Amlodipine/atorvastatin Pregnancy and Breast Feeding Warnings
Amlodipine/atorvastatin is also known as: Caduet
Overview
Do not use Amlodipine/Atorvastatin if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. One of these medicines is found in breast milk. Do not breast-feed while taking Amlodipine/Atorvastatin .
Amlodipine/atorvastatin Pregnancy Warnings
Amlodipine-atorvastatin has been assigned to pregnancy category X by the FDA. 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. Other HMG-CoA reductase inhibitors have been associated with teratogenic effects. There are no controlled data in human pregnancy. Amlodipine-atorvastatin use is considered contraindicated in pregnancy.
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 Lactation Warnings
There are no data on the excretion of amlodipine-atorvastatin into human 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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