Ketoconzole contraindications

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Ketoconzole
Ketoconazole® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]

Contraindications

Ketoconazole tablets USP, 200 mg 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

  • QT Prolongation and Drug Interactions Leading to QT Prolongation

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

Drug Interactions

Coadministration of a number of CYP3A4 substrates is contraindicated with ketoconazole tablets. Coadministration with ketoconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and ventricular tachyarrhythmias including occurrences of torsades de pointes, a potentially fatal arrhythmia.

Liver Disease

The use of ketoconazole tablets is contraindicated in patients with acute or chronic liver disease.

Hypersensitivity

Ketoconazole tablets USP, 200 mg is contraindicated in patients who have shown hypersensitivity to the drug.[1]

References

  1. "KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]".

Adapted from the FDA Package Insert.