Azelastine Dosing
For intranasal azelastine, use 1 spray per nostril twice daily in children ages 6-11 years, and 1-2 sprays per nostril twice daily (or 2 sprays once daily) in patients ≥12 years, with the 0.15% formulation preferred for both seasonal and perennial allergic rhinitis. 1
Intranasal Azelastine Formulations and Dosing
Azelastine 0.1% (Astelin) - 137 µg per spray
- FDA approved for: Seasonal allergic rhinitis and vasomotor rhinitis
- Age ≥6 years:
- Ages 6-11: 1 spray per nostril twice daily
- Ages ≥12: 1-2 sprays per nostril twice daily OR 2 sprays per nostril once daily 1
Azelastine 0.15% (Astepro) - 205.5 µg per spray
- FDA approved for: Seasonal AND perennial allergic rhinitis
- Age ≥6 years:
- Ages 6-11: 1 spray per nostril twice daily
- Ages ≥12: 1-2 sprays per nostril twice daily OR 2 sprays per nostril once daily 1
The 0.15% formulation contains sorbitol and sucralose to improve taste and is the preferred option given its broader indication for both seasonal and perennial allergic rhinitis. 1
Azelastine-Fluticasone Combination (Dymista)
- 137 µg azelastine + 50 µg fluticasone per spray
- FDA approved for: Seasonal allergic rhinitis
- Age ≥12 years only: 1 spray per nostril twice daily 1
Ophthalmic Azelastine
While the evidence provided focuses primarily on intranasal formulations, one study evaluated azelastine 0.05% eye drops with one drop per affected eye, demonstrating onset of action within 3 minutes and duration of 8-10 hours 2. However, specific FDA-approved ophthalmic dosing was not detailed in the provided guidelines.
Clinical Considerations
Onset and Duration
- Rapid onset: Symptom relief begins within 15-30 minutes of administration 3, 4
- Duration: Effects last up to 12 hours, supporting twice-daily dosing 5
Lower Dose Option
Evidence supports that 1 spray per nostril twice daily is effective and better tolerated than the traditional 2 sprays per nostril twice daily, with significantly reduced incidence of bitter taste (8.3% vs 19.7%) and somnolence (0.4% vs 11.5%) 6. This lower dose remains effective for moderate-to-severe seasonal allergic rhinitis.
Common Side Effects
- Bitter taste: Most common adverse effect (8-20% depending on formulation) 1, 3
- Somnolence: 0.4-11.5% (lower with reduced dosing and newer formulations) 1
- Epistaxis, headache, nasal discomfort 1
Important Warnings
- Caution patients about potential somnolence and assess individual response before driving or operating machinery 7
- Avoid concurrent use with alcohol or CNS depressants due to additive sedation risk 7
- Prime delivery system before initial use and after storage for ≥3 days 7
- Keep out of reach of children due to potential for serious adverse effects with oral ingestion 7
Pediatric Use
The 0.15% formulation has been studied in children ages 6-12 years with favorable safety profile and no significant effects on growth or HPA axis function 8, 9. Evidence in children under 6 years is limited, and azelastine is not FDA-approved for this age group 1.