Pronunciation:

ta-va-BOR-ole

Brand Names:

• Kerydin

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antifungal

Uses of This Medicine:

Tavaborole topical solution is used to treat fungal or yeast infections of the toenails. This medicine works by killing the fungus or yeast, or preventing its growth.

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 have not been performed on the relationship of age to the effects of tavaborole topical solution in children younger than 6 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tavaborole topical solution in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

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 only 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 ordered.

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

This medicine is for use on the toenails and surrounding skin only. It is not for use in the eyes, mouth, or vagina.

To use:

• Wash your hands with soap and water before and after using this medicine.
• Apply to the affected toenail(s) by using the dropper tip to gently spread to the entire toenail and surrounding skin. Also, apply the medicine under the entire tip of the toenail.
• Your toenails must be clean and dry when you put the medicine. Wipe away any excess solution from the surrounding skin. Let the medicine dry completely after you apply it.

To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. Since fungus or yeast infections may be very slow to clear up, you may have to continue using this medicine every day for several weeks or more. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses.

Ask your doctor before you use nail polish or other nail products while you are being treated with this medicine.

This medicine is flammable. Do not use it near heat, an open flame, or while smoking.

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 (solution):
  • For treatment of fungal infection of the toenails:
    • Adults and children 6 years of age and older—Apply to the affected toenail(s) once a day for 48 weeks.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

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.

Throw away any unused medicine after 3 months of inserting the dropper.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly and to check for any unwanted effects.

If your toenail problem does not improve or if it becomes worse, check with your doctor.

Check with your doctor right away if you have itching, swelling, redness, or irritation at the application site.

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.

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

Less common

Blistering, burning, itching, pain, stinging, or redness at the application site

ingrown toenail

Incidence not known

Crusting, dryness, or flaking of the skin

fast heartbeat

fever

hives, itching, skin rash

hoarseness

irritation

joint pain, stiffness or swelling

redness of the skin

scaling, severe redness, soreness, or swelling of the skin

swelling of the eyelids, face, lips, hands, or feet

tightness in the chest

troubled breathing or swallowing

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.