What is the recommended frequency for administering azelastine (antihistamine) nasal spray?

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From the Guidelines

Azelastine nasal spray should be used 1-2 sprays per nostril twice daily, with a maximum of 2 sprays daily, as recommended for patients aged 12 years and older, and 1 spray twice a day for children aged 6-11 years. This dosage is based on the FDA-approved guidelines for azelastine nasal spray, as outlined in the clinical practice guideline for allergic rhinitis 1. The recommended dosage may vary depending on the specific formulation of azelastine, with options including 0.1% solution (137 µg per spray) or 0.15% solution (205.5 µg per spray). It is essential to follow the prescribed dosage and not exceed it, as overuse may increase the risk of side effects such as bitter taste, epistaxis, somnolence, and headache.

Some key points to consider when using azelastine nasal spray include:

  • Starting with a low dose and adjusting as needed to minimize side effects
  • Using the spray regularly to achieve maximum benefit, which may take 1-2 weeks
  • Being cautious of somnolence, especially when initiating treatment, and following up with a clinician to assess response and side effects
  • Considering alternative treatments if side effects or twice-daily dosing are a concern.

Overall, azelastine nasal spray is an effective treatment for allergic rhinitis, offering rapid onset of action and targeted delivery, making it a useful option for patients with episodic nasal symptoms or as a pretreatment prior to nasal allergen exposure 1.

From the FDA Drug Label

U. S. placebo-controlled clinical trials of Astelin® Nasal Spray included 322 patients with seasonal allergic rhinitis who received two sprays per nostril twice a day for up to 4 weeks. Two hundred seventy five patients with seasonal allergic rhinitis received Astelin® Nasal Spray one spray per nostril twice daily for 2 weeks in two U. S. placebo-controlled trials.

The recommended dosage of azelastine nasal spray is two sprays per nostril twice daily or one spray per nostril twice daily.

From the Research

Dosage Frequency of Azelastine Nasal Spray

  • Azelastine nasal spray can be administered at a dose of 1 spray per nostril twice daily, as evidenced by studies 2, 3.
  • A dose of 2 sprays per nostril twice daily is also effective, but may have a higher incidence of bitter taste and somnolence compared to the 1-spray regimen 2, 3.
  • Azelastine nasal spray can also be used at a concentration of 0.15% with once-daily dosing, which has been shown to be effective and well-tolerated in patients with seasonal allergic rhinitis 4.
  • The 0.15% concentration has been compared to the 0.10% concentration, with both showing significant improvement in nasal symptoms, but the 0.15% concentration had a faster onset of action within 30 minutes 5.
  • Azelastine nasal spray offers flexibility in dosing, with options for fixed or as-needed use, and has been shown to have a rapid onset of action and excellent safety profile 6.

Administration and Efficacy

  • The efficacy of azelastine nasal spray has been demonstrated in various studies, with significant improvements in total nasal symptom scores and individual symptoms such as nasal congestion, runny nose, itchy nose, and sneezing 2, 3, 4, 5.
  • Azelastine nasal spray has been compared to other agents used to treat allergic rhinitis, including oral antihistamines and intranasal corticosteroids, and has shown superior or comparable efficacy 2, 6.
  • Combination therapy with intranasal corticosteroids, such as fluticasone propionate, has been shown to enhance clinical benefit and reduce symptoms in allergic rhinitis patients more than either agent alone 2, 6.

Safety and Tolerability

  • Azelastine nasal spray has been shown to be well-tolerated in both adults and children with allergic rhinitis, with a low incidence of adverse events 2, 3, 4, 5, 6.
  • The most common adverse event reported with azelastine nasal spray is bitter taste, which can be minimized with correct dosing technique 2, 3, 5.
  • Somnolence has also been reported, but at a lower incidence compared to oral antihistamines 3, 5.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Efficacy and safety of azelastine nasal spray at a dose of 1 spray per nostril twice daily.

Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2007

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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