Benzyl Alcohol Lotion 5% (Ulesfia™)
Pharmacology Update
Benzyl Alcohol Lotion 5% (Ulesfia™)
By William T. Elliott, MD, FACP, and James Chan, PharmD, PhD. Dr. Elliott is Chair, Formulary Committee, Northern California Kaiser Permanente; and Assistant Professor of Medicine, University of California, San Francisco. Dr. Chan is Pharmacy Quality and Outcomes Manager, Kaiser Permanente, Oakland, CA. Drs. Elliott and Chan report no financial relationship to this field of study.
Benzyl alcohol lotion is the latest product approved by the FDA for the treatment of head lice (Pediculosis capitis) infestation. Benzyl alcohol acts by inhibiting lice from closing their respiratory spiracles. This allows the vehicle, mineral oil, to facilitate obstruction of their airways and, ultimately, asphyxiation of the lice.1 The 5% lotion is marketed by Sciele Pharma as Ulesfia™.
Indications
Benzyl alcohol lotion is indicated for the topical treatment of head lice infestation in patients 6 months of age and older.1
Dosage
The lotion should be applied to dry hair and the dose is based on the length of the hair, varying from 4 to 6 oz for short hair (0-2 inches) up to 32-48 oz (> 33 inches).1 After 10 minutes the lotion should be rinsed off with water. Application should be repeated in 7 days. After the lotion has been washed off, a fine-tooth comb should be used to remove treated lice and nits from the hair and scalp. Use of the product in patients younger than 6 months of age is not recommended because of potential for increased systemic absorption due to high body surface to body mass ratio and immature skin barrier.1
Benzyl alcohol is available as a 5% lotion in 8 oz bottles.
Potential Advantages
Based on its mechanism of action, i.e., suffocating the lice, resistance to benzyl alcohol is unlikely to develop.
Potential Disadvantages
Benzyl alcohol is moderately effective (75% lice-free for 14 days) and is not an ovicide.1,2 Most common adverse events are pruritus (12%), erythema (10%), pyoderma (7%), and ocular irritation (6%).1
Comments
Benzyl alcohol is the latest product approved for the treatment of head lice. Efficacy was demonstrated in two multicenter, randomized, double-blind, vehicle-controlled studies in 250 subjects (6 months of age and older) with active head lice.1 Treatment involved 2 applications separated by 1 week. The proportions of subjects free of live lice 14 days after the last treatment were 76.2% for benzyl alcohol vs 4.8% for the vehicle in study 1 and 75% and 26.2%, respectively, for study 2.
Clinical Implications
Head lice are a common infestation in the United States among children 3-12 years of age. Approximately 6-12 million are infested annually.2 Permethrin 1% Crème rinse is currently the recommended treatment by the American Academy of Pediatrics. However, resistance to permethrin has been reported.3 In two recent studies, permethrin showed cure rates of 67.6% in one and 62-68% in the other.4,5 Malathion lotion is highly effective (98%) and is ovicidal but has an odor, a prolonged application time (8-12 hours), and is flammable.6 Benzyl alcohol lotion showed a cure rate of about 75% but is not an ovicide. It does provide another treatment option that appears to be similar to or marginally better than permethrin.
References
1. Ulesfia Product Labeling. Atlanta, GA: Sciele Pharma; April 2009.
2. Frankowski BL, et al; Committee on School Health, and Committee on Infectious Diseases. Head lice. Pediatrics 2002;110:638-643. Available at: http://aappolicy.aappublications.org/cgi/content/full/pediatrics;110/3/638. Accessed Nov. 4, 2009.
3. Heymann WR. Head lice treatments: Searching for the path of least resistance. J Am Acad Dermatol 2009;61:323-324.
4. Heukelbach J, et al. A highly efficacious pediculicide based on dimeticone: Randomized observer blinded comparative trial. BMC Infect Dis 2008;8:115.
5. Stough D, et al. Efficacy and safety of spinosad and permethrin crème rinses for Pediculosis capitis (head lice). Pediatrics 2009;124:e389-e395.
6. Benzyl alcohol lotion for head lice. Med Lett 2009; 51:57-58.
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