Elimination: The elimination rate of intravenous administered fluticasone propionate is linear over the 250-1000mcg dose range and are characterized by a high plasma clearance (CL=/min). Peak plasma concentrations are reduced by approximately 98% within 3-4 hours and only low plasma concentrations were associated with the terminal half-life. The renal clearance of fluticasone propionate is negligible (<%) and less than 5% as the carboxylic acid metabolite. The major route of elimination is the excretion of fluticasone propionate and its metabolites in the bile.
Results shown are from a 12-week, multicenter, randomized, double-blind, parallel-group study of 349 patients aged 12 years and older, with asthma (mean baseline forced expiratory volume in 1 second [FEV 1 ] 66% to 69% predicted) previously treated with medium doses of inhaled corticosteroids. Patients were randomized to treatment with ADVAIR DISKUS 250/50, fluticasone propionate 250 mcg, salmeterol 50 mcg, or placebo, each given twice daily through the DISKUS device. Patients were withdrawn from the study because of worsening asthma if they met any of the following criteria: a clinical exacerbation requiring emergency treatment, hospitalization, or use of asthma medication not allowed by the study protocol; a decrease in FEV 1 of more than 20% from the predose FEV 1 at the randomization visit; more than a 20% decrease from the mean morning baseline PEF (peak expiratory flow) on more than 3 of 7 days immediately preceding a visit; 12 or more albuterol puffs per day on more than 2 of 7 days immediately preceding a visit; or more than 2 nights with awakenings caused by asthma symptoms that required albuterol during the 7 days immediately preceding a clinic visit.
Withdraw systemic corticosteroid therapy gradually and monitor for objective signs of adrenal insufficiency (., fatigue, lassitude, weakness, nausea, vomiting, hypotension) during withdrawal of systemic therapy. 18 23 35 Also carefully monitor lung function (FEV 1 or morning PEF), adjunctive β 2 -adrenergic agonist use, and asthma symptoms. 23 35 Patients who have been maintained on ≥20 mg of prednisone (or its equivalent) daily may be most susceptible to such adverse events, particularly during the later part of the transfer. 18 35