations.

The use of lovastatin with cyclosporine should be avoided.

The dose of lovastatin should not exceed 40 mg daily in patients receiving concomitant medication with amiodarone. The combined use of lovastatin at doses higher than 40 mg daily with amiodarone should be avoided unless the clinical benefit is likely to outweigh the increased risk of myopathy. The risk of myopathy/rhabdomyolysis is increased when amiodarone is used concomitantly with higher doses of a closely related member of the HMG-CoA reductase inhibitor class.

Cases of myopathy, including rhabdomyolysis, have been reported with lovastatin coadministered with colchicine, and caution should be exercised when prescribing lovastatin with colchicine.

The risk of myopathy, including rhabdomyolysis, may be increased by concomitant administration of ranolazine. Dose adjustment of lovastatin may be considered during co-administration with ranolazine.

The risk of myopathy/rhabdomyolysis is increased by concomitant administration of cyclosporine.

The risk of myopathy/rhabdomyolysis is increased by concomitant administration of danazol, diltiazem, dronedarone or verapamil particularly with higher doses of lovastatin.The dose of lovastatin should not exceed 20 mg daily in patients receiving concomitant medication with danazol, diltiazem, dronedarone, or verapamil.

Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including lovastatin.

Safety in pregnant women has not been established. Lovastatin should not be used in women who are pregnant, or can become pregnant. Lovastatin should be administered to women of child-bearing potential only when such patients are highly unlikely to conceive and have been informed of the potential hazards. Treatment should be immediately discontinued as soon as pregnancy is recognized.

It is not known whether lovastatin is excreted in human milk. Because a small amount of another drug in this class is excreted in human breast milk and because of the potential for serious adverse reactions in nursing infants, women taking lovastatin should not nurse their infants.

GoToSource

• Use in patients under 10 years of age. GoToSource 

• Adult dosage greater than 80 mg per day, for adolescent patients or patients taking Amiodarone, dosage greater than 40 mg per day. GoToSource

• Regression or reduction in progression of atherosclerosis. GoToSource

• Recurrent or metastatic squamous cell carcinoma of the head, neck and cervix. GoToSource

• Dementia. GoToSource

• Multiple sclerosis. GoToSource

Rhabdomyolysis (breakdown of muscle tissue). GoToSource

Cataract development. GoToSource

Peripheral neuropathy (nerve damage). GoToSource

Cognitive impairment (memory loss, forgetfulness, amnesia, memory impairment, confusion), new-onset of diabetes mellitus, persistent elevation in serum AST and ALT (more than three times the upper limit of normal), increased creatinine phosphokinase (CK) greater than two times normal, myalgia, weakness and muscle cramps. GoToSource

Testicular pain. GoToSource

Hepatotoxicity (liver damage) and myopathy (muscle disease). GoToSource

Birth defects. GoToSource

Lawsuits filed for myopathy, rhabdomyolysis, kidney failure, liver damage and type 2 diabetes.