General: Xolegel Gel is for topical use only, and not for ophthalmic, oral or intravaginal use. If irritation occurs or if the disease worsens, use of the medication should be discontinued, and the health care provider should be contacted.
Hepatitis and, at high doses, lowered testosterone and ACTH induced corticosteroid serum levels have been seen with orally administered ketoconazole; these effects have not been seen with topical ketoconazole.
Information for Patients:
This medication is to be used as directed by the health care provider. It is for external use only.
Xolegel Gel may be irritating to mucous membranes. Contact with the eyes, nostrils and mouth should be avoided.
As with any topical medication, patients should wash their hands after application.
This medication should not be used for any disorder other than that for which it has been prescribed.
Patients should report any signs of adverse reactions to their health care provider.
Drug Interactions: Formal drug interaction studies with Xolegel Gel have not been performed.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies to assess the carcinogenic potential of Xolegel Gel have not been conducted. A long-term feeding study in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity. Ketoconazole gel at a dosage up to 5 mg/kg/dose is not photocarcinogenic when topically applied to hairless mice five days per week for a period of 40 weeks. Ketoconazole produced no evidence of mutagenicity in the dominant lethal mutation test in male and female mice at single oral doses up to 80 mg/kg. When tested in the Ames assay, ketoconazole was found to be non-mutagenic to Salmonella typhimurium in the presence and absence of metabolic activation. Ketoconazole, in combination with another drug, gave equivocal results in the mouse micronucleus test. At oral doses of 75 to 80 mg/kg/day (71 to 76 times the human dose) ketoconazole impaired the reproductive performance in female (decreased pregnancy and implantation rates) and male (increased abnormal sperm and decreased sperm motility) rats.
Pregnancy Category C: Reproductive toxicity studies have not been performed with Xolegel Gel. Ketoconazole was tested for its effects on offspring in the rat at oral doses of 10, 20, 40, 80, and 160 mg/kg. Ketoconazole was teratogenic (syndactylia and oligodactylia) at 80 mg/kg/day and embryotoxic at 160 mg/kg/day (76 and 152 times the human dose, respectively). However, these effects may be related to maternal toxicity, which was also seen at these dose levels.
Oral doses of 10, 20, 40, 80 and 160 mg/kg were studied in pre- and postnatal development studies in rats. Doses of 40 mg/kg (38 times the human dose) and above were associated with maternal toxicity, an increase in the length of gestation, and an increase in the number of stillborn fetuses. These doses of ketoconazole were also toxic to the offspring, resulting in a decrease in fetal/pup weights and viability.
There are no adequate and well controlled studies in pregnant women. Xolegel Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether Xolegel Gel is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Xolegel Gel is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 12 have not been established.
Geriatric Use: Of the 933 subjects in the three safety and efficacy studies, 193 (20.7%) were 65 and over, while 61 (6.5%) were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects but greater sensitivity of some older individuals cannot be ruled out.
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