Pharmacokinetics of CIPRODEX otic in pediatric and adolescent patients.
OBJECTIVE
Describe the pharmacokinetics of ciprofloxacin and dexamethasone after administration of CIPRODEX Otic Suspension (CIP/DEX) into the middle ears of children.


METHODS
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.


METHODS
The study was conducted through a referral pediatric otolaryngology practice with actual surgical procedures performed in an ambulatory care center.


METHODS
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+/-0.96 ng/mL (range <0.5-3.45 ng/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+/-1.04 ng/mL (range <0.05-5.10 ng/mL) and an estimated half-life of 3.9+/-2.9h.


CONCLUSIONS
These results demonstrated low systemic exposure of ciprofloxacin and dexamethasone following topical otic administration in pediatric patients.
Center for Pediatric ENT-Head and Neck Surgery, 10301 Hagen Ranch Road Suite B-900, Boynton Beach, FL 33437, USA.
Zorik
Z
Spektor
Mark C
MC
Jasek
Dan
D
Jasheway
David C
DC
Dahlin
David J
DJ
Kay
Ron
R
Mitchell
Robert
R
Faulkner
G Michael
GM
Wall
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D002853:Chromatography, Liquid; D002939:Ciprofloxacin / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D003907:Dexamethasone / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D004338:Drug Combinations; D004432:Ear, Middle; D005260:Female; D006207:Half-Life; D006801:Humans; D007223:Infant; D008297:Male; D008876:Middle Ear Ventilation / Q000295:instrumentation; D053719:Tandem Mass Spectrometry
D004338:Drug Combinations; D002939:Ciprofloxacin; D003907:Dexamethasone