Efinaconazole (Topical application)

Efinaconazole (Topical application) is used to treat fungal or yeast infections of the toenails. This medicine works by killing the fungus or yeast, or stopping it from growing.

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

It is very important for your doctor to check your or your child's progress at regular visits. This will help your doctor see if the medicine is working properly and check for any problems or side effects that may be caused by this medicine.

If your toenail problem does not get better or if it gets worse, contact your doctor.

Contact your doctor immediately if you have itching, swelling, redness, or irritation at the application site.

In deciding to use a medicine, you need to consider the risks of taking it against the benefits it may provide. This is a choice you will make together with your doctor. For this medicine, keep the following in mind:

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, like to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

So far, studies have not shown any specific problems in children 6 years of age and older that would limit the use of efinaconazole topical solution. However, safety and effectiveness have not been established in children younger than 6 years.

Geriatric

Studies have not shown any specific problems in elderly patients that would limit the use of efinaconazole topical solution. However, older adults may be more sensitive to the effects of this medicine than younger adults.

Breast Feeding

There are no adequate studies to determine the risk to infants when this medication is used during breastfeeding. Consider the potential benefits and 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 there might be an interaction. If this happens, 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]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to take your medicine in relation to 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.

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

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.

• Jublia

Available Dosage Forms:

• Solution

Therapeutic Class: Antifungal

Chemical Class: Triazole

It is very important that you 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. 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 integrated flow-through brush applicator to spread the medicine around the whole toenail, including the cuticle, folds of the skin next to the sides of the toenail, and underneath the toenail.
• Wait for at least 10 minutes after showering, bathing, or washing before applying the medicine.
• Avoid pedicures, the use of nail polish, and cosmetic nail products (eg, gel nails or acrylic nails) while using this medicine.

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.

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.