Ketoconazole Tablets

Because Ketoconazole Tablets have been associated with serious adverse reactions (see WARNINGS section), Ketoconazole Tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections.

Ketoconazole Tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks.

Hepatotoxicity

Serious hepatotoxicity, including cases with a fatal outcome or requiring liver transplantation has occurred with the use of oral ketoconazole. Some patients had no obvious risk factors for liver disease. Patients receiving this drug should be informed by the physician of the risk and should be closely monitored. See WARNINGS section.

QT Prolongation and Drug Interactions Leading to QT Prolongation

Co-administration of the following drugs with ketoconazole is contraindicated: dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedaron...