Penlac® Nail Lacquer
`(ciclopirox) Topical Solution, 8%
`
`For use on fingernails and toenails and immediately adjacent skin only
`Not for use in eyes
`
`
`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:
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`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
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`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® 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.
`
`INDICATIONS AND USAGE
`(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
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`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.
`
`
`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.
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`At Week 48 (plus Last Observation Carried Forward) for the Intent-to-Treat (ITT) Population
`Study 312
`Study 313
`
`
`Active
`
`Vehicle
`
`Active
`
`Vehicle
`
`6/110 (5.5%)
`7/107 (6.5%)
`30/105 (29%)
`
`1/109 (0.9%)
`1/108 (0.9%)
`12/106 (11%)
`
`10/118 (8.5%)
`14/116 (12%)
`41/115 (36%)
`
`0/117 (0%)
`1/115 (0.9%)
`10/114 (9%)
`
`Complete Cure*
`Almost Clear**
`Negative Mycology
`Alone***
`* 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.
`
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`Post-treatment Week 12 Data for Patients Who Achieved Complete Cure at Week 48
`Study 312
`Study 313
`Active
`Active
`
`Vehicle
`
`Vehicle
`
`118
`0
`
` 0
`
`
`0
`0
`0
`0
`
`
`119
`10
`
` 2
`
`
`8
`4
`1*
`5
`
`
`111
`1
`
` 0
`
`
`1
`1
`1
`1
`
`
`112
`6
`
` 2
`
`
`4
`3
`2*
`3
`
`
`
`Number of Treated Patients
`Complete Cure at Week 48
`Post-treatment Week 12 Outcomes:
`Patients Missing All Week 12 Assessments
`Patients with Week 12 Assessments
` Complete Cure
` Almost Clear
` Negative Mycology
`
`
`
`*Four patients (from studies 312 and 313) who were completely cured did not have post-
`treatment Week 12 planimetry data.
`
`CONTRAINDICATIONS
`PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, is contraindicated in
`individuals who have shown hypersensitivity to any of its components.
`
`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.
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`2.
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`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.
`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.
`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).
`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.
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`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
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`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.
`
`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
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`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).
`
`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
`
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`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.
`Rx ONLY
`Prescribing Information as of December 2004
`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:
`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
`
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`©Dermik Laboratories 2003
`-----∃----------------------------------------------------------------------------------------------------------------------
`
`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
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`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.
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`Patient Instructions
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`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.
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`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.
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`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).
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`Please Note:
`1. To prevent screw cap from sticking to
`the bottle, do not allow solution to get
`into the bottle threads.
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`2. To prevent the solution from drying
`out, bottle should be closed tightly after
`every use.
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`3. To protect from light, replace bottle
`into carton after each use.
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`Prescribing Information as of December 2004
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`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
`©Dermik Laboratories 2003
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