KWELLADA-P LOTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

PERMETHRIN

זמין מ:

MEDTECH PRODUCTS INC

קוד ATC:

P03AC04

INN (שם בינלאומי):

PERMETHRIN

כמות:

5%

טופס פרצבטיות:

LOTION

הרכב:

PERMETHRIN 5%

מסלול נתינה (של תרופות):

TOPICAL

יחידות באריזה:

100ML

סוג מרשם:

OTC

איזור תרפויטי:

SCABICIDES AND PEDICULICIDES

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2012-06-12

מאפייני מוצר

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