Symbicort Turbuhaler Use In Pregnancy & Lactation

For Budesonide/Formoterol (SYMBICORT TURBUHALER) 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 pMDI 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.
During pregnancy, Budesonide/Formoterol (SYMBICORT TURBUHALER) should only be used after special consideration, especially during the first three 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 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 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 (SYMBICORT TURBUHALER). 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 (SYMBICORT TURBUHALER) 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.