Ketoconazole HRA is indicated for the treatment of endogenous Cushing's syndrome in adults and adolescents above the age of 12 years. Treatment should be initiated and supervised by physicians experienced in endocrinology or internal medicine and having the appropriate facilities for monitoring biochemical responses since the dose must be adjusted to meet patient's therapeutic need, based on the normalization of the cortisol level.

This product is a subject to additional monitoring in order to allow quick identification of new safety information.


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