Pronunciation:

SPIN-oh-sad

Brand Names:

• Natroba

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Pediculicide

Uses of This Medicine:

Spinosad 0.9% topical suspension is used to treat head lice and scabies infestations.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of spinosad topical to treat head lice in children 6 months of age and older and scabies in children 4 years of age and older. Safety and efficacy of spinosad topical to treat scabies have not been established in children younger than 4 years of age. Use is not recommended in children younger than 6 months of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of spinosad topical in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor tells you. Do not change your treatment without checking with your doctor first.

Use this medicine on the skin, hair, and scalp only. Keep the medicine out of your eyes, nose, mouth, and vagina. If the medicine gets in your eyes, rinse them well with water. Do not swallow the medicine.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

To use for head lice:

• Shake the bottle well before using.
• Wash your hands before and after using this medicine.
• Apply the medicine directly to dry hair (up to 120 mL for long hair) and scalp. Do not wet your hair before applying the medicine. Leave the medicine on the hair and scalp for 10 minutes.
• After 10 minutes, rinse your hair with warm water and dry with a clean towel. Comb hair with a fine-toothed comb to remove any nits (eggs) or nit shells. They look like small white dots.
• If live lice are seen 7 days after using this medicine, you will need to use this medicine again.
• Children will need an adult to apply the medicine for them.
• You may shampoo your hair any time after the treatment.

To use for scabies:

• Shake the bottle well before using.
• Wash your hands before and after using this medicine.
• Apply the medicine directly to skin from neck to toes, including the soles of your feet. If you are going bald, apply the medicine to the scalp, hairline, temples, and forehead.
• Allow the medicine to be absorbed on the skin for 10 minutes before getting dressed.
• Leave it on the skin for at least 6 hours before showering or bathing.
• Children will need an adult to apply the medicine for them.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (suspension):
  • For head lice:
    • Adults and children 6 months of age and older—Apply directly to dry hair and scalp one time only. If you need a second treatment, it should be spaced 1 week apart.
    • Children younger than 6 months of age—Use is not recommended.
  • For scabies:
    • Adults and children 4 years of age and older—Apply directly to skin one time only.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

This medicine contains benzyl alcohol which may cause serious reactions to newborn, premature, or low-birthweight infants. Check with your doctor if you are concerned.

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

To prevent spread of lice or scabies: Dry-clean or wash your clothes, bedding, and personal items (eg, washcloths, towels, hats, scarves, combs, brushes, hairpieces, and wigs) in hot, soapy water and dry them in a hot dryer.

Do not use this medicine for a skin, hair, or scalp problem that has not been checked by your doctor.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Burning, dryness, flaking, itching, pain, redness, rash, swelling, or soreness at the site of application

redness of the eye or skin

Rare

Dryness of the scalp or skin

hair loss

thinning of the hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.