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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

In one case, a peak milk HCTZ concentration of 125 ng/mL was measured between 4 and 12 hours after a (usual daily) dose of HCTZ 50 mg in one subject. A simultaneously measured maternal serum HCTZ level was approximately 275 ng/mL. There were no detectable drug levels or electrolyte abnormalities in the baby's blood. The authors calculated that, if a 1-month-old infant takes approximately 600 mL of milk per day, and the average milk HCTZ level is approximately 80 ng/mL, the infant would be exposed to approximately 0.05 mg HCTZ a day. This usually represents an insignificant amount of HCTZ to the infant as adverse effects in the nursing infant are unlikely.

Hydrochlorothiazide is secreted into human milk in low concentrations. It is not known whether spironolactone is excreted into human milk, but its main active metabolite, canrenone, is. Side effects in the nursing infant are unlikely. Hydrochlorothiazide is considered compatible with breast-feeding by the American Academy of Pediatrics; however, 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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