Ciclopirox Topical Solution (Penlac)
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Ciclopirox Topical Solution (Penlac)

Penlac® Nail Lacquer
(ciclopirox) Topical Solution, 8%

For use on fingernails and toenails and immediately adjacent skin only.
Not for use in eyes

DRUG DESCRIPTION

PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin.

Each gram of PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, 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.

PENLAC ®NAIL LACQUER (ciclopirox) Topical Solution, 8%, 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 empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is:

Penlac® Nail Lacquer (ciclopirox) Structural Formula Illustration

What are the possible side effects of ciclopirox topical (Loprox, Penlac Nail Lacquer)?

Serious side effects of ciclopirox topical use are not expected to occur. Stop using ciclopirox topical and contact your doctor if you experience unusual or severe itching, redness, burning, dryness, or irritation of the skin or discoloration or other changes in the nails.

Mild burning, itching, or redness may occur with use of ciclopirox topical shampoo.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of Penlac »

What are the precautions when taking ciclopirox topical solution (Penlac)?

Before using ciclopirox, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, numbness in fingers/toes (such as diabetic neuropathy).

Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk....

Read All Potential Precautions of Penlac »

Last reviewed on RxList: 7/29/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)

PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, 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.
  • PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should be used only under medical supervision as described above.
  • The effectiveness and safety of PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, in the following populations has not been studied. The clinical trials with use of PENLAC®NAIL LACQUER (ciclopirox) Topical Solution, 8%, 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 PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, daily for greater than 48 weeks have not been established.

DOSAGE AND ADMINISTRATION

PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, 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 PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, is removed with alcohol.

PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails with the applicator brush provided. The PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should be applied evenly over the entire nail plate.

If possible, PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, 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 PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, 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.

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.

Dermik Laboratories, a business of sanofi-aventis U.S. LLC., Bridgewater, NJ 08807. Country of Origin: Germany. Gantrez is a registered trademark of GAF Corporation. FDA rev date: 12/03/04

Last reviewed on RxList: 7/29/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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).

Read the Penlac (ciclopirox topical solution) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 7/29/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, is not for ophthalmic, oral, or intravaginal use. For use on nails and immediately adjacent skin only.

PRECAUTIONS

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.

Information for Patients

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:

  1. 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.
  2. 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, 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 use of this medication. Inform a health care professional if they 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 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).
  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.
  8. 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity study was conducted with PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, formulation. A carcinogenicity study of ciclopirox (1% and 5% solutions in polyethylene glycol 400) in female mice dosed topically twice per week for 50 weeks followed by a 6-month drug-free observation period prior to necropsy revealed no evidence of tumors at the application sites.

In human systemic tolerability studies following daily application (~340 mg of PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%) in subjects with distal subungual onychomycosis, the average maximal serum level of ciclopirox was 31 28 ng/mL after two months of once daily applications. This level was 159 times lower than the lowest toxic dose and 115 times lower than the highest nontoxic dose in rats and dogs fed 7.7 and 23.1 mg ciclopirox (as ciclopirox olamine)/kg/day.

The following in vitro genotoxicity tests have been conducted with ciclopirox: evaluation of gene mutation in Ames Salmonella and E. coli assays (negative); chromosome aberration assays in V79 Chinese hamster lung fibroblasts, with and without metabolic activation (positive); gene mutation assay in the HGPRT-test with V79 Chinese hamster lung fibroblasts (negative); unscheduled DNA synthesis in human A549 cells (negative); and BALB/c3T3 cell transformation assay (negative). In an in vivo Chinese hamster bone marrow cytogenetic assay, ciclopirox was negative for chromosome aberrations at 5,000 mg/kg.

The following in vitro genotoxicity tests were conducted with PENLAC ®NAIL LACQUER (ciclopirox) Topical Solution, 8%: Ames Salmonella test (negative); unscheduled DNA synthesis in the rat hepatocytes (negative); cell transformation assay in BALB/c3T3 cell assay (positive). The positive response of the lacquer formulation in the BALB/c3T3 test was attributed to its butyl monoester of poly[methylvinyl ether/maleic acid] resin component (Gantrez® ES-435), which also tested positive in this test. The cell transformation assay may have been confounded because of the film-forming nature of the resin. Gantrez® ES-435 tested nonmutagenic in both the in vitro mouse lymphoma forward mutation assay with or without activation and unscheduled DNA synthesis assay in rat hepatocytes.

Oral reproduction studies in rats at doses up to 3.85 mg ciclopirox (as ciclopirox olamine)/kg/day [equivalent to approximately 1.4 times the potential exposure at the maximum recommended human topical dose (MRHTD)] did not reveal any specific effects on fertility or other reproductive parameters. MRHTD (mg/m2) is based on the assumption of 100% systemic absorption of 27.12 mg ciclopirox (~340 mg PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%) that will cover all the fingernails and toenails including 5 mm proximal and lateral fold area plus onycholysis to a maximal extent of 50%.

Pregnancy

Teratogenic effects: Pregnancy Category B

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.

Nursing Mothers

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.

Pediatric Use

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.

Geriatric Use

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.

Last reviewed on RxList: 7/29/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

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

Last reviewed on RxList: 7/29/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Microbiology

Mechanism of Action

The mechanism of action of ciclopirox has been investigated using various in vitro and in vivo infection models. One in vitro study suggested that ciclopirox acts by chelation of polyvalent cations (Fe+3 or Al+3) resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell. The clinical significance of this observation is not known.

Activity in vitro and ex vivo

In vitro methodologies employing various broth or solid media with and without additional nutrients have been utilized to determine ciclopirox minimum inhibitory concentration (MIC) values for the dermatophytic molds.(1-2) As a consequence, a broad range of MIC values, 1-20 ug/mL, were obtained for Trichophyton rubrum and Trichophyton mentagrophytes species. Correlation between in vitro MIC results and clinical outcome has yet to be established for ciclopirox.

One ex vivo study was conducted evaluating 8% ciclopirox against new and established Trichophyton rubrum and Trichophyton mentagrophytes infections in ovine hoof material.(3) After 10 days of treatment the growth of T. rubrum and T. mentagrophytes in the established infection model was very minimally affected. Elimination of the molds from hoof material was not achieved in either the new or established infection models.

Susceptibility testing for Trichophyton rubrum species

In vitro susceptibility testing methods for determining ciclopirox MIC values against the dermatophytic molds, including Trichophyton rubrum species, have not been standardized or validated. Ciclopirox MIC values will vary depending on the susceptibility testing method employed, composition and pH of media and the utilization of nutritional supplements. Breakpoints to determine whether clinical isolates of Trichophyton rubrum are susceptible or resistant to ciclopirox have not been established.

Resistance

Studies have not been conducted to evaluate drug resistance development in T. rubrum species exposed to 8% ciclopirox topical solution. Studies assessing cross-resistance to ciclopirox and other known antifungal agents have not been performed.

Antifungal Drug Interactions

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.

Pharmacokinetics

As demonstrated in pharmacokinetic studies in animals and man, ciclopirox olamine is rapidly absorbed after oral administration and completely eliminated in all species via feces and urine. Most of the compound is excreted either unchanged or as glucuronide. After oral administration of 10 mg of radiolabeled drug (14C-ciclopirox) to healthy volunteers, approximately 96% of the radioactivity was excreted renally within 12 hours of administration. Ninety-four percent of the renally excreted radioactivity was in the form of glucuronides. Thus, glucuronidation is the main metabolic pathway of this compound.

Systemic absorption of ciclopirox was determined in 5 patients with dermatophytic onychomycoses, after application of PENLAC (ciclopirox topical solution) ® NAIL LACQUER (ciclopirox) Topical Solution, 8%, to all 20 digits and adjacent 5 mm of skin once daily for six months. Random serum concentrations and 24 hour urinary excretion of ciclopirox were determined at two weeks and at 1, 2, 4 and 6 months after initiation of treatment and 4 weeks post-treatment. In this study, ciclopirox serum levels ranged from 12-80 ng/mL. Based on urinary data, mean absorption of ciclopirox from the dosage form was < 5% of the applied dose. One month after cessation of treatment, serum and urine levels of ciclopirox were below the limit of detection.

In two vehicle-controlled trials, patients applied PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, to all toenails and affected fingernails. Out of a total of 66 randomly selected patients on active treatment, 24 had detectable serum ciclopirox concentrations at some point during the dosing interval (range 10.0-24.6 ng/mL). It should be noted that eleven of these 24 patients took concomitant medication containing ciclopirox as ciclopirox olamine (Loprox® Cream, 0.77%).

The penetration of the PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, was evaluated in an in vitro investigation. Radiolabeled ciclopirox applied once to onychomycotic toenails that were avulsed demonstrated penetration up to a depth of approximately 0.4 mm. As expected, nail plate concentrations decreased as a function of nail depth. The clinical significance of these findings in nail plates is unknown. Nail bed concentrations were not determined.

Clinical Trials Data

The results of use of PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, 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% in conjunction with monthly removal of the unattached, infected toenail by the investigator. PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, 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:
Patients Missing All Week 12 Assessments 2 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 patients (from studies 312 and 313)who were completely cured did not have post-treatment Week 12 planimetry data.

