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Quantifiable levels were observed in 15.1 % of paediatric patients following intranasal dosing of 110 micrograms once daily and only 6.8 % of paediatric patients following 55 micrograms once daily. Re-priming (approximately 6 sprays until a fine mist is seen) is only necessary if the cap is left off for 5 days or the intranasal device has not been used for 30 days or more.The device should be cleaned after each use and the cap replaced.Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.Systemic effects of nasal corticosteroid may occur, particularly at high doses prescribed for prolonged periods. Median fluticasone furoate concentrations in those subjects with quantifiable levels at 55 micrograms were 18.4 pg/mL and 18.9 pg/mL for 2-5 yrs and 6-11 yrs, respectively.At 110 micrograms, median concentrations in those subjects with quantifiable levels were 14.3 pg/mL and 14.4 pg/mL for 2-5 yrs and 6-11 yrs, respectively. When suggestions are available use up and down arrows to review and ENTER to select. The renal clearance of fluticasone propionate is negligible (<0.2%) and less than 5% as the carboxylic acid metabolite. Fluticasone furoate is widely distributed with volume of distribution at steady-state of, on average, 608 L.Fluticasone furoate is rapidly cleared (total plasma clearance of 58.7 L/h) from systemic circulation principally by hepatic metabolism to an inactive 17β-carboxylic metabolite (GW694301X), by the cytochrome P450 enzyme CYP3A4. The values are similar to those seen in adults (12+) where median concentrations in those subjects with quantifiable levels were 15.4 pg/mL and 21.8 pg/mL at 55 micrograms and 110 micrograms, respectively.Only a small number of elderly patients (≥ 65 years, n=23/872; 2.6 %) provided pharmacokinetic data. No evidence of clinically relevant changes in HPA axis function or bone mineral density was observed as assessed by 12-hour urinary cortisol excretion and dual-energy x-ray absorptiometry, respectively.Absorption: Following intranasal dosing of fluticasone propionate, (200mcg/day) steady-state maximum plasma concentrations were not quantifiable in most subjects (<0.01ng/mL). These events were transient in nature for six subjects in the fluticasone furoate group and one placebo subject. Following intranasal dosing of fluticasone propionate, (200mcg/day) no significant change in 24h serum cortisol AUC was found compared to placebo (ratio1.01, 90%CI 0.9-1.14).In a 1-year randomised, double-blind, placebo-controlled, parallel group growth study in pre-pubescent children aged 3 to 9 years (56 patients receiving intranasal fluticasone propionate and 52 receiving placebo,) no statistically significant difference in growth velocity was observed in patients receiving intranasal fluticasone propionate (200 micrograms per day nasal spray) compared to placebo. It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. At weeks 52 and 104, 95% of subjects in both treatment groups had posterior subcapsular opacity values within ± 0.1 of baseline values for each eye and, at week 104, ≤1% of subjects in both treatment groups had ≥0.3 increase from baseline in posterior subcapsular opacity. Fluticasone furoate 110 micrograms once daily was not associated with hypothalamic-pituitary-adrenal (HPA) axis suppression in adult, adolescent or paediatric subjects. Urinary excretion accounted for approximately 1 % and 2 % of the orally and intravenously administered dose, respectively.In the majority of patients fluticasone furoate is not quantifiable (< 10 pg/mL) following intranasal dosing of 110 micrograms once daily. Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression. The minimum dose should be used at which effective control of symptoms is maintained. The combination should be avoided unless the benefit outweighs the increased risk of systemic glucocorticoid side-effects.In a small study using inhaled fluticasone propionate in healthy volunteers, the slightly less potent CYP3A inhibitor ketoconazole increased the exposure of fluticasone propionate after a single inhalation by 150%.

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