Spinosad Topical

Conditions Treated

Spinosad suspension is used to treat head lice (small bugs that attach themselves to the skin) in adults and children 4 years of age and older. Spinosad is in a class of medications called pediculicides. It works by killing the lice.

Possible Side Effects

What Side Effects Can This Cause?

Spinosad suspension may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness of the scalp area

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• irritation of the scalp area

Spinosad suspension may cause other side effects. Call your doctor if you have any unusual problems while using this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Usage Instructions

How Should This Medication Be Used

Topical spinosad comes as a suspension (liquid) to apply to the scalp and hair. It is usually applied to the scalp and hair in one or sometimes two treatments. If live lice are seen one week after the first treatment then a second treatment of spinosad suspension should be applied. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use spinosad suspension exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor. Your hair length will determine how much suspension to use for each treatment. If you have long hair or thick, medium length hair, you may need to use the entire bottle. Be sure to use enough suspension to cover all of your scalp area and hair. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient. Read these instructions carefully. Spinosad suspension should only be used on the hair and scalp. Avoid getting spinosad suspension in your eyes, mouth, or vagina. If spinosad suspension gets in your eyes, flush them with water right away. If your eyes are still irritated after flushing with water, call your doctor or get medical help right away. To use the suspension, follow these steps:

Shake the suspension well right before each use to mix the medication evenly.

Use a towel to cover your face and eyes. Be sure to keep your eyes closed during this treatment. You may need to have an adult help you apply the suspension.

Apply spinosad suspension to dry hair and scalp area. Be sure to use enough suspension to cover the entire scalp area first and then apply outwards towards the ends of the hair to cover all of the hair on your head.

Keep the suspension on your hair and scalp for 10 minutes after you finish applying the suspension. You should use a timer or clock to track the time.

After 10 minutes, rinse the suspension from your scalp and hair with warm water in a sink. You should not use a shower or bathtub to rinse the suspension away because you do not want to get the suspension over the rest of your body.

You and anyone who helped you apply the suspension should wash your hands carefully after the application and rinsing steps.

You may shampoo your hair after rinsing the suspension from your scalp and hair.

A lice comb may also be used to remove the dead lice and nits (empty egg shells) after this treatment. You may also need to have an adult help you to do this.

If you see live lice on your head one week after treatment, repeat this entire process.

After using spinosad suspension, sanitize all the clothing, underwear, pajamas, hats, sheets, pillowcases, and towels you have used recently. These items should be washed in very hot water or dry-cleaned. You should also wash combs, brushes, hairs clips and other personal care items in hot water.

What Dietary Instructions Should I Follow

Unless your doctor tells you otherwise, continue your normal diet.

Are There Any Special Instructions

Before using spinosad suspension, tell your doctor and pharmacist if you are allergic to spinosad, any other medications, or any of the ingredients in spinosad suspension. Ask your pharmacist for a list of the ingredients. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. tell your doctor if you have or have ever had skin conditions or sensitivities.