Spinosad Topical suspension

What is this medication?

SPINOSAD (SPIN oh sad) treats head lice, tiny insects that live in hair. It works by killing the lice and their eggs. It may also be used to treat scabies, a condition caused by tiny insects that irritate your skin. It works by killing the mites and their eggs.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Natroba

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Skin conditions or sensitivity
• An unusual or allergic reaction to spinosad, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for external use only. Do not take by mouth. Use it as directed on the prescription label. Wash your hands before and after use. Do not get this medication in your eyes. If you do, rinse your eyes with plenty of cool tap water.

If treating head lice: Do not use a conditioner or a shampoo with a conditioner on the hair before using this medication. Follow product-specific instructions for length of application and product removal. Rinse out the hair over a sink or tub to limit skin exposure; do not use hot water. In general, do not re-wash the hair for 1 to 2 days after use.

If treating scabies: Apply enough medication to completely cover the body from the neck to the soles of the feet. Apply to folds of skin, between fingers and toes, and under finger and toe nails. If bald or balding, apply to scalp, hairline, temples, and forehead. If the body is not completely covered, some scabies mites may escape treatment. Follow product-specific instructions for length of application and product removal.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 6 months for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication is not for regular use.

What may interact with this medication?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Head lice is spread to others by direct contact with clothing, hats, scarves, bedding, towels, washcloths, hairbrushes, and combs. All members of your household should be examined for head lice. Anyone with lice should get treated. Ask your care team if questions.

Do the following to prevent giving lice to others or getting a second infection. Machine wash all clothing, bedding, and towels in very hot water. Dry them in the dryer using the hot cycle for 20 minutes or longer. Shampoo wigs or hairpieces. Wash all hairbrushes and combs in very hot soapy water for 5 to 10 minutes. Do not share your hairbrushes or combs with other people. Wash all toys in very hot water for 5 to 10 minutes. Vacuum furniture, rugs, and floors. If clothing, bedding, rugs, or toys cannot be washed, seal them in an airtight plastic bag for 2 weeks.

If someone in your household has scabies, all members of your household should be treated for scabies. Ask your care team if questions.

Scabies can be spread by direct skin-to-skin contact. It can also spread by sharing clothing or belongings where scabies have crawled. To prevent the spread of scabies, do not share clothing, towels, or bedding.

Do the following to prevent giving scabies to others or getting a second infection. Machine wash all clothing, bedding, and towels that were used during the 3 days before treatment. Wash these items in very hot water. Dry them in the dryer using the hot cycle for 20 minutes or longer. Do not share clothing, towels, or bedding. Vacuum furniture, rugs, and floors. If clothing, bedding, rugs, or toys cannot be washed, seal them in an airtight plastic bag for 3 days.

When using this medication for scabies, this medication is applied to the whole body. If you are breast-feeding, wash your chest with soap and water before feeding your baby. Talk to your care team about the best way to feed your baby while taking this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Burning or pain at application site
• Mild skin irritation, redness, or dryness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.