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Patient Info
Information for Patients
Patients being treated with NASONEX Nasal Spray, 50 mcg should be given the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all intended or possible adverse effects. Patients should use NASONEX Nasal Spray, 50 mcg at regular intervals (once daily) since its effectiveness depends on regular use. Improvement in nasal symptoms of allergic rhinitis has been shown to occur 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 after the first dose in two randomized, double-blind, placebo-controlled, parallel-group seasonal allergic rhinitis studies. Text Continues Below
Maximum benefit is usually achieved within 1 to 2 weeks after initiation of dosing. Patients should take the medication as directed and should not increase the prescribed dosage by using it more than once a day in an attempt to increase its effectiveness. Patients should contact their physician if symptoms do not improve, or if the condition worsens. To assure proper use of this nasal spray, and to attain maximum benefit, patients should read and follow the accompanying Patient's Instructions for Use carefully. Administration to young children should be aided by an adult. Patients should be cautioned not to spray NASONEX Nasal Spray, 50 mcg into the eyes or directly onto the nasal septum. Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles, and patients should also be advised that if they are exposed, medical advice should be sought without delay. Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses of 67 mcg/ kg (approximately 3 and 2 times the maximum recommended daily intranasal dose in adults and children, respectively, on a mcg/ m 2 basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/ kg (approximately 3 and 2 times the maximum recommended daily intranasal dose in adults and children, respectively, on a mcg/ m 2 basis). Page: 1 | 2 | 3 | 4 | 5 | Next >>
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