Spinosad (Topical application)

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

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

This medicine contains benzyl alcohol, which may cause serious reactions in newborns, premature, or low-birthweight infants. Check with your doctor if you have any concerns.

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

To prevent the spread of lice or scabies: Dry-clean or wash your clothes, bedding, and personal items (such as 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.

In deciding to use a medicine, you and your doctor need to weigh the risks of taking the medicine against the benefits it may provide. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any pediatric-specific problems that would limit the use of spinosad (Topical application) to treat head lice in children 6 months and older and scabies in children 4 years and older. The safety and effectiveness of spinosad (Topical application) for treating scabies have not been established in children younger than 4 years old. Use is not recommended in children younger than 6 months old.

Geriatric

Studies have not shown any geriatric-specific problems that would limit the use of spinosad (Topical application) in elderly patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In such cases, your doctor may want to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, 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 gets used 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 happen 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.

In the U.S.

• Natroba

Available Dosage Forms:

• Suspension

Therapeutic Class: Pediculicide

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.