Can a 10‑month‑old infant be given fluticasone (nasal spray or inhaled corticosteroid)?

Can a 10-Month-Old Infant Take Fluticasone?

No, fluticasone nasal spray is not approved for infants under 2 years of age, and inhaled fluticasone propionate for asthma is not approved for children under 4 years of age. 1, 2

Age-Specific FDA Approval for Fluticasone Formulations

Nasal Spray Formulations

• Fluticasone propionate (Flonase): Approved for ≥4 years of age 1
• Fluticasone furoate (Veramyst): Approved for ≥2 years of age 1
• Neither formulation is approved for a 10-month-old infant 1

Inhaled Corticosteroid Formulations for Asthma

• Fluticasone propionate HFA/MDI: Approved for ≥4 years of age 1, 2
• Not approved for infants under 4 years 1

Alternative for Infants with Asthma or Wheezing

If your 10-month-old requires inhaled corticosteroid therapy for asthma or recurrent wheezing, budesonide inhalation suspension is the only FDA-approved option for this age group. 3

Budesonide Approval and Indications

• FDA-approved for children as young as 12 months of age 3
• The only inhaled corticosteroid approved for children younger than 4 years 3
• Administered via jet nebulizer with face mask 3

When to Initiate Budesonide in Infants

Start daily controller therapy if the infant meets any of the following criteria 3:

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

Budesonide Dosing for Infants

• Starting dose: 0.25 mg twice daily (0.5 mg total daily) via nebulizer with face mask 3
• Delivered using jet nebulizer with properly fitted face mask 3
• Wash infant's face immediately after each treatment to prevent oral candidiasis 3

Monitoring and Discontinuation

• Reassess every 2-6 weeks to verify proper administration technique and clinical response 3
• Discontinue if no clear benefit within 4-6 weeks and consider alternative diagnoses 3
• Because many infants who wheeze with viral infections achieve remission by approximately 6 years of age, maintenance therapy should be regularly reassessed and not continued indefinitely 3

Critical Safety Considerations

Why Fluticasone Is Not Used in This Age Group

• Lack of safety and efficacy data in children under 2 years (nasal) or under 4 years (inhaled) 1, 2
• No FDA approval for this age group indicates insufficient evidence to support safe use 1, 2
• Potential for systemic corticosteroid effects including HPA axis suppression, particularly at higher doses 2, 4

Post-Prematurity Respiratory Disease Context

• For infants born preterm with recurrent respiratory symptoms, inhaled corticosteroids showed no significant benefit in reducing symptom-free days, supplemental oxygen duration, or hospitalizations in one large trial 1
• The American Thoracic Society suggests inhaled corticosteroids only for infants with PPRD who have chronic cough or recurrent wheezing, with monitoring for clinical improvement 1
• Bronchodilators (short-acting β₂-agonists) are preferred for acute symptom relief in preterm infants with wheezing 1

Common Pitfalls to Avoid

• Never use fluticasone formulations off-label in infants under the approved age without compelling clinical justification and specialist consultation 1, 2
• Do not assume all inhaled corticosteroids have the same age approval—budesonide is the only option for infants 3
• Do not continue inhaled corticosteroid therapy indefinitely in wheezing infants without regular reassessment, as many achieve remission 3
• Ensure proper nebulizer technique with snugly fitting face mask and post-treatment face washing to maximize efficacy and minimize side effects 3