he diaper area, as diapers or plastic pants may constitute occlusive dressings. geriatric use: in studies where geriatric patients (65 years of age or older, see precautions ) have been treated with fluticasone propionate cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

ty study. fluticasone propionate cream was applied twice daily for 3 to 4 weeks over an arithmetic mean body surface area of 64% (range, 35% to 95%). the mean morning cortisol levels with standard deviations before treatment (prestimulation mean value = 13.76 ± 6.94 mcg/dl, poststimulation mean value = 30.53 ± 7.23 mcg/dl) and at end treatment (prestimulation mean value = 12.32 ± 6.92 mcg/dl, poststimulation mean value = 28.84 ± 7.16 mcg/dl) showed little change. in 2 of 43 (4.7%) patients with end-treatment results, peak cortisol levels following cosyntropin stimulation testing were < 18 µg/dl, indicating adrenal suppression. follow-up testing after treatment discontinuation, available for 1 of the 2 subjects, demonstrated a normally responsive hpa axis. local drug-related adverse events were transient burning, resolving the same day it was reported; transient urticaria, resolving the same day it was reported; erythematous rash; dusky erythema, resolving within 1 month after cessation of fluticasone propionate cream; and telangiectasia, resolving within 3 months after stopping fluticasone propionate cream. the following local adverse reactions have been reported infrequently with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. these reactions are listed in an approximately decreasing order of occurrence: irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. also, there are reports of the development of pustular psoriasis from chronic plaque psoriasis following reduction or discontinuation of potent topical corticosteroid products. to report suspected adverse reactions, contact cosette pharmaceuticals, inc. at 1-800-922-1038 or fda at 1-800-fda-1088 or www.fda.gov/medwatch . table1 table2

receptor complex. the half-life of the fluticasone propionate-glucocorticoid receptor complex is approximately 10 hours. studies performed with fluticasone propionate cream indicate that it is in the medium range of potency as compared with other topical corticosteroids. pharmacokinetics: absorption: the activity of fluticasone propionate cream is due to the parent drug, fluticasone propionate. the extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. occlusive dressing enhances penetration. topical corticosteroids can be absorbed from normal intact skin. inflammation and/or other disease processes in the skin increase percutaneous absorption. in a human study of 12 healthy males receiving 12.5 g of 0.05% fluticasone propionate cream twice daily for 3 weeks, plasma levels were generally below the level of quantification (0.05 ng/ml). in another study of 6 healthy males administered 25 g of 0.05% fluticasone propionate cream under occlusion for 5 days, plasma levels of fluticasone ranged from 0.07 to 0.39 ng/ml. in an animal study using radiolabeled 0.05% fluticasone propionate cream and ointment preparations, rats received a topical dose of 1 g/kg for a 24-hour period. total recovery of radioactivity was approximately 80% at the end of 7 days. the majority of the dose (73%) was recovered from the surface of the application site. less than 1% of the dose was recovered in the skin at the application site. approximately 5% of the dose was absorbed systemically through the skin. absorption from the skin continued for the duration of the study (7 days), indicating a long retention time at the application site. distribution: following intravenous administration of 1 mg fluticasone propionate in healthy volunteers, the initial disposition phase for fluticasone propionate was rapid and consistent with its high lipid solubility and tissue binding. the apparent volume of distribution averaged 4.2 l/kg (range, 2.3 to 16.7 l/kg). the percentage of fluticasone propionate bound to human plasma proteins averaged 91%. fluticasone propionate is weakly and reversibly bound to erythrocytes. fluticasone propionate is not significantly bound to human transcortin. metabolism: no metabolites of fluticasone propionate were detected in an in vitro study of radiolabeled fluticasone propionate incubated in a human skin homogenate. the total blood clearance of systemically absorbed fluticasone propionate averages 1,093 ml/min (range, 618 to 1,702 ml/min) after a 1-mg intravenous dose, with renal clearance accounting for less than 0.02% of the total. fluticasone propionate is metabolized in the liver by cytochrome p450 3a4-mediated hydrolysis of the 5-fluoromethyl carbothioate grouping. this transformation occurs in 1 metabolic step to produce the inactive 17-ß-carboxylic acid metabolite, the only known metabolite detected in man. this metabolite has approximately 2,000 times less affinity than the parent drug for the glucocorticoid receptor of human lung cytosol in vitro and negligible pharmacological activity in animal studies. other metabolites detected in vitro using cultured human hepatoma cells have not been detected in man. excretion: following intravenous dose of 1 mg in healthy volunteers, fluticasone propionate showed polyexponential kinetics and had an average terminal half-life of 7.2 hours (range, 3.2 to 11.2 hours).

eatment are shown in table 6. table3 table4 table5 table6