Minimum Age for Symbicort (Budesonide/Formoterol) Use in Asthma
Symbicort is FDA-approved for asthma treatment in children 6 years of age and older, with no approval for children under 6 years of age. 1
Age-Based Approvals and Evidence
The FDA approval for Symbicort (budesonide/formoterol) varies by age group:
Ages 12 and older: Symbicort has established safety and efficacy data for asthma treatment in patients 12 years and older, with studies conducted for up to 12 months 1
Ages 6 to 11 years: The safety and effectiveness of Symbicort 80/4.5 in asthma patients 6 to less than 12 years of age have been established in studies of up to 12-week duration 1, 2
- Clinical trials showed that budesonide/formoterol pMDI 160/9 μg demonstrated statistically significant lung function improvements compared to budesonide alone in this age group 2
Ages under 6 years: The safety and effectiveness of Symbicort in asthma patients less than 6 years of age have not been established 1
Formoterol Component Age Limitations
The formoterol component in Symbicort has specific age restrictions:
- Formoterol administered by dry powder inhaler (DPI) is FDA-approved for children as young as 5 years of age 3
- However, in the fixed combination of budesonide/formoterol (Symbicort), the product is only approved for children 6 years and older 1
Considerations for Younger Children
For children younger than 6 years with asthma requiring controller medication:
- Alternative medications with FDA approval for younger children include:
Practical Considerations for Pediatric Inhaler Use
When considering inhaled medications for children:
- Children under 4 years of age often cannot effectively use dry powder inhalers (DPIs) or metered-dose inhalers (MDIs) independently 3
- Most 4-year-olds can generate sufficient peak inspiratory flows for DPIs, but younger children typically require assistance with an MDI plus valved holding chamber or nebulizer with face mask 3
- Children under 5 years may have different response patterns to asthma therapy, particularly those with predominantly virus-induced wheezing 3
Growth Considerations
Parents and clinicians should be aware that:
- Inhaled corticosteroids, including the budesonide component in Symbicort, may cause a reduction in growth velocity in pediatric patients 1, 5
- This effect has been observed even in the absence of laboratory evidence of HPA-axis suppression 1
- The long-term effect on final adult height is not fully established, though one study showed a mean reduction of 1.20 cm in adult height in children treated with budesonide compared to placebo 5
- Growth velocity should be monitored in children receiving Symbicort 1
Key Takeaways
- Symbicort should not be used in children under 6 years of age
- For children 6-11 years, only the lower strength formulation (80/4.5) has been studied and approved
- Alternative controller medications exist for younger children with persistent asthma
- Growth monitoring is recommended for children using Symbicort or other inhaled corticosteroids