permethrin 10 MG/ML Medicated Shampoo [Nix Cream Rinse]

INDICATIONS AND USAGE ELIMITE ® (permethrin) 5% Cream is indicated for the treatment of infestation with Sarcoptes scabiei (scabies).

DOSAGE AND ADMINISTRATION Adults and Children - Thoroughly massage ELIMITE ® (permethrin) 5% 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.

WARNINGS If hypersensitivity to ELIMITE ® (permethrin) 5% Cream occurs, discontinue use.

CONTRAINDICATIONS ELIMITE ® (permethrin) 5% Cream is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin.

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 14 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.