Pharmacokinetics of CIPRODEX® otic in pediatric and adolescent patients

Zorik Spektor, Mark C. Jasek, Dan Jasheway, David C. Dahlin, David J. Kay, Ron Mitchell, Robert Faulkner, G. Michael Wall

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

Abstract

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 <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. Conclusion: These results demonstrated low systemic exposure of ciprofloxacin and dexamethasone following topical otic administration in pediatric patients.

Original languageEnglish (US)
Pages (from-to)97-102
Number of pages6
JournalInternational Journal of Pediatric Otorhinolaryngology
Volume72
Issue number1
DOIs
StatePublished - Jan 1 2008

Keywords

  • Acute otitis externa
  • Acute otitis media
  • Ciprofloxacin
  • Dexamethasone
  • Pharmacokinetics
  • Tympanostomy tubes

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Otorhinolaryngology

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