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Two randomized, double-blind, parallel-group, multicenter, vehicle placebo-controlled 28-day trials were conducted in the United States in 732 patients (243 given FLONASE) 12 years of age and older to investigate "as-needed" use of FLONASE Nasal Spray (200 mcg) in patients with seasonal allergic rhinitis. Patients were instructed to take the study medication only on days when they thought they needed the medication for symptom control, not to exceed 2 sprays per nostril on any day, and not more than once daily. "As-needed" use was prospectively defined as average use of study medication no more than 75% of study days. Average use of study medications was 57% to 70% of days for all treatment arms. The studies demonstrated significantly greater reduction in TNSS (sum of nasal congestion, rhinorrhea, sneezing, and nasal itching) with FLONASE Nasal Spray 200 mcg compared to placebo. The relative difference in efficacy with as-needed use as compared to regularly administered doses was not studied. Three randomized, double-blind, parallel-group, vehicle placebo-controlled trials were conducted in 1,191 patients to investigate regular use of FLONASE Nasal Spray in patients with perennial nonallergic rhinitis. These trials evaluated the patient-rated TNSS (nasal obstruction, postnasal drip, rhinorrhea) in patients treated for 28 days of double-blind therapy and in 1 of the 3 trials for 6 months of open-label treatment. Two of these trials demonstrated that patients treated with FLONASE Nasal Spray at a dose of 100 mcg twice daily exhibited statistically significant decreases in TNSS compared with patients treated with vehicle. Text Continues Below
Individualization of Dosage Patients should use FLONASE Nasal Spray at regular intervals for optimal effect. Adult patients may be started on a 200-mcg once-daily regimen (two 50-mcg sprays in each nostril once daily). An alternative 200-mcg/ day dosage regimen can be given as 100 mcg twice daily (one 50-mcg spray in each nostril twice daily). Individual patients will experience a variable time to onset and different degree of symptom relief. In 4 randomized, double-blind, vehicle placebo-controlled, parallel-group allergic rhinitis studies and 2 studies of patients in an outdoor "park" setting (park studies), a decrease in nasal symptoms in treated subjects compared to placebo was shown to occur as soon as 12 hours after treatment with a 200-mcg dose of FLONASE Nasal Spray. Maximum effect may take several days. Regular-use patients who have responded may be able to be maintained (after 4 to 7 days) on 100 mcg/ day (1 spray in each nostril once daily). Some patients (12 years of age and older) with seasonal allergic rhinitis may find as-needed use of FLONASE Nasal Spray (not to exceed 200 mcg daily) effective for symptom control (see Clinical Trials). Greater symptom control may be achieved with scheduled regular use. Efficacy of as-needed use of FLONASE Nasal Spray has not been studied in pediatric patients under 12 years of age with seasonal allergic rhinitis, or patients with perennial allergic or nonallergic rhinitis. Pediatric patients (4 years of age and older) should be started with 100 mcg (1 spray in each nostril once daily). Treatment with 200 mcg (2 sprays in each nostril once daily or 1 spray in each nostril twice daily) should be reserved for pediatric patients not adequately responding to 100 mcg daily. Once adequate control is achieved, the dosage should be decreased to 100 mcg (1 spray in each nostril) daily. Maximum total daily doses should not exceed 2 sprays in each nostril (total dose, 200 mcg/ day). There is no evidence that exceeding the recommended dose is more effective. Page: << Prev | 1 | 2 | 3 | 4 | 5
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