Rosuzet Use In Pregnancy & Lactation

Pregnancy: Ezetimibe + Rosuvastatin (ROSUZET): Ezetimibe + Rosuvastatin (ROSUZET) is contraindicated during pregnancy. Women of child-bearing potential should use appropriate contraceptive measures (see CONTRAINDICATIONS).
Ezetimibe: 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.
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.
Rosuvastatin: The safety of rosuvastatin during pregnancy and whilst breast-feeding has not been established.
Nursing Mothers: Ezetimibe + Rosuvastatin (ROSUZET): Ezetimibe + Rosuvastatin (ROSUZET) is contraindicated in nursing mothers. Because of the potential for serious adverse reactions in a breastfed infant, women who are nursing should not take Ezetimibe + Rosuvastatin (ROSUZET).
Ezetimibe: Studies in rats have shown that ezetimibe is excreted in milk. It is not known whether ezetimibe is excreted into human breast milk.
Rosuvastatin: The safety of rosuvastatin during pregnancy and whilst breast-feeding has not been established.