Hydrochlorothiazide/spironolactone Pregnancy and Breast Feeding Warnings
Hydrochlorothiazide/spironolactone is also known as: Aldactazide
Overview
It is not known if Hydrochlorothiazide/Spironolactone can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hydrochlorothiazide/Spironolactone while you are pregnant. Hydrochlorothiazide/Spironolactone is found in breast milk. Do not breast-feed while taking Hydrochlorothiazide/Spironolactone .
Hydrochlorothiazide/spironolactone Pregnancy Warnings
Hydrochlorothiazide (HCTZ) has been assigned to pregnancy category B by the FDA. There are no data from controlled human studies, but retrospective reviews have shown an increased risk of malformations associated with thiazide diuretics. Spironolactone has not been formally assigned to a pregnancy category by the FDA. Some experts believe it should be assigned to pregnancy category D based on animal studies that have shown antiandrogenic effects on male fetuses when the mother was administered spironolactone. Some experts believe that diuretics, in general, are contraindicated in pregnancy, except when necessary in patients with cardiovascular disease, since they do not prevent or alter the course of toxemia and they may cause a decrease in placental perfusion. Spironolactone is considered contraindicated in pregnancy.
Hydrochlorothiazide/spironolactone Lactation Warnings
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.
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.
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