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.
Use in Lactation: 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.