KETOCONAZOLE HRA (ketoconazole), imidazole
ENDOCRINOLOGY - New medicinal product
Opinions on drugs - Posted on Sep 15 2015
Reason for request
- KETOCONAZOLE HRA has Marketing Authorisation in the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years.
- In retrospective studies with a number of methodological limitations, its efficacy was demonstrated by a reduction in 24-hour urinary free cortisol and in clinical symptoms and comorbidities, in particular arterial hypertension and diabetes.
- Because of the known hepatic toxicity of ketoconazole, regular monitoring of liver function and tailoring of the dosage are essential.
Clinical Added Value
Évaluation des médicaments