Aeronide Use In Pregnancy & Lactation

Pregnancy: Pregnancy Category B.
Teratogenic Effects: Budesonide produced fetal loss, decreased pup weights, and skeletal abnormalities at SC doses of 25 mcg/kg/day in rabbits (less than the maximum recommended daily inhalation dose in adults on a mcg/m² basis) and 500 mcg/kg/day in rats (approximately 4 times the maximum recommended daily inhalation dose in adults on a mcg/m² basis). In another study in rats, no teratogenic or embryocidal effects were seen at inhalation doses up 250 mcg/kg/day (approximately 2 times the maximum recommended daily inhalation dose in adults on a mcg/m² basis).
Despite the animal findings, it would appear that the possibility of fetal harm is remote if the drug is used during pregnancy. Nevertheless, because the studies in humans cannot rule out the possibility of harm, budesonide inhalation should be used during pregnancy only if clearly needed.
Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully observed.
Lactation: It is not known whether budesonide is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exercised if budesonide is administered to nursing women.