Azelastine Hydrochloride 0.1% Nasal Spray Azelastine Hydrochloride 0.15% Nasal Spray

FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Allergic Rhinitis Azelastine Hydrochloride Nasal Spray 0.1% and 0.15% is indicated for the relief of the symptoms of seasonal and perennial allergic rhinitis in patients 6 years of age and older. 2 DOSAGE AND ADMINISTRATION 2.1 Seasonal Allergic Rhinitis In children 6 to 11 years of age, the recommended dose of Azelastine Hydrochloride Nasal Spray 0.1% and 0.15% is 1 spray per nostril twice daily. In adults and adolescents 12 years of age and older, the recommended dose of Azelastine Hydrochloride Nasal Spray 0.1% and 0.15% is 1 or 2 sprays per nostril twice daily. Azelastine Hydrochloride Nasal Spray 0.15% may also be administered as 2 sprays per nostril once daily. 2.2 Perennial Allergic Rhinitis In children 6 to 11 years of age, the recommended dose of Azelastine Hydrochloride Nasal Spray 0.1% and 0.15% is 1 spray per nostril twice daily. In adults and adolescents 12 years of age and older, the recommended dose of Azelastine Hydrochloride Nasal Spray 0.15% is 2 sprays per nostril twice daily. 2.3 Important Administration Instructions Administer Azelastine Hydrochloride Nasal Spray by the intranasal route only. Priming: Prime Azelastine Hydrochloride Nasal Spray before initial use by releasing 6 sprays or until a fine mist appears. When Azelastine Hydrochloride Nasal Spray has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying Azelastine Hydrochloride Nasal Spray into the eyes. 3 DOSAGE FORMS AND STRENGTHS Azelastine Hydrochloride Nasal Spray is a nasal spray solution. Each spray of Azelastine Hydrochloride Nasal Spray 0.1% delivers a volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride. Each spray of Azelastine Hydrochloride Nasal Spray 0.15% delivers a volume of 0.137 mL solution containing 205.5 mcg of azelastine hydrochloride. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS