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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. 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. Ketoconazole can cause elevated plasma concentrations of these drugs and may prolong QT intervals, sometimes resulting in life-threatening ventricular dysrhythmias such as torsades de pointes. Ketoconazole, USP is a synthetic broad-spectrum antifungal agent. Each tablet, for oral administration, contains mg ketoconazole, USP base. Mean peak plasma concentrations of approximately 3. Oral bioavailability is maximal when the tablets are taken with a meal.

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