What is the minimum age for initiating azelastine nasal spray and ophthalmic solution in pediatric patients?

Minimum Age for Azelastine Initiation

Azelastine nasal spray is FDA-approved starting at age 5 years for seasonal allergic rhinitis, while azelastine ophthalmic solution is approved for children aged 3 years and older for allergic conjunctivitis. 1, 2

Nasal Spray Formulations and Age-Specific Dosing

Ages 5-11 Years

• The FDA-approved dosing for azelastine 0.1% (Astelin) nasal spray is 1 spray per nostril twice daily for children ages 5-11 years with seasonal allergic rhinitis 1
• More recent guidelines from the American Academy of Otolaryngology-Head and Neck Surgery recommend azelastine for children aged 6 years and older, with dosing of 1 spray per nostril twice daily for ages 6-11 years 3
• Both the 0.1% and 0.15% formulations use the same dosing regimen (1 spray per nostril twice daily) for children 6-11 years, regardless of concentration 4

Ages 12 Years and Older

• For patients 12 years and older, the approved dosing is 1-2 sprays per nostril twice daily for seasonal allergic rhinitis 5, 1
• The 0.15% formulation (Astepro) can also be dosed as 2 sprays per nostril once daily in this age group, which may improve adherence 3

Ophthalmic Solution Age Restrictions

• Azelastine ophthalmic solution is approved for children aged 3 years and older for treatment of allergic conjunctivitis 2, 6
• Safety and effectiveness in children below age 3 have not been established for the ophthalmic formulation 2

Clinical Considerations for Pediatric Use

Efficacy Profile

• Azelastine demonstrates rapid onset of action within 15 minutes after administration, making it particularly useful for episodic symptoms or pretreatment before allergen exposure 3, 4
• The medication is especially effective for nasal congestion compared to oral antihistamines, a distinguishing feature among antihistamine options 3

Common Side Effects in Children

• Bitter taste is the most frequent adverse effect, reported by approximately 20% of pediatric patients, and represents the primary barrier to compliance 4, 7
• Epistaxis (nosebleed) is commonly observed 3, 4
• Somnolence occurs in only 0.4-3% of children, comparable to placebo rates and significantly lower than first-generation antihistamines 3, 4
• At the lower dose of 1 spray per nostril twice daily, bitter taste occurs in only 8.3% of patients (compared to 19.7% with 2 sprays per nostril) and somnolence in 0.4% (compared to 11.5% with higher dosing) 7

Important Caveats

• The combination product azelastine-fluticasone (137 mcg/50 mcg per spray) is only FDA-approved for patients ≥12 years, not for younger children 8
• For children 6-11 years requiring combination therapy, separate devices must be used (azelastine spray plus fluticasone spray administered separately) 8
• If bitter taste significantly affects adherence, switching between 0.1% and 0.15% formulations or to newer formulations containing sorbitol and sucralose may improve tolerability 4