Pronunciation:

sye-kloe-PIR-ox

Brand Names:

• Ciclodan
• CNL8
• Loprox
• Loprox TS
• Penlac

Dosage Forms:

• Solution
• Shampoo
• Suspension
• Cream
• Gel/Jelly

Classifications:

Therapeutic—

Antifungal

Uses of This Medicine:

Ciclopirox 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.

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—

Studies on this medicine 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, this medicine 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 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:

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

• Keep this medicine 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 this medicine:

• Keep this medicine 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 this medicine:

• Keep this medicine away from the eyes and mucous membranes
• This medicine comes with a patient instruction sheet. Read this sheet carefully and follow the directions. If you have any questions on how to use this medicine, be sure to ask your health care professional.
• In addition to daily application of this medicine, 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 this medicine 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 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 .

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 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 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.

Precautions While Using This Medicine:

If your skin problem does not improve within 2 to 4 weeks, or if it becomes worse, check with your doctor.

Inform your doctor right away if the area where you applied the medicine shows signs of increased irritation (e.g., redness, itching, burning, blistering, swelling, or oozing) because it could be an allergic reaction.

Nail problems treated with the topical solution form of this medicine may take up to 6 months to start improving.

To help clear up your infection completely and to help make sure it does not return, good health habits are also required. The following measures will help reduce chafing and irritation and will also help keep the area cool and dry.

• For patients using ciclopirox for ringworm of the groin (tinea cruris):
  • Avoid wearing underwear that is tight-fitting or made from synthetic materials (for example, rayon or nylon). Instead, wear loose-fitting, cotton underwear.
  • Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder (for example, tolnaftate) on the skin. It is best to use the powder between applications of ciclopirox.
• For patients using ciclopirox for ringworm of the foot (tinea pedis):
  • Carefully dry the feet, especially between the toes, after bathing.
  • Avoid wearing socks made from wool or synthetic materials (for example, rayon or nylon). Instead, wear clean, cotton socks and change them daily or more often if the feet sweat freely.
  • Wear sandals or well-ventilated shoes (for example, shoes with holes on top or on the side).
  • Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder (for example, tolnaftate) between the toes, on the feet, and in socks and shoes freely once or twice a day. It is best to use the powder between applications of ciclopirox.

If you have any questions about these measures, check with your health care professional.

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 as soon as possible if any of the following side effects occur:

Less common

(with ciclopirox shampoo)

Fainting

fast, pounding, or irregular heartbeat or pulse

palpitations

Rare

Burning, itching, redness, swelling, or other signs of irritation not present before use of this medicine

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

(with ciclopirox shampoo)

Dandruff

headache

itching skin or scalp

oily skin

rash

skin disorder

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.