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Pharmacokinetics: ADVAIR DISKUS: Following administration of ADVAIR DISKUS to healthy subjects, peak plasma concentrations of fluticasone propionate were achieved in 1 to 2 hours and those of salmeterol were achieved in about 5 minutes. In a single-dose crossover study, a higher than recommended dose of ADVAIR DISKUS was administered to 14 healthy subjects. Text Continues Below
Two (2) inhalations of the following treatments were administered: ADVAIR DISKUS 500/50, fluticasone propionate powder 500 mcg and salmeterol powder 50 mcg given concurrently, and fluticasone propionate powder 500 mcg alone. Mean peak plasma concentrations of fluticasone propionate averaged 107, 94, and 120 pg/mL, respectively, and of salmeterol averaged 200 and 150 pg/mL, respectively, indicating no significant changes in systemic exposures of fluticasone propionate and salmeterol. In a repeat-dose study, the highest recommended dose of ADVAIR DISKUS was administered to 45 patients with asthma. One (1) inhalation twice daily of the following treatments was administered: ADVAIR DISKUS 500/50, fluticasone propionate powder 500 mcg and salmeterol powder 50 mcg given concurrently, or fluticasone propionate powder 500 mcg alone. Mean peak steady-state plasma concentrations of fluticasone propionate averaged 57, 73, and 70 pg/mL, respectively, indicating no significant changes in systemic exposure of fluticasone propionate. No plasma concentrations of salmeterol were measured in this repeat-dose study. No significant changes in excretion of fluticasone propionate or salmeterol were observed. The terminal half-life of fluticasone propionate averaged 5.33 to 7.65 hours when ADVAIR DISKUS was administered, which is similar to that reported when fluticasone propionate was given concurrently with salmeterol or when fluticasone propionate was given alone (average, 5.30 to 6.91 hours). No terminal half-life of salmeterol was reported upon administration of ADVAIR DISKUS or salmeterol given concurrently with fluticasone propionate. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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