Is Symbicort (budesonide and formoterol) suitable for a 1 year and 4 month old child?

Symbicort is NOT Appropriate for a 1 Year and 4 Month Old Child

Symbicort (budesonide/formoterol combination) should not be used in this child because the long-acting beta-agonist (LABA) component formoterol is only FDA-approved for children 4 years of age and older. 1

Why Symbicort is Contraindicated at This Age

FDA Approval Limitations

• LABA salmeterol (and by extension, formoterol) in combination with inhaled corticosteroids is only approved for children ≥4 years of age 1
• The combination product has not been adequately studied in children under 4 years, and safety data are insufficient for this age group 1
• Data on LABA combined with ICS show improvement in impairment but not the risk domain in the limited number of 4-year-old children studied 1

Safety Concerns in Young Children

• Adding LABA to medium-dose ICS should be considered only before increasing to high-dose ICS in children <4 years, but this is not standard practice due to limited safety data 1
• The evidence for LABA use in very young children is insufficient, with most recommendations based on extrapolations from older children and adults 1

What IS Appropriate for This Age

Preferred Treatment: Budesonide Nebulizer Solution Alone

For a 16-month-old child requiring asthma controller therapy, budesonide nebulizer solution (WITHOUT formoterol) is the only FDA-approved inhaled corticosteroid option 1

Specific Dosing Recommendations

• Low-dose therapy: 0.25-0.5 mg twice daily via nebulizer with face mask 2, 3
• Medium-dose therapy: >0.5-1.0 mg twice daily if low-dose is insufficient 2, 3
• Budesonide nebulizer solution is FDA-approved for children 1-8 years of age 1

Administration Technique Critical for This Age

• Use a jet nebulizer with a face mask that fits snugly over the nose and mouth 2, 3
• Wash the child's face immediately after each treatment to prevent oral candidiasis 2, 3
• Avoid nebulizing near the eyes 2
• Only approximately 14% of the nominal dose reaches the airways, but prescribed doses already account for this 3

When to Consider Controller Therapy at This Age

Indications for Starting Daily Therapy

Long-term control therapy should be considered if the child has: 1

• ≥4 episodes of wheezing in the past year lasting >1 day and affecting sleep PLUS a positive asthma predictive index (parental asthma history, atopic dermatitis, or aeroallergen sensitization) 1
• Symptomatic treatment required >2 days per week for >4 weeks 1
• 2 exacerbations requiring systemic corticosteroids within 6 months 1

Important Diagnostic Caveats

• Not all wheeze and cough in this age group is asthma—viral respiratory infections are the most common cause 1
• Most young children who wheeze with viral infections experience remission by 6 years of age 1
• Caution is needed to avoid inappropriate, prolonged therapy in children who may not have true asthma 1

Alternative Controller Options for This Age

If budesonide nebulizer solution is not suitable or available: 1

• Montelukast granules: FDA-approved down to 1 year of age 1
• Cromolyn: Alternative option, though evidence for efficacy in children <5 years is inconsistent 1

Monitoring and Reassessment

Trial Period Approach

• Assess response within 4-6 weeks of starting therapy 1
• If no clear beneficial response is observed and technique/adherence are satisfactory, stop treatment and consider alternative diagnoses 1
• If beneficial response is sustained for ≥3 months, attempt step-down therapy to evaluate continued need 1

Growth Monitoring

• Monitor growth velocity, particularly at medium doses, though low-to-medium dose ICS effects on growth are small, nonprogressive, and may be transient 1, 2
• Benefits of ICS outweigh concerns about potential growth effects 1

Common Pitfalls to Avoid

• Never use combination ICS/LABA products (like Symbicort) in children <4 years of age 1
• Do not use metered-dose inhalers or dry powder inhalers in this age group—nebulizer with face mask is required 1, 2
• Do not prescribe once-daily budesonide dosing—twice-daily administration is required 2, 3
• Do not continue therapy indefinitely without reassessment—children in this age group have high rates of spontaneous remission 1