PERMETHRIN cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PERMETHRIN (UNII: 509F88P9SZ) (PERMETHRIN - UNII:509F88P9SZ)

Available from:

H.J. Harkins Company, Inc.

INN (International Name):

PERMETHRIN

Composition:

PERMETHRIN 50 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Permethrin Cream, 5% (w/w) is available as follows: 60 g tube (NDC 45802-269 -37)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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