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Pregnancy: No clinical data on exposed pregnancies are available. Animal studies of ezetimibe administered alone do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. However, caution should be exercised when prescribing to pregnant women.
When ezetimibe was given with lovastatin, simvastatin, pravastatin or atorvastatin, no teratogenic effects were observed in embryo-fetal development studies in pregnant rats. In pregnant rabbits, a low incidence of skeletal malformations was observed.
When ezetimibe is to be administered with a statin, refer to the Package Insert for that particular statin.
Lactation: It is not known if ezetimibe is excreted in breast milk, therefore, ezetimibe should not be used during breastfeeding unless the potential benefit justifies the potential risk to infant.
