Cortiment Use In Pregnancy & Lactation

Pregnancy: Data on use of inhaled budesonide in a very large number of exposed pregnancies indicate no adverse effects. Although there are no data of outcomes of pregnancies after oral administration, the bioavailability after oral administration is low. In animal experiments, at high exposures, corticosteroids proved to be harmful (see Pharmacology: Toxicology: PRECLINICAL SAFETY DATA under Actions). Budesonide (CORTIMENT) should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.
Breast-feeding: Budesonide is excreted in breast milk.
Maintenance treatment with inhaled budesonide (200 or 400 micrograms twice daily) in asthmatic nursing women results in negligible systemic exposure to budesonide in breast-fed infants.
In a pharmacokinetic study the estimated daily infant dose was 0.3% of the daily maternal dose for both dose levels, and the average plasma concentration in infants was estimated to be 1/600^th of the concentrations observed in maternal plasma, assuming complete infant oral bioavailability. Budesonide concentrations in infant plasma samples were all less than the limit of quantification.
Based on data from inhaled budesonide and the fact that budesonide exhibits linear PK properties within the therapeutic dosage intervals after inhaled, oral and rectal administrations, at therapeutic doses of budesonide, exposure to the suckling child is anticipated to be low. These data support continued use of budesonide, oral and rectal administrations, during breast-feeding.
Fertility: There is no data on the effect of Budesonide (CORTIMENT) on fertility in humans. There were no effects on fertility in rats after treatment with budesonide.