NASONEX is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis in patients 2 years and older.

NASONEX is indicated for the relief of nasal congestion associated with seasonal allergic rhinitis in patients 2 years and older.

NASONEX is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in patients 12 years and older when initiated 2 to 4 weeks prior to allergy season.

NASONEX is indicated for the treatment of nasal polyps in patients 18 years and older.

SELECTED SAFETY INFORMATION ABOUT NASONEX

In clinical studies with NASONEX, the development of localized infections of the nose and pharynx with Candida albicans has occurred. When such an infection develops, use of NASONEX should be discontinued and appropriate local or systemic therapy instituted, if needed.

Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septum ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.

Nasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

Hypersensitivity reactions including instances of wheezing may occur after the intranasal administration of mometasone furoate monohydrate. Discontinue NASONEX if such reactions occur.

Persons who are on drugs which suppress the immune system are more susceptible to infections. Chickenpox and measles, for example, can have a more serious or even fatal course in nonimmune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract, or in untreated fungal, bacterial, systemic viral infections, or ocular herpes simplex because of the potential for worsening of these infections.

When intranasal steroids are used at higher than recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of NASONEX should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy.

Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving NASONEX. To minimize the systemic effects of intranasal corticosteroids, including NASONEX, titrate each patient's dose to the lowest dosage that effectively controls his/her symptoms.

The adverse events >5% for NASONEX (vs placebo) in clinical studies for allergic rhinitis in adults and adolescents 12 years of age and older included: headache 26% (vs 22%), viral infection 14% (vs 11%), pharyngitis 12% (vs 10%), epistaxis 11% (vs 6%), coughing 7% (vs 6%), upper respiratory tract infection 6% (vs 2%), dysmenorrhea 5% (vs 3%), musculoskeletal pain 5% (vs 3%), and sinusitis 5% (vs 3%).

The adverse events >5% for NASONEX (vs placebo) in clinical studies for allergic rhinitis in pediatric patients ages 3 to 11 years included: upper respiratory tract infection 5% (vs 4%) and vomiting 5% (vs 4%).

The adverse event >5% for NASONEX (vs placebo) in clinical studies for allergic rhinitis in pediatric patients ages 2 to 5 years included: upper respiratory tract infection 7% (vs 0%).

The adverse events in clinical studies for nasal congestion associated with seasonal allergic rhinitis in patients ages 12 years and older that occurred more frequently in patients treated with NASONEX (vs placebo) included: sinus headache 1.2% (vs 0.2%), and epistaxis 1% (vs 0.2%); the overall adverse event profile was similar to that observed in other allergic rhinitis trials.

The types of adverse events observed in controlled clinical studies of patients 18 years of age and older with nasal polyps were similar to those observed for patients with allergic rhinitis. The overall incidence of adverse events for patients treated with NASONEX was comparable to placebo except for epistaxis, which was 9% for 200 mcg once daily, 13% for 200 mcg twice daily, and 5% for the placebo. Nasal ulcers and nasal and oral candidiasis were also reported in patients treated with NASONEX, primarily in patients treated for longer than 4 weeks.