In the U.S.—

In Canada—

• Antifungal, topical

Ciclopirox (sye-kloe-PEER-ox) is used to treat infections caused by fungus. It works by killing the fungus or preventing its growth.

Ciclopirox cream, gel, or lotion are applied to the skin to treat:

• ringworm of the body (tinea corporis);
• ringworm of the foot (tinea pedis; athlete's foot);
• ringworm of the groin (tinea cruris; jock itch);
• “sun fungus” (tinea versicolor; pityriasis versicolor); and
• certain other fungus infections, such as Candida (Monilia) infections.

Ciclopirox gel or shampoo may also be applied to the scalp to treat seborrheic dermatitis.

Ciclopirox topical solution (nail lacquer) is applied to the nails to treat ringworm of the nails (tinea unguium).

Ciclopirox is available only with your doctor's prescription, in the following dosage forms:

Topical
• Cream (U.S. and Canada)
• Gel (U.S.)
• Lotion (U.S. and Canada)
• Shampoo (U.S.)
• Topical Solution (U.S.)

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 ciclopirox, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to ciclopirox. Also tell your health care professional if you are allergic to any other substances, such as preservatives or dyes.

Pregnancy—Ciclopirox has not been studied in pregnant women. However, this medication has not been shown to cause birth defects or other problems in animal studies. Tell your doctor if you are pregnant or plan on becoming pregnant.

Breast-feeding—It is not known whether ciclopirox passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are using PENLAC and who wish to breast-feed should discuss this with their doctor.

Children—Studies on PENLAC have been done only in adult patients, and there is no specific information comparing use of ciclopirox in children under the age of 10 with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of ciclopirox in the elderly with use in other age groups, PENLAC is not expected to cause different side effects or problems in older people than it does in 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 health care professional if you are using any other topical prescription or nonprescription (over-the-counter [OTC]) medicine that is to be applied to the same area of the skin.

For patients using the cream, gel, or lotion form of PENLAC:

• Keep PENLAC away from the eyes.
• Apply enough ciclopirox to cover the affected and surrounding skin or scalp areas and rub in gently.

For patients using the shampoo form of PENLAC:

• Keep PENLAC away from the eyes.
• Apply shampoo to wet hair. Lather and leave on hair and scalp for 3 minutes. A timer may be used. Rinse off.

For patients using the topical solution form of PENLAC:

• Keep PENLAC away from the eyes and mucous membranes
• PENLAC comes with a patient instruction sheet. Read this sheet carefully and follow the directions. If you have any questions on how to use PENLAC, be sure to ask your health care professional.
• In addition to daily application of PENLAC, you will need to trim your nails as directed, and visit your healthcare professional at regular intervals to have the unattached infected nails removed.
• Do not use nail polish or other nail cosmetic products on the treated nails.
• Do not use near heat or open flame.

When ciclopirox is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over the medicine. To do so may irritate the skin. Do not apply an airtight covering over PENLAC unless you have been directed to do so by your doctor.

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

Dosing—

The dose of topical ciclopirox 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 topical ciclopirox. If your dose is different, do not change it unless your doctor tells you to do so.

• For topical cream and lotion dosage forms:
  • Fungus infections (treatment):
    • Adults and children 10 years of age and over—Apply two times a day, morning and evening.
    • Children up to 10 years of age—Use and dose must be determined by your doctor.
  For topical gel dosage form:
  • Fungus infections (treatment) or seborrheic dermatitis (treatment):
    • Adults and children 16 years of age and over—Apply two times a day, morning and evening.
    • Children up to 16 years of age—Use and dose must be determined by your doctor.
  For shampoo dosage form:
  • Seborrheic dermatitis (treatment):
    • Adults and children 16 years of age and over—Apply 1 teaspoon (or up to 2 teaspoons for long hair) two times a week for four weeks with at least three days between each application.
    • Children up to 16 years of age—Use and dose must be determined by your doctor.
  For topical solution dosage form:
  • Fungus infections (treatment):
    • Adults —Apply once daily, preferably at bedtime or eight hours before washing.
    • Children up to 18 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of PENLAC, 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—

To store PENLAC:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Store the topical solution in the carton to protect from light.
• Store the topical solution away from heat and flame.
• Keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.