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Indapamide Pregnancy and Breastfeeding Warnings

Indapamide is also known as: Lozol

Indapamide Pregnancy Warnings

Indapamide has been assigned to pregnancy category B by the FDA. Animal studies have revealed no evidence of teratogenicity or impaired fertility after doses up to 6,250 times the therapeutic human dosage. There are no controlled data in human pregnancy. Indapamide should only be given during pregnancy when need has clearly been established.

Many experts consider the routine use of diuretics in an otherwise healthy woman to be inappropriate. Diuretics have been used with caution in pregnant women with cardiovascular disorders because they can decrease placental perfusion. 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, such as hyponatremia, hypokalemia, thrombocytopenia, hyperglycemia, and may have a direct effect on smooth muscle, resulting in inhibition of labor. Cases of neonatal thrombocytopenia associated with antepartum administration of thiazide diuretics have been reported. Data from the Michigan Medicaid Birth Defects Study has failed to reveal an association between the use of indapamide and congenital abnormalities (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). This was a retrospective study of 229,101 completed pregnancies between 1985 and 1992, of which 46 were exposed to indapamide at some time during the first trimester, and 58 were exposed to the drug at any time during pregnancy. Of the 46 pregnancies, 3 birth defects were observed (2 were expected). There were no observations of cardiovascular defects, cleft palate, spina bifida, limb reduction, polydactyly, or hypospadias.

Indapamide Breastfeeding Warnings

There are no data on the excretion of indapamide into human milk. 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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