What is the recommended dosing of Symbicort (budesonide and formoterol) for pediatric patients with asthma?

Symbicort Dosing for Pediatric Asthma

Recommended Dosing by Age Group

For children aged 6-11 years with asthma, Symbicort (budesonide/formoterol) should be dosed at 80/4.5 mcg, 2 inhalations twice daily (total daily dose 160/9 mcg), which provides superior lung function improvement compared to budesonide alone and represents the evidence-based standard for this age group. 1, 2

Children 6-11 Years Old

• Start with budesonide/formoterol 80/4.5 mcg × 2 inhalations twice daily (160/9 mcg total daily dose) for children with persistent asthma requiring combination therapy 1, 2
• This dose demonstrated statistically significant and clinically meaningful lung function improvements versus budesonide alone in children aged 6 to <12 years 2
• The lower strength formulation (80/2.25 mcg) did not show significant benefit over budesonide monotherapy in this age group 2
• Bronchodilator effects appear within 15 minutes of the first dose and are maintained throughout 12 weeks of treatment 2

Children and Adolescents ≥12 Years

• For mild to moderate persistent asthma: budesonide/formoterol 80/4.5 mcg × 2 inhalations twice daily (160/9 mcg total daily) 1
• For moderate to severe persistent asthma: budesonide/formoterol 160/4.5 mcg × 2 inhalations twice daily (320/9 mcg total daily) 1
• This represents low-dose ICS combined with LABA, which is the preferred Step 3 therapy for patients ≥12 years 1

Children Under 6 Years

• Symbicort is not FDA-approved for children under 6 years of age 3, 4
• For children under 4 years requiring inhaled corticosteroids, use budesonide inhalation suspension (the only FDA-approved ICS for this age group) at 0.25-0.5 mg twice daily via nebulizer 3, 4

Critical Dosing Principles

• LABA (formoterol) must never be used as monotherapy—it must always be combined with an inhaled corticosteroid 1
• Administer twice daily dosing consistently; once-daily dosing results in significantly more asthma worsening events (19.6% vs 8.2%) compared to twice-daily administration 5
• Start with the lowest appropriate dose for asthma severity and titrate upward only if control remains inadequate after 2-6 weeks 1

Administration Technique

• Rinse mouth thoroughly after each use to reduce risk of oral candidiasis and dysphonia 1
• Consider using a spacer or valved holding chamber to optimize drug delivery and reduce local side effects 1
• For children 6-11 years who cannot coordinate MDI technique, a spacer with mask may be necessary 3

Monitoring and Dose Adjustment Algorithm

• Assess asthma control every 2-6 weeks initially, verifying proper inhaler technique and medication adherence before making any dose adjustments 1, 4
• If well-controlled for ≥3 consecutive months, step down to a lower dose or consider discontinuing LABA 1
• If rescue SABA use increases to >2 days/week (excluding pre-exercise use), this indicates inadequate control requiring step-up therapy 1
• Reassess for alternative diagnoses if no clear benefit occurs within 4-6 weeks despite verified technique and adherence 4

Safety Considerations

• Common local effects include cough, dysphonia, and oral thrush 1
• At recommended doses, adverse events are similar to placebo in pediatric studies 4
• Monitor growth velocity in children on medium-to-high doses, though effects are minimal at recommended doses 1, 4
• The benefits of inhaled corticosteroids outweigh the risks of small, nonprogressive reductions in growth velocity 4

Common Pitfalls to Avoid

• Do not start with unnecessarily high doses—begin with the lowest dose appropriate for severity (typically 160/9 mcg daily for ages 6-11) and titrate upward only if needed 1
• Do not use once-daily dosing in children—twice-daily administration is required for optimal efficacy and safety 5
• Do not prescribe Symbicort for children under 6 years—use age-appropriate budesonide nebulizer suspension instead 3, 4
• Do not assume asthma control based solely on symptom reduction—verify with objective measures including peak flow monitoring and rescue medication use 1