Rozuor Use In Pregnancy & Lactation

Rosuvastatin/ezetimibe (Rozuor) is contraindicated in pregnancy and breastfeeding.
Women of childbearing potential should use appropriate contraceptive measures.
Pregnancy: Rosuvastatin: Since cholesterol and other products of cholesterol biosynthesis are essential for the development of the fetus, the potential risk from inhibition of HMG-CoA reductase outweighs the advantage of treatment during pregnancy. Animal studies provide limited evidence of reproductive toxicity. If a patient becomes pregnant during use of rosuvastatin/ezetimibe (Rozuor), treatment should be discontinued immediately.
Ezetimibe: No clinical data are available on the use of ezetimibe during pregnancy.
Animal studies on the use of ezetimibe in monotherapy have shown no evidence of direct or indirect harmful effects on pregnancy, embryofetal development, birth or postnatal development.
Breastfeeding: Rosuvastatin: Rosuvastatin is excreted in the milk of rats. There are no data with respect to excretion of rosuvastatin in milk in humans.
Ezetimibe: Studies on rats have shown that ezetimibe is secreted into milk. It is not known if ezetimibe is secreted into human breast milk.
Fertility: No clinical trial data are available on the effects of ezetimibe on human fertility. Ezetimibe had no effect on the fertility of male or female rats.