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Penlac

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Penlac

Indications
Dosage
How Supplied

INDICATIONS

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)

PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum. The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures.

  • No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis, is not recommended.
  • PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should be used only under medical supervision as described above.
  • The effectiveness and safety of PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, in the following populations has not been studied. The clinical trials with use of PENLAC®NAIL LACQUER (ciclopirox) Topical Solution, 8%, excluded patients who: were pregnant or nursing, planned to become pregnant, had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex), were HIV seropositive, received organ transplant, required medication to control epilepsy, were insulin dependent diabetics or had diabetic neuropathy. Patients with severe plantar (moccasin) tinea pedis were also excluded.
  • The safety and efficacy of using PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, daily for greater than 48 weeks have not been established.

DOSAGE AND ADMINISTRATION

PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should be used as a component of a comprehensive management program for onychomycosis. Removal of the unattached, infected nail, as frequently as monthly, by a health care professional, weekly trimming by the patient, and daily application of the medication are all integral parts of this therapy. Careful consideration of the appropriate nail management program should be given to patients with diabetes (see PRECAUTIONS).

Nail Care By Health Care Professionals

Removal of the unattached, infected nail, as frequently as monthly, trimming of onycholytic nail, and filing of excess horny material should be performed by professionals trained in treatment of nail disorders.

Nail Care By Patient

Patients should file away (with emery board) loose nail material and trim nails, as required, or as directed by the health care professional, every seven days after PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, is removed with alcohol.

PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails with the applicator brush provided. The PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should be applied evenly over the entire nail plate.

If possible, PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis).

The PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should not be removed on a daily basis. Daily applications should be made over the previous coat and removed with alcohol every seven days. This cycle should be repeated throughout the duration of therapy.

HOW SUPPLIED

PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, is supplied in 3.3 mL (NDC 0066-8008-01) and 6.6 mL (NDC 0066-8008-02) glass bottles with screw caps which are fitted with brushes.

Protect from light (e.g., store the bottle in the carton after every use).

PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should be stored at room temperature between 59° and 86° F (15° and 30° C).

CAUTION: Flammable. Keep away from heat and flame.

Dermik Laboratories, a business of sanofi-aventis U.S. LLC., Bridgewater, NJ 08807. Country of Origin: Germany. Gantrez is a registered trademark of GAF Corporation. FDA rev date: 12/03/04

Last reviewed on RxList: 7/29/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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