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.
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.