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Elimination: Following intravenous administration, the effective plasma elimination half-life of mometasone furoate is 5.8 hours. Any absorbed drug is excreted as metabolites mostly via the bile, and to a limited extent, into the urine. Special Populations Text Continues Below
The effects of renal impairment, hepatic impairment, age, or gender on mometasone furoate pharmacokinetics have not been adequately investi-gated. Pharmacodynamics Three clinical pharmacology studies have been conducted in humans to assess the effect of NASONEX Nasal Spray, 50 mcg at various doses on adrenal function. In one study, daily doses of 200 and 400 mcg of NASONEX Nasal Spray, 50 mcg and 10 mg of prednisone were compared to placebo in 64 patients with allergic rhinitis. Adrenal function before and after 36 consecutive days of treatment was assessed by measuring plasma cortisol levels following a 6-hour Cortrosyn (ACTH) infusion and by measuring 24-hour urinary-free cortisol levels. NASONEX Nasal Spray, 50 mcg, at both the 200-and 400-mcg dose, was not associated with a statistically significant decrease in mean plasma cortisol levelspost-Cortrosyninfusion or a statistically significant decrease in the 24-hour urinary-free cortisol levels com-pared placebo. A statistically significant decrease in the mean plasma cortisol levels post-Cortrosyn infusion and 24-hour urinary-free cortisol levels was detected in the prednisone treatment group compared to placebo. A second study assessed adrenal response to NASONEX Nasal Spray, 50 mcg (400 and 1600 mcg/ day), prednisone (10 mg/ day), and placebo, administered for 29 days in 48 male volunteers. The 24-hour plasma cortisol area under the curve (AUC0-24), during and after an 8-hour Cortrosyn infusion and 24-hour urinary-free cor-tisol levels were determined at baseline and after 29 days of treatment. No statistical-ly significant differences of adrenal function were observed with NASONEX Nasal Spray, 50 mcg compared to placebo. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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