PRECAUTIONS
General: If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued.
Information for Patients: May be irritating to mucous membranes of the eyes and contact with this area should be avoided.
There have been reports that use of the shampoo resulted in removal of the curl from permanently waved hair.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
The dominant lethal mutation test in male and female mice revealed that single oral doses of ketoconazole as high as 80 mg/kg produced no mutation in any stage of germ cell development. The Ames Salmonella microsomal activator assay was also negative. A long-term feeding study of ketoconazole in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity.
Pregnancy: Teratogenic effects: Pregnancy Category C:
Ketoconazole is not detected in plasma after chronic shampooing. Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (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 pregnant women. Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing mothers: Ketoconazole is not detected in plasma after chronic shampooing. Nevertheless, caution should be exercised when NIZORAL® (ketoconazole) 2% Shampoo is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in children have not been established.
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