Natroba Information
Natroba (Spinosad) Dosage And Administration
For topical use only. Natroba (Spinosad) Topical Suspension is not for oral, ophthalmic, or intravaginal use.
Shake bottle well. Apply sufficient Natroba (Spinosad) Topical Suspension to cover dry scalp, then apply to dry hair. Depending on hair length, apply up to 120 mL (one bottle) to adequately cover scalp and hair. Leave on for 10 minutes, then thoroughly rinse off Natroba (Spinosad) Topical Suspension with warm water. If live lice are seen 7 days after the first treatment, a second treatment should be applied. Avoid contact with eyes.
Natroba (Spinosad) Dosage Forms And Strengths
0.9%, viscous, slightly opaque, light orange-colored suspension.
Natroba (Spinosad) Contraindications
Natroba (Spinosad) Use In Specific Populations
The safety and effectiveness of Natroba (Spinosad) Topical Suspension have been established in pediatric patients 4 years of age and older with active head lice infestation
Safety in pediatric patients below the age of 4 years has not been established. Natroba (Spinosad) Topical Suspension is not recommended in pediatric patients below the age of 6 months 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.
Natroba (Spinosad) Topical Suspension contains benzyl alcohol which has been associated with serious adverse reactions and death in neonates and low birth-weight infants. The "gasping syndrome" (characterized by central nervous system 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 neonates and low-birthweight infants. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.
The minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birthweight infants, as well as patients receiving high dosages, may be more likely to develop toxicity
Natroba (Spinosad) Overdosage
If oral ingestion occurs, seek medical advice immediately.
Natroba (Spinosad) Description
Natroba (Spinosad) Topical Suspension, is a slightly opaque, light orange colored, viscous topical suspension.
Spinosad, the active ingredient, is derived from the fermentation of a soil actinomycete bacterium, .
Spinosad is a mixture of spinosyn A and spinosyn D in a ratio of approximately 5 to 1 (spinosyn A to spinosyn D).
Natroba (Spinosad) Topical Suspension contains 9 mg spinosad per gram in a viscous, slightly opaque, light orange colored vehicle consisting of Water, Isopropyl Alcohol, Benzyl Alcohol, Hexylene Glycol, Propylene Glycol, Cetearyl Alcohol, Stearalkonium Chloride, Ceteareth-20, Hydroxyethyl Cellulose, Butylated Hydroxytoluene, FD&C Yellow #6.
Natroba (Spinosad) Clinical Studies
Two multicenter, randomized, investigator-blind, active-controlled studies were conducted in 1038 subjects 6 months of age and older with head lice infestation. A total of 552 subjects were treated with Natroba (Spinosad) Topical Suspension. For the evaluation of efficacy, the youngest subject from each household was considered to be the primary subject of the household, and other members in the household were enrolled in the study as secondary subjects, and evaluated for all safety parameters.
In Study 1, 91 primary subjects were randomized to Natroba (Spinosad) Topical Suspension, and 89 primary subjects were randomized to permethrin 1%. In Study 2, 83 and 84 primary subjects were randomized to Natroba (Spinosad) Topical Suspension and permethrin 1%, respectively.
In both studies, all subjects who were treated on Day 0 returned for efficacy evaluation at Day 7. Subjects with live lice present at Day 7 received a second treatment. Subjects who were lice free on Day 7 were to return on Day 14 for evaluation. Subjects with live lice and who received a second treatment were to return on Days 14 and 21.
Efficacy was assessed as the proportion of primary subjects who were free of live lice 14 days after the final treatment. Table 2 contains the proportion of primary subjects who were free of live lice in each of the two trials.
Natroba (Spinosad) Patient Counseling/information
The patient should be instructed as follows:
Natroba (Spinosad)
Natroba (Spinosad)