References:

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.

Last reviewed on RxList: 7/29/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

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:

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

Patient Instructions - illustration 1 Patient Instructions - illustration 2

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.

Patient Instructions - illustration 3 Patient Instructions - illustration 4

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.

Patient Instructions - illustration 5

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).

Patient Instructions - illustration 6

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.

Last reviewed on RxList: 7/29/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

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:

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

Patient Instructions - illustration 1 Patient Instructions - illustration 2

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.

Patient Instructions - illustration 3 Patient Instructions - illustration 4

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.

Patient Instructions - illustration 5

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).

Patient Instructions - illustration 6

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.

Last reviewed on RxList: 7/29/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Penlac Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

CICLOPIROX LACQUER - TOPICAL

(cyc-low-PIE-rocks)

COMMON BRAND NAME(S): PENLAC

USES: This medication is used to treat fungal infections of the fingernails and toenails. It is used as part of a treatment program that includes the removal of unattached, infected nails by a health care professional as frequently as once a month. Ciclopirox works by stopping the growth of fungus.

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using ciclopirox and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Before starting treatment, remove any loose nail material using nail clippers or a file. If you have diabetes or numbness in your fingers/toes, talk to your doctor before filing or trimming your nails. It may be safer for your doctor to file or remove your nails.

Use this medication on the nails and skin next to the nails only. Apply ciclopirox as directed by your doctor, usually once daily at bedtime. Using the applicator provided, apply this medication evenly over the entire affected nail and to the area of the skin next to the nail (5 millimeters or 1/5 of an inch around the nail). If the applicator can reach the undersurface of the nail and the skin under the nail, apply the medication to those areas as well. Avoid contact with skin that is not right next to the affected nail. Do not use nail cosmetic products (such as nail polish) on the treated nails.

Do not apply the medication in the eyes, nose, or mouth, or inside the vagina. If you do get the medication in those areas, rinse with plenty of water.

Let the medication dry (around 30 seconds) before putting on socks or stockings. Do not wash the treated area for at least 8 hours.

Every 7 days, remove the medication from the nail by applying alcohol. Then trim the nail and file away any loose nail material.

Since this product is flammable, do not use this product near heat or open flame.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.

Continue to use this medication for the full time prescribed, even if symptoms disappear. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition worsens or does not improve after 6 months of treatment. It may take up to one year for the nail to be clear or almost clear.

Disclaimer

Penlac Consumer (continued)

SIDE EFFECTS: Redness/burning of treated skin or changes in shape/color of nail may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering/swelling/oozing at the application site.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Penlac (ciclopirox topical solution) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using ciclopirox, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, numbness in fingers/toes (such as diabetic neuropathy).

Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Penlac Consumer (continued)

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

OVERDOSE: This medication may be harmful if swallowed. If overdose or swallowing is suspected, contact a poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light, heat, or open flame. To protect the medication from light, store the bottle in the carton after each use. Keep bottle tightly closed. To prevent the cap from sticking to the bottle, avoid getting the medication on the bottle threads. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.

Penlac Patient Information Including Side Effects

Brand Names: Loprox, Penlac Nail Lacquer

Generic Name: ciclopirox topical (Pronunciation: sye kloe PEER ox)

What is ciclopirox topical (Penlac)?

Ciclopirox is an antifungal medication. Ciclopirox topical prevents fungus from growing.

Ciclopirox topical cream and lotion formulations are used to treat skin infections such as athlete's foot, jock itch, ringworm, and yeast infections. Ciclopirox shampoo is used to treat seborrheic dermatitis (inflammatory skin condition) of the scalp. Ciclopirox topical nail lacquer is used to treat fungal infections of the toenails and fingernails.

Ciclopirox topical may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of ciclopirox topical (Penlac)?

Serious side effects of ciclopirox topical use are not expected to occur. Stop using ciclopirox topical and contact your doctor if you experience unusual or severe itching, redness, burning, dryness, or irritation of the skin or discoloration or other changes in the nails.

Mild burning, itching, or redness may occur with use of ciclopirox topical shampoo.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Penlac (ciclopirox topical solution) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about ciclopirox topical (Penlac)?

Avoid getting ciclopirox topical in the eyes, nose, or mouth.

Do not use bandages or dressings that do not allow air to circulate (occlusive dressings) on areas treated with ciclopirox cream or lotion, unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Use ciclopirox topical nail lacquer on nails and immediately surrounding skin only.

Ciclopirox topical nail lacquer is flammable, keep it away from heat and flame.

Use ciclopirox topical for the full amount of time prescribed by your doctor. Your symptoms may improve before the infection is completely healed however, it is important to use the medication for the full amount of time.

