Ciclopirox (topical route)


    Brand Name

    US Brand Name

    Ciclodan

    CNL8

    Loprox

    Loprox TS

    Penlac


    Description

    Ciclopirox is used to treat fungus infections of the skin, including tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis cutaneous candidiasis caused by Candida albicans, and tinea (pityriasis) versicolor caused by Malassezia furfur. It works by killing the fungus or preventing its growth.

    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).

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

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

    Before Using

    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.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of ciclopirox topical in children younger than 10 years of age. Safety and efficacy have not been established.

    Geriatric

    No information is available on the relationship of age to the effects of ciclopirox topical in geriatric patients.

    Drug Interactions

    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

    Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

    This medicine is for use on the skin only. Do not get it into your eyes, nose, mouth, or vagina. If it does get on these areas, rinse it off right away with water.

    To use the topical suspension:

    • Wash your hands with soap and water before and after using this medicine.
    • Shake well before each use.
    • Apply a thin layer to the affected area. Rub it in gently.
    • Avoid using occlusive dressings.

    To help clear up your skin problem 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.

    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.

    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 dosage forms (cream, lotion, and suspension):
      • For fungus infections of the skin:
        • Adults and children 10 years of age and over—Apply to the affected area of the skin 2 times a day, in the morning and evening for 2 to 4 weeks.
        • Children up to 10 years of age—Use and dose must be determined by your doctor.
    • For topical dosage form (gel):
      • For fungus infections or seborrheic dermatitis:
        • 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 topical dosage form (shampoo):
      • For seborrheic dermatitis:
        • 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 dosage form (solution):
      • For fungus infections:
        • 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.

    Ask your healthcare professional how you should dispose of any medicine you do not use.


    Precautions

    It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly.

    If your or your child's symptoms do not improve within 2 to 4 weeks of treatment, or if they become worse, check with your doctor.

    Check with your doctor right away if you have a skin rash, burning, stinging, redness, swelling, or irritation on the skin.

    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

    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 immediately if any of the following side effects occur:

    Less common

    • Skin itching

    Incidence not known

    • Burning, stinging, redness, swelling, or irritation on the skin

    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.






    DRG-20062888

    There’s still time

    Hurry! Your gift now goes 2× as far to help more patients.