In the 3-month, open label, active-controlled, safety trial in pediatric patients 6-11 years of age 264 patients (128 patients ≥ 6 to < 9 years of age, and 136 patients ≥ 9 to < 12 years of age) with allergic rhinitis (based on the Investigator's assessment) were treated with DYMISTA, 1 spray per nostril twice daily and 89 patients (44 patients ≥ 6 to < 9 years of age, and 45 patients ≥ 9 to < 12 years of age) were treated with fluticasone propionate nasal spray, 1 spray per nostril twice daily. Overall, adverse reactions were 40% in the DYMISTA treatment group and 36% in the fluticasone propionate nasal spray group. The most frequently reported adverse reactions ( ≥ 2%) with DYMISTA were epistaxis, headache, oropharyngeal pain, vomiting, upper abdominal pain, cough, pyrexia, otitis media, upper respiratory tract infection, diarrhea, nausea, otitis externa, and urticaria. In the DYMISTA treatment group 23 patients (9%) had mild epistaxis and 3 patients (1%) had moderate epistaxis. In the fluticasone propionate nasal spray treatment group 8 patients (9%) had mild epistaxis. No patients had reports of severe epistaxis. Focused nasal examinations were performed and no ulcerations or septal perforations were observed. Four of 264 patients (2%) treated with DYMISTA and 3 of 89 (3%) treated with fluticasone propionate nasal spray discontinued from the trial due to adverse events. There were two reports of somnolence, one severe, among children taking DYMISTA [see WARNINGS AND PRECAUTIONS ].
Decongestant nasal sprays are available over-the-counter in many countries. They work to very quickly open up nasal passages by constricting blood vessels in the lining of the nose. Prolonged use of these types of sprays can damage the delicate mucous membranes in the nose. This causes increased inflammation, an effect known as rhinitis medicamentosa or the rebound effect . Decongestant nasal sprays are advised for short-term use only, preferably 5 to 7 days at maximum. Some doctors advise to use them 3 days at maximum. A recent clinical trial has shown that a corticosteroid nasal spray may be useful in reversing this condition.  Topical nasal decongestants include: