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Pharmacokinetics of CIPRODEX otic in pediatric and adolescent patients

Zorik Spektor1, Mark C Jasek, Dan Jasheway

  • 1Center for Pediatric ENT-Head and Neck Surgery, 10301 Hagen Ranch Road Suite B-900, Boynton Beach, FL 33437, USA.

International Journal of Pediatric Otorhinolaryngology
|November 24, 2007
PubMed

Insights

This study assessed ciprofloxacin and dexamethasone pharmacokinetics in children receiving CIPRODEX Otic Suspension via tympanostomy tubes. Results showed low systemic exposure for both drugs after topical otic administration.

Area of Science:

  • Pediatric Otolaryngology
  • Pharmacokinetics
  • Otic Drug Delivery

Background:

  • Ciprofloxacin and dexamethasone are commonly used in otic preparations.
  • Tympanostomy tubes facilitate middle ear drug administration.
  • Understanding systemic absorption is crucial for pediatric safety.

Purpose of the Study:

  • To determine the pharmacokinetics of ciprofloxacin and dexamethasone.
  • To evaluate systemic exposure following topical otic administration of CIPRODEX Otic Suspension.
  • To assess drug levels in pediatric patients with tympanostomy tubes.

Main Methods:

  • Open-label, single-dose pharmacokinetic study.
  • Four drops of CIPRODEX Otic Suspension administered to each middle ear via tympanostomy tubes.
  • Blood samples collected for 6 hours and analyzed using LC/MS/MS.

Main Results:

  • Peak ciprofloxacin plasma levels (mean Cmax 1.33 ng/mL) observed around 1 hour, with a half-life of 3.0 hours.
  • Peak dexamethasone plasma levels (mean Cmax 0.90 ng/mL) observed within 2 hours, with a half-life of 3.9 hours.
  • Low systemic exposure demonstrated for both ciprofloxacin and dexamethasone.

Conclusions:

  • Topical otic administration of CIPRODEX Otic Suspension results in minimal systemic absorption in pediatric patients.
  • This supports the safety profile of ciprofloxacin and dexamethasone for otic use in children.
  • Pharmacokinetic data provides valuable insights for otic drug development in pediatrics.
Abstract

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