Symbicort Rapihaler Use In Pregnancy & Lactation

For Budesonide + Formoterol fumarate dihydrate (SYMBICORT RAPIHALER) or the concomitant treatment with budesonide and formoterol no clinical data on exposed pregnancies are available. Data from an embryo-fetal development study in the rat, using the Budesonide + Formoterol fumarate dihydrate (SYMBICORT RAPIHALER) formulation, showed no evidence of any additional effect from the combination or evidence of any effects attributable to the excipients on the rodent.
There are no adequate data from use of formoterol in pregnant women. In animal studies formoterol has caused adverse effects in reproduction studies at very high systemic exposure levels (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Data on approximately 2500 exposed pregnancies indicate no increased teratogenic risk associated with the use of inhaled budesonide. In animal studies glucocorticosteroids have been shown to induce malformations. This is not likely to be relevant for humans given recommended doses.
During pregnancy, Budesonide + Formoterol fumarate dihydrate (SYMBICORT RAPIHALER) should only be used when the benefits outweigh the potential risk, especially during the first 3 months and shortly before delivery. The lowest effective dose of budesonide needed to maintain adequate asthma control should be used.
A clinical pharmacology study has shown that inhaled budesonide Turbuhaler is excreted in breast milk. However, budesonide was not detected in nursing infant blood samples. Based on pharmacokinetic parameters, the plasma concentration in the child is estimated to be less than 0.17% of the mother's plasma concentration. Consequently, no effects due to budesonide are anticipated in breast-fed children whose mothers are receiving therapeutic doses of Budesonide + Formoterol fumarate dihydrate (SYMBICORT). It is not known whether formoterol passes into human breast milk. In rats, small amounts of formoterol have been detected in maternal milk. Administration of Budesonide + Formoterol fumarate dihydrate (SYMBICORT) to women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.