Ulesfia Information
Ulesfia (Benzyl) Dosage And Administration
Ulesfia (Benzyl) Lotion is not for oral, ophthalmic, or intravaginal use.
Using the guideline in Table1, apply sufficient Ulesfia (Benzyl) Lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat treatment after 7 days. Avoid contact with eyes.
Ulesfia (Benzyl) Dosage Form And Strength
Ulesfia (Benzyl) Lotion is a white topical lotion containing benzyl alcohol, 5% (50 mg/g of lotion).
Ulesfia (Benzyl) Contraindications
Ulesfia (Benzyl) Drug Interactions
Drug interaction studies were not conducted with Ulesfia (Benzyl) Lotion.
Ulesfia (Benzyl) Use In Specific Populations
The safety and effectiveness of Ulesfia (Benzyl) Lotion was evaluated in two multicenter, randomized, double-blind, vehicle-controlled studies which were conducted in 628 subjects 6 months of age and older with active head lice infestation .
Rates of adverse events in younger children (6 months to 12 years) were similar to those of older children and adults.
Safety in pediatric patients below the age of 6 months has not been established. Ulesfia (Benzyl) Lotion is not recommended in pediatric patients under six months of age because of the potential for increased systemic absorption due to a high ratio of skin surface area to body mass and the potential for an immature skin barrier.
Neonates could be at risk for gasping syndrome if treated with Ulesfia (Benzyl) Lotion
Intravenous administration of products containing benzyl alcohol has been associated with neonatal gasping syndrome. The gasping syndrome (characterized by central nervous depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages > 99 mg/kg/day in preterm neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hemotologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Although expected systemic exposure of benzyl alcohol from proper use of Ulesfia (Benzyl) Lotion is substantially lower than those reported in association with the gasping syndrome, the minimum amount of benzyl alcohol at which toxicity may occur is not known.
Ulesfia (Benzyl) Overdosage
If oral ingestion occurs, seek medical advice immediately.
Ulesfia (Benzyl) Description
Ulesfia (Benzyl) (benzyl alcohol) Lotion is supplied as a white topical lotion containing benzyl alcohol, 5%. Inactive ingredients in this formulation are water, mineral oil, sorbitan monooleate, polysorbate 80, carbomer 934P and trolamine.
The active ingredient, benzyl alcohol, is a clear, colorless liquid with a mild aromatic odor. Benzyl alcohol has a molecular mass of 108.14 g/mol. The molecular formula is CHO.
The chemical structure of benzyl alcohol is
Ulesfia (Benzyl) Clinical Studies
Two multicenter, randomized, double-blind, vehicle-controlled studies were conducted in 628 subjects 6 months of age and older with active head lice infestation. For the evaluation of efficacy, the youngest subject from each household was enrolled in the Primary Treatment Cohort with Ulesfia (Benzyl) Lotion or vehicle. Other infested household members were enrolled in a Secondary Treatment Cohort and received the same treatment as the youngest subjects. The Secondary Treatment Cohort was not included in the efficacy analysis, but was evaluated for all safety parameters.
In Study One, 125 Primary Treatment Cohort Subjects were randomized to Ulesfia (Benzyl) Lotion (N=63) and vehicle (N=62). Study Two enrolled 125 Primary Treatment Cohort Subjects: 64 randomized to Ulesfia (Benzyl) Lotion and 61 to vehicle. Treatment was applied two times separated by one week.
Efficacy was assessed as the proportion of subjects who were free of live lice 14 days after the final treatment. Subjects with live lice present at any time after first treatment were considered to be treatment failures. Table 4 contains the proportion of subjects who were free of live lice in each of the two trials.
Ulesfia (Benzyl) How Supplied/storage And Handling
Ulesfia (Benzyl) Lotion is a white topical lotion containing benzyl alcohol, 5% (50 mg/g of lotion) supplied as 4 fl oz (113 g) (NDC 59630-780-04) or as 8 fl oz (227 g) (NDC 59630-780-08) in polypropylene bottles.
Store at 20º - 25º C (68º - 77º F); excursions permitted to 15º - 30º C (59º - 86º F) [See USP controlled room temperature].
Do not freeze. Keep out of reach of children.
Ulesfia (Benzyl) Patient Counseling Information
This medication is to be used as directed by the physician. Use only on scalp and scalp hair. Avoid contact with eyes. As with any topical medication, patients should wash hands after application.
Instruct patients on proper use of Ulesfia (Benzyl) Lotion, including the amount to apply, how long to leave it on the hair, and the importance of a second treatment 1 week (7 days) after the initial application.
Inform patients that Ulesfia (Benzyl) Lotion may cause eye irritation, skin irritation, and contact sensitization.
Instruct patients to inform a physician if the area of the application shows signs of irritation and any signs of adverse reactions.
Ulesfia (Benzyl)
Ulesfia (Benzyl)
