Penetration of clarithromycin into middle ear fluid of children with acute otitis media

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Abstract
To determine the steady state plasma and middle ear fluid concentrations of clarithromycin and its metabolite, 14(R)-hydroxyclarithromycin in 32 pediatric patients with acute otitis media. After the sixth dose of a 7.5-mg/kg every-12-h regimen of clarithromycin suspension, tympanocentesis was performed at 2, 4, 8 or 12 hours postdose. Plasma and middle ear fluid samples were assayed for concentrations of clarithromycin and its 14-hydroxy metabolite. Mean middle ear fluid concentrations ranged from 3.0 to 8.3 micrograms/g during the dosing interval for clarithromycin and from 1.5 to 3.8 micrograms/g for 14(R)-hydroxyclarithromycin. The mean middle ear fluid concentrations were consistently greater than corresponding mean plasma concentrations, which ranged from 0.7 to 3.4 micrograms/ml for clarithromycin and from 0.8 to 1.8 micrograms/ml for 14(R)-hydroxyclarithromycin. The ratios of middle ear fluid to plasma concentration appeared to increase during the dosing interval and were 8.8 and 3.8 for clarithromycin and 14(R)-hydroxyclarithromycin, respectively, 12 h after dosing. Multiple oral doses of clarithromycin suspension produced sustained middle ear fluid concentrations of clarithromycin and 14(R)-hydroxyclarithromycin which exceed the minimum inhibitory concentrations of most otic pathogens.

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