There were few adverse events reported in the Phase III clinical studies. The most commonly occurring adverse events included application-site erythema (redness of the skin) which occurred in 3% of the Natroba™ patients (vs. 7% of permethrin), ocular erythema (redness and irritation of the eyes) which occurred in 2% of the Natroba™ patients (vs. 3% of permethrin) and application-site irritation which occurred in 1% of Natroba™ patients (vs. 2% permethrin). Although adverse event rates were low for both products, application site redness occurred significantly less frequently in patients treated with Natroba™ than in patients treated with permethrin (P = 0.007).
Indication
Natroba™ Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in patients four (4) years of age and older.
Adjunctive Measures
Natroba™ Topical Suspension should be used in the context of an overall lice management program:
- Wash (in hot water) or dry clean all recently worn clothing, hats, used bedding and towels
- Wash personal care items such as combs, brushes, and hair clips in hot water
A fine-toothed comb or special nit comb may be used to remove dead lice and nits.
Important Safety Information
Natroba™ Topical Suspension contains benzyl alcohol and is not
recommended for use in neonates and infants below the age of 6 months. Systemic exposure to benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants. Most common adverse events were: application site redness (3%), eye redness (2%) and application site irritation (1%).
Consult the Patient Information, Full Prescribing Information and your doctor for more complete information on Natroba™ Topical Suspension.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
