At what age can azelastine nasal spray be initiated for allergic rhinitis in children?

Azelastine Nasal Spray Age Initiation

Azelastine nasal spray can be started at age 5 years for seasonal allergic rhinitis and age 6 years for perennial allergic rhinitis, according to FDA approval and current guidelines. 1

FDA-Approved Age Indications

The FDA label for Astelin® (azelastine) nasal spray specifies:

• Age ≥5 years: Approved for seasonal allergic rhinitis symptoms (rhinorrhea, sneezing, nasal pruritus) 1
• Age ≥12 years: Approved for vasomotor rhinitis symptoms (rhinorrhea, nasal congestion, postnasal drip) 1

Guideline-Based Dosing by Age

For children 6-11 years:

• Azelastine 0.1% solution: 1 spray per nostril twice daily 2

For children ≥12 years and adults:

• Azelastine 0.1% solution: 1-2 sprays per nostril twice daily, or 2 sprays once daily 2

Clinical Context and Positioning

Azelastine offers rapid symptom relief with onset of action within 15-30 minutes, making it particularly useful for episodic symptoms or pretreatment before allergen exposure. 2 This rapid onset is superior to intranasal corticosteroids, which require 12 hours to days for maximal effect. 2

However, intranasal corticosteroids remain more effective than azelastine for comprehensive symptom control, particularly for nasal congestion. 2 Azelastine should be considered as first- or second-line therapy when patients fail oral antihistamines or need rapid symptom relief. 2

Important Safety Considerations

Common side effects include:

• Bitter taste (most frequent complaint) 2
• Epistaxis 2
• Somnolence (0.4-3% incidence) 2
• Headache 2

Monitor for somnolence at therapy initiation, as sedation can occur despite azelastine being a second-generation antihistamine. 2 This is particularly important in school-age children where cognitive effects could impact academic performance.

Combination Therapy Option

For children ≥12 years with inadequate response to monotherapy, the combination product azelastine-fluticasone (137 mcg/50 mcg per spray) is FDA-approved and provides superior efficacy to either agent alone. 3 However, this combination is not approved for children under 12 years. 3

For children ages 6-11 years requiring combination therapy, use separate devices (azelastine spray plus fluticasone propionate spray) rather than the fixed-dose combination product. 3

Common Pitfall to Avoid

Do not use azelastine in children under 5 years of age for seasonal allergic rhinitis, as safety and efficacy have not been established in this age group per FDA labeling. 1 For children ages 2-5 years with allergic rhinitis, consider oral cetirizine (5 mg once daily) or intranasal corticosteroids like mometasone furoate (approved for age ≥2 years) or fluticasone propionate (approved for age ≥4 years) instead. 3, 4