Hepatotoxicity; QT Prolongation and Drug Interactions
NIZORAL® 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. 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, dronedarone, ranolazine. 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. See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: Drug Interactions sections.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Monitor liver function tests and bilirubin at baseline and at frequent intervals during therapy.
- Use with caution with other potentially hepatotoxic drugs. Patients should be carefully monitored, particularly those requiring prolonged therapy or those who have had a history of liver disease.
- Patients should be instructed to report any symptoms and signs which may suggest liver dysfunction (e.g., unusual fatigue, anorexia, nausea and/or vomiting, jaundice, dark urine or pale stools)
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