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Captopril / hydrochlorothiazide Pregnancy and Breastfeeding Warnings

Captopril / hydrochlorothiazide is also known as: Capozide, Capozide 25/15, Capozide 25/25, Capozide 50/15, Capozide 50/25

Captopril / hydrochlorothiazide Pregnancy Warnings

Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered during pregnancy. A committee of the National Institutes of Health has recommended that these drugs be avoided during pregnancy. Limited data have shown an association between major congenital malformations and the use of ACE inhibitors during the first trimester. In addition, the use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to exposure to the drug. Mothers whose embryos and fetuses are exposed to an ACE inhibitor only during the first trimester should be informed of the risks. When pregnancy is detected or expected, captopril should be discontinued as soon as possible. The Collaborative Perinatal Project monitored 50,282 mother-child pairs, of whom 233 were exposed to thiazide or related diuretics during the first trimester. An increased risk of malformations was found for thiazide diuretics. Use of thiazides after the first trimester does not seem to carry this risk. Thiazide diuretics may, however pose metabolic risks to the mother and fetus (hyponatremia, hypokalemia, thrombocytopenia, hyperglycemia), and may have a direct effect on smooth muscle, resulting in inhibition of labor. Case reports of neonatal thrombocytopenia associated with antepartum administration of thiazide diuretics have been reported.

Captopril has been assigned to pregnancy category D by the FDA for use during the second and third trimesters, and to category C for use in the first trimester. Animal and human data have revealed evidence of embryolethality and teratogenicity associated with captopril. There are no controlled data in human pregnancy. However, fetal and neonatal toxicity and death, as well as congenital anomalies, are reported with the use of ACE inhibitors, including captopril, during pregnancy. Hydrochlorothiazide has been assigned to pregnancy category B by the FDA. There are no data from controlled human studies, but retrospective reviews have show an increased risk of malformations associated with thiazide diuretics. Captopril-hydrochlorothiazide is considered contraindicated during pregnancy.

Captopril / hydrochlorothiazide Breastfeeding Warnings

Both captopril and hydrochlorothiazide are excreted into human milk in small amounts. 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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