Monday, June 21, 2021

FDA Approves a Nasal Antihistamine for Nonprescription Use - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

FDA Approves a Nasal Antihistamine for Nonprescription Use

The U.S. Food and Drug Administration approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch. The FDA approved Astepro (azelastine hydrochloride nasal spray, 0.15%) for seasonal and perennial allergic rhinitis—commonly known as allergies—for adults and children six years of age and older. 

Azelastine can cause drowsiness. The label warns that consumers using this product should avoid alcoholic drinks and be careful when driving a motor vehicle or operating machinery. Using azelastine nasal spray with alcohol, sedatives, or tranquilizers may increase drowsiness.

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