Brand Name
Natroba
Generic Name
Spinosad
View Brand Information FDA approval date: January 25, 2011
Classification: Pediculicide
Form: Suspension
What is Natroba (Spinosad)?
NATROBA is a pediculicide indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older.
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A Single Treatment Pharmacokinetic and Safety Study of Natroba (Spinosad) Topical Suspension 0.9% w/w in Subjects 1 Month to 3 Years 11 Months of Age With an Active Scabies Infestation
Summary: A population of approximately 50 pediatric subjects will be enrolled to assess the PK of spinosad and benzyl alcohol for 3 hours following a single, full-body topical application (open label) on a single in-clinic visit (Day 1, or Day 2 if screening only on Day 1). There will be approximately 50 subjects ages 1 month to 3 years 11 months of age enrolled with the goal of completing approximately 16...
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Brand Information
Natroba (spinosad)
1DOSAGE FORMS AND STRENGTHS
Topical suspension: 0.9% w/w; each gram contains 9 mg of spinosad in a viscous, slightly opaque (white soft particles may be visible), light orange-colored suspension in 120 mL bottles.
2CONTRAINDICATIONS
None.
3OVERDOSAGE
No specific antidotes for spinosad overdosage are known. If oral ingestion occurs, contact Poison Control (1-800-222-1222) for latest recommendations and seek medical attention immediately.
4DESCRIPTION
NATROBA (spinosad) is a slightly opaque, light orange-colored, viscous topical suspension.
NATROBA is a pediculicide and scabicide. 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).
Spinosyn A: The chemical name is: 1H-as-Indaceno[3,2-d]oxacyclododecin-7,a5-dione, 2-[(6-deoxy-2,3,4-tri-O-methyl-alpha-L-mannopyranosyl)oxy]-13-[[2R,5S,6R)-5-(dimethylamino) tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-, (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-
Spinosyn D: The chemical name is: 1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-2,3,4-tri-O-methyl-alpha-L-mannopyranosyl)oxy]-13-[[2R,5S,6R)-5-(dimethylamino) tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-, (2S,3aSR,5aS,5bS,9S,13S,14R,16aS,16bS)-
NATROBA contains 9 mg spinosad per gram in a vehicle consisting of Benzyl Alcohol, Butylated Hydroxytoluene, Ceteareth-20, Cetearyl Alcohol, FD&C Yellow #6, Hexylene Glycol, Hydroxyethyl Cellulose, Isopropyl Alcohol, Propylene Glycol, Stearalkonium Chloride, Water, Hydrochloric acid (HCl) as pH adjuster.
5HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
NATROBA (spinosad) topical suspension, 0.9% w/w; each gram contains 9 mg of spinosad in a slightly opaque (white soft particles may be visible), light orange-colored, viscous liquid, supplied in 4 oz (120 mL) high density polyethylene (HDPE) bottles. NDC 52246-929-04
Storage and Handling
Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F).
6PATIENT COUNSELING/INFORMATION
Advise patients to read the FDA-approved patient labeling (Patient Information)
Important Administration Instructions
Instruct the patient to:
Instruct the patient to:
- Shake bottle well immediately prior to application.
- Do not swallow.
- Avoid contact with eyes. If NATROBA gets in or near the eyes, rinse thoroughly with water.
- Apply NATROBA on pediatric patient only under direct supervision of an adult.
- If skin/scalp irritation occurs after use, contact your physician
Head Lice Infestation Treatment
- Apply NATROBA only on dry scalp and dry scalp hair.
- Repeat treatment only if live lice are seen seven (7) days after first treatment.
- Wash hands after applying NATROBA.
Scabies Infestation Treatment
- Apply NATROBA to completely cover the body from the neck to the toes (including the soles of the feet).
- For patients with balding scalp, also apply product to the scalp, hairline, temples, and forehead.
- Allow it to absorb in the skin and dry for 10 minutes before getting dressed.
- Leave on the skin for at least 6 hours before showering or bathing.
- Wash your hands after applying NATROBA to someone else.
- For breastfeeding women, remove NATROBA from the breast with soap and water before breastfeeding to avoid direct infant exposure to NATROBA