Ezetrol Use In Pregnancy & Lactation

Use in 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, which is contraindicated during pregnancy and lactation, please refer to the information for that particular statin.
Use in lactation: Studies in rats have shown that ezetimibe is excreted in milk. It is not known whether ezetimibe is excreted into human breast milk. Therefore, Ezetrol should not be used in nursing mothers unless the potential benefit justifies the potential risk to the infant.