Pharmacokinetics of CIPRODEX j otic in pediatric and adolescent patients § Zorik Spektor a , Mark C. Jasek b , Dan Jasheway b , David C. Dahlin b , David J. Kay a , Ron Mitchell c , Robert Faulkner b , G. Michael Wall b, * a Center for Pediatric ENT–—Head and Neck Surgery, 10301 Hagen Ranch Road Suite B-900, Boynton Beach, FL 33437, United States b Alcon Research Ltd., 6201 South Freeway, Fort Worth, TX 76134, United States c St. Louis University School of Medicine, Cardinal Glennon Children’s Hospital, 1465 South Grand, Suite 4740, St. Louis, MO 63104, United States Received 10 May 2007; received in revised form 24 September 2007; accepted 28 September 2007 Available online 26 November 2007 International Journal of Pediatric Otorhinolaryngology (2008) 72, 97—102 www.elsevier.com/locate/ijporl KEYWORDS Ciprofloxacin; Dexamethasone; Pharmacokinetics; Tympanostomy tubes; Acute otitis externa; Acute otitis media Summary Objective: Describe the pharmacokinetics of ciprofloxacin and dexamethasone after administration of CIPRODEX 1 Otic Suspension (CIP/DEX) into the middle ears of children. Design: Open-label, single-dose, pharmacokinetic studies, administering four drops of CIP/DEX instilled into each middle ear through the tympanostomy tubes immedi- ately following tube placement. Blood was collected for 6 h and analyzed for ciprofloxacin and dexamethasone concentrations using a validated liquid chromato- graphy and tandem mass spectrometry (LC/MS/MS) method. Setting: The study was conducted through a referral pediatric otolaryngology prac- tice with actual surgical procedures performed in an ambulatory care center. Patients: Twenty-five randomly selected patients, 1—14 years of age (mean age, 5 years), receiving tympanostomy tubes. Results: Peak ciprofloxacin plasma levels were observed at about 1 h, with a mean C max of 1.33  0.96 ng/mL (range <0.5—3.45 ng/mL) and an estimated half-life of 3.0  1.2 h. Peak dexamethasone plasma levels were observed within 2 h with a mean C max of 0.90  1.04 ng/mL (range <0.05—5.10 ng/mL) and an estimated half-life of 3.9  2.9 h. Conclusion: These results demonstrated low systemic exposure of ciprofloxacin and dexamethasone following topical otic administration in pediatric patients. # 2007 Elsevier Ireland Ltd. All rights reserved. § Presented in part at the American Society for Pediatric Otolaryngology Annual Meeting, Phoenix, AZ, May 2004. * Corresponding author. Tel.: +1 817 551 8104; fax: +1 817 615 3502. E-mail address: Michael.wall@alconlabs.com (G.M. Wall). 0165-5876/$ — see front matter # 2007 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.ijporl.2007.09.017