AMLODIPINE

Fetal Risk Summary

Amlodipine is a calcium channel-blocking agent used in the treatment of hypertension and angina. The drug is not teratogenic or embryotoxic in rats and rabbits given doses up to 8 and 23 times, respectively, the maximum recommended human dose (MRHD) on a body surface area basis during their respective periods of major organogenesis (1). However, rats administered 8 times the MRHD for 14 days before mating and throughout gestation had a significant decrease in litter size (by about 50%), a significant increase in intrauterine deaths (about 5-fold), and prolonged labor and gestation (1). This dose, however, had no effect on fertility in the rat.

No reports describing the placental transfer of amlodipine in humans have been located. The molecular weight (about 567 for the besylate salt) is low enough, however, that passage to the fetus should be expected.

No reports on the use of amlodipine in human pregnancy have been located.

Breast Feeding Summary

No reports describing the use of amlodipine during human lactation have been located. The molecular weight (about 567 for the besylate salt) is low enough, however, that excretion into breast milk should be expected. The effect of the drug on a nursing effect is unknown.

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