Generic Name: ciclopirox Dosage Form: Nail Lacquer
Ciclopirox belongs to the group of medications known as antifungals. It works by preventing certain types of fungus from growing and reproducing. The cream and lotion form of this medication are used to treat certain types of fungal infections of the skin.
Penlac Nail Lacquer is a topical treatment for nail fungus. The lacquer form is used as part of a treatment plan for fungal infections of the nails. The shampoo form of this medication is used to treat and prevent dandruff or to treat seborrhoeic dermatitis (a condition of the scalp that causes itchy, scaly, flaky, and red skin) caused by specific fungus on the scalp.
Penlac® NAIL LACQUER (ciclopirox) Topical Solution, 8%, contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin.
Each gram of Penlac® NAIL LACQUER (ciclopirox) Topical Solution, 8%, contains 80 mg ciclopirox in a solution base consisting of ethyl acetate, NF; isopropyl alcohol, USP; and butyl monoester of poly[methylvinyl ether/maleic acid] in isopropyl alcohol. Ethyl acetate and isopropyl alcohol are solvents that vaporize after application.
Penlac ®NAIL LACQUER (ciclopirox) Topical Solution, 8%, is a clear, colorless to slightly yellowish solution.
The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0].
The chemical structure is:
Product description
Safety information
Side Effects
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.
Product description
Safety information
Side Effects
Serious side effects of ciclopirox topical use are not expected to occur. Stop using ciclopirox topical and contact your doctor if you experience unusual or severe itching, redness, burning, dryness, or irritation of the skin or discoloration or other changes in the nails.
Mild burning, itching, or redness may occur with use of ciclopirox topical shampoo.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
