GENERIC NAME: ciclopirox

BRAND NAME: Penlac

DRUG CLASS AND MECHANISM: Ciclopirox is a synthetic broad-spectrum antifungal agent that inhibits the growth of dermatophytes, a type of fungus that grows on the skin, hair, and nails. Approved for use in the U.S. by the FDA in December, 1999.

GENERIC AVAILABLE: no

PRESCRIPTION: yes

PREPARATIONS: Topical Solution 8%

STORAGE: Protect from light (store the bottle in the carton after each use). Topical Solution 8% should be stored at room temperature, 15-30°C (59-86°F). Avoid use or storage near heat or open flame as the product is flammable.

PRESCRIBED FOR: Penlac Topical Solution 8% is topical therapy without systemic side effects to treat finger or toenail fungus that does not involve the white portion of the nail (lunula) in persons with normal immune systems. In controlled clinical trials it was found to be safe and effective in treating nail fungus, with some patients experiencing resolution of the infection.

DOSING: Penlac Topical Solution 8% is applied once a day with an applicator brush to all affected nails and immediately adjacent skin. Daily applications should be made over the previous coat and removed every seven days. Up to 48 weeks of daily applications, weekly trimming by the patient, and monthly professional removal of the unattached, infected nail, is needed. Safety of use greater than 48 weeks has not been evaluated.

DRUG INTERACTIONS: Use together with other medications for fungal infection is not recommended. Do not use nail polish or other cosmetic products on the treated nails.

PREGNANCY: There are no adequate studies of Penlac Topical Solution 8% in pregnant women. Therefore, it can be used in pregnancy if the physician determines that it is needed.

NURSING MOTHERS: It is not known whether this drug is excreted in breast milk. Because of a potential for side effects in the nursing infant, the physician must weigh the potential benefits and possible risks before prescribing Penlac Topical Solution 8% for nursing mothers.

SIDE EFFECTS: If rash, or itching occurs Penlac Topical Solution 8% should be discontinued. Skin burning may occur, though infrequently.

Avoid contact with the eyes and any other skin than that around the nail(s) being treated. Contact with the surrounding skin may produce mild, temporary irritation and redness.

It is critical that patients use Penlac Topical Solution 8% as a part of a comprehensive treatment program. This means that patients must be under the regular care of a healthcare professional and follow the guidelines for clean, dry, foot care maximize benefit and to prevent recurrence.

Reference: FDA Prescribing Information