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Nisoldipine Pregnancy and Breastfeeding Warnings

Nisoldipine is also known as: Sular

Nisoldipine Pregnancy Warnings

Nisoldipine has been assigned to pregnancy category C by the FDA. Animal data have revealed evidence of fetotoxicity (but not teratogenicity) after rats and rabbits were given doses that resulted in maternal toxicity (reduced maternal weight gain). In pregnant rats, increased fetal resorption was observed at 100 mg/kg/day, and decreased fetal weight was observed at both 30 and 100 mg/kg/day (which are approximately 5 and 16 times the maximum recommended human dose (MRHD) on a mg/m2 basis). In pregnant rabbits, decreased fetal and placental weights were observed at a dose of 30 mg/kg/day, approximately 10 times the MRHD when compared on a mg/m2 basis. In a study in which pregnant monkeys (both treated and control) had high rates of abortion and mortality, the only surviving fetus from a group exposed to a maternal dose of 100 mg/kg/day (approximately 30 times the MRHD on a mg/m2 basis) presented with forelimb and vertebral abnormalities not previously seen in control monkeys of the same strain. There are no controlled data in human pregnancy. Nisoldipine should only be given during pregnancy when benefit outweighs risk.

Nisoldipine Breastfeeding Warnings

There are no data on the excretion of nisoldipine into human milk. The manufacturer states that a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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