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Special Populations: Formal pharmacokinetic studies using ADVAIR DISKUS have not been conducted to examine gender differences or in special populations, such as elderly patients or patients with hepatic or renal impairment. Drug Interactions: Text Continues Below
In the repeat-and single-dose studies, there was no evidence of significant drug interaction in systemic exposure between fluticasone propionate and salmeterol when given as ADVAIR DISKUS. Fluticasone Propionate: Absorption: Fluticasone propionate acts locally in the lung; therefore, plasma levels do not predict therapeutic effect. Studies using oral dosing of labeled and unlabeled drug have demonstrated that the oral systemic bioavailability of fluticasone propionate is negligible (<1%), primarily due to incomplete absorption and presystemic metabolism in the gut and liver. In contrast, the majority of the fluticasone propionate delivered to the lung is systemically absorbed. The systemic bioavailability of fluticasone propionate from the DISKUS device in healthy volunteers averages 18%. Peak steady-state fluticasone propionate plasma concentrations in adult patients with asthma (N = 11) ranged from undetectable to 266 pg/mL after a 500-mcg twice-daily dose of fluticasone propionate inhalation powder using the DISKUS device. The mean fluticasone propionate
plasma concentration was 110 pg/mL. Peak steady-state fluticasone propionate plasma concentrations in subjects with COPD averaged 53 pg/mL (range, 19.3 to 159.3 pg/mL) after treatment with 250 mcg twice daily (N = 30) via the DISKUS device. Distribution: Following intravenous administration, the initial disposition phase for fluticasone propionate was rapid and consistent with its high lipid solubility and tissue binding. The volume of distribution averaged 4.2 L/kg. The percentage of fluticasone propionate bound to human plasma proteins averages 91%. Fluticasone propionate is weakly and reversibly bound to erythrocytes and is not significantly bound to human transcortin. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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