With more than 12 years in clinical use as a prescription product, Astepro has a well-established safety profile.1
- In clinical trials, drowsiness was observed in less than 4% of patients taking Astepro2,3
Astepro is a steroid-free allergy relief option4 for patients who want to avoid ongoing steroid use.
- Astepro does not have a warning regarding pediatric growth suppression in its Drug Facts Label4
- Astepro® Allergy is the same strength as prescription Astepro® (azelastine HCI) 0.15% Nasal Spray, 205.5 mcg (Rx approval in 2009), and is the maximum strength of azelastine HCI available as a prescription or over the counter.2,4,5
Astepro® Allergy also has the same improved taste profile as prescription Astepro®2,4
- In clinical trials, 94% of patients receiving Astepro® reported no bitter taste2,6
- It is different than both Astelin® (azelastine HCI) Nasal Spray 137 mcg (Rx approval in 1996), and Astepro (azelastine HCI) 0.10% Nasal Spray 137 mcg (Rx approval in 2008).2,7 It has a 50% higher concentration of azelastine HCI than prescription Astelin2,4,7 and also has the same improved taste profile as prescription Astepro.2,4,6
- Astepro Allergy includes the artificial sweetener ingredients sucralose and sorbitol.4,6
References:
1. US Food and Drug Administration. NDA 22-371. Drug Approval package for Astepro® Nasal Spray. August 31, 2009. 2. Astepro® Prescribing information. Meda Pharmaceuticals Inc; 2018. 3. Data on file. Bayer. MP436 CSR Safety and tolerability. 4. NDA 213872. 5. US Department of Health and Human Services. Pediatric Postmarketing Pharmacovigilance and Drug Utilization Review. November 3, 2016. Accessed October 28, 2021. https://www.fda gov/media/100100/download 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. doi:10.2500/aap.2009.30.3284. 7. Astelin. Prescribing information. Meda Pharmaceuticals Inc; 2014.