There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, and because of the data listed below with the individual components, this drug should be used during pregnancy only if needed. Reproduction studies in rats at 20 times the expected maximum daily dose for humans showed no evidence of impaired fertility. At approximately 5 or more times the expected maximum daily dose for humans, some toxicity was seen in adult rats and rabbits and a decrease in rat pup growth and survival occurred. There are, however, no adequate and well-controlled studies in pregnant women.
Thiazides cross the placental barrier and appear in cord blood.
There is a risk of fetal or neonatal jaundice, thrombocytopenia , and possibly other adverse reactions that have occurred in adults. Nursing Mothers Studies in rats have shown that amiloride is excreted in milk in concentrations higher than those found in blood , but it is not known whether amiloride HCl is excreted in human milk. However, thiazides appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug , taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness in pediatric patients have not been established.