Ciclopirox
NDC 54868-6064

The NDC code 54868-6064 is assigned by the FDA to the product Ciclopirox. This pharmaceutical product is labeled by Physicians Total Care, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 54868-6064-0. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

(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 Trichophytonrubrum. 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 DataThe 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 to 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 312Study 313ActiveVehicleActiveVehicleCompleteCure*6/110 (5.5%)1/109 (0.9%)10/118 (8.5%)0/117 (0%)AlmostClear**7/107 (6.5%)1/108 (0.9%)14/116 (12%)1/115 (0.9%)NegativeMycologyAlone***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 cultureThe 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 48Study 312Study 313ActiveVehicleActiveVehicleNumber of Treated Patients112111119118Complete Cure at Week 4861100Post-Treatment Week 12 Outcomes:Patients Missing All Week 12 Assessments2020Patients with Week 12 Assessments4180Complete Cure3140Almost Clear2*11*0Negative Mycology3150*   Four patients (from studies 312 and 313) who were completely cured did not have post-treatment Week 12 planimetry data.

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

• RxCUI: 309291 - ciclopirox 8 % Topical Solution
• RxCUI: 309291 - ciclopirox 80 MG/ML Topical Solution
• RxCUI: 309291 - ciclopirox 8 % (nail lacquer) Topical Solution