PENETRATION OF AZITHROMYCIN INTO MIDDLE-EAR EFFUSIONS IN ACUTE AND SECRETORY OTITIS-MEDIA IN CHILDREN

In an open-label study, the concentrations of azithromycin in middle e ar effusions and plasma were determined in 29 children between 1 and 8 years of age with a diagnosis of either secretory otitis media of at least 1 month's duration or acute otitis media. Azithromycin (10 mg/kg ) was administered as a single dose 12, 24 or 48 h before the insertio n of tympanostomy tubes to 17 children with secretory otitis media and once daily for 5 days (10 mg/kg on day 1, 5 mg/kg on days 2-5) to 12 children with acute otitis media. In the 16 evaluable patients with se cretory otitis media, azithromycin penetrated middle ear effusions, wi th group mean concentrations approximately two orders of magnitude gre ater than the concurrent plasma concentrations 12, 24 and 48 h after a dministration. Similar plasma:effusion ratios were found 24 and 48 h a fter starting once-daily therapy in 10 evaluable patients with acute o titis media.