Spinosad Topical Suspension

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.

NATROBA Topical Suspension was studied in two randomized, active-controlled trials (N=552) in subjects with head lice; the results are presented in Table 1.

Table 1: Selected Adverse Events Occurring in at least 1% of Subjects

Other less common reactions (less than 1% but more than 0.1%) were application site dryness, application site exfoliation, alopecia, and dry skin.

Systemic safety was not assessed in pediatric subjects under 6 months of age as laboratory parameters were not monitored in these controlled studies.

Read the entire FDA prescribing information for Natroba (Spinosad Topical Suspension)

If oral ingestion occurs, seek medical advice immediately.

[See FDA-approved patient labeling (Patient Information)]

The patient should be instructed as follows:

• Shake bottle well immediately prior to use
• Do not swallow
• Use Spinosad Topical Suspension only on dry scalp and dry scalp hair.
• Repeat treatment only if live lice are seen seven days after first treatment.
• Avoid contact with eyes. If Spinosad Topical Suspension gets in or near the eyes, rinse thoroughly with water.
• Wash hands after applying Spinosad Topical Suspension
• Use Spinosad Topical Suspension on children only under direct supervision of an adult.

SPINOSAD (SPIN oh sad) is used to treat head lice infestations. It acts by destroying the lice.

This drug can cause serious side effects. See which side effects you should report to your doctor right away.

Know how to use your medication, and learn what might happen if you miss a dose.

Talk to your healthcare provider if you have any of these conditions.

Know what to watch for and get tips for reducing your risks while taking this drug.