ELIMITE- permethrin cream
Prestium Pharma, Inc.
PERMETHRIN) 5%*
*W/W
Rx Only
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
Chemical Name - The permethrin used is an approximate 1:3 mixture of the cis and trans isomers of the pyrethroid 3-(2,2-dichloroethenyl)-2, 2-dimethylcyclopropanecarboxylic acid, (3-phenoxyphenyl) methyl ester. Permethrin has a molecular formula of C21 H20 CI2 O3 and a molecular weight of 391.29. It is a yellow to light orange-brown, low melting solid or viscous liquid.
Active Ingredient - Each gram contains permethrin 50 mg (5%).
Inactive Ingredients - Butylated hydroxytoluene, carbomer homopolymer type B, 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 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.
INDICATIONS AND USAGE
ELIMITE� (permethrin) 5% Cream is indicated for the treatment of infestation with Sarcoptes scabiei (scabies).
CONTRAINDICATIONS
ELIMITE� (permethrin) 5% Cream is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin.
WARNINGS
If hypersensitivity to ELIMITE� (permethrin) 5% Cream occurs, discontinue use.
PRECAUTIONS
General -
Scabies infestation is often accompanied by pruritus, edema, and erythema. Treatment with ELIMITE� (permethrin) 5% Cream 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� (permethrin) 5% Cream. 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. 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.
