Penlac nail lacquer, topical solution, 8%

Name: Penlac nail lacquer, topical solution, 8%

Penlac nail lacquer, topical solution, 8% drug

Contraindications

PENLAC NAIL LACQUER (ciclopirox) Topical Solution, 8%, is contraindicated in individuals who have shown hypersensitivity to any of its components.

Adverse Reactions

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 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).

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.

Rx ONLY.

Prescribing Information as of December 2003

Manufactured for:

Dermik Laboratories

A Division of Aventis Pharmaceuticals Inc

Berwyn, PA 19312 USA

by:

Aventis Pharma Deutschland GmbH

D-65926 Frankfurt am Main

Germany

REFERENCES:

Dittmar W., Lohaus G. 1973. HOE296, A new antimycotic compound with a broad antimicrobial spectrum. Arzneim-Forsch./Drug Res. 23:670-674.
Niewerth et. al., 1998. Antimicrobial susceptibility testing of dermatophytes: Comparison of the agar macrodilution and broth micro dilution tests. Chemotherapy. 44:31-35.
Yang et. al. 1997. A new simulation model for studying in vitro topical penetration of antifungal drugs into hard keratin. J. Mycol. Med. 7:195-98.
Gantrez is a registered trademark of GAF Corporation

PENLAC NAIL LACQUER (ciclopirox)
Topical Solution, 8%

Patient Information and Instructions

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. Discuss your treatment plan with your health care professional for regular removal of the unattached, infected nail.

Before using this medication, tell your doctor if you:

Are pregnant or nursing
Are an insulin dependent diabetic or have diabetic neuropathy
Have a history of immunosuppression
Are immunocompromised (e.g., received an organ transplant, etc.)
Require medication to control epilepsy
Use or require topical corticosteroids on a repeated monthly basis
Use steroid inhalers on a regular basis

Patient Information:

Use PENLAC NAIL LACQUER (ciclopirox) Topical Solution, 8%, as directed by your health care professional.
PENLAC NAIL LACQUER (ciclopirox) Topical Solution, 8%, is for external use only.
Contact with skin other than skin immediately surrounding the treated nail(s) should be avoided.
Avoid contact with the eyes and mucous membranes.
Removal of the unattached, infected nail, as frequently as monthly, by your health care professional is needed with use of this medication to obtain maximal benefit with use of this product. If you have diabetes or problems with numbness in your toes or fingers, talk to your health care provider before trimming your nails or removing any nail material.
Inform your 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, as frequently as monthly, of the unattached, infected nail are considered the full treatment time 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 clear or almost clear toenail.
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.

Patient Instructions

1. Before starting treatment, remove any loose nail or nail material using nail clippers or nail files. If you have diabetes or problems with numbness in your toes or fingers, talk to your health care provider before trimming your nails or removing any nail material.

2.Apply PENLAC NAIL LACQUER (ciclopirox) Topical Solution, 8%, once daily (preferably at bedtime) to all affected nails with the applicator brush provided. Apply the lacquer evenly over the entire nail. Where possible, nail lacquer should also be applied to the underside of the nail and to the skin beneath it. Allow lacquer to dry (approximately 30 seconds) before putting on socks or stockings. After applying medication, wait 8 hours before taking a bath or shower.

3.Apply PENLAC NAIL LACQUER (ciclopirox) Topical Solution, 8%, daily over the previous coat.

4. Once a week, remove the PENLAC NAIL LACQUER (ciclopirox) Topical Solution, 8%, with alcohol. Remove as much as possible of the damaged nail using scissors, nail clippers, or nail files.

5. Repeat process (steps 2 through 4).

Please Note:

1. To prevent screw cap from sticking to the bottle, do not allow solution to get into the bottle threads.

2. To prevent the solution from drying out, bottle should be closed tightly after every use.

3. To protect from light, replace bottle into carton after each use.