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6. For the proper use of FLOVENT DISKUS and to attain maximum improvement, the patient should read and follow carefully the Patient's Instructions for Use accompanying the product. Drug Interactions: In a placebo-controlled, crossover study in 8 healthy volunteers, coadministration of a single dose of fluticasone propionate (1000 mcg) with multiple doses of ketoconazole (200 mg) to steady state resulted in increased mean fluticasone propionate concentrations, a reduction in plasma cortisol AUC, and no effect on urinary excretion of cortisol. This interaction may be due to an inhibition of cytochrome P450 3A4 by ketoconazole, which is also the route of metabolism of fluticasone propionate. Care should be exercised when FLOVENT is coadministered with long-term ketoconazole and other known cytochrome P450 3A4 inhibitors. Text Continues Below
Carcinogenesis, Mutagenesis, Impairment of Fertility: Fluticasone propionate demonstrated no tumorigenic potential in mice at oral doses up to 1000 mcg/kg (approximately 2 times the maximum recommended daily inhalation dose in adults and approximately 10 times the maximum recommended daily inhalation dose in children on a mcg/m 2 basis) for 78 weeks or in FLOVENT DISKUS 50 mcg (fluticasone propionate inhalation powder, 50 mcg) FLOVENT DISKUS 100 mcg (fluticasone propionate inhalation powder, 100 mcg) FLOVENT DISKUS 250 mcg (fluticasone propionate inhalation powder, 250 mcg) 13 rats at inhalation doses up to 57 mcg/kg (less than the maximum recommended daily inhalation dose in adults and approximately equal to the maximum recommended daily inhalation dose in children on a mcg/m 2 basis) for 104 weeks. Fluticasone propionate did not induce gene mutation in prokaryotic or eukaryotic cells in vitro. No significant clastogenic effect was seen in cultured human peripheral lymphocytes in vitro or in the mouse micronucleus test. No evidence of impairment of fertility was observed in reproductive studies conducted in male and female rats at subcutaneous doses up to 50 mcg/kg (less than the maximum recommended daily inhalation dose in adults on a mcg/m 2 basis). Prostate weight was significantly reduced at a subcutaneous dose of 50 mcg/kg. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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