Spinosad Topical

Spinosad suspension is used to treat head lice (small insects that attach themselves to the scalp) in adults and children 6 months of age and older. It is also used to treat scabies (mites 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 and mites.

Topical spinosad comes as a suspension (liquid) to apply to the scalp, hair, and skin. When used to treat lice, 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. When used to treat scabies, it is usually applied to the skin in one treatment. 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.

If used to treat lice, 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, scalp, and skin. 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 to treat head lice, follow these steps:

1. Shake the suspension well right before each use to mix the medication evenly.
2. Use a towel to cover your face and eyes. Be sure to keep your eyes closed during this treatment. You may need to have another person help you apply the suspension.
3. 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.
4. 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.
5. 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.
6. You and anyone who helped you apply the suspension should wash your hands carefully after the application and rinsing steps.
7. You may shampoo your hair after rinsing the suspension from your scalp and hair.
8. 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 another person help you to do this.

After using spinosad suspension for lice, clean all recently used clothing, underwear, pajamas, hats, sheets, pillowcases, and towels. These items should be washed in very hot water (150°F) and tumbled in a hot dryer for 20 minutes or dry-cleaned. You should also wash combs, brushes, hair clips and other personal care items in hot water.

To use the suspension to treat scabies, follow these steps:

1. Shake the suspension well right before each use to mix the medication evenly.
2. Apply spinosad suspension to skin by rubbing it in to completely cover the body from the neck down to the soles of the feet. If balding, be sure to use enough suspension to cover the scalp, hairline, temples, and forehead.
3. Be sure to apply spinosad suspension to folds of skin, between fingers and toes, and under finger and toe nails. If you do not completely cover your body with spinosad suspension, some scabies mites may escape treatment.
4. Allow the suspension to dry on your skin for 10 minutes before getting dressed. You should use a timer or clock to track the time.
5. Leave on the skin for at least 6 hours before showering or bathing.
6. If anyone helped you apply the suspension, they should wash their hands carefully after the application and rinsing steps.

After using spinosad suspension for scabies, machine-wash or dry clean any bedding, clothing and towels that you have used anytime during the 3 days before treatment by washing in hot water and drying in a hot dryer, or by sealing in a plastic bag for at least 72 hours. These items should be washed in very hot water (150°F) and tumbled in a hot dryer for 20 minutes or dry-cleaned.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using spinosad suspension,

• tell your doctor and pharmacist if you are allergic to spinosad, any other medications, benzyl alcohol, 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.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using spinosad suspension, call your doctor. If you are breastfeeding, wash your breasts with soap and water to remove spinosad suspension before feeding your baby.

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

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
• dry skin

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

• irritation of the scalp area
• pain, burning, irritation of the skin 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

If someone swallows spinosad suspension, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Keep all appointments with your doctor.

Do not let anyone else use your medication. Your prescription is probably not refillable. If you feel you need additional treatment, call your doctor.

To help prevent the spread of lice from one person to another, do not share combs, brushes, towels, pillows, hats, scarves, or hair accessories. Be sure to check everyone in your immediate family for head lice if another family member is being treated for lice.

To help prevent the spread of scabies from one person to another, get your household members or immediate family checked by their doctor for scabies. Avoid direct body-to-body contact with anyone known to have scabies, including sexual partners. Do not share clothing, towels, bedding or linens with anyone else. The scabies mite can live in bedding, pillows, and carpets that have recently been used by a person with scabies.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Natroba^®