Astelin Nasal Spray (Azelastine )

ASTELIN (azelastine HCl) Nasal Spray, 137 mcg, is the only marketed second-generation antihistamine that has been used to treat the symptoms of both seasonal allergic rhinitis in adults and children 5 years and older and nonallergic vasomotor rhinitis in adults and children 12 years and older. Your doctor may prescribe ASTELIN (azelastine HCl) Nasal Spray because Allegra, Claritin, Clarinex and Zyrtec are not indicated for both seasonal allergic rhinitis and nonallergic vasomotor rhinitis. Seasonal Allergic Rhinitis The recommended dose of ASTELIN (azelastine HCl) Nasal Spray in adults and children 12 years and older with seasonal allergic rhinitis is two sprays per nostril twice daily. The recommended dose of ASTELIN (azelastine HCl) Nasal Spray in children 5 years to 11 years of age is one spray per nostril twice daily Vasomotor Rhinitis The recommended dose of ASTELIN (azelastine HCl) Nasal Spray in adults and children 12 years and older with vasomotor rhinitis is two sprays per nostril twice daily. Before initial use of ASTELIN (azelastine HCl), the screw cap on the bottle should be replaced with the pump unit and the delivery system should be primed with 4 sprays or until a fine mist appears. When 3 or more days have elapsed since the last use of ASTELIN (azelastine HCl), the pump should be reprimed with 2 sprays or until a fine mist appears.

For adults and children 12 years and older with seasonal allergic rhinitis or nonallergic vasomotor rhinitis, bitter taste, headache, somnolence, nasal burning and rhinitis are the most commonly reported Astelin side effects. ASTELIN Nasal Spray is contraindicated in patients with a known hypersensitivity to azelastine hydrochloride or any of its components.

Concurrent use of ASTELIN Nasal Spray with alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur. Cimetidine (400 mg twice daily) increased the mean Cmax and AUC of orally administered azelastine hydrochloride (4 mg twice daily) by approximately 65%. Ranitidine hydrochloride (150 mg twice daily) had no effect on azelastine pharmacokinetics. Interaction studies investigating the cardiac effects, as measured by the corrected QT interval (QTc), of concomitantly administered oral azelastine hydrochloride and erythromycin or ketoconazole were conducted. Oral erythromycin (500 mg three times daily for seven days) had no effect on azelastine pharmacokinetics or QTc based on analyses of serial electrocardiograms. Ketoconazole (200 mg twice daily for seven days) interfered with the measurement of azelastine plasma concentrations; however, no effects on QTc were observed. No significant pharmacokinetic interaction was observed with the coadministration of an oral 4 mg dose of azelastine hydrochloride twice daily and theophylline 300 mg or 400 mg twice daily.