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  2. FAQ

FREQUENTLY ASKED QUESTIONS FOR
HEALTHCARE PROVIDERS

    Is Astepro® Allergy the full prescription strength of azelastine?

    Over-the-counter Astepro Allergy is the same strength as the prescription product. It is the maximum strength of azelastine HCl available as a prescription or over the counter. Astepro Allergy is the same as prescription Astepro (azelastine HCl) 0.15% Nasal Spray, 205.5 mcg (Rx approval in 2009).1-3

    Astepro Allergy is different from both Astelin® (azelastine HCl) 0.10% Nasal Spray 137 mcg (Rx approval in 1996), and Astepro (azelastine HCl) 0.10% Nasal Spray 137 mcg (Rx approval in 2008). Astepro Allergy has a 50% higher concentration of azelastine HCl but has the same improved taste profile as prescription Astepro.1-5

    How is Astepro Allergy different from intranasal steroids (INS) sprays like Flonase®, Nasacort®, and Rhinocort®?

    Astepro Allergy and INS sprays both relieve nasal allergy symptoms. Astepro and INS sprays have different mechanisms of action.6 As an intranasal antihistamine, Astepro blocks histamine receptors.2 INS sprays work by reducing inflammatory gene products through a multistep process.6 Each product has a unique dosing regimen.1,7-9

    Flonase®, Nasacort®, and Rhinocort® are trademarks of their respective owners.

    What is the taste profile of Astepro Allergy?

    Astepro Allergy includes the taste-masking agent sucralose and sorbitol and has the same improved taste profile as prescription Astepro. In clinical trials, 94% of patients receiving Astepro reported no bitter taste.1,2,5

    How long does Astepro Allergy work?

    In patients with indoor or outdoor allergies, Astepro Allergy relieves nasal symptoms including congestion, runny nose, itchy nose, and sneezing for up to 24 hours when used either once or twice a day.1

    What symptoms does Astepro Allergy relieve?

    In clinical trials, Astepro Allergy significantly improved Total Nasal Symptom Scores (TNSS) compared with placebo: nasal congestion, runny nose, itchy nose, and sneezing.5,10

    Does Astepro Allergy cause drowsiness?

    Astepro Allergy has a drowsiness warning. In clinical trials, drowsiness was observed in less than 4% of patients taking Astepro Allergy. Instruct patients to read the Drug Facts Label for relevant information for the use of the product.2,11

    What is the dosing regimen for Astepro Allergy?

    For adults and children 12 years and older, Astepro Allergy can be used once daily (2 sprays in each nostril) OR twice daily (1 or 2 sprays in each nostril every 12 hours). Patients should not use more than 4 sprays per nostril in a 24 hour period. For children 6 to 11 years old, dosing is 1 spray in each nostril every 12 hours. These patients should not use more than 2 sprays in each nostril in a 24 hour period. Children under the age of 6 years should not use Astepro.1

    Can Astepro Allergy be used in pediatric patients?

    Astepro Allergy is approved for use in children ages 6 to 11 years and in children and adults ages 12 years and older.1 Children ages 6 to 11 years should use 1 spray in each nostril every 12 hours and should not use more than 2 sprays per nostril in a 24 hour period.1

    Is Astepro Allergy habit forming?

    Astepro is not considered to be habit forming.1

    Is Astepro Allergy associated with pediatric growth suppression?

    Astepro Allergy does not have a warning regarding pediatric growth suppression in its Drug Facts Label.1


    References:

    1. NDA 213872.

    2. Astepro. Prescribing information. Meda Pharmaceuticals Inc; 2018.

    3. US Department of Health and Human Services. Pediatric Postmarketing Pharmacovigilance and Drug Utilization Review. November 3, 2016. Accessed April 7, 2022. https://www.fda.gov/media/100100/download

    4. Astelin. Prescribing information. Meda Pharmaceuticals Inc; 2014.

    5. van Bavel J, Howland WC, Amar NJ, Wheeler W, Sacks H. Efficacy and safety of azelastine 0.15% nasal spray administered once daily in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2009;30(5):512-518. doi:10.2500/aap.2009.30.3284

    6. Watts AM, Cripps AW, West NP, Cox AJ. Modulation of allergic inflammation in the nasal mucosa of allergic rhinitis sufferers with topical pharmaceutical agents. Front Pharmacol. 2019;10:294:1-22. doi:10.3389/fphar.2019.00294

    7. Flonase® Drug Facts Label. NDA205434.

    8. Nasacort® Drug Facts Label. NDA020468.

    9. Rhinocort® Drug Facts Label. NDA020746.

    10. Shah S, Berger W, Lumry W, La Force C, Wheeler W, Sacks H. Ecacy and safety of azelastine 0.15% nasal spray and azelastine 0.10% nasal spray in patients with seasonal allergic rhinitis. Allergy Asthma Proc. 2009:30(6):628-633. doi:10.2500/aap.2009.30.3296

    11. Data on file. Bayer. MP436 CSR. Safety and tolerability.

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