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Effects on fertility: There are no animal studies on the effect of the budesonide/formoterol combination on fertility.
Long-term treatment of female mice and rats with formoterol fumarate causes ovarian stimulation, the development of ovarian cysts and hyperplasia of granulosa/theca cells as a result of the β-agonist properties of the compound. A study by another company showed no effect on fertility of female rats dosed orally with formoterol fumarate at 60 mg/kg/day for two weeks. This finding was repeated in an AstraZeneca study where no effect was seen on the fertility of female rats dosed orally with formoterol fumarate at 15 mg/kg/day for two weeks.
Testicular atrophy was observed in mice given formoterol fumarate in the diet at 0.2 to 50 mg/kg/day for two years, but no effect on male fertility was observed in rats dosed orally at 60 mg/kg/day for nine weeks, in studies undertaken by another company.
Use in pregnancy: Category B3. For Symbicort Turbuhaler or the concomitant treatment with budesonide and formoterol, no clinical data on exposed pregnancies are available. Animal studies with respect to the reproductive toxicity of the combination have not been performed.
Symbicort Turbuhaler should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Only after special consideration should Symbicort Turbuhaler be used during the first 3 months and shortly before delivery.
Because β-agonists, including formoterol, may potentially interfere with uterine contractility, due to a relaxant effect on uterine smooth muscle, Symbicort Turbuhaler should be used during labour only if the potential benefit justifies the potential risk.
Budesonide: Results from a large prospective epidemiological study and from worldwide post marketing experience indicate no adverse effects of inhaled budesonide during pregnancy on the health of the fetus or newborn child.
If treatment with glucocorticosteroids during pregnancy is unavoidable, ICS such as budesonide should be considered due to their lower systemic effect. The lowest effective dose of budesonide to maintain asthma control should be used.
Formoterol: No teratogenic effects were observed in rats receiving formoterol fumarate at doses up to 60 mg/kg/day orally or 1.2 mg/kg/day by inhalation. Fetal cardiovascular malformations were observed in one study in which pregnant rabbits were dosed orally at 125 or 500 mg/kg/day during the period of organogenesis, but similar results were not obtained in another study at the same dose range. In a third study, an increased incidence of subcapsular hepatic cysts was observed in fetuses from rabbits dosed orally at 60 mg/kg/day. Decreased birth weight and increased perinatal/postnatal mortality were observed when formoterol fumarate was given to rats at oral doses of 0.2 mg/kg/day or greater during late gestation.
Use in lactation: Budesonide is excreted in breast milk. However, due to the relatively low doses used via the inhalational route the amount of drug present in the breast milk, if any, is likely to be low.
It is not known whether formoterol is excreted in human milk. In reproductive studies in rats, formoterol was excreted into breast milk. There are no well-controlled human studies of the use of Symbicort Turbuhaler in nursing mothers. Administration of 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.
