Страна: Канада
мова: англійська
Джерело: Health Canada
PERMETHRIN
MEDTECH PRODUCTS INC
P03AC04
PERMETHRIN
5%
LOTION
PERMETHRIN 5%
TOPICAL
100ML
OTC
SCABICIDES AND PEDICULICIDES
Active ingredient group (AIG) number: 0120085002; AHFS:
APPROVED
2012-06-12
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 Прочитайте повний документ