Pronunciation:

a-ba-MET-a-pir

Brand Names:

• Xeglyze

Uses of This Medicine:

Abametapir topical lotion is used together with an overall lice management program to treat head lice infestation.

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 abametapir topical lotion in children 6 months of age and older. Safety and efficacy have been established. However, use is not recommended in infants 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 abametapir topical lotion in the geriatric population.

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 first with your doctor.

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

To use the topical lotion:

• Wash your hands before and after using this medicine.
• Shake the bottle well before use.
• Use this medicine as directed on the hair and scalp only. Do not get the medicine in your eyes, nose, mouth, and vagina. If it gets in your eyes, rinse them well with water.
• Children will need an adult to apply the medicine for them.
• Apply the medicine directly to dry hair. Start closest to the scalp and then apply outwards. Completely cover your entire scalp and all of your hair, from the roots to the tips. Use the whole tube of medicine, if needed.
• Leave the medicine on the hair and scalp for 10 minutes.
• Rinse your hair with warm water and dry with a clean towel. Comb your hair with a fine-toothed comb or special nit comb to remove dead lice and any nits (eggs) or nit shells. They look like small white dots.
• You may shampoo your hair any time after your treatment ends.
• After completing your dose of this medicine, do not use it again. Throw away any unused medicine. Do not flush it down the sink or toilet.

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 (lotion):
  • For head lice:
    • Adults and children 6 months of age and older—Apply directly to dry hair and scalp one time only.
    • Infants younger than 6 months of age—Use is not recommended.

Storage—

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.

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

Store the bottle in an upright position. Do not refrigerate or freeze.

Precautions While Using This Medicine:

Head lice can easily spread from one person to another by direct contact with clothing, hats, bandannas, scarves, bedding, towels, washcloths, ribbons, hair bands, helmets, hairbrushes and combs, or hairs from infected persons. All members of your household should be checked 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.

If your or your child's symptoms do not improve within a few days or if they become worse, check with your doctor.

To prevent the spread of lice:

• Avoid direct head-to-head contact with persons who have lice.
• Dry clean or wash your clothes, hats, and bedding in hot, soapy water. Tumble dry them in a hot dryer.
• Non-washable items can be dry cleaned or sealed inside a plastic bag for 2 weeks.
• Disinfect personal care items, including combs or brushes by soaking them in hot water for 5 to 10 minutes.
• Do not share any hair-related personal items (eg, combs, brushes, hats, scarves, bandannas, ribbons, barrettes, hair bands, towels, helmets, hairpieces, wigs) with anyone.

This medicine contains benzyl alcohol, which may cause serious reactions to newborn or premature babies. Discuss this with your doctor if you are concerned.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

Blistering, burning, crusting, dryness, flaking, itching, scaling, severe redness, soreness, or swelling of the scalp or skin

eye irritation

hair color changes

skin rash

vomiting

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.