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Amlodipine/atorvastatin is contraindicated in pregnancy due to the atorvastatin component. Women of childbearing potential should use adequate contraceptive measures.
Amlodipine/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 to the fetus.
Amlodipine/atorvastatin is contraindicated while breast-feeding due to the atorvastatin component. It is not known whether atorvastatin is excreted in human milk. Because of the potential for adverse reactions in nursing infants, women taking amlodipine/atorvastatin should not breast-feed.
Safety of amlodipine in human pregnancy or lactation has not been established. Amlodipine did not demonstrate toxicity in animal reproductive studies other than to delay parturition and prolong labor in rats at a dose level 50 times the maximum recommended dose in humans. There was no effect on the fertility of rats treated with amlodipine (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Experience in humans indicates that amlodipine is transferred into human breast milk. The median amlodipine concentration ratio of milk/plasma in 31 lactating women with pregnancy-induced hypertension was 0.85 following amlodipine administration at an initial dose of 5 mg once daily which was adjusted as needed (mean daily dose and body weight adjusted daily dose: 6 mg and 98.7 mcg/kg, respectively). The estimated daily dose of amlodipine in the infant via breast milk was 4.17 mcg/kg.
