Oral ketoconazole (Nizoral) 200 mg tablets

Product deregistration

10 October 2013

Consumers and health professionals are advised that Janssen-Cilag (Australia), in consultation with the TGA, is deregistering and discontinuing supply of oral ketoconazole (Nizoral) 200 mg tablets, commencing 1 December 2013.

Oral ketoconazole is an antifungal medicine that kills or stops the growth of certain types of fungi or yeasts, which cause infection.

Liver injury is a known risk associated with oral ketoconazole treatment and, for this reason, a number of risk minimisation measures have been in place for a number of years.

Topical ketoconazole (Nizoral cream and shampoo) is not affected by this and will continue to be available.

Information for consumers

All medicines have risks and benefits. If you are being treated with oral ketoconazole, your doctor has weighed the risks of you taking this medicine against the benefits it is expected to have for you.

If you have been prescribed oral ketoconazole, do not stop using your medicine without first discussing it with your doctor. Also, consider talking to your doctor about switching to an alternative antifungal treatment.

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.

If you have any questions or concerns about this issue, speak to a health professional.

Information for health professionals

Janssen-Cilag (Australia) has written to health professionals to advise that it is deregistering and discontinuing supply of oral ketoconazole 200 mg tablets, commencing 1 December 2013.

Commencing treatment with oral ketoconazole for new patients is not recommended.

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 400 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 1800 226 334 or email medinfo@janau.jnj.com.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA’s monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.