KWELLADA-P LOTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

PERMETHRIN

Dostopno od:

MEDTECH PRODUCTS INC

Koda artikla:

P03AC04

INN (mednarodno ime):

PERMETHRIN

Odmerek:

5%

Farmacevtska oblika:

LOTION

Sestava:

PERMETHRIN 5%

Pot uporabe:

TOPICAL

Enote v paketu:

100ML

Tip zastaranja:

OTC

Terapevtsko območje:

SCABICIDES AND PEDICULICIDES

Povzetek izdelek:

Active ingredient group (AIG) number: 0120085002; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2012-06-12

Lastnosti izdelka

PRODUCT MONOGRAPH
KWELLADA-P LOTION
Permethrin Lotion 5% w/w
Topical Scabicide
Date of Preparation: 20 June 2012
Medtech Products Inc.
90 N. Broadway
Tarrytown, NY 10591,USA
--------------------------------
Control No: 156219
1
PRODUCT
MONOGRAPH
NAME OF DRUG
KWELLADA-P LOTION
Permethrin Lotion 5% w/w
THERAPEUTIC CLASSIFICATION
Topical scabicide
ACTIONS AND CLINICAL PHARMACOLOGY
Permethrin, a synthetic pyrethroid, has a broad spectrum of
insecticidal activity combined with
high potency when applied topically to insects.
Like other pyrethroids permethrin is a sodium channel toxin. In
susceptible nerve cells small
amounts of permethrin cause a change in the kinetics of the sodium
channel. Although the
activation of the sodium current is unaffected, the rate of
inactivation of the current is greatly
slowed. This tail current, even at low doses, is adequate to cause
repetitive activity. One
normal action potential, in the presence of permethrin, leads to a
series of abnormal action
potentials. Consequently, there is repetitive firing of the neuron.
Clinical studies have demonstrated that permethrin is active against
_Sarcoptes scabiei_, scabies.
In clinical trials 5% permethrin was found to be an efficacious
treatment for scabies. After one
application of 5% permethrin lotion 93% of patients were cured at 28
days. At the interim
assessment at 14 days 37% were already cured and 61% were improving.
Only a very minimal amount of permethrin is absorbed when applied
topically. In a
bioavailability study it was determined that <0.032% of a topically
applied dose of 5%
permethrin lotion was absorbed.
2
INDICATIONS AND CLINICAL USE
Kwellada-P Lotion is indicated for the treatment of scabies _Sarcoptes
scabiei_. One application of
Kwellada-P Lotion is usually adequate to eradicate the infestation of
scabies. If new lesions
appear or live scabies mites are seen, a second treatment can occur
seven to ten days after the
initial treatment.
CONTRAINDICATIONS
Kwellada-P Lotion is contraindicated in patients with a known
sensitivity