ASTEPRO® ALLERGY ANTIHISTAMINE NASAL SPRAY

Astepro® Allergy Nasal Spray packshot
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ASTEPRO® ALLERGY ANTIHISTAMINE NASAL SPRAY

Astepro allergy is now approved. Previously only available as Rx. The first1 and only2 OTC antihistamine nasal spray3 

OVERVIEW

Proven to relieve nasal congestion—the most bothersome symptom for many allergy sufferers4—as well as runny nose, itchy nose, and sneezing5-8

In clinical trials, Astepro significantly improved all 4 TNSS components5-8

comparison chart

ENLARGE          LONG DESCRIPTION

Results of a 2-week, placebo-controlled, double-blind study comparing azelastine HCl 0.15% nasal spray, 2 sprays per nostril once daily, with placebo in patients with SAR (n=266 for patients receiving Astepro and n=266 for patients receiving placebo). The study was conducted in the United States during Texas Mountain Cedar season. The primary efficacy variable was change from baseline in 12-hour reflective TNSS over the entire 2 weeks of treatment. TNSS consisted of nasal congestion, itchy nose, runny nose, and sneezing, scored on a 4-point (0 to 3) scale with a maximum possible daily score of 24.

SAR, seasonal allergic rhinitis; TNSS, Total Nasal Symptom Score.

Astepro Allergy is the same as prescription Astepro (azelastine HCl) 0.15% Nasal Spray, 205.5 mcg (Rx approval in 2009)3,9-11

It is different than both Astelin® (azelastine HCl) Nasal Spray 137 mcg (Rx approval in 1996), and Astepro (azelastine HCl) 0.10% Nasal Spray 137 mcg (Rx approval in 2008).9-11

Astepro Allergy has:

  • The same prescription strength as Astepro 0.15% and 50% higher concentration of azelastine HCl than prescription Astelin3,9,11
  • The same improved taste profile as prescription Astepro3,6
  • Once or twice daily dosing3,*

* 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 years 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.

 

PROVIDES UP TO 24 HOUR RELIEF OF3:

NASAL CONGESTIONRUNNING NOSE
NASAL CONGESTIONRUNNY NOSE
NASAL CONGESTIONRUNNING NOSE
SNEEZING
 		ITCHY NOSE
 

DOWNLOAD THE PRODUCT LABEL (PDF)

DIRECTIONS3

Read the User Guide for how to: 

  • prime the bottle before first use
  • prime bottle again if not used for 3 or more days
  • use the spray
  • clean the spray nozzle if it gets clogged

Adults and children 12 years and older

This product may be used either once or twice a day.

  • Once daily: use 2 sprays in each nostril, OR
  • Twice daily: use 1 or 2 sprays in each nostril every 12 hours
  • Do not use more than 4 sprays in each nostril in a 24 hour period

Children 6 years to 11 years
  • An adult should supervise use
  • 1 spray in each nostril every 12 hours
  • Do not use more than 2 sprays in each nostril in a 24 hour period

Children under 6 years

Do not use

 

INGREDIENTS3

Active ingredient (in each spray):
Azelastine hydrochloride 0.15% (205.5 mcg)

Inactive ingredients:
Benzalkonium chloride, edetate disodium, hypromellose, purified water, sodium citrate, sorbitol, sucralose

WARNINGS FOR PATIENTS3

Only for use in the nose. Do not spray in eyes or mouth.

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you:

  • have had recent nose ulcers or nose surgery
  • have had a nose injury that has not healed

When using this product:

  • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
  • you may get a bitter taste in your mouth. To help avoid this, tilt your head downward while spraying
  • nasal discomfort or sneezing may occur right after use
  • do not share this bottle with anyone else as this may spread germs

Stop use and ask a doctor if:

  • an allergic reaction, such as a skin rash, to this product occurs
  • you have severe or frequent nosebleeds

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

OTHER INFORMATION FOR PATIENTS3

Store between 20° to 25°C (68° to 77°F). Protect from freezing.

Keep the carton and the enclosed User Guide for important information.

Do not use if tape printed with “sealed for your protection” on top and bottom carton flaps is not intact.

FAQ

    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).3,9,10

    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.3,6,9-11

    How is Astepro Allergy different from intranasal steroid (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.12 As an intranasal antihistamine, Astepro blocks histamine receptors.9 INS sprays work by reducing inflammatory gene products through a multistep process.12 Each product has a unique dosing regimen.3,13-15

    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.3,6,9

    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.3

    SEE ALL ASTEPRO ALLERGY FAQ


    References:

    1. FDA approves a nasal antihistamine for nonprescription use. Approval is a first-in-class and was enabled by the prescription to nonprescription switch process. News release. FDA; June 17, 2021. Accessed March 2, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-nasal-antihistamine-nonprescription-use.  

    2. Data on file. Bayer. IRI data. Only OTC AH. 

    3. NDA 213872.

    4. Stewart M, Ferguson BJ, Fromer L. Epidemiology and burden of nasal congestion. Int J Gen Med. 2010;3:37-45. 

    5. Data on file. Bayer. MP440 CSR. Symptom scores. 

    6. 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.

    7. Shah S, Berger W, Lumry W, La Force C, Wheeler W, Sacks H. Efficacy 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 

    8. Howland WC, Amar NJ, Wheeler W, Sacks H. Efficacy and safety of azelastine 0.15% nasal spray administered once daily in patients with allergy to Texas mountain cedar pollen. Int Forum Allergy Rhinol. 2011;1(4):275-279. doi:10.1002/alr.20065 

    9. Astepro®. Prescribing information. Meda Pharmaceuticals Inc; 2018. 

    10. 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. 

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

    12. 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  

    13. Flonase® Drug Facts Label. NDA205434.  

    14. Nasacort® Drug Facts Label. NDA020468. 

    15. Rhinocort® Drug Facts Label. NDA020746.