Natroba (spinosad) topical suspension
(description)
| For topical use Initial U.S. Approval: 2011 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, Saccharopolyspora spinosa. Spinosad is a mixture of spinosyn A and spinosyn D in a ratio of approximately 5 to 1 (spinosyn A to spinosyn D). |
Clinical pharmacology
| Mechanism of Action Spinosad causes neuronal excitation in insects. After periods of hyperexcitation, lice become paralyzed and die. |
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.
Adjunctive Measures Wash (in hot water) or dry-clean all recently worn clothing, hats, used bedding and towels. |
Precautions
| WARNINGS AND PRECAUTIONS Benzyl alcohol toxicity: Not recommended in infants below the age of 6 months; potential for increased systemic absorption. USE IN SPECIFIC POPULATIONS |
Adverse reactions
| Most common adverse events (>1% ) were application site erythema and ocular erythema. |
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. ----------------- For topical use only. NATROBA Topical Suspension is not for oral, ophthalmic, or intravaginal use. Shake bottle well. Apply sufficient NATROBA 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 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. |
How supplied
| NATROBA (spinosad) Topical Suspension, 0.9% is a slightly opaque, light orange colored, viscous liquid, supplied in 4 oz (120 mL) high density polyetheylene (HDPE) bottles. NDC 52246-929-04
Storage and Handling |
Reference(s)
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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