Ofloxacin otic solution: a review of its use in the management of ear infections.

Abstract

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% produces very high concentrations of drug in the ear, thus broadening the spectrum 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 the treatment of otitis externa (clinical cure rate >80% in adults and >95% in children for both treatments) and oral amoxicillin/clavulanic acid in the treatment of otitis media in the presence of tympanostomy tubes in children (clinical cure rates 76 and 69% for ofloxacin and amoxicillin/clavulanic acid, respectively). It is also effective in the treatment of chronic suppurative otitis media in adolescents and adults with perforated tympanic membranes (75 to 91% clinical cure rate). Because of the limited systemic absorption after topical administration, ofloxacin otic solution 0.3% is well tolerated. Adverse events were usually classed as mild to moderate, with < or =2% considered severe. The most frequent adverse events were bitter taste (5%), primarily in patients with non-intact tympanic membranes, and pruritus (2%). The incidence of adverse events with ofloxacin otic solution 0.3% was similar to that with 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 in clinical studies in humans. Ofloxacin otic solution 0.3% is clinically effective in the treatment of otitis externa and otitis media in patients with tympanic membrane perforations or tympanostomy tubes. The high concentrations achieved with this ototopical solution render it active against a broad spectrum of organisms. It is well tolerated, avoiding many systemic adverse events, and is not associated with ototoxicity. As the first ototopical agent approved for use in patients with non-intact tympanic membranes, ofloxacin otic solution 0.3% provides a valuable advantage over current treatment alternatives.