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Pharmacokinetics of ketoconazole and treatment evaluation in candidal infections
Insights
This study investigated ketoconazole treatment for pediatric candidiasis. A daily dose of 7-10 mg/kg is recommended for effective treatment and achieving therapeutic drug concentrations in children.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology
- Mycology
Background:
- Candidiasis is a significant fungal infection in children.
- Ketoconazole is an antifungal agent with varying efficacy in pediatric populations.
- Optimal dosing for pediatric candidiasis requires further investigation.
Purpose of the Study:
- To evaluate the efficacy and pharmacokinetics of ketoconazole in children with candidiasis.
- To determine appropriate ketoconazole dosage regimens for pediatric patients.
- To assess the safety and tolerability of ketoconazole in children.
Main Methods:
- A cohort of 26 children (5 months to 14 years) with various forms of candidiasis received ketoconazole.
- Treatment involved different formulations and daily doses ranging from 3 to 13 mg/kg for 7 days to 18 months.
- Pharmacokinetic studies were conducted in 22 children to assess drug concentrations.
Main Results:
- A daily dose of 8-10 mg/kg achieved therapeutic ketoconazole concentrations, unlike 3 mg/kg/day.
- Treatment was effective, with negative mycological tests in 88% and clinical cure in 73% of patients.
- Only mild side effects (nausea, pyrosis) were observed in 4 patients, with no laboratory abnormalities.
Conclusions:
- A daily ketoconazole dosage of 7-10 mg/kg, divided into two or three doses, is suggested for achieving therapeutic concentrations in children.
- Ketoconazole demonstrates good efficacy and safety for treating pediatric candidiasis.
- Further research may refine optimal dosing strategies for specific pediatric candidiasis presentations.
Abstract:
Twenty six children with candidiasis, aged between 5 months and 14 years, were treated with different formulations and regimens of ketoconazole. Fifteen children had alimentary tract candidiasis, two had oesophagitis, one had urinary tract candidiasis, two vaginitis, two septicaemia, one endo-ophthalmitis, and three had chronic pulmonary illness with persistence of Candida albicans in sputum. Daily drug doses ranged from 3 to 13 mg/kg and duration of treatment from seven days to 18 months. Pharmacokinetic studies in 22 of the children are reported. A total of 3 mg/kg/day given in three divided doses did not yield sufficiently high concentrations, which were achieved with a daily dose of 8 to 10 mg/kg. The effectiveness of treatment was proved by negative mycological tests (cultures or specific antibodies, or both) in 88%, by cure in 73%, and improvement in 11%. In three patients evaluation was not possible due to an insufficiently proved diagnosis. Nausea and pyrosis in four patients were the only side effects noted and no laboratory abnormalities were found. To achieve therapeutic concentrations of ketoconazole in children we suggest a daily dosage of 7 to 10 mg/kg in two or three divided doses.