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Recently, you received an e-mail discussing how Ulesfia® Lotion is an effective non-neurotoxic head lice therapy. Even though we hope you have not had to deal with any instances of head lice in your school thus far this year, if you did, we hope you kept this information in mind while recommending a potential therapy.
Beyond its non-neurotoxic benefits–which may appeal to parents and children alike–Ulesfia® Lotion has significant efficacy. Clinical trials showed that 76% of patients had no live head lice 14 days after the second application.1
Continue to encourage parents to talk with their child’s doctor about all available treatment options, and if an efficacious, non-neurotoxic therapy may be right for them.
Indication
Ulesfia® (benzyl alcohol) Lotion is indicated for the topical treatment of head lice infestation in patients 6 months of age and older. Ulesfia® Lotion does not have ovicidal activity.
Important Safety Information
- Intravenous administration of products containing benzyl alcohol has been associated with neonatal gasping syndrome consisting of severe metabolic acidosis, gasping respirations, progressive hypotension, seizures, central nervous system depression, intraventricular hemorrhage, and death in preterm, low birth weight infants. Neonates (ie, patients less than 1 month of age or preterm infants with a corrected age of less than 44 weeks) could be at risk for gasping syndrome if treated with Ulesfia® Lotion. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse
- Avoid eye exposure. Ulesfia® Lotion may cause eye irritation. If Ulesfia® Lotion comes in contact with the eyes, flush them immediately with water
- Ulesfia® Lotion may cause allergic or irritant dermatitis
- Ulesfia® Lotion should only be used on children (6 months of age and older) under the direct supervision of an adult. Keep out of reach of children
- Most common application site adverse reactions were: site irritation (2%), and site anesthesia and hypoesthesia (2%), and pain (1%)
- The most common adverse reactions are: pruritus, erythema, pyoderma, and ocular irritation
To report suspected adverse reactions, contact Concordia Pharmaceuticals Inc. at 1-877-370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Reference: 1. Ulesfia® (benzyl alcohol) Lotion 5% [package insert]. Florham Park, NJ: Shionogi Inc; 2012.
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