KETOCONAZOLE HRA (ketoconazole), imidazole
ENDOCRINOLOGY - New medicinal product
Opinions on drugs -
Posted on
Sep 15 2015
Reason for request
Inclusion
- 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 Benefit
Substantial |
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Clinical Added Value
minor |
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Therapeutic use
- |
English version
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