Penlac Patient Information including How Should I Take

What should I discuss with my healthcare provider before using ciclopirox topical (Penlac)?

Do not use ciclopirox topical if you have had an allergic reaction to it in the past.

Before using ciclopirox topical, tell your doctor if you

  • have diabetes;
  • are immunosuppressed (e.g., have received an organ transplant or have AIDS);
  • take medication to control epilepsy or another seizure disorder;
  • use a topical corticosteroid on a regular basis; or
  • use a steroid inhaler on a regular basis.

You may not be able to use ciclopirox topical nail lacquer or you may require a dosage adjustment or special monitoring during your treatment .

Ciclopirox topical is the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not use ciclopirox topical without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether ciclopirox passes into breast milk. Do not use ciclopirox topical without first talking to your doctor if you are breast-feeding a baby.

How should I use ciclopirox topical (Penlac)?

Use ciclopirox topical exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

To use ciclopirox topical cream or lotion:

  • Wash your hands before and after using this medication, unless you are using ciclopirox topical to treat a hand condition.
  • Clean and dry the affected area. Apply a small amount of the cream (usually twice daily) for 2 to 4 weeks. Follow your doctor's instructions.
  • Do not use bandages or dressings that do not allow air to circulate (occlusive dressings) on areas treated with ciclopirox cream or lotion, unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).
  • If the infection does not clear up in 4 weeks, or if it appears to get worse, see your doctor.

To use ciclopirox shampoo:

  • Wet the hair and apply approximately 1 teaspoon (5 mL) of the shampoo to the scalp. Up to 2 teaspoons (10 mL) may be used for long hair. Lather and leave on the hair and scalp for 3 minutes. A timer may be used. Rinse off the shampoo after 3 minutes have passed.
  • Avoid contact with the eyes, nose, and inside of the mouth.
  • Treatment should be repeated twice per week for 4 weeks, with a minimum of 3 days between applications. If no improvement is seen after 4 weeks of treatment, contact your doctor.

To use ciclopirox topical nail lacquer:

  • Remove any loose nail or nail material using nail clippers or a nail file.
  • Apply ciclopirox topical 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, apply the nail laquer to the underside of the nail and to the skin beneath it. Allow the lacquer to dry (approximately 30 seconds) before putting on socks or stockings. After applying the medication, wait 8 hours before taking a bath or shower.
  • Apply ciclopirox topical nail lacquer daily over the previous coat. Once a week, remove ciclopirox topical nail lacquer with alcohol. Remove as much as possible of the damaged nail using nail clippers or nail a file.
  • Use ciclopirox topical nail lacquer on nails and immediately surrounding skin only. Avoid contact with other areas.
  • Treatment with ciclopirox topical nail lacquer may require six months or more before initial improvement of symptoms is noticed. Up to 48 weeks of daily application of the nail lacquer, monthly removal of the unattached infected nail by a health care professional, and weekly trimming by the patient may be required for complete treatment.
  • To prevent the screw cap from sticking to the bottle, do not allow the solution to get into the bottle treads. To prevent the solution from drying out, close the bottle tightly after every use.

Use ciclopirox topical for the full amount of time prescribed by your doctor. Your symptoms may improve before the infection is completely healed however, it is important to use the medication for the full amount of time.

Avoid getting ciclopirox topical in the eyes, nose, or mouth.

Store ciclopirox topical at room temperature away from moisture and heat. Ciclopirox topical nail lacquer is flammable, keep it away from heat and flame. Protect the ciclopirox topical nail lacquer from light by storing the bottle in the carton after every use. Once a bottle of ciclopirox topical shampoo is opened, it should be used within 8 weeks.

Penlac Patient Information including If I Miss a Dose

What happens if I miss a dose (Penlac)?

Apply the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the dose you missed and apply only the regular amount of ciclopirox topical. Do not use a double dose unless otherwise directed by your doctor.

What happens if I overdose (Penlac)?

An overdose of ciclopirox topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that ciclopirox topical has been ingested, contact an emergency room or a poison control center.

What should I avoid while using ciclopirox topical (Penlac)?

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Do not use nail polish, artificial nails, or other cosmetic nail products on the nails treated with ciclopirox topical nail lacquer.

What other drugs will affect ciclopirox topical (Penlac)?

Avoid using other topical products at the same time unless directed otherwise by your doctor. Other skin medications may affect the absorption or effectiveness of ciclopirox topical formulations.

Do not use nail polish, artificial nails, or other cosmetic nail products on the nails treated with ciclopirox topical nail lacquer.

Drugs other than those listed here may also interact with ciclopirox topical. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

Your pharmacist has additional information about ciclopirox topical written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.04. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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