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Hydrochlorothiazide / spironolactone Pregnancy and Breastfeeding Warnings

Hydrochlorothiazide / spironolactone is also known as: Aldactazide

Hydrochlorothiazide / spironolactone Pregnancy Warnings

Hydrochlorothiazide-spironolactone has been assigned to pregnancy category C by the FDA. Hydrochlorothiazide given to pregnant mice and rats at high human doses showed no evidence of harm to the fetus. Spironolactone, at 20 mg/kg/dose caused an increased rate of resorption and a lower number of live fetuses in rabbits but no teratogenic or other embryo-toxic effects were observed in mice. Because of its antiandrogenic activity and the requirement of testosterone for male morphogenesis, spironolactone may have the potential for adversely affecting sex differentiation of the male during embryogenesis. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developing toxemia. There are no controlled data for either drug in human pregnancy. Hydrochlorothiazide-spironolactone should only be given during pregnancy when benefit outweighs risk.

Hydrochlorothiazide / spironolactone Breastfeeding Warnings

Spironolactone has been found to be tumorigenic in rats.

A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes (hydrochlorothiazide); Unknown (spironolactone, but canrenone which is a major and active metabolite of spironolactone, is excreted into human milk) Excreted into animal milk: Yes (hydrochlorothiazide); Unknown (spironolactone, but canrenone which is a major and active metabolite of spironolactone, is excreted into animal milk) The effects in the nursing infant are unknown.

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