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The 22R form was preferentially cleared with clearance value of 1.4 L/ min vs. 1.0 L/ min for the 22S form. The terminal half-life, 2 to 3 hours, was similar for both epimers and it appeared to be independent of dose. Special Populations Geriatric Text Continues Below
No specific pharmacokinetic study has been undertaken in subjects >65 years of age. Pediatric After administration of RHINOCORT AQUA Nasal Spray, the time to reach peak drug concentrations and plasma half-life were similar in chil-dren and in adults. Children had plasma concentrations approximately twice those observed in adults due primarily to differences in weight between children and adults. Gender No specific pharmacokinetic study has been conducted to evaluate the effect of gender on budesonide pharmacokinetics. However, following administration of 400 mcg RHINOCORT AQUA Nasal Spray to 7 male and 8 female volunteers in a pharmacokinetic study, no major gender differ-ences in the pharmacokinetic parameters were found. Race No specific study has been undertaken to evaluate the effect of race on budesonide pharmacokinetics. Renal Insufficiency The pharmacokinetics of budesonide have not been investigated in patients with renal insufficiency. Hepatic Insufficiency Reduced liver function may affect the elimination of corticosteroids. The pharmacokinetics of orally administered budesonide were affected by compromised liver function as evidenced by a doubled systemic availability. The relevance of this finding to intranasally adminis-tered budesonide has not been established. Pharmacodynamics A 3-week clinical study in seasonal rhinitis, comparing RHINOCORT Nasal Inhaler, orally ingested budesonide, and placebo in 98 patients with allergic rhinitis due to birch pollen, demonstrated that the therapeutic effect of RHINOCORT Nasal Inhaler can be attributed to the topical effects of budes-onide. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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