ivermectin topical lotion（伊维菌素局部乳液）.docVIP

Ivermectin 0.5% Topical Lotion (Sklice) National Drug Monograph January 2013 VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives The purpose of VA PBM Services drug monographs is to provide a comprehensive drug review for making formulary decisions. These documents will be updated when new clinical data warrant additional formulary discussion. Documents will be placed in the Archive section when the information is deemed to be no longer current. Executive Summary: Ivermectin 0.5% topical lotion received FDA approval for the topical treatment of head lice infestation (Pediculosis humanus capitis) in patients 6 months of age and older. The regimen includes a single 10 minute application of ivermectin 0.5% topical lotion.1 Ivermectin 0.5% topical lotion binds with high affinity to glutamate-gated chloride channels which leads to a hyperpolarization of the nerve or muscle and results in paralysis and death of the parasite.2 Two pivotal, Phase III clinical trials were conducted to evaluate the efficacy and safety of the home use of ivermectin 0.5% topical lotion in the treatment of head lice. In these trials, ivermectin 0.5% topical lotion demonstrated superiority over a vehicle control in the proportion of patients who were lice free through 15 days after treatment (i.e., primary efficacy endpoint).3 Most common adverse effects (1% incidence) reported include: conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation. The 2010 American Academy of Pediatrics (AAP) Clinical Report on Head Lice as part of the Guidance for the Clinicians in Rendering Pediatric Care recommends 1% permethrin or pyrethrin as first-line therapy for treatment of head lice infestation in pediatrics unless resistance to these agents are circulating in the community. The AAP Clinical Report on Head Lice states that benzyl alcohol 5% and malathion can be used in individuals that failed first-line agents or known