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XOLEGEL is flammable. Avoid being near fire, flame, or smoking during and immediately following application of XOLEGEL.
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 topically administered ketoconazole.
XOLEGEL can cause local irritation at the application site. If irritation occurs or if the disease worsens, use of the medication should be discontinued and the health care provider should be contacted [see ADVERSE REACTIONS].
Patient Counseling Information
[See FDA-Approved Patient Labeling (PATIENT INFORMATION)]
- This medication is to be used as directed by the health care provider. It is for external use only.
- XOLEGEL may be irritating to mucus 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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
The carcinogenic potential of ketoconazole gel has been evaluated in a 2-year dermal carcinogenicity study in CD-1 mice. Ketoconazole gel applied topically at doses up to 80 mg ketoconazole/kg/day (76 times the human dose) exhibited no evidence of dermal or systemic tumorigenic effects attributable to ketoconazole or the gel vehicle. 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.
Use In Specific Populations
Pregnancy Category C
There are no adequate and well controlled trials in pregnant women. XOLEGEL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Reproductive toxicity studies have not been performed with XOLEGEL. 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.
It is not known whether XOLEGEL is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when XOLEGEL is administered to a nursing woman.
If used during lactation and XOLEGEL is applied to the chest, care should be taken to avoid accidental ingestion by the infant.
Safety and effectiveness in pediatric subjects below the age of 12 have not been established.
Of the 933 subjects in the three safety and efficacy trials, 193 (20.7%) were 65 and older, while 61 (6.5%) were 75 and older. 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.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/22/2012
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