Nasonex

[Mometasone]

Pediatric patients treated with NASONEX Nasal Spray, 50 mcg (100 mcg total daily dose, 374 patients) had a significant decrease in total nasal symptom (congestion, rhinorrhea, itching, and sneezing) scores, compared to placebo-treated patients. No additional benefit was observed for the 200-mcg mometasone furoate total daily dose in pediatric patients (ages 3 to 11 years). A total of 163 pediatric patients have been treated for 1 year. In patients with seasonal allergic rhinitis, NASONEX Nasal Spray, 50 mcg, demon-strated improvement in nasal symptoms (vs placebo) within 11 hours after the first dose based on one single-dose, parallel-group study of patients in an outdoor "park" setting(park study)and one environmental exposure unit (EEU) study, and within 2 days in two randomized, double-blind, placebo-controlled, parallel-group seasonal allergic rhinitis studies.

Maximum benefit is usually achieved within 1 to 2 weeks after initiation of dosing. Prophylaxis of seasonal allergic rhinitis for patients 12 years of age and older with Nasal Spray, 50 mcg, given at a dose of 200 mcg/ day, was evaluated in two clinical studies in 284 patients. These studies were designed such that patients received 4 weeks of prophylaxis with NASONEX Nasal Spray, 50 mcg prior to the anticipated onset of the pollen season; however, some patients received only 2 to 3 weeks of prophylaxis. Patients receiving 2 to 4 weeks of prophylaxis with NASONEX Nasal Spray, 50 mcg demonstrated a statistically significantly smaller mean increase in total nasal symptom scores with onset of the pollen season as compared to placebo patients.

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