For use on fingernails and toenails and immediately adjacent skin only

Not for use in eyes

Ciclopirox Topical Solution, 8% (Nail Lacquer) contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin.

Each gram of Ciclopirox Topical Solution, 8% (Nail Lacquer) 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.

Ciclopirox Topical Solution, 8% (Nail Lacquer) 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 molecular formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is:

(To understand fully the indication for this product, please read the entire INDICATIONS 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 Tricho-phyto 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.

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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.

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Ciclopirox Topical Solution, 8% (Nail Lacquer) should be used only under medical supervision as described above.

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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.

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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.

To report SUSPECTED ADVERSE REACTIONS, contact Akorn Operating Company LLC at 1-800-932-5676 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 and erythema 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 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 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 allergic contact sensitization for either the Ciclopirox Topical Solution, 8% (Nail Lacquer) or the vehicle base. In a separate study of the photosensitization potential of Ciclopirox Topical 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% (Nail Lacquer) 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 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).

Ciclopirox Topical Solution, 8% (Nail Lacquer) 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).

Ciclopirox Topical Solution, 8% (Nail Lacquer) is supplied in 3.3 mL (NDC 50383-419-03) and 6.6 mL (NDC 50383-419-06) glass bottles with screw caps which are fitted with brushes.

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

Ciclopirox Topical Solution, 8% (Nail Lacquer) 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

Patients should have detailed instruction regarding the use of Ciclopirox Topical Solution, 8% (Nail Lacquer) 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:

1.

Use Ciclopirox Topical Solution, 8% (Nail Lacquer) as directed by a health care professional. Avoid contact with eyes and mucous membranes. Contact with skin other than skin immediately surrounding the treated nail(s) should be avoided. Ciclopirox Topical Solution, 8% (Nail Lacquer) is for external use only.

2.

Ciclopirox Topical Solution, 8% (Nail Lacquer) should be applied evenly over the entire nail plate and 5 mm of surrounding skin. If possible, Ciclopirox. Topical Solution, 8% (Nail Lacquer) 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). Contact with the surrounding skin may produce mild, transient irritation (redness).

3.

Removal of the unattached, infected nail, as frequently as monthly, by a health care professional is needed with the 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.

4.

Inform a health care professional if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing).

5.

Up to 48 weeks of daily applications with Ciclopirox Topical Solution, 8% (Nail Lacquer) 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).

6.

Six months of therapy with professional removal of the unattached, infected nail may be required before initial improvement of symptoms is noticed.

7.

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.

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Do not use the medication for any disorder other than that for which it is prescribed.

9.

Do not use nail polish or other nail cosmetic products on the treated nails.

10.

Avoid use near heat or open flame, because product is flammable.

1. Dittmar W., Lohaus G. 1973. HOE296, A new antimycotic compound with a broad antimicrobial spectrum. Arzneim- Forsch./Drug Res. 23:670-674.

2. Niewerth et al., 1998. Antimicrobial susceptibility testing of dermatophytes: Comparison of the agar macrodilution and broth micro dilution tests. Chemotherapy. 44:31-35.

3. 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

Distributed by:

Akorn Operating Company LLC

Gurnee, IL 60031

Rev. 419:04 07/22

Patients should have detailed instructions regarding the use of Ciclopirox Topical Solution, 8% (Nail Lacquer) 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.

Call your doctor for medical advice about side effects. You may report side effects to Akorn Operating Company LLC at 1-800-932-5676 or FDA at 1-800-FDA-1088.

Before using this medication, tell your doctor if you:

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Are pregnant or nursing

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Are an insulin dependent diabetic or have diabetic neuropathy

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Have a history of immunosuppression

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Are immunocompromised (e.g., received an organ transplant, etc.)

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Require medication to control epilepsy

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Use or require topical corticosteroids on a repeated monthly basis

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Use steroid inhalers on a regular basis

Patient Information:

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Use Ciclopirox Topical Solution, 8% (Nail Lacquer) as directed by your health care professional.

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Ciclopirox Topical Solution, 8% (Nail Lacquer) is for external use only.

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Contact with skin other than skin immediately surrounding the treated nail(s) should be avoided.

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Avoid contact with the eyes and mucous membranes

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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 Ciclopirox Topical Solution, 8% (Nail Lacquer) 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 Instruction

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 Ciclopirox Topical Solution, 8% (Nail Lacquer) 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 Ciclopirox Topical Solution, 8% (Nail Lacquer) daily over the previous coat.

4. Once a week, remove the Ciclopirox Topical Solution, 8% (Nail Lacquer) 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.

Distributed by:

Akorn Operating Company LLC

Gurnee, IL 60031

Rev. 419:04 07/22

AKORN

NDC 50383-419-06

Ciclopirox Topical Solution, 8% (Nail Lacquer)

FOR DERMATOLOGIC USE ONLY

NOT FOR USE IN EYES

6.6 mL

Rx only