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Effects on fertility: No data available.
Use in pregnancy (Category B3): Category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
Pentamidine has been found to cross the placenta in rats given high doses late in pregnancy. Studies in rabbits have also shown pentamidine to be mildly embryotoxic, with an increase in post-implantation losses and delayed foetal ossification at doses of 1, 3 and 8 mg/kg of body weight.
It is not known whether pentamidine isethionate crosses the placenta or causes foetal harm when administered to pregnant women; therefore, pentamidine is contraindicated during pregnancy and should only be used when considered essential.
Use in lactation: Since it is not known whether pentamidine isethionate is distributed into milk, the medicine is contraindicated during lactation and should only be administered to nursing mothers when considered essential.
