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PRECAUTIONS General Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients (see PRECAUTIONS, Pediatric Use Section). Text Continues Below
In clinical studies with NASONEX Nasal Spray, 50 mcg, the development of infections of the nose and pharynx with Candida albicans has occurred only rarely.When such an infection develops, use of NASONEX Nasal Spray, 50 mcg should be discontinued and appropriate local or systemic therapy instituted, if needed. Nasal corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infection of the respiratory tract, or in untreated fungal, bacterial, systemic viral infections, or ocular herpes simplex. Rarely, immediate hypersensitivity reactions may occur after the intranasal adminis-tration of mometasone furoate monohydrate. Extremely rare instances of wheezing have been reported. Rare instances of nasal septum perforation and increased intraocular pressure have also been reported following the intranasal application of aerosolized corticosteroids.
As with any long-term topical treatment of the nasal cavity, patients using NASONEX Nasal Spray, 50 mcg over several months or longer should be examined periodically for possible changes in the nasal mucosa. Because of the inhibitory effect of corticosteroids onwound healing, patients who have experienced recent nasal septum ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred. Glaucoma and cataract formation was evaluated in one controlled study of 12 weeks' duration and one uncontrolled study of 12 months' duration in patients treated with NASONEX Nasal Spray, 50 mcg at 200 mcg/ day, using intraocular pressure measure-ments and slit lamp examination. No significant change from baseline was noted in the mean intraocular pressure measurements for the 141 NASONEX-treated patients in the 12-week study, as compared with 141 placebo-treated patients. No individual NASONEX-treated patient was noted to have developed a significant elevation in intraocular pressure or cataracts in this 12-week study. Likewise, no significant change from baseline was noted in the mean intraocular pressure measurements for the 139 NASONEX-treated patients in the 12-month study and again, no cataracts were detect-ed in these patients. Page: << Prev | 1 | 2 | 3 | Next >>
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