Is budesonide approved for use in an 8‑month‑old infant with asthma?

Can You Use Budesonide in an 8-Month-Old?

Yes, budesonide inhalation suspension is FDA-approved and indicated for maintenance treatment of asthma in children as young as 12 months of age, but it is NOT approved for infants under 12 months, making an 8-month-old outside the approved age range. 1

FDA Approval and Age Restrictions

• Budesonide inhalation suspension received FDA approval for children 12 months to 8 years of age for maintenance and prophylactic asthma therapy. 1
• This is the only inhaled corticosteroid with FDA approval for children younger than 4 years. 2, 3
• The FDA label explicitly states the indication is for children "12 months to 8 years of age," which excludes infants under 1 year. 1
• Safety and efficacy in children under 1 year has not been established according to regulatory guidance. 3

Clinical Context and Off-Label Considerations

While the FDA approval begins at 12 months, the clinical trial evidence base includes some younger infants:

• Published studies enrolled children as young as 6 months of age, demonstrating efficacy and safety in this younger population. 4, 5
• In these trials of 6-month to 8-year-olds with persistent asthma, budesonide inhalation suspension (0.25-1.0 mg daily) significantly improved daytime/nighttime symptoms and reduced rescue medication use compared to placebo, with adverse event rates similar to placebo. 4, 5
• One-year safety data in children aged 3.5 to 7 years showed no adverse effects on growth, bone age, or adrenal function. 6

Practical Guidance for the 8-Month-Old

If you are considering budesonide for an 8-month-old infant:

• Recognize this is off-label use below the FDA-approved age threshold. 1
• The decision requires careful risk-benefit assessment, as regulatory approval reflects the evidence package submitted, not necessarily the limits of safety. 3
• Clinical trial data suggest budesonide can be used safely in infants as young as 6 months, but this remains outside formal FDA indication. 4, 5

When to Consider Initiating Controller Therapy in Infants

Guidelines support starting daily long-term controller therapy in infants and young children who meet any of these criteria:

• Require symptomatic rescue treatment more than twice per week. 2
• Experience severe exacerbations requiring inhaled β₂-agonist more frequently than every 4 hours over 24 hours, with episodes occurring less than 6 weeks apart. 2
• Have >3 wheezing episodes in the past year lasting >1 day that disturbed sleep AND possess risk factors for persistent asthma (parental asthma, atopic dermatitis, allergic rhinitis, peripheral eosinophilia >4%, or wheezing apart from colds). 7, 2

Dosing If Prescribed Off-Label

If budesonide is prescribed for an 8-month-old (off-label):

• Start with 0.25 mg once daily or 0.25 mg twice daily via jet nebulizer with properly fitted face mask. 1, 5
• For symptomatic infants not responding to bronchodilators alone, 0.25 mg once daily is the lowest starting dose. 1
• If once-daily dosing does not provide adequate control, increase the total daily dose or divide into twice-daily administration. 1

Monitoring and Discontinuation

• Assess response every 2-6 weeks initially, verifying proper nebulizer technique and adherence before any dose adjustment. 2
• Discontinue therapy if no clear clinical benefit is observed within 4-6 weeks, and consider alternative diagnoses or therapies. 7, 2
• Once asthma control is achieved and sustained for ≥3 consecutive months, step down to the lowest effective dose. 2

Delivery Technique for Infants

• Use a jet nebulizer (not ultrasonic) with a face mask that fits snugly over nose and mouth. 3, 1
• Wash the infant's face immediately after each treatment to minimize risk of oral candidiasis. 2
• Only approximately 14% of the nominal dose reaches the airways, but prescribed doses already account for this—do not adjust downward. 2

Common Pitfalls to Avoid

• Do not use metered-dose inhalers or dry powder inhalers in infants—nebulizer with face mask is the only appropriate delivery method. 2
• Do not prescribe for acute bronchospasm or status asthmaticus—budesonide is a maintenance controller, not a rescue medication. 1
• Do not discontinue abruptly if the infant has been on therapy for weeks to months—taper gradually to prevent exacerbations. 2
• Do not continue indefinitely without reassessment—many infants who wheeze with viral infections experience remission by age 6 years. 7

Bottom Line

Budesonide inhalation suspension is not FDA-approved for an 8-month-old infant (approval starts at 12 months), but clinical trial data in infants as young as 6 months support its safety and efficacy when used off-label in carefully selected cases with appropriate monitoring. 1, 4, 5 If prescribed, use the lowest effective dose, verify proper technique, and discontinue if no benefit is seen within 4-6 weeks. 2, 1