Pregnancy: Category B according to US pregnancy category; Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women, or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester and there is no evidence of a risk in later trimesters.
In some animal reproduction studies, adverse events have been observed with corticosteroids. Hypoadrenalism may occur in infants born to women receiving corticosteroids during pregnancy. Based on available data, an overall increased risk of congenital malformations or a decrease in fetal growth has not been associated with maternal use of inhaled corticosteroids during pregnancy.
In addition, studies of pregnant women specifically using inhaled budesonide have not demonstrated an increased risk of congenital abnormalities.
Labor and delivery: The effects of budesonide on labor and delivery in pregnant woman are unknown.
Lactation: Although budesonide is secreted in breast milk, but at therapeutic dose of budesonide no effects on the suckling children are anticipated. PULVISONIDE 200 can be used during breast feeding.
Data with budesonide delivered via powder for oral inhalation demonstrates that approximately 0.3% to 1% of the dose inhaled by the mother was found in breast milk. The maximum concentration appeared within 45 minutes of dosing. Plasma budesonide levels obtained from infants 90 minutes after breast-feeding (140 minutes after maternal dose) were below the limit of quantification.