Ciprofloxacin plus fluocinolone acetonide versus ciprofloxacin alone in the treatment of diffuse otitis externa

Abstract

Ciprofloxacin plus fluocinolone acetonide is a more effective treatment for diffuse otitis externa than ciprofloxacin alone. The ciprofloxacin plus fluocinolone acetonide combination also has an excellent safety profile.

Efficacy and Safety of Ciprofloxacin Plus Fluocinolone in Otitis Media With Tympanostomy Tubes in Pediatric Patients

“…1,18,20 Two studies revealed the superiority of topical treatment with ciprofloxacin and dexamethasone combination compared w ith oral amoxicillin-clavulanate 1 and topical ofloxacin. 21 A previously published trial 18 also confirmed an overall clinical cure rate advantage and a shorter TCO when comparing the topical administration of ciprofloxacin and dexamethasone combination with ciprofloxacin alone in children with AOMT. That study found a 1-day difference in reduction of otorrhea when a combination of antibiotic and steroid medication was used.…”

“…This combination has proved to be a safe and effective treatment, with superior levels of clinical efficacy and bacteriologic response to those obtained with ciprofloxacin alone. 21 This article presents the results of 2 clinical studies (Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients [CIFLOTIII/10IA02] and Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients [CIFLOTIII/ 10IA04]) designed to evaluate the efficacy and safety of topical ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, otic solution relative to ciprofloxacin, 0.3%, otic solution alone and fluocinolone acetonide, 0.025%, otic solution alone in children with AOMT.…”

Efficacy and safety of fluocinolone acetonide 0.025% otic solution in patients with otic eczema: a randomized, double-blind, placebo-controlled clinical trial

“…These results concur with previous studies demonstrating the good tolerability of fluocinolone acetonide treatment. 17 – 19 In two RCTs, fluocinolone acetonide 0.01% in peanut oil showed a good efficacy response, 20 , 21 although this formulation raised concerns about possible peanut-derived allergies. Multiple single-entity and combination products containing fluocinolone acetonide at 0.01% and 0.025% have been commercialized in different formulations (creams, ointments, oils, ophthalmic solutions).…”

“…Multiple single-entity and combination products containing fluocinolone acetonide at 0.01% and 0.025% have been commercialized in different formulations (creams, ointments, oils, ophthalmic solutions). 16 – 19 The only product specifically indicated for otic eczema and approved by the FDA is an oil formulation of fluocinolone acetonide at 0.01%. In the present study, fluocinolone acetonide was assessed at 0.025% based on previous results reporting the safety and good tolerability of this fluocinolone concentration in combination with antibiotics, 17 , 18 with the hypothesis that 0.025% fluocinolone acetonide would achieve high biological activity and induce a rapid response, at a minimum risk of AEs.…”

“… 16 – 19 The only product specifically indicated for otic eczema and approved by the FDA is an oil formulation of fluocinolone acetonide at 0.01%. In the present study, fluocinolone acetonide was assessed at 0.025% based on previous results reporting the safety and good tolerability of this fluocinolone concentration in combination with antibiotics, 17 , 18 with the hypothesis that 0.025% fluocinolone acetonide would achieve high biological activity and induce a rapid response, at a minimum risk of AEs. In addition, otic solutions can release high local concentrations of the active ingredient within the external auditory canal, 26 thus becoming efficacious alternatives to other formulations, such as ointments or creams.…”