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Ciclopirox Topical

(sye kloe peer' ox)

Brand Name(s): Penlac® Nail Lacquer; also available generically

WHY is this medicine prescribed?

Ciclopirox topical solution is used along with regular nail trimming to treat fungal infections of the fingernails and toenails (an infection that may cause nail discoloration, splitting and pain). Ciclopirox is in a class of medications called antifungals. It works by stopping the growth of nail fungus.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ciclopirox comes as a solution to apply to nails and the skin immediately surrounding and under the nails. It is usually applied once a day. To help you remember to use ciclopirox, apply it around the same time every day, usually at bedtime. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use ciclopirox exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Ciclopirox is used to improve the condition of nails, but may not completely cure nail fungus. It may take 6 months or longer before you notice that your nails are getting better. Continue to use ciclopirox daily as directed. Do not stop using ciclopirox without talking to your doctor.

Ciclopirox topical solution will work best if you trim your nails regularly during your treatment. You should remove all loose nail or nail material using a nail clipper or nail file before you begin treatment and every week during your treatment. Your doctor will show you how to do this. Your doctor will also trim your nails once each month during your treatment.

Only apply ciclopirox topical solution to your nails and the skin under and around your nails. Be careful not to get the solution on any other areas of the skin or parts of your body, especially in or near your eyes, nose, mouth, or vagina.

Do not use nail polish or other nail cosmetic products on nails treated with ciclopirox topical solution.

Do not take a bath, shower, or swim for at least 8 hours after applying ciclopirox topical solution.

Ciclopirox topical solution may catch fire. Do not use this medication near heat or an open flame, such as a cigarette.

To use ciclopirox topical solution, follow these steps:

  1. Be sure that you have trimmed your nails properly before your first treatment.
  2. Use the applicator brush attached to the bottle cap to apply ciclopirox topical solution evenly to all affected nails. Also apply the solution to the underside of the nail and the skin beneath it if you can reach these areas.
  3. Wipe off the bottle cap and neck and replace the cap tightly on the bottle.
  4. Let the solution dry for about 30 seconds before you put on socks or stockings.
  5. When it is time for your next dose, apply ciclopirox topical solution over the medication that is already on your nails.
  6. Once a week, remove all the ciclopirox from your nail(s) with a cotton square or tissue soaked with rubbing alcohol. Then, remove as much of the damaged nail as possible using scissors, nail clippers, or nail files.

What SPECIAL PRECAUTIONS should I follow?

Before using ciclopirox topical solution,

  • tell your doctor and pharmacist if you are allergic to ciclopirox or any other medications.

  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: inhaled steroids such as beclomethasone (Beconase, Vancenase), budesonide (Pulmicort, Rhinocort), flunisolide (AeroBid); fluticasone (Advair, Flonase, Flovent), mometasone (Nasonex), and triamcinolone (Azmacort, Nasacort, Tri-Nasal); oral medications to treat fungal infections such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), terbinafine (Lamisil) and voriconazole (Vfend); medications for seizures; and steroid creams, lotions, or ointments such as alclometasone (Aclovate), betamethasone (Alphatrex, Betatrex, Diprolene, others), clobetasol (Cormax, Temovate), desonide (DesOwen, Tridesilon), desoximetasone (Topicort), diflorasone (Maxiflor, Psorcon), fluocinolone (DermaSmoothe, Synalar), fluocinonide (Lidex), flurandrenolide (Cordran), halcinonide (Halor), hydrocortisone (Cortizone, Westcort, others), mometasone (Elocon), prednicarbate (Dermatop), and triamcinolone (Aristocort, Kenalog, others). 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 an organ transplant, if you have recently had chicken pox, and if you have or have ever had any disease that affects your immune system, such as human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) or severe combined immunodeficiency syndrome (SCID); cancer; cold sores; diabetes; flaky, itchy, or crusty skin; genital herpes (sexually transmitted disease that causes painful blisters on reproductive organs); shingles (painful blisters caused by the chicken pox virus); fungal infections on your skin such as athlete's foot and ringworm (ring-shaped discolored patches of scales and blisters on the skin, hair, or nails); peripheral vascular disease (narrowing of blood vessels in feet, legs, or arms causing numbness, pain, or coldness in that part of the body); or seizures.

  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ciclopirox, call your doctor.

  • you should know that you should keep your nails clean and dry during treatment with ciclopirox topical solution. Do not share nail care tools. Use different tools for infected and healthy nails. If your toenails are affected, wear well-fitting, low heeled shoes, and change them change frequently, and do not go barefoot in public areas. Wear protective shoes and gloves when playing sports, using strong cleaners, or during work that might injure or irritate fingernails and toenails.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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 a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Ciclopirox topical solution may cause side effects. Tell your doctor if the following symptom is severe or does not go away:

  • redness at the place where you applied ciclopirox

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

  • irritation, itching, burning, blistering, swelling, or oozing at the place where you applied ciclopirox
  • pain at the affected nail(s) or surrounding area
  • discoloration or change in shape of nail(s)
  • ingrown nail(s)

Ciclopirox topical solution may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Keep the bottle of ciclopirox topical solution in the package it came in, away from light.

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

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use 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.

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