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Natroba (spinosad) topical suspension, 0.9%

Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.    [  Read the disclaimer    |   <<Back    |    New drug index   ]
DESCRIPTION CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE CONTRAINDICATIONS
PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED

(DESCRIPTION) top of page

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: top of page

Mechanism of Action
Spinosad causes neuronal excitation in insects. After periods of hyperexcitation, lice become paralyzed and die.

INDICATIONS AND USAGE  top of page

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-tooth comb or special nit comb may be used to remove dead lice and nits.

CONTRAINDICATIONS top of page

None.

PRECAUTIONS top of page

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
Nursing Mothers: Caution should be exercised when administered to a nursing mother.
Pediatric Use: Safety in pediatric patients below the age of 4 years has not been established.

ADVERSE REACTIONS top of page

Most common adverse events (>1% ) were application site erythema and ocular erythema.

DOSAGE AND ADMINISTRATION  top of page

-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.
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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 top of page

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
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Keep out of reach of children

REFERENCE

Package Insert data: 
MANUFACTURED FOR:
ParaPRO LLC
Carmel, IN 46032

DISTRIBUTED BY:
ParaPRO and/or Pernix Therapeutics, Inc.
Magnolia, TX 77354

PRINCIPAL DISPLAY PANEL - 120mL Carton
NDC 52246-929-04

120mL
Rx only

Natroba™
(spinosad)
Topical Suspension
0.9%
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