Can Inhaled Fluticasone 50 µg Be Given to a 10-Month-Old Infant?
No, fluticasone propionate inhaler is not FDA-approved for a 10-month-old infant and should not be used; budesonide inhalation suspension is the only FDA-approved inhaled corticosteroid for this age group, approved for children as young as 12 months. 1
FDA Approval Status and Age Restrictions
Fluticasone propionate inhaler (HFA/MDI) is FDA-approved only for children ≥ 4 years of age, making it inappropriate for a 10-month-old infant. 1
There is insufficient safety and efficacy data for inhaled fluticasone in children < 4 years, which is why FDA approval was not granted for this age group. 1
Budesonide inhalation suspension (Pulmicort Respules) is the only inhaled corticosteroid approved by the FDA for children younger than 4 years, with approval starting at 12 months of age. 1, 2
Recommended Alternative: Budesonide for Infants ≥ 12 Months
Clinical Indications for Starting Controller Therapy
Initiate daily budesonide controller therapy in a 10-month-old (once they reach 12 months) when any of the following criteria are met: 1, 2
- Need for symptomatic rescue treatment > 2 times per week
- Severe exacerbations requiring inhaled β₂-agonist more frequently than every 4 hours over a 24-hour period, with episodes occurring < 6 weeks apart
- > 3 wheezing episodes in the past year lasting > 1 day, disrupting sleep, and presence of risk factors for persistent asthma (parental asthma, atopic dermatitis, allergic rhinitis, peripheral eosinophilia > 4%, or wheezing unrelated to colds)
Dosing and Administration
Starting dose: 0.25 mg twice daily (total 0.5 mg per day) delivered via jet nebulizer with a properly fitted face mask. 1
After each nebulized treatment, wash the infant's face promptly to reduce the risk of oral candidiasis. 1
Use a jet nebulizer with a face mask that fits snugly over the nose and mouth to maximize drug delivery. 2
Monitoring and Reassessment
Reassess technique, adherence, and clinical response every 2–6 weeks initially. 1, 2
Discontinue therapy if no clear benefit is observed within 4–6 weeks, and consider alternative diagnoses such as anatomic abnormalities or viral-related wheeze. 1, 2
Because many infants with viral-related wheeze achieve remission by approximately 6 years of age, maintenance inhaled corticosteroid therapy should be regularly reviewed and not continued indefinitely without evaluation. 1, 2
Critical Pitfalls to Avoid
Do not use fluticasone formulations off-label in infants below the approved age (< 4 years for inhaled fluticasone) without specialist consultation and compelling justification. 1
Do not assume all inhaled corticosteroids share the same age approval—budesonide is the only FDA-approved option for infants and young children. 1
Ensure proper nebulizer technique with a snug face mask and post-treatment face washing to maximize efficacy and minimize side effects. 1
Evidence from Preterm Infants
A large randomized trial found that inhaled corticosteroids did not significantly improve symptom-free days, duration of supplemental oxygen, or hospitalization rates in preterm infants with recurrent respiratory symptoms. 1
For acute symptom relief in infants with wheeze, short-acting β₂-agonists are the preferred therapy rather than inhaled corticosteroids. 1