Patients with known hypersensitivity to any component of Auritz. Hypersensitivity reactions including rash, pruritus, urticaria and angioedema have been reported with rosuvastatin.
Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels.
Use in pregnancy: Pregnancy Category: X.
Rosuvastatin is contraindicated in women who are or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy and cholesterol products are essential for fetal development. Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hyperlipidemia therapy.
There are no adequate and well-controlled studies of rosuvastatin in pregnancy women. There have been rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors.
Rosuvastatin may cause fetal harm when administered to a pregnant woman. If the patient becomes pregnant while taking rosuvastatin, the patient should be apprised of the potential risks to the fetus and the lack of known clinical benefit with continued use during pregnancy.
Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, rosuvastatin may cause fetal harm when administered to pregnant women. Additionally, there is no apparent benefit to therapy during pregnancy and safety in pregnant women has not been established. If the patient becomes pregnant while taking Auritz, the patient should be apprised of the potential hazard to the fetus and the lack of known clinical benefit with continued use during pregnancy.
Use in lactation: It is not known whether rosuvastatin is excreted in human milk, but a small amount of another drug in this class does pass into breast milk.
Because another drug in this class passes into human milk and because HMG-CoA reductase inhibitors have a potential to cause serious adverse reactions in nursing infants, women who require rosuvastatin treatment should be advised not to nurse their infants.