Spinosad Topical suspension

What is this medicine?

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

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

What should I tell my health care provider before I take this medicine?

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

• skin conditions or sensitivity

• an unusual or allergic reaction to spinosad, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for external use only. Do not take by mouth. Shake well before use. Apply to dry hair and scalp. Apply enough medicine to your hair to wet the hair and scalp. Do not get this medicine in your eyes. If you do, rinse out with plenty of cool tap water. Thoroughly rub the medicine into your hair and scalp. Make sure you get behind the ears and on the back of the neck. Leave on your hair for 10 minutes. Then rinse thoroughly with water. Dry with a clean towel. When your hair is dry, comb it with a fine toothed comb to remove any leftover nits (eggs) or nit shells. If you still have lice after one week, see your doctor or health care professional. You may need a second treatment. If you are applying this medicine to another person, wear plastic or disposable gloves to protect yourself from infestation.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 months old for selected conditions, precautions do apply.

Overdosage: If you think you've 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 as this medicine is applied as a single dose.

What may interact with this medicine?

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 medicine?

This medicine is used as a single application treatment. If live lice are observed 7 or more days after initial application, a second treatment may be needed.

Head lice can be spread from one person to another by direct contact with clothing, hats, scarves, bedding, towels, washcloths, hairbrushes, and combs. All members of your household should be examined for head lice and should receive treatment if they are found to be infected. If you have any questions about this, check with your doctor or health care professional.

To prevent reinfection or spreading of the infection, the following steps should be taken: Machine wash all clothing, bedding, towels, and washcloths in very hot water and dry them using the hot cycle of a dryer for at least 20 minutes. Clothing or bedding that cannot be washed should be dry cleaned or sealed in an airtight plastic bag for 2 weeks. Shampoo any wigs or hairpieces. You should also wash all hairbrushes and combs in very hot soapy water (above 130 degrees F) for 5 to 10 minutes. Do not share your hairbrushes or combs with other people. Wash all toys in very hot water (above 130 degrees F) for 5 to 10 minutes or seal in an airtight plastic bag for 2 weeks. Also, clean the house or room by vacuuming furniture, rugs, and floors.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• itching

• redness or mild swelling of the scalp or eyes

• stinging or burning

• tingling sensation

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 medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

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.