Ivermectin (Topical application)

Ivermectin 0.5% topical lotion is used to treat head lice infestations.

Ivermectin 1% topical cream is used to treat lesions of rosacea. Rosacea is a skin disease that causes redness and pimples on your nose, cheeks, chin, and forehead.

This medicine is available over-the-counter.

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

For patients using Sklice®:

• Head lice can easily spread from one person to another through direct contact with clothing, hats, bandannas, scarves, bedding, towels, washcloths, ribbons, hair bands, helmets, hairbrushes and combs, or hairs from infected people. 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.
• To prevent the spread of lice: Dry-clean or wash your clothes, bedding, and personal items (including washcloths, towels, hats, scarves, combs, brushes, hairpieces, and wigs) in hot, soapy water. Tumble dry in a hot dryer for 20 minutes.
• Call your doctor right away if you have trouble breathing, eye irritation, skin or scalp irritation, or rash.
• Do not use this medicine for a hair or scalp problem that has not been checked by your doctor.
• Do not use this medicine to treat lice in the eyebrows or eyelashes. If you have lice in these areas, check with your doctor.

For patients using Soolantra®:

• If your skin problem does not improve within a few days or if it becomes worse, check with your doctor.
• Do not use this medicine for a skin problem that has not been checked by your doctor.
• If you have any questions about this, check with your doctor.

In deciding to use a medicine, you and your doctor need to think about the risks compared to the benefits. Here are some important things to consider for this medicine:

Allergies

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

Pediatric

Studies conducted so far have not shown any specific problems related to using ivermectin topical lotion in children 6 months of age and older that would limit its usefulness. However, it is not recommended for infants younger than 6 months.

Studies have not been done to see how age affects the use of ivermectin topical cream in children. Its safety and effectiveness have not been established.

Geriatric

Studies conducted to date have not shown any specific problems related to using ivermectin topical lotion or cream in older adults.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if an interaction might happen. In such cases, your doctor may need to adjust the dose or take other precautions. 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 around mealtime or with certain foods, as interactions may occur. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to inform your doctor about any other medical problems you have, especially:

• Skin problems or sensitivities—Use with caution.

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

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Skin rash
• trouble breathing

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:

Rare

• Burning, itching, redness, or stinging of the skin
• burning, dry, or itching eyes
• dandruff
• discharge or excessive tearing
• dry skin
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

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.

In the U.S.

• Sklice
• Soolantra

Available Dosage Forms:

• Cream
• Lotion

Therapeutic Class: Anthelmintic

Chemical Class: Avermectin

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 Sklice® topical lotion:

• Use Sklice® on the hair and scalp only. Keep the medicine out of your eyes, nose, mouth, and vagina. Keep your eyes tightly closed and protect them with a washcloth or towel. If the medicine gets in your eyes, rinse them well with water.
• Wash your hands before and after using this medicine.
• Apply the medicine directly to the scalp and dry hair closest to the scalp and then apply outwards to the ends of your hair.
• Completely cover your scalp and hair (up to 1 tube). 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, tell your doctor right away.
• Do not use this medicine again without talking first with your doctor.
• Children will need an adult to apply the medicine for them.
• If you are breastfeeding, do not put the lotion on your breast.
• Throw away any unused medicine left in the tube after each use.
• It is best to wait for 24 hours before applying shampoo on the treated hair and scalp areas. Do not use cosmetics and other hair products on these areas as well.

To use Soolantra® topical cream:

• This medicine is for use on the skin only. Do not get it in your eyes, mouth, or vagina. Do not use it on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.
• Wash your hands before and after using this medicine.
• Use a pea-sized amount for each affected area of the face (forehead, chin, nose, cheeks).
• Spread a thin layer and avoid the eyes and lips.

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 (cream):For rosacea: Adults—Apply to the affected area(s) of the face once a day. Children—Use and dose must be determined by your doctor.
• 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. Children 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.

Do not freeze Sklice® topical lotion.

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