Atorvastatin / ezetimibe Pregnancy and Breastfeeding Warnings
Atorvastatin / ezetimibe is also known as: Liptruzet
Atorvastatin / ezetimibe Pregnancy Warnings
Serum cholesterol and triglycerides increase during normal pregnancy. Lipid-lowering drugs offer no benefit during pregnancy, because cholesterol and cholesterol derivatives are needed for normal fetal development. Atherosclerosis is a chronic process, and discontinuation of lipid-lowering drugs during pregnancy should have little or no impact on long-term outcomes of primary hypercholesterolemia. Animal studies at high human doses were not teratogenic but there was decreased pup survival at birth, neonate, weaning, and development was delayed. Rare reports of congenital anomalies have been received following intrauterine exposure to atorvastatin. There are no adequate and well-controlled studies in human pregnancy. FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
FDA pregnancy category: X Use of atorvastatin-ezetimibe is contraindicated. Women of childbearing potential should be encouraged to use adequate contraception.
Atorvastatin / ezetimibe Breastfeeding Warnings
Exposure to total ezetimibe in nursing rat pups was up to half of that observed in maternal plasma.
Use of atorvastatin-ezetimibe is not recommended. Excreted into human milk: Atorvastatin: Unknown (a small amount of another drug in this class does pass into breast milk); ezetimibe: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.
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