Zenon Use In Pregnancy & Lactation

Rosuvastatin/Ezetimibe (Zenon) is contraindicated during pregnancy and breast-feeding (see Contraindications). Women of childbearing potential should use appropriate contraceptive measures.
Pregnancy: 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, embryofoetal development, birth or postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Since cholesterol and other products of cholesterol biosynthesis are essential for the development of the foetus, the potential risk from inhibition of HMG-CoA reductase outweighs the advantage of treatment during pregnancy. Animal studies provide limited evidence of reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). If a patient becomes pregnant during use of Rosuvastatin/Ezetimibe (Zenon), treatment should be discontinued immediately.
Breast-feeding: Studies on rats have shown that ezetimibe is secreted into breast milk. It is not known if ezetimibe is secreted into human breast milk.
Rosuvastatin is excreted in the milk of rats. There are no data with respect to excretion in milk in humans (see Contraindications).
Fertility: No clinical trial data are available on the effects of ezetimibe or rosuvastatin on human fertility. Ezetimibe had no effects on the fertility of male or female rats, rosuvastatin at higher doses showed testicular toxicity in monkeys and dogs (see Pharmacology: Toxicology: Preclinical safety data under Actions).