PERMETHRIN cream

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Actavis Pharma, Inc.

INN (Mezinárodní Name):

PERMETHRIN

Složení:

PERMETHRIN 50 mg in 1 g

Podání:

TOPICAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Permethrin cream is indicated for the treatment of infestation with Sarcoptes scabiei (scabies). Permethrin cream is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin.

Přehled produktů:

Permethrin Cream 5% (wt./wt.) is supplied in 60 g tubes. Store at room temperature 15°-25°C (59°-77°F). Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 12/2019

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

PERMETHRIN- PERMETHRIN CREAM
ACTAVIS PHARMA, INC.
----------
PERMETHRIN CREAM 5%
RX ONLY
DESCRIPTION
Permethrin Cream 5% is a topical scabicidal agent for the treatment of
infestation with _Sarcoptes scabiei_
(scabies). It is available in a white to off-white, vanishing cream
base.
Permethrin cream is for topical use only.
STRUCTURAL FORMULA:
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.
Each gram contains permethrin 50 mg (5%) and the inactive ingredients
butylated hydroxytoluene,
carbomer 934P, coconut oil, glycerin, glyceryl stearate, isopropyl
myristate, lanolin alcohols, light
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
Permethrin cream is indicated for the treatment of infestation with
_Sarcoptes scabiei _(scabies).
21
20
2
3
14
CONTRAINDICATIONS
Permethrin cream is contraindicated in patients with known
hy