Indication:
Natroba (spinosad) topical suspension, 0.9% For topical use
Initial U.S. Approval: 2011
Drug Name- Natroba
Active Ingredient - Spinosad
For the treatment of head lice infestation in patients ages 4 years and older
Indication-
Treatment of head lice infestation in patients ages 4 years and older
Approved by FDA on 18-1-2011 (Ref- FDA approved List- 2011)
Adverse Reaction:
Most common adverse events (>1% ) were application site erythema and ocular erythema.
Contra-Indications:
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Benzyl alcohol toxicity: Not recommended in infants below the age of 6 months;
potential for increased systemic absorption.
Dosages/ Overdosage Etc:
Indication-
Treatment of head lice infestation in patients ages 4 years and older
INDICATIONS AND USAGE
NATROBA -Topical Suspension is a pediculicide indicated for the topical
treatment of head lice infestations in patients four (4) years of age and older.
DOSAGE AND ADMINISTRATION
For topical use only. Not for oral, ophthalmic, or intravaginal use.
Shake bottle well.
Apply product to dry scalp and hair using only the amount needed to cover
the scalp and hair.
Rinse off with warm water after 10 minutes.
Repeat treatment if live lice are seen 7 days after first treatment.
DOSAGE FORMS AND STRENGTHS
Suspension: 9 mg of spinosad per gram of NATROBA Topical Suspension
Patient Information:
PATIENT COUNSELING/INFORMATION
The patient should be instructed as follows:
Shake bottle well immediately prior to use
Use NATROBA Topical Suspension only on dry scalp and dry scalp hair.
Do not swallow
Pharmacology/ Pharmacokinetics:
1. Mechanism of Action-
Spinosad causes neuronal excitation in insects.
After periods of hyperexcitation, lice become paralyzed and die.
2. Pharmacokinetics
An open-label, single-center study was conducted over a period of seven days to
determine the pharmacokinetic profile of spinosad 1.8% in pediatric subjects with
head lice infestation.
Fourteen (14) subjects, 4- 15 years of age, with head lice were enrolled into the study.
All subjects applied a single topical (scalp) treatment of spinosad 1.8% for 10 minutes,
after which the test article was washed off, and subjects underwent plasma sampling.
Plasma samples were analyzed by a validated LC/MS/MS method.
Results demonstrated that spinosad was below the limit of quantitation (3ng/mL)
in all samples.
The bioavailability of benzyl alcohol from NATROBA Topical Suspension is unknown
as plasma concentrations of benzyl alcohol were not determined in these subjects.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category B.
There are no adequate and well-controlled studies with NATROBA Topical Suspension
in pregnant women.
Because animal reproduction studies are not always predictive of human response,
this drug should be used during pregnancy only if clearly needed.
2. Nursing Mothers
Spinosad, the active ingredient in NATROBA Topical Suspension is not systemically
absorbed; and therefore, will not be present in human milk.
However, NATROBA Topical Suspension contains benzyl alcohol, which may be
systemically absorbed through the skin, and the amount of benzyl alcohol excreted
in human milk with use of NATROBA Topical Suspension is unknown.
Caution should be exercised when NATROBA Topical Suspension is administered to a
lactating woman. .
3. Pediatric Use
The safety and effectiveness of NATROBA 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 Topical Suspension is not recommended in pediatric patients below
the age of 6 months
4. Geriatric Use
Clinical studies of NATROBA Topical Suspension did not include sufficient numbers
of subjects aged 65 and over to determine whether they respond differently from
younger subjects. Other reported clinical experience has not identified differences
in responses between the elderly and younger patients.
Manufacturer Details