Lypstaplus Use In Pregnancy & Lactation

LYPSTAPLUS is contraindicated in pregnancy and breast-feeding. 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 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 LYPSTAPLUS, 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, embryofoetal development, birth or postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Breast-feeding: Rosuvastatin: Rosuvastatin is excreted in the milk of rats. There are no data with respect to excretion of rosuvastatin in milk in humans (see Contraindications).
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 (see Pharmacology: Toxicology: Preclinical safety data under Actions).