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Amlodipine Pregnancy and Breastfeeding Warnings

Amlodipine is also known as: Norvasc

Overview

If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Amlodipine while you are pregnant. It is not known if Amlodipine is found in breast milk. Do not breast-feed while taking Amlodipine.

Amlodipine Pregnancy Warnings

Amlodipine has been assigned to pregnancy category C by the FDA. Animal studies have revealed decreased litter size and intrauterine deaths, as well as prolonged gestation after oral doses exceeding 8 to 23 times the maximum recommended human dose. Animal studies have failed to reveal evidence of teratogenicity or fetal toxicity. There are no controlled data in human pregnancy. Amlodipine should only be given during pregnancy when benefit outweighs risk.

Rats and mice treated with amlodipine maleate in the diet for up to two years (at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 mg/kg/day) showed no evidence of carcinogenic effects. For the mouse, the highest dose was similar to the maximum recommended human dose of 10 mg/day (based on mg/m2). For the rat, the highest dose was about twice the maximum recommended human dose (based on mg/m2).

Amlodipine Breastfeeding Warnings

There are no data on the excretion of amlodipine 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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