What is the daily dose of azelastine (nasal spray)?

From the Guidelines

The recommended dose of azelastine nasal spray is typically 1-2 sprays in each nostril twice daily, as indicated in the clinical practice guideline for allergic rhinitis 1. For the standard 137 mcg per spray formulation (such as Astelin or generic equivalents), this means a total daily dose of 548-1096 mcg. For the 205.5 mcg per spray formulation (such as Astepro), the total daily dose would be 822-1644 mcg. Azelastine is an antihistamine that works by blocking histamine receptors, reducing nasal allergy symptoms like sneezing, itching, and runny nose. The medication begins working within 30 minutes, but may take up to two weeks for maximum benefit. Before using, gently blow your nose and prime the pump if it's new or hasn't been used recently. Keep the spray upright during use, and avoid spraying directly onto the nasal septum. If you miss a dose, take it when you remember, but skip it if it's almost time for your next dose. Never double up on doses to catch up.

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

• The medication is approved for use in adults and children 6 years and older 1
• It is available in two formulations: 0.1% and 0.15% solution 1
• The 0.15% solution plus sorbitol and sucralose formulation is approved for both seasonal and perennial allergic rhinitis 1
• Intranasal antihistamines have shown equality or superiority to oral antihistamines in numerous well-designed randomized, controlled, and blinded studies 1
• Somnolence rates have been found to be around 0.4% to 3%, which were equal or only slightly greater than in placebo groups 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. Trials Supporting One Spray Per Nostril Twice Daily 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 dose of azelastine per day nasal spray is two sprays per nostril twice daily or one spray per nostril twice daily 2 2.

• The recommended dose is 2 sprays per nostril twice daily for some patients.
• The recommended dose is 1 spray per nostril twice daily for other patients.

From the Research

Azelastine Nasal Spray Dosage

• The recommended dose of azelastine nasal spray varies, but common dosages include:
  • 1 spray per nostril twice daily 3, 4
  • 2 sprays per nostril twice daily 5, 6
  • 2 sprays per nostril once daily (for a 0.15% concentration) 7
• The dosage of azelastine per day can be calculated based on the concentration of the nasal spray, which is typically 0.1% or 0.15% 7, 6
• A 0.1% concentration is equivalent to 0.28 mg per dose, while a 0.15% concentration is equivalent to 0.42 mg per dose (assuming a standard spray volume)
• Based on the studies, the total daily dose of azelastine can range from 0.56 mg (1 spray per nostril twice daily of 0.1% concentration) to 1.68 mg (2 sprays per nostril twice daily of 0.15% concentration) 5, 3, 7, 6

Efficacy and Safety

• Azelastine nasal spray has been shown to be effective in reducing nasal symptoms associated with seasonal allergic rhinitis, including nasal congestion, runny nose, itchy nose, and sneezing 5, 3, 7, 6
• The safety profile of azelastine nasal spray is generally well-tolerated, with common adverse events including bitter taste and nasal discomfort 3, 7, 6
• Somnolence has been reported in some patients, but the incidence is generally low 3, 6