Topical Ciprofloxacin/Dexamethasone Otic Suspension Is Superior to Ofloxacin Otic Solution in the Treatment of Children With Acute Otitis Media With Otorrhea Through Tympanostomy Tubes

Abstract

ABSTRACT. Objective. To determine the efficacy and safety of topical ciprofloxacin/dexamethasone otic suspension compared with ofloxacin otic solution in the treatment of acute otitis media with otorrhea through tympanostomy tubes (AOMT) in pediatric patients.Methods. This multicenter, prospective, randomized, observer-masked, parallel-group study was conducted at 39 sites in 599 children aged >6 months to 12 years with an AOMT episode of <3 weeks' duration. The mean age of patients was 2.5 years (standard deviation: 2.37 years). Patients received either ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension 4 drops twice daily for 7 days or ofloxacin 0.3% otic solution 5 drops twice daily for 10 days. Clinical signs and symptoms of AOMT were evaluated at clinic visits on days 1 (baseline), 3 (on therapy), 11 (end of therapy), and 18 (test of cure). A patient diary was used to measure time to cessation of otorrhea. Principal pretherapy pathogens included Streptococcus pneumoniae (16.8%), Staphylococcus aureus (13.0%), Pseudomonas aeruginosa (12.7%), Haemophilus influenzae (12.4%), S epidermidis (10.2%), and Moraxella catarrhalis (4.1%).Results. Ciprofloxacin/dexamethasone is superior to ofloxacin for clinical cure (90% vs 78%) and microbiologic success (92% vs 81.8%) at the test-of-cure visit, produces fewer treatment failures (4.4% vs 14.1%), and results in a shorter median time to cessation of otorrhea (4 days vs 6 days). Ciprofloxacin/dexamethasone treatment is also superior to improvement in clinical response by visit, absence of otorrhea by visit, and reduction of otorrhea volume by visit. Both topical otic preparations are safe and well tolerated in pediatric patients. No change in speech recognition threshold or decrease in hearing from baseline, based on audiometric testing, was noted with either regimen.Conclusion. Topical ciprofloxacin/dexamethasone treatment is superior to topical ofloxacin in the treatment of AOMT. Pediatrics 2004;113:e40 -e46. URL: http://www. pediatrics.org/cgi/content/full/113/1/e40; ciprofloxacin, dexamethasone, ofloxacin, otorrhea, AOM, tympanostomy tubes.ABBREVIATIONS. AOMT, acute otitis media with otorrhea through tympanostomy tubes; CSOM, chronic suppurative otitis media; TOC, test of cure; ITT, intention-to-treat.T he most common surgery performed in children for treatment of recurrent otitis media with effusion is the insertion of a tympanostomy tube into the eardrum. 1 However, otorrhea is a common complication after their insertion. The vast majority (90%-95%) of cases of acute otitis media with otorrhea through tympanostomy tubes (AOMT) occur in children aged 1 to 12 years, and typically 2 to 6 episodes of AOMT are experienced. 2,3 Topical ciprofloxacin is an effective and safe therapy for AOMT 4,5 and chronic suppurative otitis media (CSOM). 6 -8 Bacteria commonly isolated from patients with AOMT include Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, and Pseudomonas aeruginosa. 3 Because of the inflammatory response indu...

Ciprofloxacin/dexamethasone drops decrease the incidence of physician and patient outcomes of otorrhea after tube placement

“…Ciprodex demonstrates no ototoxicity in animal studies [15] and in clinical trials with patients with TTs, ciprofloxacin demonstrates a favorable safety profile with no detrimental effects on hearing [16][17][18]. One clinical question is whether the steroid component will slow healing of the tympanic membrane, resulting in an increase number of tympanic membrane perforations.…”

Topical Application of Mitomycin C in Combination with Dexamethasone: Effective Delay of Myringotomy Closure

“…Results of our study suggest that multiple dexamethasone applications during the postoperative period might help to reduce the number of necessary reapplications of MMC or even substitute a repetition. Dexamethasone is a content of different otic preparations and has been proven safe and well tolerated in pediatric patients with tympanostomy tubes [23] . Even dexamethasone given intratympanically does not adversely affect the outer hair cell function measured by otoacoustic emission in humans [24] .…”

Pharmacokinetics of CIPRODEX® otic in pediatric and adolescent patients

“…The efficacy of ciprofloxacin/dexamethasone treatment for the management of chronic otitis media with otorrhea has been well documented [12][13][14]. This study is the first to demonstrate the low systemic exposure of ciprofloxacin and dexamethasone following topical otic administration of CIP/DEX combination product in the middle ears of pediatric patients.…”

“…The relative anti-inflammatory activity of dexamethasone is $25-fold greater than that for cortisol (hydrocortisone) and $7-fold greater than that for prednisolone or prednisone [8]. Currently, most of the information available concerning the safety of steroids in the human middle ear is derived from animal data [6,[9][10][11], and a few ototopical [12][13][14] and intratympanic [15] studies in humans.…”