Pharmacokinetics of CIPRODEX® otic in pediatric and adolescent patients

Summary Objective Describe the pharmacokinetics of ciprofloxacin and dexamethasone after administration of CIPRODEX® 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 6 h 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 1 h, with a mean Cmax of 1.33 ± 0.96 ng/mL (range