Flonase

[Fluticasone]

Coadministration with ritonavir resulted in a significant increase in plasma fluticasone propionate exposure and a significant decrease (86%) in plasma cortisol area under the plasma concentration versus time curve (AUC). Coadministration with ketoconazole resulted in a slight increase in fluticasone propionate exposure and a 7% reduction in the area under the plasma cortisol AUC. Coadministration with erythromycin did not affect fluticasone propionate pharmacokinetics; there was a 2% reduction in the plasma cortisol AUC.

Caution should be exercised when potent cytochrome P450 3A4 inhibitors (e. g., ketoconazole) are coadministered with fluticasone propionate

Pharmacodynamics:

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In a trial to evaluate the potential systemic and topical effects of FLONASE Nasal Spray on allergic rhinitis symptoms, the benefits of comparable drug blood levels produced by FLONASE Nasal Spray and oral fluticasone propionate were compared. The doses used were 200 mcg of FLONASE Nasal Spray, the nasal spray vehicle (plus oral placebo), and 5 and 10 mg of oral fluticasone propionate (plus nasal spray vehicle) per day for 14 days. Plasma levels were undetectable in the majority of patients after intranasal dosing, but present at low levels in the majority after oral dosing. FLONASE Nasal Spray was significantly more effective in reducing symptoms of allergic rhinitis than either the oral fluticasone propionate or the nasal vehicle.

This trial demonstrated that the therapeutic effect of FLONASE Nasal Spray can be attributed to the topical effects of fluticasone propionate. In another trial, the potential systemic effects of FLONASE Nasal Spray on the hypothalamic-pituitary-adrenal (HPA) axis were also studied in allergic patients. FLONASE Nasal Spray given as 200 mcg once daily or 400 mcg twice daily was compared with placebo or oral prednisone 7.5 or 15 mg given in the morning. FLONASE Nasal Spray at either dose for 4 weeks did not affect the adrenal response to 6-hour cosyntropin stimulation, while both doses of oral prednisone significantly reduced the response to cosyntropin.

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