CNL8 (Topical)

Ciclopirox is used to treat infections caused by fungus. It works by killing the fungus or stopping it from growing.

Ciclopirox cream, gel, or lotion are put on 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
• some other fungus infections, like Candida (Monilia) infections.

Ciclopirox gel or shampoo can also be used on the scalp to treat seborrheic dermatitis.

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

Ciclopirox is available only with your doctor's prescription.

If your skin problem does not improve within 2 to 4 weeks, or if it gets worse, contact your doctor.

Tell your doctor immediately 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 completely clear up your infection and help prevent it from returning, good health habits are also needed. 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 tight-fitting underwear or underwear 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, contact your health care professional.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. Consider the following for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have only been done in adults, and there is no specific information comparing the use of ciclopirox in children under the age of 10 with its use in other age groups.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be known if they work the same way in older people as they do in younger adults. Although there is no specific information comparing the use of ciclopirox in the elderly with its use in other age groups, this medicine is not expected to cause different side effects or problems in older people compared to younger adults.

Interactions with Medicines

While some medicines should not be used together at all, in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional about taking your medicine with food, alcohol, or tobacco.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, 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 using 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. Your health care professional may also be able to tell you how 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.

In the U.S.

• Ciclodan
• CNL8
• Loprox
• Loprox TS
• Penlac

Available Dosage Forms:

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

Therapeutic Class: Antifungal

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.

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