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Amlodipine / atorvastatin Pregnancy and Breastfeeding Warnings

Amlodipine / atorvastatin is also known as: Caduet

Amlodipine / atorvastatin Pregnancy Warnings

Doses of 20, 100, or 225 mg/kg/day of atorvastatin from day 7 of gestation through day 21 of weaning resulted in decreased pup survival at birth, developmental delays, and pinnae detachment and eye opening alterations. Other HMG-CoA reductase inhibitors have been associated with increased fetal skeletal malformations. Additionally, the VATER association (vertebral anomalies, anal atresia, esophageal fistula with esophageal atresia, renal and radial dysplasia) was reported in an infant girl whose mother received lovastatin 10 mg daily and dextroamphetamine 10 mg daily during the first trimester of pregnancy for the treatment of hypercholesterolemia and progressive weight gain. Both drugs were discontinued five weeks later, at approximately 9 weeks gestation, when pregnancy was confirmed.

Amlodipine-atorvastatin has been assigned to pregnancy category X by the FDA. The atorvastatin component of amlodipine-atorvastatin 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. Atherosclerosis is a chronic process and discontinuation of lipid lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. There are no adequate and well-controlled studies of atorvastatin use during pregnancy; however in rare reports congenital anomalies were observed following intrauterine exposure to HMG-CoA reductase inhibitors (statins). In rat and rabbit animal reproduction studies, atorvastatin revealed no evidence of teratogenicity. Atorvastatin should be administered to women of childbearing 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. Animal studies have not revealed evidence of teratogenicity, although decreased litter size and intrauterine deaths, as well as prolonged gestation have been observed following oral doses of amlodipine (as a single agent) of more than 8 to 23 times the maximum recommended human dose.

Amlodipine / atorvastatin Breastfeeding Warnings

There are no data on the excretion of amlodipine-atorvastatin into human milk; however, a small amount of another statin does pass into breast milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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