The safety and effectiveness of NASONEX Nasal Spray 50 mcg for allergic rhinitis in children 12 years of age and older have been established [see Adverse Reactions (6.1) and Clinical Studies (14.1)]. Use of NASONEX Nasal Spray 50 mcg for allergic rhinitis in pediatric patients 2 to 11 years of age is supported by safety and efficacy data from clinical studies. Seven hundred and twenty (720) patients 3 to 11 years of age with allergic rhinitis were treated with mometasone furoate nasal spray 50 mcg (100 mcg total daily dose) in controlled clinical trials [see Adverse Reactions (6.1) and Clinical Studies (14.2)]. Twenty-eight (28) patients 2 to 5 years of age with allergic rhinitis were treated with mometasone furoate nasal spray 50 mcg (100 mcg total daily dose) in a controlled trial to evaluate safety [see Adverse Reactions (6.1)]. Safety and effectiveness of Nasonex Nasal Spray 50 mcg for allergic rhinitis in children less than 2 years of age have not been established.

The safety and effectiveness of Nasonex Nasal Spray for the treatment of nasal polyps in children less than 18 years of age have not been established. One 4-month trial was conducted to evaluate the safety and efficacy of Nasonex in the treatment of nasal polyps in pediatric patients 6 to 17 years of age. The primary objective of the study was to evaluate safety; efficacy parameters were collected as secondary endpoints. A total of 127 patients with nasal polyps were randomized to placebo or Nasonex Nasal Spray 100 mcg once or twice daily (patients 6 to 11 years of age) or 200 mcg once or twice daily (patients 12 to 17 years of age). The results of this trial did not support the efficacy of Nasonex Nasal Spray in the treatment of nasal polyps in pediatric patients. The adverse events reported in this trial were similar to the adverse events reported in patients 18 years of age and older with nasal polyps.

Controlled clinical studies have shown intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for "catch up" growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including NASONEX Nasal Spray, 50 mcg, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, including NASONEX Nasal Spray, 50 mcg, each patient should be titrated to his/her lowest effective dose.

A clinical study to assess the effect of NASONEX Nasal Spray 50 mcg (100 mcg total daily dose) on growth velocity has been conducted in pediatric patients 3 to 9 years of age with allergic rhinitis. No statistically significant effect on growth velocity was observed for NASONEX Nasal Spray 50 mcg compared to placebo following one year of treatment. No evidence of clinically relevant HPA axis suppression was observed following a 30-minute cosyntropin infusion.

The potential of NASONEX Nasal Spray 50 mcg to cause growth suppression in susceptible patients or when given at higher doses cannot be ruled out.