Jublia (efinaconazole)

(ef'' in a kon' a zole)

Efinaconazole topical solution is used to treat fungal toenail infections (infections that may cause nail discoloration, splitting, or pain). Efinaconazole topical solution is in a class of medications called antifungals. It works by stopping the growth of nail fungus.

Efinaconazole comes as a topical solution to apply to the affected toenails. It is usually applied once a day for 48 weeks. Apply efinaconazole topical solution at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use efinaconazole topical solution exactly as directed. Do not apply more or less of it or apply it more often than prescribed by your doctor. Efinaconazole topical solution is only for use on the toenails. Try not to get efinaconazole anywhere on your skin except for the area right around your affected toenails. Do not get efinaconazole in your eyes, nose, mouth, or vagina. Efinaconazole topical solution may catch fire. Stay away from heat and flames while you are applying this medication. Do not get a pedicure or apply nail polish or other cosmetic nail products to your toenails during your treatment with efinaconazole topical solution. To apply the topical solution, follow these steps:

• Make sure that your toenails are clean and dry. Wait at least ten minutes after showering, bathing, or washing your toenails before you apply the medication.
• Remove the cap from the bottle and hold the bottle upside down over your affected toe.
• Squeeze the bottle gently to apply one drop of medication to your toenail. If you are applying the medication to your big toe, squeeze the bottle again to apply a second drop to the tip of your toenail.
• Use the brush attached to the bottle to spread the medication all over your toenail, including the cuticle, the folds of skin on both sides of the nail, and the skin under the toenail. Be careful not to squeeze the bottle while you are spreading the medication.
• If you have more than one affected toenail, repeat steps 3-4 to apply the medicaton to each affected toenail.
• Put the cap back on the bottle and screw it on tightly.
• Allow your toenails to dry completely.
• Wash your hands with soap and water.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before using efinaconazole topical solution,
• tell your doctor and pharmacist if you are allergic to efinaconazole, any other medications, or any of the ingredients in efinaconazole topical solution. Ask your pharmacist or check the manufacturer's patient information for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had any medical condition.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using efinaconazole topical solution, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra solution to make up for a missed dose.

Efinaconazole topical solution may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, itching, or swelling of the skin around the affected toenail(s)
• burning, stinging, or pain in the area around the affected toenail(s)
• blisters in the area around the affected toenail(s)
• ingrown toenail

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it upright at room temperature and away from open flames, excess heat and moisture (not in the bathroom). Do not allow the medication to freeze. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.