The approximate oral LD₅₀ is greater than 2 g/kg in mice and greater than 0.7 g/kg in rats.

The maximum single oral dose of Lescol® (fluvastatin sodium) capsules received by healthy volunteers was 80 mg. No clinically significant adverse experiences were seen at this dose. The maximum dose administered with an extended-release formulation was 640 mg for two weeks. This dose was not well tolerated and produced a variety of GI complaints and an increase in transaminase values (i.e., SGOT and SGPT).

There has been a single report of 2 children, one 2 years old and the other 3 years of age, either of whom may have possibly ingested fluvastatin sodium. The maximum amount of fluvastatin sodium that could have been ingested was 80 mg (4 x 20 mg capsules). Vomiting was induced by ipecac in both children and no capsules were noted in their emesis. Neither child experienced any adverse symptoms and both recovered from the incident without problems.

Should an accidental overdose occur, treat symptomatically and institute supportive measures as required. The dialyzability of fluvastatin sodium and of its metabolites in humans is not known at present.

Information about the treatment of overdose can often be obtained from a certified Regional Poison Control Center. Telephone numbers of certified Regional Poison Control Centers are listed in the Physicians' Desk Reference®.*

Hypersensitivity to any component of this medication. Lescol® (fluvastatin sodium) and Lescol® XL (fluvastatin sodium) are contraindicated in patients with active liver disease or unexplained, persistent elevations in serum transaminases (see WARNINGS).

Pregnancy and Lactation

Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Cholesterol and other products of cholesterol biosynthesis are essential components for fetal development (including synthesis of steroids and cell membranes). Since HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, they may cause fetal harm when administered to pregnant women. Therefore, HMG-CoA reductase inhibitors are contraindicated during pregnancy and in nursing mothers. Fluvastatin sodium should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this class of drug, therapy should be discontinued and the patient apprised of the potential hazard to the fetus.

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