Rosalta Use In Pregnancy & Lactation

10 mg: Atherosclerosis is a chronic process and discontinuation of lipid-lowering drug during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Cholesterol and other products of cholesterol biosynthesis are essential components for fetal development (including synthesis of steroids and cell membranes). Since HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substance derived from cholesterol, they may cause fetal harm when administered to pregnant women.
Therefore, HMG-CoA reductase inhibitors are contraindicated during pregnancy and in nursing mothers. Rosuvastatin should be administered to women of children bearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, therapy should be discontinued immediately and the patient apprised of the potential hazard to the fetus.
20 mg: Rosuvastatin is contraindicated in pregnancy and lactation.
Women of child bearing potential should use appropriate contraceptive measures.
Since cholesterol and other products of cholesterol biosynthesis are essential for the development of the foetus, the potential risk from inhibitor 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 this product, treatment should be discontinued immediately.
Rosuvastatin is excreted in the milk of rats. There are no data with respect to excretion in milk in humans (see Contraindications).