Permethrin Information
Permethrin () Description
Permethrin () Cream 5% is a topical scabicidal agent for the treatment of infestation with (scabies). It is available in a white to off-white, vanishing cream base.
Permethrin () cream is for topical use only.
Each gram contains Permethrin () 50 mg (5%) and the inactive ingredients butylated hydroxytoluene, carbomer 934P, coconut oil, glycerin, glyceryl stearate, isopropyl myristate, lanolin alcohols, light mineral oil, polyoxyethylene cetyl ethers, purified water, and sodium hydroxide. Formaldehyde 1 mg (01%) is added as a preservative.
Permethrin () Clinical Pharmacology
Permethrin () , a pyrethroid, is active against a broad range of pests including lice, ticks, fleas, mites, and other arthropods. It acts on the nerve cell membrane to disrupt the sodium channel current by which the polarization of the membrane is regulated. Delayed repolarization and paralysis of the pests are the consequences of this disturbance.
Permethrin () is rapidly metabolized by ester hydrolysis to inactive metabolites which are excreted primarily in the urine. Although the amount of Permethrin () absorbed after a single application of the 5% cream has not been determined precisely, data from studies with C-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 () Indications And Usage
Permethrin () cream is indicated for the treatment of infestation with (scabies).
Permethrin () Contraindications
Permethrin () cream is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin.
Permethrin () Warnings
If hypersensitivity to Permethrin () cream occurs, discontinue use.
Permethrin () Precautions
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 and 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.
Permethrin () Adverse Reactions
In clinical trials, generally mild and transient burning and stinging followed application with Permethrin () cream in 10% of patients and was associated with the severity of infestation. Pruritis was reported in 7% of patients at various times post-application. Erythema, numbness, tingling, and rash were reported in 1 to 2% or less of patients (see : ).
Permethrin () Overdosage
No instance of accidental ingestion of Permethrin () cream has been reported. If ingested, gastric lavage and general supportive measures should be employed.
Permethrin () Dosage And Administration
Adults and children: Thoroughly massage Permethrin () cream into the skin from the head to the soles of the feet. Scabies rarely infests the scalp of adults, although the hairline, neck, temple, and forehead may be infested in infants and geriatric patients. Usually 30 grams is sufficient for an average adult. The cream should be removed by washing (shower or bath) after 8 to 14 hours. Infants should be treated on the scalp, temple and forehead. ONE APPLICATION IS GENERALLY CURATIVE.
Patients may experience persistent pruritus after treatment. This is rarely a sign of treatment failure and is not an indication for retreatment. Demonstrable living mites after 14 days indicate that retreatment is necessary.
Permethrin () How Supplied
Permethrin () Cream 5% (wt./wt.) is supplied in 60 g tubes.
Store at room temperature 15°-25°C (59°-77°F).
Manufactured byActavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USA
FORM NO. 0242Rev. 8/06VC2882
