Penlac Nail Lacquer Topical Drug Information

Breast-feeding—It is not known if 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 this medicine and who wish to breast-feed should discuss this with their doctor.

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—There are many medicines that 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 some medicines should not be used together at all, there are cases when 2 different medicines maybe used together even if an interaction might occur. In such cases, your doctor may advise you to change the dose, or other precautions may be required. 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.

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 topical ciclopirox will vary for different patients. Adhere to the orders of your doctor or the instructions on the label . The information below includes only the average doses of topical ciclopirox. If your dose differs, you should 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 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—To store this medicine properly, follow the instructions below:

• 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.

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

Alongside with its expected effects, any medicine may be the cause of some unwanted effects. Although not all of these side effects may happen, if they do happen they may require medical attention.

Consult your doctor immediately if any of the side effects from the list below occur:

Less common—with ciclopirox shampoo

Fainting; fast, pounding, or irregular heartbeat or pulse; palpitations

Rare

Other side effects that may occur generally do not require any medical attention. These side effects may disappear in the course of treatment as your body gets used to the medicine. However, 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:

Other side effects not mentioned above may also happen in some patients. If you notice any other effects, tell your doctor about it.