Apo-Pravastatin Use In Pregnancy & Lactation

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 such as pravastatin sodium 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, APO-PRAVASTATIN is contraindicated during pregnancy and in nursing mothers.
Women of Childbearing Potential: APO-PRAVASTATIN 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 again apprised of the potential hazard to the fetus.
Use in Pregnancy: APO-PRAVASTATIN is contraindicated during pregnancy (see Contraindications).
Safety in pregnant women has not been established. Although pravastatin was not teratogenic in rats at doses as high as 1000 mg/kg daily nor in rabbits at doses of up to 50 mg/kg daily, APO-PRAVASTATIN should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of potential hazards. If a woman becomes pregnant while taking APO-PRAVASTATIN, APO-PRAVASTATIN should be discontinued and the patient advised again as to the potential hazards to the fetus.
Nursing Mothers: A negligible amount of pravastatin is excreted in human breast milk. Because of the potential for adverse reactions in nursing infants, if the mother is being treated with APO-PRAVASTATIN, nursing should be discontinued or treatment with APO-PRAVASTATIN stopped.