Pharmacokinetics of CIPRODEX((R)) otic in pediatric and adolescent patients.

Author(s): Spektor Z, Jasek MC, Jasheway D, Dahlin DC, Kay DJ, Mitchell R, Faulkner R, Wall GM

Affiliation(s): Center for Pediatric ENT-Head and Neck Surgery, 10301 Hagen Ranch Road Suite B-900, Boynton Beach, FL 33437, United States.

Publication date & source: 2008-01, Int J Pediatr Otorhinolaryngol., 72(1):97-102. Epub 2007 Nov 26.

Publication type:

OBJECTIVE: Describe the pharmacokinetics of ciprofloxacin and dexamethasone after administration of CIPRODEX((R)) 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 immediately following tube placement. Blood was collected for 6h and analyzed for ciprofloxacin and dexamethasone concentrations using a validated liquid chromatography and tandem mass spectrometry (LC/MS/MS) method. SETTING: The study was conducted through a referral pediatric otolaryngology practice 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 1h, with a mean C(max) of 1.33+/-0.96ng/mL (range <0.5-3.45ng/mL) and an estimated half-life of 3.0+/-1.2h. Peak dexamethasone plasma levels were observed within 2h with a mean C(max) of 0.90+/-1.04ng/mL (range <0.05-5.10ng/mL) and an estimated half-life of 3.9+/-2.9h. CONCLUSION: These results demonstrated low systemic exposure of ciprofloxacin and dexamethasone following topical otic administration in pediatric patients.