Clinical and pharmacokinetic investigations of oral itraconazole in the treatment of onychomycosis

A clinical study was carried out in 19 patients with onychomycosis in whom itraconazole was orally administered in a single daily dose of 100 mg. A fo llow-up period was instituted subsequent to the administration period so th at the course of the nail lesions could be monitored. The concentrations of the drug in the plasma and in the nails were also determined. in patients in whom itraconazole was administered for 12-16 weeks, the decrease in the turbidity and thickening of the nails was maintained even after the adminis tration period was completed. The efficacy rating in the overall evaluation at 12 weeks was 84.2% (16/19). In the evaluation performed at 24 weeks, th e rating was 94.7% (18/19). These data indicate that the effect of itracona zole was maintained even after completion of the administration period. The retention of the drug in the nail after. completion of the administration period was investigated in terms of the mean concentration of the drug in t he nail with the passage of time in patients administered itraconazole for 10-16 weeks. It was found that a certain level of itraconazole was retained in the nail until at least the 24th week. Adverse reactions seen in this s tudy consisted of diarrhoea and drug eruption, one ease each, and elevation s of glutamic oxaloacctic transaminase and glutamic pyruvic transaminase in one case.