11/11/2023 0 Comments Pill look up tv 7155Patients should be advised that if they become pregnant they should stop taking simvastatin tablets and call their healthcare professional. Discuss future pregnancy plans with your patients, and discuss when to stop taking simvastatin tablets if they are trying to conceive. Women of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using simvastatin tablets. A decision should be made whether to discontinue nursing or discontinue drug, taking into account the importance of the drug to the mother [ Because a small amount of another drug in this class is excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women taking simvastatin should not nurse their infants. It is not known whether simvastatin is excreted in human milk. If pregnancy occurs, simvastatin should be immediately discontinued. For women trying to conceive, discontinuation of simvastatin should be considered. Women of childbearing potential, who require treatment with simvastatin for a lipid disorder, should be advised to use effective contraception. However, in studies with another structurally-related statin, skeletal malformations were observed in rats and mice. Simvastatin was not teratogenic in rats or rabbits at doses (25, 10 mg/kg/day, respectively) that resulted in 3 times the human exposure based on mg/mĢ surface area. Surveillance of Lovastatin and Simvastatin Exposure During Pregnancy, In 89% of these cases, drug treatment was initiated prior to pregnancy and was discontinued during the first trimester when pregnancy was identified.Ģ Manson, J.M., Freyssinges, C., Ducrocq, M.B., Stephenson, W.P., Postmarketing However, the study was only able to exclude a 3- to 4-fold increased risk of congenital anomalies over the background rate. In a reviewĢ of approximately 100 prospectively followed pregnancies in women exposed to simvastatin or another structurally related statin, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed those expected in the general population. There are rare reports of congenital anomalies following intrauterine exposure to statins. If simvastatin is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Because statins decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, simvastatin may cause fetal harm when administered to a pregnant woman. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. Animal reproduction studies of simvastatin in rats and rabbits showed no evidence of teratogenicity. There are no adequate and well-controlled studies of use with simvastatin during pregnancy however, there are rare reports of congenital anomalies in infants exposed to statins Atherosclerosis is a chronic process, and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hypercholesterolemia therapy. Lipid lowering drugs offer no benefit during pregnancy, because cholesterol and cholesterol derivatives are needed for normal fetal development. Simvastatin is contraindicated in women who are or may become pregnant.
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