title: Penetration of ceftibuten into middle ear fluid.
abstract: The penetration of ceftibuten, an extended-spectrum oral cephalosporin, into middle ear fluid (MEF) was evaluated in pediatric patients during a course of daily oral doses of 9 mg/kg of body weight for 10 days. Plasma and MEF collected at 2, 4, 6, or 12 h after at least 3 days of dosing were analyzed for ceftibuten by a high-pressure liquid chromatography method, and the data were used to calculate pharmacokinetic parameters. Plasma and MEF had almost identical maximum concentrations (Cmax) of ceftibuten (14 micrograms/ml). These Cmax values in MEF during acute otitis media were well in excess of the MIC for 90% of the isolates of each of four major pathogens in this disease. The time to Cmax was longer in MEF (4 h) than in plasma (2 h). Excellent penetration (71%) of ceftibuten into MEF was observed on the basis of the area under the curve ratio (MEF/plasma). These data clearly indicate that ceftibuten penetrated well into the MEF to yield clinically effective concentrations.
authors.affiliation: Department of Drug Metabolism and Pharmacokinetics, Schering-Plough Research Institute, Kenilworth, NJ 07033, USA.
authors.forename: C
authors.initials: C
authors.lastname: Lin
authors.forename: P
authors.initials: P
authors.lastname: Kumari
authors.forename: R J
authors.initials: RJ
authors.lastname: Perrotta
authors.forename: B E
authors.initials: BE
authors.lastname: Reidenberg
mesh_terms: D000208:Acute Disease; D000077722:Ceftibuten; D002511:Cephalosporins / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002675:Child, Preschool; D002851:Chromatography, High Pressure Liquid; D004432:Ear, Middle / Q000378:metabolism*; D006801:Humans; D007223:Infant; D010033:Otitis Media / Q000188:drug therapy* / Q000378:metabolism
chemical_list: D002511:Cephalosporins; D000077722:Ceftibuten