Elimite Warnings, Precautions, Pregnancy, Nursing, Abuse - Permethrin

Elimite Warnings, Precautions, Pregnancy, Nursing, Abuse - Permethrin

WARNINGS

If hypersensitivity to ELIMITE® occurs, discontinue use.

General:   Scabies infestation is often accompanied by pruritus, edema and erythema. Treatment with ELIMITE® may temporarily exacerbate these conditions.

Information for patients:   Patients with scabies should be advised that itching, mild burning and/or stinging may occur after application of ELIMITE®. In clinical trials approximately 75% of patients treated with ELIMITE® who continued to manifest pruritus at 2 weeks had cessation by 4 weeks. If irritation persists, they should consult their physician. ELIMITE® may be very mildly irritating to the eyes. Patients should be advised to avoid contact with eyes during application and to flush with water immediately if ELIMITE® gets in the eyes.

Carcinogenesis, mutagenesis, impairment of fertility:   Six carcinogenicity bioassays were evaluated with permethrin, three each in rats and mice. No tumorigenicity was seen in the rat studies. However, species-specific increases in pulmonary adenomas, a common benign tumor of mice of high spontaneous background incidence, were seen in the three mouse studies. In one of these studies there was an increased incidence of pulmonary alveolar-cell carcinomas and benign liver adenomas only in female mice when permethrin was given in their food at a concentration of 5000 ppm. Mutagenicity assays, which give useful correlative data for interpreting results from carcinogenicity bioassays in rodents, were negative. Permethrin showed no evidence of mutagenic potential in a battery of in vitro and in vivo genetic toxicity studies.

Permethrin did not have any adverse effect on reproductive function at a dose of 180 mg/kg/day orally in a three-generation rat study.

Pregnancy: teratogenic effects:   Pregnancy Category B: Reproduction studies have been performed in mice, rats, and rabbits (200 to 400 mg/kg/day orally) and have revealed no evidence of impaired fertility or harm to the fetus due to permethrin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing mothers:   It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the evidence for tumorigenic potential of permethrin in animal studies, consideration should be given to discontinuing nursing temporarily or withholding the drug while the mother is nursing.

Pediatric use:   ELIMITE® is safe and effective in pediatric patients two months of age and older. Safety and effectiveness in infants less than two months of age have not been established.