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Severe hypersensitivity reactions, including anaphylaxis, have been reported during post-marketing use of NIZORAL® (ketoconazole) Shampoo. If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Long-term studies to assess the carcinogenic potential of NIZORAL® (ketoconazole) 2% Shampoo have not been conducted. A long-term feeding study of ketoconazole in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity. The dominant lethal mutation test in male and female mice revealed that single oral doses of ketoconazole as high as 80 mg/kg were not genotoxic. The Ames Salmonella microsomal activator assay was also negative.
Teratogenic effects - Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In humans, ketoconazole is not detected in plasma after chronic shampooing on the scalp.
Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (a dose 10 times the maximum recommended human oral dose). However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels.
There are no adequate and well-controlled studies in nursing women. Ketoconazole is not detected in plasma after chronic shampooing on the scalp. Caution should be exercised when NIZORAL® (ketoconazole) 2% Shampoo is administered to a nursing woman.
Safety and effectiveness in children have not been established.
Last reviewed on RxList: 12/14/2012
This monograph has been modified to include the generic and brand name in many instances.
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