Azelastine Nasal Spray Dosing for Children Ages 6-11 Years
Yes, you can prescribe azelastine nasal spray one spray per nostril twice daily for children aged 6-11 years—this is the FDA-approved dosing for this age group. 1, 2
FDA-Approved Dosing by Age
The dosing is clearly delineated by age group:
- Children ages 6-11 years: 1 spray per nostril twice daily 1, 2
- Children ages 5 years (for seasonal allergic rhinitis only): 1 spray per nostril twice daily 2
- Adolescents and adults ≥12 years: 1-2 sprays per nostril twice daily (or 2 sprays once daily for some formulations) 1, 2
Available Formulations
Both azelastine formulations are approved for children ≥6 years:
- Azelastine 0.1% (Astelin): 137 µg per spray, approved for seasonal allergic rhinitis and vasomotor rhinitis 1
- Azelastine 0.15% (Astepro): 205.5 µg per spray, approved for both seasonal and perennial allergic rhinitis 1
The dosing remains the same (1 spray per nostril twice daily) for ages 6-11 years regardless of which concentration you prescribe. 1
Clinical Considerations
Efficacy Profile
Azelastine nasal spray offers several advantages for pediatric patients:
- Rapid onset of action within 15 minutes 3
- Superior efficacy compared to oral antihistamines like cetirizine and desloratadine 3
- Effective for nasal congestion, which oral antihistamines address poorly 1
- Can be used as first- or second-line therapy for allergic rhinitis 1
Common Side Effects to Counsel Families About
The most frequently reported adverse effects include:
- Bitter taste (most common complaint that may affect compliance) 1
- Epistaxis (nose bleeds) 1
- Somnolence (0.4-3% in recent studies, similar to placebo rates) 1
- Headache 1
Important Pitfalls to Avoid
Taste aversion is the primary compliance issue. If a child experiences significant bitter taste with one formulation, consider switching to the alternative concentration (0.1% vs 0.15%) or the newer formulation with sorbitol and sucralose added for improved taste. 1
Proper administration technique is critical:
- Keep head tilted downward (not backward) when spraying 2
- Breathe gently to avoid drawing medication into the throat where it will be tasted 2
- Alternate sprays between nostrils 2
Safety Data in Pediatric Population
Long-term safety has been established in children:
- 3-month continuous use in children ages 4-11 years showed excellent safety profile 4
- Treatment-related adverse events were low (16% for azelastine/fluticasone combination) 4
- No cases of mucosal ulceration or nasal septal perforation were observed 4
- Postmarketing surveillance in 211 children under age 13 showed 90% reported no adverse events 5
When to Consider Azelastine
Azelastine is particularly useful for: