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A Benefit-Risk Assessment of Ofloxacin Otic Solution in Ear Infection

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Abstract

Ofloxacin is a fluoroquinolone antibacterial with potent bactericidal activities and the topical otological preparation of this drug has been clinically utilised since the late 1980s. The rate of eradication with ofloxacin ranges from 83.3% to 100% for all pathogens commonly isolated from middle ear effusions in cases of otitis media and otitis externa. Despite the significant length of its usage, emergence of resistant pathogens has been rarely encountered in clinical trials; only two strains of Pseudomonas aeruginosa have been documented with decreased susceptibility to ofloxacin following the use of the otic solution.

Ear infections, including otitis externa, chronic suppurative otitis media and otorrhoea associated with tympanostomy tubes, are common problems in clinical practice. The potential complications associated with ear infection can be otological, extratemporal, or even psychosocial. They are sometimes fatal and the effect can be long-lasting and detrimental. The use of an effective topical antibacterial with high cost-effectiveness is definitely warranted. As regards various clinical aspects, including overall success rate, symptomatic relief of otalgia and otorrhoea, ofloxacin otic solution was found to be more effective than comparator agents, be it a topical antibacterial, a systemic antibacterial or combination drugs.

The systemic absorption of fluoroquinolones is minimal after topical application. Ofloxacin otic solution 0.3% has been shown to have a low rate of adverse drug reactions. Adverse reactions to ofloxacin otic solution were generally mild. The lack of ototoxic effect from ofloxacin eardrops, even in the concentration higher than 0.3%, has been demonstrated in animal studies. In the clinical setting, no increase in bone-conduction threshold has been shown after the treatment of topical ofloxacin otic solution. There have not been any reports of ototoxicity with ofloxacin otic solution since its approval.

To conclude, ofloxacin otic solution 0.3% is clinically effective in the treatment of otitis externa and chronic suppurative otitis media in particular with respect to the overall cure rate, relief of otalgia and otorrhoea. It is well tolerated, with minimal adverse effects. It is not associated with any ototoxicity both experimentally and clinically.

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Acknowledgments

The authors would like to thank Daiichi Pharmaceutical Corporation for supplying relevant information on global consumptions and studies on efficacies of the drug. This review was made possible by internal funding from the Department of Surgery of the Chinese University of Hong Kong, Hong Kong SAR, PRC.

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  1. Division of Otorhinolaryngology, Department of Surgery, University of Hong Kong, Prince of Wales Hospital, Shatin, New Territories, Hong Kong

    Talen K.H. Wai &  Michael C.F. Tong

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  1. Talen K.H. Wai
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Correspondence to Michael C.F. Tong.

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Wai, T.K., Tong, M.C. A Benefit-Risk Assessment of Ofloxacin Otic Solution in Ear Infection. Drug-Safety 26, 405–420 (2003). https://doi.org/10.2165/00002018-200326060-00003

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