PENLAC Nail lacquer Ref.[10918] Active ingredients: Ciclopirox olamine

PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, 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 PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, 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 and erythema of the proximal nail fold were reported more frequently in patients treated with PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, (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 PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, 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 PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, (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 PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, 32% with the vehicle and 2% with the negative control, but all were reactions of mild transient erythema. There was no evidence of allergic contact sensitization for either the PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, or the vehicle base. In a separate study of the photosensitization potential of PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, 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 PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, discontinued treatment due to a rash, localized to the palm (causal relation to test material undetermined).

Use of PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, 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 PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, experienced at least one TEAE that the investigator 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 most frequently 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 “broke away” and another had an elevated creatine phosphokinase level on Day 1 (after 48 weeks of treatment with vehicle in the previous vehicle-controlled study).

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

If a reaction suggesting sensitivity or chemical irritation should occur with the use of PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, treatment should be discontinued and appropriate therapy instituted.

So far there is no relevant clinical experience with patients with insulin dependent diabetes or who have diabetic neuropathy. The risk of removal of the unattached, infected nail, by the health care professional and trimming by the patient should be carefully considered before prescribing to patients with a history of insulin dependent diabetes mellitus or diabetic neuropathy.

Patients should have detailed instructions regarding the use of PENLAC Nail Lacquer (ciclopirox)Topical Solution, 8%, as a component of a comprehensive management program for onychomycosis in order to achieve maximum benefit with the use of this product.

The patient should be told to:

• Use PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, as directed by a health care professional. Avoid contact with the eyes and mucous membranes. Contact with skin other than skin immediately surrounding the treated nail(s) should be avoided. PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, is for external use only.
• PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, should be applied evenly over the entire nail plate and 5 mm of surrounding skin. If possible, PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, should be applied to the nail bed, hypoynchium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis). Contact with the surrounding skin may produce mild, transient irritation (redness).
• Removal of the unattached, infected nail, as frequently as monthly, by a health care professional is needed with use of this medication. Inform a health care professional if you have diabetes or problems with numbness in your toes or fingers for consideration of the appropriate nail management program.
• Inform a health care professional if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing).
• Up to 48 weeks of daily applications with PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, and professional removal of the unattached, infected nail, as frequently as monthly, are considered the full treatment needed to achieve a clear or almost clear nail (defined as 10% or less residual nail involvement).
• Six months of therapy with professional removal of the unattached, infected nail may be required before initial improvement of symptoms is noticed.
• A completely clear nail may not be achieved with use of this medication. In clinical studies, less than 12% of patients were able to achieve either a completely clear or almost clear toenail.
• Do not use the medication for any disorder other than that for which it is prescribed.
• Do not use nail polish or other nail cosmetic products on the treated nails.
• Avoid use near heat or open flame, because product is flammable.

Teratology studies in mice, rats, rabbits, and monkeys at oral doses of up to 77, 23, 23, or 38.5 mg, respectively, of ciclopirox as ciclopirox olamine/kg/day (14, 8, 17, and 28 times MRHTD), or in rats and rabbits receiving topical doses of up to 92.4 and 77 mg/kg/day, respectively (33 and 55 times MRHTD), did not indicate any significant fetal malformations.

There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women. PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, is administered to a nursing woman.

Based on the safety profile in adults, PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, is considered safe for use in children twelve years and older. No clinical trials have been conducted in the pediatric population.

Clinical studies of PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients.