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allergy nasal spray

FDA Approval of Astepro (Azelastine) as OTC

allergy nasal spray

FDA Approval of Astepro (Azelastine) as OTC

A nasal spray that has only been available with a prescription is now available over the counter after the FDA approved Astepro for OTC sales. Astepro is an antihistamine nasal spray intended to relieve nasal allergy symptoms such as nasal congestion, runny nose, sneezing, and itchy nose. Prior to July 2022, this medication was only available with a prescription. Individuals can now purchase this azelastine 0.15% nasal spray product over-the-counter at most retail pharmacies. 

What is Azelastine?

Astepro is the brand name for a drug called azelastine, which is an antihistamine that temporarily relieves nasal symptoms of allergies when administered in a nasal spray. It can ease symptoms of both indoor and outdoor allergies. Unlike some treatments for allergies it is not a steroid. The medication can be used in patients 6 and older and provides up to 24 hours of relief from allergy symptoms. 

Azelastine is an antihistamine, which means it inhibits the effects of histamine. Histamine is the substance that causes allergy symptoms like a runny nose and sneezing. When compared to intranasal corticosteroids (another common drug class used for treating allergies), azelastine has been shown to work faster and have a better side effect profile. In certain cases where a patient’s allergy symptoms are persistent even with treatment, a corticosteroid is sometimes combined with azelastine. 

Allergic Rhinitis

Rhinitis is an inflammatory disease of the upper airways that can be classified as allergic or non-allergic. It is considered allergic if it is the result of an immunoglobulin E (IgE) mediated response. Allergic rhinitis can then be categorized as seasonal or perennial. Usually seasonal allergies are related to changes in the environment due to pollen produced by trees, grass, and other plants. Perennial allergies are often due to exposure to indoor allergens like dust and animal hair.

The two main drug classes that are used for treating allergic rhinitis are antihistamines and corticosteroids. Oral and intranasal forms of these drugs are used. In general, if the symptoms that are the main concern are nasal, an intranasal formulation may be preferred as there are fewer systemic side effects and the medication targets the treatment area. Other treatments include decongestants, intranasal cromolyn, and daily nasal rinsing.

Side Effects and Directions

Side effects of intranasal azelastine to watch out for are breathing problems, fast heartbeat, and high blood pressure. More mild side effects that tend to go away when the medication is discontinued include bitter taste, cough, feeling tired, headache, nose or throat irritation, nosebleed, and sneezing.  

When using Astepro you need to make sure to prime the bottle before the initial use and again if you do not use it for 3 or more days. No more than 4 sprays should be used in each nostril in a 24 hour period. Any drowsiness experience from the medication will be enhanced if combined with alcohol or sedatives. 

Prescription vs. Over-the-Counter

Effective July 2022, Astepro can be purchased over-the-counter at retail pharmacies. This is the first OTC antihistamine nasal spray available for treating allergy symptoms and the first time a drug in this class has made the switch from prescription-only to over-the-counter. The strength that is used for treating patients 6 months to 6 years of age will remain prescription-only, however. 

A prescription product means that a patient needs to get a doctor’s appointment to get a prescription before they can get a medication at their pharmacy. The new OTC designation for Astepro allows patients to access this proven medication to treat their allergic rhinitis symptoms without needing to visit a doctor.


Bayer’s Astepro Allergy now available over the counter – Drug Store News

Azelastine – In: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US) – PubMed

Azelastine inhibits viropexis of SARS-CoV-2 spike pseudovirus by binding to SARS-CoV-2 entry receptor ACE2 – Elsevier Public Health Emergency Collection

Effectiveness of twice daily azelastine nasal spray in patients with seasonal allergic rhinitis – Therapeutics and Clinical Risk Management

FDA Approves a Nasal Antihistamine for Nonprescription Use – FDA Press Release