PERMETHRIN cream

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Padagis Israel Pharmaceuticals Ltd

INN:

PERMETHRIN

composition:

PERMETHRIN 50 mg in 1 g

administration_route:

TOPICAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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.

leaflet_short:

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

authorization_status:

Abbreviated New Drug Application

SPC

PERMETHRIN- PERMETHRIN CREAM
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
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
21
20
2
3
14
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
Permethrin Cream, 5% is indicated for the treatment of infestation
with _Sarcoptes scabiei_
(scabies).
CONTRAINDICATIONS
Permethrin C