Nebenwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)
Ketoconazole Esteve 200 mg tablets · Abschnitt 4.8 · PDF-Seite 17
HOS-132896 · Präparat HOS-097310
Paediatric population Frequency of hepatotoxicity could be higher in adolescents than in adults. In the literature, among 24 paediatric patients treated with ketoconazole, two developed severe hepatoxicity. A 14 year-old girl who was treated for Cushing’s disease with ketoconazole 200 mg twice daily presented one month later with jaundice, fever anorexia, nausea and vomiting. Ketoconazole was stopped, but she deteriorated rapidly and died. A 17 years old girl was treated on ketoconazole 1,200 mg/day for an adrenal carcinoma with liver metastasis and had altered liver function tests at 22 days. After ketoconazole withdrawal, liver enzymes returned to normal levels within 3 weeks (section 5.1).
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