Clinical and pharmacokinetic studies on S-1108 for otorhinolaryngological infection

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Clinical and pharmacokinetic studies of S-1108, a new oral cephem, produced the following results 1) Pharmacokinetic study The serum, maxillary mucosa and parotid gland concentrations of S-1006 were measured in eight patients with chronic sinusitis and three with parotid tumors, who were given single oral doses of 100 or 200mg.Peak serum levels were 0.49μg/ml at 90 minutes after administration of the lower dose and 0.69μg/ml at 150 minutes after administration of the higher dose. Maxillary mucosa concentrations were 0.32μg/g at the lower dose and that of the higher dose peaked 1.02 μg/g at 150 minutes after administration. Based on the results obtained S-1108 exhibited dose-related maxillary mucosa levels. 2) Clinical study Seven patients, 1 with acute exacerbation of chronic sinusitis, 1 with chronic sinusitis, 1 with acute otitis media, 2 with acute exacerbation of chronic otitis media, 1 with chronic otitis media and 1 with nasopharyngitis were given oral S-1108 100 mg×3/day or 200mg×3/day for 7-21 days. The clinical effects were excellent in 3, fair in 1 and poor in 2, excluding one patient with nasopharyngitis. One mild case of loose stools was observed, but there were no elevations of laboratory values. It was shown that S-1108 in an effective and useful oral antibiotic for the treatment of acute exacerbations of chronic sinusitis, chronic sinusitis and chronic otitis media.
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