Ofloxacin otic solution - A review of its use in the management of ear infections

Ofloxacin is a synthetic fluoroquinolone antibacterial agent that inhibits the supercoiling activity of bacterial DNA gyrase, halting DNA replication. Ofloxacin has been formulated as a 0.3% otic solution for the treatment of ear infections. Topical administration of ofloxacin otic solution 0.3% pro duces very high concentrations of drug in the ear. thus broadening the spec trum of activity of ofloxacin greatly to cover most common ear pathogens. Results of clinical trials indicate that ofloxacin otic solution 0.3% is as effective as topical neomycin/polymixin B/hydrocortisone preparations in t he treatment of otitis externa (clinical cure rate >80% in adults and >95% in children for both treatments) and oral amoxicillin/clavulanic acid in th e treatment of otitis media in the presence of tympanostomy tubes in childr en (clinical cure rates 76 and 69% for ofloxacin and amoxicillin/clavulanic acid, respectively). It is also effective in the treatment of chronic supp urative otitis media in adolescents and adults with perforated tympanic mem branes (75 to 91% clinical cure rate). Because of the limited systemic absorption after topical administration, of loxacin otic solution 0.3% is well tolerated. Adverse events were usually c lassed as mild to moderate, with less than or equal to 2% considered severe , The most frequent adverse events were bitter taste (5%), primarily in pat ients with non-intact tympanic membranes, and pruritis (2%). The incidence of adverse events with ofloxacin otic solution 0.3% was similar to that wit h other ototopical preparations and significantly less than that with oral amoxicillin/clavulanic acid. Unlike comparative ototopical antibacterials, ofloxacin was not ototoxic or chondrotoxic in animal studies. In addition, no ototoxicity was detected i n clinical studies in humans. Conclusions: Ofloxacin otic solution 0.3% is clinically effective in the tr eatment of otitis externa and otitis media in patients with tympanic membra ne perforations or tympanostomy tubes. The high concentrations achieved wit h this ototopical solution render it active against a broad spectrum of org anisms. It is well tolerated. avoiding many systemic adverse events, and is not associated with ototoxicity. As the first ototopical agent approved fo r use in patients with non-intact tympanic membranes, ofloxacin otic soluti on 0.3% provides a valuable advantage over current treatment alternatives.