Ciclopirox 71.3 mg/mL Solution, 6.6 mL — NDC 62135-814-45 (Billing 62135-0814-45)

INDICATIONS AND USAGE (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 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. Clinical Trials Data : The results of use of ciclopirox topical solution, 8% (Nail Lacquer), in treatment of onychomycosis of the toenail without lunula involvement were obtained from two double-blind, placebo-controlled studies conducted in the US.

In these studies, patients with onychomycosis of the great toenails without lunula involvement were treated with ciclopirox topical solution, 8% (Nail Lacquer) in conjunction with monthly removal of the unattached, infected toenail by the investigator. Ciclopirox topical solution, 8% (Nail Lacquer), was applied for 48 weeks. At baseline, patients had 20–65% involvement of the target great toenail plate.

Statistical significance was demonstrated in one of two studies for the endpoint “complete cure” (clear nail and negative mycology), and in two studies for the endpoint “almost clear” (≤ 10% nail involvement and negative mycology) at the end of study. These results are presented below. At Week 48 (plus Last Observation Carried Forward) for the Intent-to-Treat (ITT) Population Study 312 Study 313 Active Vehicle Active Vehicle Complete Cure* 6/110 (5.5%) 1/109 (0.9%) 10/118 (8.5%) 0/117 (0%) Almost Clear** 7/107 (6.5%) 1/108 (0.9%) 14/116 (12%) 1/115 (0.9%) Negative Mycology Alone*** 30/105 (29%) 12/106 (11%) 41/115 (36%) 10/114 (9%) * Clear nail and negative mycology ** ≤10% nail involvement and negative mycology *** Negative KOH and negative culture The summary of reported patient outcomes for the ITT population at 12 weeks following the end of treatment are presented below.

Note that post-treatment efficacy assessments were scheduled only for patients who achieved a complete cure. Post-treatment Week 12 Data for Patients Who Achieved Complete Cure at Week 48 Study 312 Study 313 Active Vehicle Active Vehicle Number of Treated Patients 112 111 119 118 Complete Cure at Week 48 6 1 10 0 Post-treatment Week 12 Outcomes: 2 Patients Missing All Week 12 Assessments 0 2 0 Patients with Week 12 Assessments 4 1 8 0 Complete Cure 3 1 4 0 Almost Clear 2* 1 1* 0 Negative Mycology 3 1 5 0 *Four pa… [Excerpted — this section continues on DailyMed.]

DOSAGE AND ADMINISTRATION 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 ).

Nail Care By Health Care Professionals : Removal of the unattached, infected nail, as frequently as monthly, trimming of onycholytic nail, and filing of excess horny material should be performed by professionals trained in treatment of nail disorders. Nail Care By Patient : Patients should file away (with emery board) loose nail material and trim nails, as required, or as directed by the health care professional, every seven days after ciclopirox topical solution, 8% (Nail Lacquer), is removed with alcohol. Ciclopirox topical solution, 8% (Nail Lacquer), should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails with the applicator brush provided.

The ciclopirox topical solution, 8% (Nail Lacquer), should be applied evenly over the entire nail plate. 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). The ciclopirox topical solution, 8% (Nail Lacquer), should not be removed on a daily basis.

Daily applications should be made over the previous coat and removed with alcohol every seven days. This cycle should be repeated throughout the duration of therapy.

Print Patient Information at: https://www.chartwellpharma.com/our-products/ Patient Package Instructions Ciclopirox Topical Solution, USP 8% (Nail Lacquer) Patient Information and Instructions 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.

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 ciclopirox topical solution, 8% (Nail Lacquer), as directed by your health care professional. Ciclopirox topical solution, 8% (Nail Lacquer), 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 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 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 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.

Call your doctor for medical advice about side effects. You may report side effe… [Excerpted — this section continues on DailyMed.]