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Following multiple doses in pediatric patients receiving 440 mcg/day, plasma drug concentrations, AUC, Cmax and Tmax were similar to those values observed in adult patients. In animal studies using rats and dogs, three metabolites of triamcinolone acetonide have been identified. They are 6ß-hydroxytriamcinolone acetonide, 21-carboxytriamcinolone acetonide and 21-carboxy-6ß-hydroxytriamcinolone acetonide. All three metabolites are expected to be substantially less active than the parent compound due to (a) the dependence of anti-inflammatory activity on the presence of a 21-hydroxyl group, (b) the decreased activity observed upon 6-hydroxylation, and (c) the markedly increased water solubility favoring rapid elimination. There appeared to be some quantitative differences in the metabolites among species. No differences were detected in metabolic pattern as a function of route of administration. In order to determine if systemic absorption plays a role in Nasacort AQ's treatment of allergic rhinitis symptoms, a two week double-blind, placebo-controlled clinical study was conducted comparing Nasacort AQ, orally ingested triamcinolone acetonide, and placebo in 297 adult patients with seasonal allergic rhinitis. The study demonstrated that the therapeutic efficacy of Nasacort AQ Nasal Spray can be attributed to the topical effects of triamcinolone acetonide. In order to evaluate the effects of systemic absorption on the Hypothalamic-Pituitary-Adrenal (HPA) axis, a clinical study was performed in adults comparing 220 mcg or 440 mcg Nasacort AQ per day, or 10 mg prednisone per day with placebo for 42 days. Text Continues Below
Adrenal response to a six-hour cosyntropin stimulation test showed that Nasacort AQ administered at doses of 220 mcg and 440 mcg had no statistically significant effect on HPA activity versus placebo. Conversely, oral prednisone at 10 mg/day significantly reduced the response to ACTH. A study evaluating plasma cortisol response thirty and sixty minutes after cosyntropin stimulation in 80 pediatric patients who received 220 mcg or 440 mcg (twice the maximum recommended daily dose) daily for six weeks was conducted. No abnormal response to cosyntropin infusion (peak serum cortisol <18 mcg/dL) was observed in any pediatric patient after six weeks of dosing with Nasacort AQ at 440 mcg per day. Page: << Prev | 1 | 2 | 3 | Next >>
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