Ciclopirox

(To understand fully the indication for this product, please read the entireINDICATIONS AND USAGE section of the labeling.) Ciclopirox Topical Solution, 8% (Nail Lacquer), 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. Ciclopirox Topical Solution, 8% (Nail Lacquer) should be used only under medical supervision as described above. The effectiveness and safety of Ciclopirox Topical Solution, 8% (Nail Lacquer) in the following populations has not been studied.

The clinical trials with use of Ciclopirox Topical Solution, 8% (Nail Lacquer) 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 Ciclopirox Topical Solution, 8% (Nail Lacquer) daily for greater than 48 weeks have not been established.

Ciclopirox Topical Solution, 8% (Nail Lacquer) is contraindicated in individuals who have shown hypersensitivity to any of its components.

Ciclopirox Topical Solution, 8% (Nail Lacquer) is not for ophthalmic, oral, or intravaginal use. For use on nails and immediately adjacent skin only.

In the vehicle-controlled clinical trials conducted in the US, 9% (30/327) of patients treated with Ciclopirox Topical Solution, 8% (Nail Lacquer) and 7% (23/328) of patients treated with vehicle reported treatment-emergent adverse events (TEAE) considered by the investigator to be causally related to the test material. The incidence of these adverse events, within each body system, was similar between the treatment groups except for Skin and Appendages: 8% (27/327) and 4% (14/328) of subjects in the ciclopirox and vehicle groups reported at least one adverse event, respectively.

The most common were rash-related adverse events: periungual erythema anderythema of the proximal nail fold were reported more frequently in patients treated with Ciclopirox Topical Solution, 8% (Nail Lacquer) (5% [16/327]) than in patients treated with vehicle (1% [3/328]). Other TEAEs thought to be causally related included nail disorders such as shape change, irritation, ingrown toenail, and discoloration. The incidence of nail disorders was similar between the treatment groups (2% [6/327] in the Ciclopirox Topical Solution, 8% (Nail Lacquer) group and 2% [7/328] in the vehicle group).

Moreover, application site reactions and/or burning of the skin occurred in 1% of patients treated with Ciclopirox Topical Solution, 8% (Nail Lacquer) (3/327) and vehicle (4/328). A 21-Day Cumulative Irritancy study was conducted under conditions of semi-occlusion. Mild reactions were seen in 46% of patients with the Ciclopirox Topical Solution, 8% (Nail Lacquer), 32% with the vehicle and 2% with the negative control, but all were reactions of mild transient erythema.

There was no evidence of allergiccontact sensitization for either the Ciclopirox Topical Solution, 8% (Nail Lacquer), or the vehicle base. In a separate study of the photosensitization potential of CiclopiroxTopical Solution, 8% (Nail Lacquer) in a maximized test design that included the occluded application of sodium lauryl sulfate, no photoallergic reactions were noted.In four subjects localized allergic contact reactions were observed.

In the vehicle-controlled studies, one patient treated with Ciclopirox Topical Solution, 8% (NailLacquer) discontinued treatment due to a rash, localized to the palm (causal relation to test material undetermined). Use of Ciclopirox Topical Solution, 8% (Nail Lacquer) for 48 additional weeks was evaluated in an open-label extension study conducted in patients previously treated in the vehicle-controlled studies. Three percent (9/281) of subjects treated with Ciclopirox Topical Solution, 8% (Nail Lacquer) experienced at least one TEAE that theinvestigator thought was causally related to the test material.

Mild rash in the form of periungual erythema (1% [2/281]) and nail disorders (1% [4/281]) were the mostfrequently reported. Four patients discontinued because of TEAEs. Two of the four had events considered to be related to test material: one patient’s great toenail “brokeaway” and another had an elevated creatine phosphokinase level on Day 1 (after 48 weeks of treatment with vehicle in the previous vehicle-controlled study).