If you are being treated with oral ketoconazole and experience any signs of liver injury, such as anorexia, nausea, vomiting, fatigue, jaundice, abdominal pain or dark urine, promptly seek medical attention. Janssen-Cilag Australia has written to health professionals to advise that it is deregistering and discontinuing supply of oral ketoconazole mg tablets, commencing 1 December If a patient is already being treated with oral ketoconazole, consider switching them to an alternative antifungal therapy.
If a patient continues taking oral ketoconazole, treatment duration should be restricted to a maximum of four weeks, with a maximum daily dose of less than or equal to mg. Monitoring of liver function is also strongly advised. If these tests indicate liver injury, you should stop treatment immediately. Instruct patients being treated with oral ketoconazole to promptly seek medical attention if they experience signs of liver injury, such as anorexia, nausea, vomiting, fatigue, jaundice, abdominal pain or dark urine.
The Product Information for oral ketoconazole includes important information regarding hepatotoxicity. If you have any questions or concerns about this issue, contact Janssen-Cilag Australia on or email medinfo janau. In summary, the drug label for Nizoral tablets has been updated to include the following information:.
FDA has also approved a new patient Medication Guide containing information on the potential risks associated with Nizoral tablets, which must be dispensed with every prescription for the drug. In addition to the indications for treatment of infections caused by dermatophytes and Candida, the previous US drug label also included indications for the following serious fungal infections: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis.
In the revised US drug label, indications for dermatophyte and Candida infections have been removed and the indications for treatment of blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis have been retained only for patients in whom other antifungal treatments have failed or are not tolerated.
FDA will continue to evaluate the safety of Nizoral tablets and will communicate with the public again if additional information becomes available. Serious hepatic injury was identified as the major toxicity for Nizoral tablets and was noted to be unrelated to dose, duration, or indication for treatment.
In conducting the benefit-risk assessment, spontaneous adverse event reports of ketoconazole-induced liver injury, including fatalities and liver transplantations, retrieved from the FDA Adverse Event Reporting System AERS were assessed independently by a hepatology expert in FDA. The overall risk for ketoconazole-induced serious liver injury appeared higher than that associated with other azole antifungal drugs as assessed from pharmacoepidemiologic studies.
One published study in the U. However, in view of various methodological limitations, there was uncertainty in quantifying precise estimates of the risk of acute liver injury for Nizoral tablets compared to other marketed oral azole antifungals.
Through its inhibition of the cytochrome P isoenzyme system, ketoconazole can block production of adrenal steroids.
This accounts for clinically important endocrinologic abnormalities observed in some patients particularly when the drug is administered at high dosages , including gynecomastia in men and menstrual irregularities in women.
The clearance of other co-administered drugs that are metabolized by CYP3A4 is decreased by ketoconazole and can result in increased drug concentrations in plasma, which can predispose patients to potentially serious adverse reactions including QT prolongation.
Thus, the co-administration of ketoconazole with some other drugs is restricted or contraindicated in the drug labels. In conclusion, ketoconazole should not be a first-line treatment for any fungal infection.
Ketoconazole is not recommended for the treatment of any form of candidiasis or any superficial fungal infection. Ketoconazole may be considered in the treatment of certain life-threatening systemic mycoses in patients for whom alternate antifungal drugs are not available or cannot be tolerated.
Liver Injury Hepatotoxicity Nizoral tablets can cause liver injury, which may potentially result in liver transplantation or death. Drug Interactions Nizoral tablets may interact with other drugs a patient is taking and can result in serious and potentially life-threatening outcomes, such as heart rhythm problems.
In summary, the drug label for Nizoral tablets has been updated to include the following information: Limitation of the usage of Nizoral tablets by removing indications in which the risk outweighs the benefits.
The use of ketoconazole tablets in Candida and dermatophyte infections is no longer indicated. Nizoral tablets should be used only when other antifungal drugs are not available or tolerated by the patient.
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