[Ketoconazole treatment of candidiasis in children: clinico-pharmacokinetic study].

Twenty-one children, age range 5 mo - 14 yrs, affected by candidosis, were treated with ketoconazole (tablets or suspension). Patients had alimentary tract involvement (12), oesophagitis (1), urinary tract candidosis (3), vaginitis (2), septicaemia (1), endophtalmitis (1) and chronic pulmonary illness with persistence of Candida albicans in sputum (3). Daily drug doses ranged from 3 to 13 mg/Kg and treatment period from 7 days to 14 months. Pharmacokinetic study in 15 children showed large individual variability of drug serum levels. Pharmacokinetic parametres, related to different schedules of the two ketoconazole formulations (tablets and suspension) are reported; drug levels after chronic administration are also evaluated. A daily dose of 3 mg/Kg of ketoconazole suspension, given in 3 administrations, did not result in sufficiently high levels, which indeed were obtained with a daily dose of 10 mg/Kg (3.3 X 3). The effect of treatment is proven by negativization of cultures in 90% of patients, by disappearance of clinical signs in 67% by improvement in 9%. The therapeutic effect on the remaining 24% (5 patients) is not evaluable. Adverse effects were only nausea and pyrosis in four cases; no laboratory abnormalities were found. A daily dosage from 7 to 10 mg/Kg, in two or three administrations, is suggested to obtain therapeutic levels in children.