Each nasal spray delivers 0.137 mL solution containing 205.5 mcg of azelastine hydrochloride. The product may be administered as a once-daily or twice-daily dosage regimen. The OTC formulation includes a number of benefits, including flexible once- or twice-daily dosing, that provide up to 24-hour relief of nasal congestion, runny nose, sneezing, and itchy nose from indoor and outdoor allergies. Due to the risk of somnolence associated with the use of azelastine, the label for Astepro Allergy warns consumers to avoid alcoholic drinks and to be cautious when driving a motor vehicle or operating machinery.
Additionally, consumers should avoid sedatives or tranquilizers when using the product. While the 0.15% strength is approved for OTC use, the 0.1% strength will remain prescription-based for seasonal and perennial allergic rhinitis. The manufacturer anticipates to have Astepro Allergy available at national mass retail locations in the first quarter of 2022.
In an interview, Theresa M. Michele, MD, director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, stated, “Seasonal and perennial allergies affect millions of Americans every year, causing them to experience symptoms of nasal congestion, runny nose, sneezing and more. Today’s approval provides individuals an option for a safe and effective nasal antihistamine without requiring the assistance of a healthcare provider.”
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
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