![]() Geriatric Use -Ĭlinical studies of Elimite™ (permethrin) 5% Cream did not identify sufficient numbers of subjects aged 65 and over to allow a definitive statement regarding whether elderly subjects respond differently from younger subjects. Safety and effectiveness in infants less than two months of age have not been established. Pediatric Use -Įlimite™ (permethrin) 5% Cream is safe and effective in pediatric patients two months of age and older. 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. It is not known whether this drug is excreted in human milk. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. There are, however, no adequate and well-controlled studies in pregnant women. 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. Pregnancy: Teratorgenic Effects: Pregnancy Category B. 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. Permethrin showed no evidence of mutagenic potential in a battery of in vitro and in vivo genetic toxicity studies. ![]() Mutagenicity assays, which give useful correlative data for interpreting results from carcinogenicity bioassays in rodents, were negative. 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. 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. No tumorigenicity was seen in the rat studies. Six carcinogenicity bioassays were evaluated with permethrin, three each in rats and mice. Carcinogenesis, Mutagenesis, Impairment of Fertility. Patients should be advised to avoid contact with eyes during application and to flush with water immediately if Elimite™ (permethrin) 5% Cream gets in the eyes. Elimite™ (permethrin) 5% Cream may be very mildly irritating to the eyes. If irritation persists, they should consult their physician. In clinical trials, approximately 75% of patients treated with Elimite™ (permethrin) 5% Cream who continued to manifest pruritus at 2 weeks had cessation by 4 weeks. Patients with scabies should be advised that itching, mild burning and/or stinging may occur after application of Elimite™ (permethrin) 5% Cream. Treatment with Elimite™ (permethrin) 5% Cream may temporarily exacerbate these conditions. Scabies infestation is often accompanied by pruritus, edema, and erythema. If hypersensitivity to Elimite™ (permethrin) 5% Cream occurs, discontinue use. ContraindicationsĮlimite™ (permethrin) 5% Cream is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin. Indications and Usage for ElimiteĮlimite™ (permethrin) 5% Cream is indicated for the treatment of infestation with Sarcoptes scabiei(scabies). Although the amount of permethrin absorbed after a single application of the 5% cream has not been determined precisely, data from studies with 14C-labeled permethrin and absorption studies of the cream applied to patients with moderate to severe scabies indicate it is 2% or less of the amount applied. Permethrin is rapidly metabolized by ester hydrolysis to inactive metabolites which are excreted primarily in the urine. Delayed repolarization and paralysis of the pests are the consequences of this disturbance. It acts on the nerve cell membrane to disrupt the sodium channel current by which the polarization of the membrane is regulated. Permethrin, a pyrethroid, is active against a broad range of pests including lice, ticks, fleas, mites, and other arthropods. Related/similar drugs ivermectin topical, sodium chloride topical, permethrin topical, acetic acid topical, lindane topical, spinosad topical, Natroba Elimite - Clinical Pharmacology
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