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.
Information about Nizoral.
The following adverse reactions have been identified during postapproval use of Nizoral tabletsBecause these reactions are reported voluntarily from a population of uncertain sizeit is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Serious hepatotoxicityincluding cases with a fatal outcome or requiring liver transplantationhas occurred with the use of oral ketoconazoleSome patients had no obvious risk factors for liver diseaseSerious hepatotoxicity was reported both by patients receiving high doses for short treatment durations and by patients receiving low doses for long durations.
Some medicines can interact with Nizoral and should not be used at the same timeYour doctor may need to change your treatment plan if you use any of the following drugsalprazolamcisapridedihydroergotaminedisopyramidedofetilidedronedaroneeplerenoneergotaminelovastatinmethadonemidazolamnisoldipinepimozidequinidineranolazinesimvastatinor triazolamCertain drug interactions can cause life-threatening irregular heartbeats.
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the following adverse drug reactions have been identified during post-marketing experience with nizoral ketoconazole shampoo there have been reports of hair discoloration and abnormal hair texture, itching, skin burning sensation, contact dermatitis, hypersensitivity, angioedema, alopecia, rash, urticaria, skin irritation, dry skin, and application site reactions.