What is the recommended dosing for Symbicort (budesonide/formoterol)?

Symbicort Dosing Recommendations

For asthma, Symbicort (budesonide/formoterol) should be dosed at 2 inhalations twice daily, with the specific strength (80/4.5 mcg or 160/4.5 mcg) determined by asthma severity and prior treatment requirements. 1

Standard Dosing by Asthma Severity

Mild to Moderate Persistent Asthma

• Start with budesonide/formoterol 80/4.5 mcg: 2 inhalations twice daily (total daily dose 160/9 mcg) 2
• This provides low-dose ICS-LABA combination therapy appropriate for Step 3 treatment 3

Moderate to Severe Persistent Asthma

• Use budesonide/formoterol 160/4.5 mcg: 2 inhalations twice daily (total daily dose 320/9 mcg) 2
• This medium-dose ICS-LABA combination is appropriate for Step 3-4 treatment 3
• Maximum approved dose is 640/18 mcg twice daily (4 inhalations of 160/4.5 mcg strength twice daily), though this is rarely needed 2

Alternative Dosing Strategy: Adjustable Maintenance

Adjustable maintenance dosing reduces exacerbations by approximately 50% compared to fixed dosing while using 24-36% less medication. 4, 5

How to Implement Adjustable Dosing:

• Baseline: Start with 2 inhalations twice daily 4
• Step down when controlled: Reduce to 1 inhalation twice daily or 2 inhalations once daily at bedtime if asthma symptoms are well controlled 4, 5
• Step up when worsening: Temporarily increase to 4 inhalations twice daily for 7-14 days if asthma deteriorates, then return to baseline 4, 5
• This approach reduced exacerbations from 8.9% to 4.0% (number needed to treat = 21) 4

Pediatric Dosing (Ages 6-11 Years)

• Use the 80/4.5 mcg strength: 2 inhalations twice daily 6
• This is the only approved strength for children in this age group 6

Critical Dosing Principles

Timing and Administration

• Always administer twice daily (morning and evening), approximately 12 hours apart 1, 2
• Budesonide requires twice-daily dosing for optimal anti-inflammatory effect 1
• The formoterol component provides 12-hour bronchodilation 3

Common Pitfalls to Avoid

• Never use Symbicort as monotherapy without the ICS component—LABAs alone increase mortality risk 3
• Do not exceed 4 inhalations twice daily (maximum dose 640/18 mcg twice daily) 2
• Do not use as rescue medication unless specifically prescribed as maintenance and reliever therapy (MART), which uses budesonide/formoterol for both maintenance and as-needed relief 3
• Do not abruptly discontinue—taper the dose gradually once control is achieved for at least 3 consecutive months 3, 1

Comparison with Higher-Dose ICS Monotherapy

Adding formoterol to low-dose budesonide (200 mcg twice daily) is more effective than doubling the budesonide dose to 400 mcg twice daily for:

• Reducing exacerbations by 40% for mild exacerbations and 29% for severe exacerbations 3
• Improving lung function and symptom control 3
• This supports using combination therapy at Step 3 rather than increasing ICS dose alone 3

When to Adjust Dosing

Step Up If:

• Using rescue inhaler more than 2 days per week 3
• Nocturnal awakenings due to asthma 3
• Any limitation of activities due to asthma 3
• FEV1 <80% predicted 3

Step Down If:

• Asthma well controlled for at least 3 consecutive months 3
• Reduce to next lower strength or frequency 3
• Monitor closely for 2-6 weeks after any dose reduction 3

Special Populations

COPD Dosing

• Budesonide/formoterol 160/4.5 mcg: 2 inhalations twice daily reduces severe exacerbations by 24% versus placebo in moderate-to-severe COPD 7
• This is off-label use in the United States but supported by evidence 7