Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
PERMETHRIN (UNII: 509F88P9SZ) (PERMETHRIN - UNII:509F88P9SZ)
H.J. Harkins Company, Inc.
PERMETHRIN
PERMETHRIN 50 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Permethrin Cream, 5% is indicated for the treatment of infestation with Sarcoptes scabiei (scabies). Permethrin Cream, 5% is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin.
Permethrin Cream, 5% (w/w) is available as follows: 60 g tube (NDC 45802-269 -37)
Abbreviated New Drug Application
PERMETHRIN - PERMETHRIN CREAM H.J. HARKINS COMPANY, INC. ---------- PERMETHRIN CREAM, 5%* _PERMETHRIN CREAM, 5%*_ _*W/W_ _RX ONLY_ DESCRIPTION Permethrin Cream, 5% is a topical scabicidal agent for the treatment of infestation with _Sarcoptes scabiei_ (scabies). It is available in an off-white, vanishing cream base. Permethrin Cream, 5% 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 C H Cl O 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 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 21 20 2 3 14 Permethrin Cream, 5% is indicated for the treatment of infestation with _Sarcoptes scabiei_ (scabies). CONTRAINDI Läs hela dokumentet