Pharmacokinetics of CIPRODEX® otic in pediatric and adolescent patients

SummaryObjectiveDescribe the pharmacokinetics of ciprofloxacin and dexamethasone after administration of CIPRODEX® Otic Suspension (CIP/DEX) into the middle ears of children.DesignOpen-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.SettingThe study was conducted through a referral pediatric otolaryngology practice with actual surgical procedures performed in an ambulatory care center.PatientsTwenty-five randomly selected patients, 1–14 years of age (mean age, 5 years), receiving tympanostomy tubes.ResultsPeak ciprofloxacin plasma levels were observed at about 1 h, with a mean Cmax 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 Cmax 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.ConclusionThese results demonstrated low systemic exposure of ciprofloxacin and dexamethasone following topical otic administration in pediatric patients.