Women of childbearing potential: Women of childbearing potential should use appropriate contraceptive measures during treatment.
Pregnancy: Atorvastatin is contraindicated during pregnancy. Safety in pregnant women has not been established. No controlled clinical trials with Atorvastatin have been conducted in pregnant women.
Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. Studies in animals have shown toxicity to reproduction.
Maternal treatment with Atorvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atherosclerosis is a chronic process, and ordinarily, discontinuation of lipid-lowering medicinal products during pregnancy should have little impact on the long-term risk associated with primary hypercholesterolemia.
For these reasons, Atorvastatin should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with Atorvastatin should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant.
Breastfeeding: It is unknown whether Atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of Atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking Atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.
Fertility: In animal studies, Atorvastatin had no effect on male or female fertility.
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