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Hydralazine / isosorbide dinitrate Pregnancy and Breastfeeding Warnings

Hydralazine / isosorbide dinitrate is also known as: BiDil

Hydralazine / isosorbide dinitrate Pregnancy Warnings

Hydralazine-isosorbide dinitrate has been assigned to pregnancy category C by the FDA. Animal studies with hydralazine have revealed evidence of teratogenicity after doses 20 to 30 times the maximum recommended daily human dose (on a per kg basis) were given to mice. Teratogenicity was possibly related to hydralazine after doses 10 to 15 times the maximum recommended daily human dose (on a per kg basis) were given to rabbits. Animal studies have revealed evidence of embryotoxicity associated with isosorbide dinitrate at oral dosages 35 and 150 times the maximum recommended human daily dosage. There are no controlled data in human pregnancy on the use of either agent (alone or in combination). Hydralazine-isosorbide should only be given during pregnancy when benefit outweighs risk.

Hydralazine / isosorbide dinitrate Breastfeeding Warnings

There are no data on excretion of hydralazine-isosorbide dinitrate into human milk. The manufacturer recommends that caution be used when administering hydralazine-isosorbide dinitrate to nursing women.

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