Ofloxacin otic solution in patients with otitis media - An analysis of drug concentrations

M. Ohyama et al., Ofloxacin otic solution in patients with otitis media - An analysis of drug concentrations, ARCH OTOLAR, 125(3), 1999, pp. 337-340
Citations number
Categorie Soggetti
Otolaryngology,"da verificare
Journal title
ISSN journal
0886-4470 → ACNP
Year of publication
337 - 340
SICI code
Objective: To measure the concentration of ofloxacin in otorrhea, serum, an d middle ear mucosa after topical administration of 0.3% ofloxacin otic sol ution. Design: Study of 0.3% ofloxacin otic solution administered in a single dose of 0.5 mL in adults or 0.25 mL in children with chronic suppurative otitis media and perforated tympanic membrane, with serial sampling of otorrhea a nd serum up to 8 hours after dosing and middle ear mucosa up to 2 hours aft er dosing. Setting: Three hospitals in Kagoshima, Japan. Patients: Thirty-eight patients (age range, 3-81 years) with chronic suppur ative otitis media and perforated tympanic membrane; 20 patients had sampli ng of otorrhea and serum and 18 patients (who required middle ear surgery) had middle ear mucosa and serum sampling. Results: High concentrations of ofloxacin were measured in otorrhea samples taken immediately after dosing, followed by a rapid, nonlogarithmic declin e. Elimination of the drug through otorrhea was believed to be related to l oss from the application site with ear drainage, rather than to biologic me chanisms. Maximum concentration of ofloxacin in otorrhea was seen at the in itial sampling time, 30 minutes after dosing, with concentrations measured up to the last sampling at 8 hours. Very low concentrations of ofloxacin we re found in serum after topical administration of the drug. Concentrations were not detected in serum samples of most of the patients. The highest con centration measured was 10 ng/mL. Drug concentrations were detected primari ly in samples obtained up to 1 hour after the dose was administered. Mucosa l drug concentrations were highly variable, ranging from nondetectable to 6 02 mu g/g. For the 6 bacterial strains isolated from the middle ear, the hi ghest minimum inhibitory concentration of ofloxacin was covered by otorrhea drug concentrations measured at up to 8 hours after dosing in some patient s. No adverse events were observed. No clinically significant adverse chang es in laboratory test results or audiometric results were observed. Conclusions: Drug concentrations were high in otorrhea, very low or not det ected in serum, and highly variable in middle ear mucosa. Nonbiologic loss of the drug with the ear drainage through the external auditory canal and e ustachian tube was probably related to the high concentration in otorrhea s amples. Drug concentrations in middle ear mucosa suggest that the drug reac hes the infection site.