Altoprev (Lovastatin Extended-Release Tablets) Drug Information: Overdosage and Contraindications

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May 24, 2012

Altoprev

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Statins (or HMG-CoA reductase inhibitors) are a class of drugs that reduce cholesterol in individuals who have dyslipidemia (abnormal fats in the blood) and thus are at risk for cardiovascular disease. Dyslipidemia may involve an elevation of total cholesterol, a reduction of low density lipoprotein (LDL) cholesterol and/or triglycerides, or a reduction of high density lipoprotein (HDL) cholesterol in blood. Statins work by blocking the enzyme in the liver that is responsible for making cholesterol. This enzyme is called hydroxy-methylglutaryl-coenzyme A reductase (HMG-CoA reductase).

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OVERDOSE

After oral administration of lovastatin immediate-release to mice the median lethal dose observed was > 15 g/m².

Five healthy human volunteers have received up to 200 mg of lovastatin as a single dose without clinically significant adverse experiences. A few cases of accidental overdosage with lovastatin immediate-release have been reported; no patients had any specific symptoms, and all patients recovered without sequelae. The maximum dose taken was 5g - 6 g.

Until further experience is obtained, no specific treatment of overdosage with ALTOPREV® can be recommended.

The dialyzability of lovastatin and its metabolites in man is not known at present.

CONTRAINDICATIONS

Hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminases (see WARNINGS).

Pregnancy and Lactation

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 ALTOPREV® (lovastatin extended-release tablets) to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, ALTOPREV® (lovastatin extended-release tablets) is contraindicated during pregnancy and in nursing mothers. ALTOPREV® (lovastatin extended-release tablets) should be administered to women of childbearing age only when such patients are highly unlikely to conceive. If the patient becomes pregnant while taking this drug, ALTOPREV® (lovastatin extended-release tablets) should be discontinued immediately and the patient should be apprised of the potential hazard to the fetus (see PRECAUTIONS, Pregnancy).

Last reviewed on RxList: 7/31/2007
This monograph has been modified to include the generic and brand name in many instances.