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Amlodipine Pregnancy and Breastfeeding Warnings

Amlodipine is also known as: Norvasc

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

Use of amlodipine is not recommended. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

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