General Info:

DESCRIPTION:

ELIMITE (permethrin) 5% Cream is a topical scabicidal agent for the treatment of infestation with Sarcoptes scabiei (scabies). It is available in an off-white, vanishing cream base. ELIMITE (permethrin) 5% Cream is for topical use only.

Active Ingredient:

Each gram contains permethrin 50 mg (5%).

Inactive Ingredients:

Butylated hydroxytoluene, carbomer 934 P, fractionated coconut oil, glycerin, glyceryl monostearate, isopropyl myristate, lanolin alcohols, mineral oil, polyoxyethylene cetyl ethers, purified water, and sodium hydroxide. Formaldehyde 1 mg (0.1%) is added as a preservative.

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 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.

INDICATIONS AND USAGE:

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

WARNINGS:

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

Scabies infestation is often accompanied by pruritus, edema and erythema. Treatment with ELIMITE (permethrin) 5% Cream may temporarily exacerbate these conditions.

Patients with scabies should be advised that itching, mild burning and/or stinging may occur after application of ELIMITE (permethrin) 5% Cream. In clinical trials approximately 75% of patients treated with ELIMITEr (permethrin) 5% Cream who continued to manifest pruritus at 2 weeks had cessation by 4 weeks. If irritation persists, they should consult their physician. ELIMITE (permethrin) 5% Cream 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 (permethrin) 5% Cream gets in the eyes.