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DRUGS & SUPPLEMENTS
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Onylac
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Onylac uses
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Dosage and administration
- How supplied
- Storage and handling
- References
- Patient package insert
INDICATIONS AND USAGE
(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)
Onylac 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 Onylac might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of 8% Onylac topical solution and systemic antifungal agents for onychomycosis, is not recommended.
- Onylac Topical Solution, 8%, (Nail Lacquer), should be used only under medical supervision as described above.
- The effectiveness and safety of Onylac Topical Solution, 8%,(Nail Lacquer), in the following populations has not been studied. The clinical trials with use of Onylac 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 Onylac Topical Solution, 8%,(Nail Lacquer), daily for greater than 48 weeks have not been established.
Clinical Trials Data:
The results of use of Onylac 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 Onylac topical solution, 8% in conjunction with monthly removal of the unattached, infected toenail by the investigator. Onylac 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.
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.
*Four patients (from studies 312 and 313) who were completely cured did not have post-treatment Week 12 planimetry data.
CONTRAINDICATIONS
Onylac Topical Solution, 8%, (Nail Lacquer), is contraindicated in individuals who have shown hypersensitivity to any of its components.
WARNINGS
Onylac Topical Solution, 8%, (Nail Lacquer), 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 Onylac Topical Solution, 8%, (Nail Lacquer), 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 Onylac Topical Solution, 8%, (Nail Lacquer), as a component of a comprehensive management program for onychomycosis in order to achieve maximum benefit with the use of this product.
The patient should be told to:
1. Use Onylac Topical Solution, 8%, (Nail Lacquer), 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. Onylac Topical Solution, 8%, (Nail Lacquer), is for external use only.
2. Onylac Topical Solution, 8%, (Nail Lacquer), should be applied evenly over the entire nail plate and 5 mm of surrounding skin. If possible, Onylac Topical Solution, 8%, (Nail Lacquer),should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g.,onycholysis). Contact with the surrounding skin may produce mild, transient irritation (redness).
3. Removal of the unattached, infected nail, as frequently as monthly, by a health care professional is needed with 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 Onylac Topical Solution, 8%, (Nail Lacquer), and professional removal of the unattached, infected nail, as frequently as monthly, are considered the full treatment needed to achieve a clear or almost clear nail (defined as 10% or less residual nail involvement).
6. Six months of therapy with professional removal of the unattached, infected nail may be required before initial improvement of symptoms is noticed.
7. A completely clear nail may not be achieved with use of this medication. In clinical studies less than 12% of patients were able to achieve either a completely clear or almost clear toenail.
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 Onylac Topical Solution, 8%, (Nail Lacquer), formulation. A carcinogenicity study of Onylac (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 Onylac Topical Solution, 8%, (Nail Lacquer)) in subjects with distal subungual onychomycosis, the average maximal serum level of Onylac 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 Onylac (as Onylac olamine)/kg/day.
The following in vitro genotoxicity tests have been conducted with Onylac: 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, Onylac was negative for chromosome aberrations at 5,000 mg/kg.
The following in vitro genotoxicity tests were conducted with Onylac Topical Solution, 8%, (Nail Lacquer): 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 Onylac (as Onylac 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 Onylac (~340 mg Onylac Topical Solution, 8%, (Nail Lacquer)) 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 Onylac as Onylac 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 Onylac in pregnant women. Onylac Topical Solution, 8%, (Nail Lacquer), 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 Onylac Topical Solution, 8%, (Nail Lacquer), is administered to a nursing woman.
Pediatric Use:
Based on the safety profile in adults, Onylac Topical Solution, 8%, (Nail Lacquer), 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 Onylac Topical Solution, 8%, (Nail Lacquer), 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 Onylac Topical Solution, 8%, (Nail Lacquer), and 7% (23/328) of patients treated with vehicle reported treatment-emergent adverse events (TEAE) considered by the investigator to be causally related to the test material. The incidence of these adverse events, within each body system, was similar between the treatment groups except for Skin and Appendages: 8%(27/327) and 4% (14/328) of subjects in the Onylac 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 Onylac Topical Solution, 8%, (Nail Lacquer), (5% [16/327]) than in patients treated with vehicle (1% [3/328]). Other TEAEs thought to be causally related included nail disorders such as shape change, irritation, ingrown toenail, and discoloration.
The incidence of nail disorders was similar between the treatment groups (2% [6/327] in the Onylac Topical Solution, 8%, (Nail Lacquer), group and 2% [7/328] in the vehicle group). Moreover, application site reactions and/or burning of the skin occurred in 1% of patients treated with Onylac Topical Solution, 8%, (Nail Lacquer), (3/327) and vehicle (4/328).
A 21-Day Cumulative Irritancy study was conducted under conditions of semi-occlusion. Mild reactions were seen in 46% of patients with the Onylac Topical Solution, 8%, (Nail Lacquer), 32% with the vehicle and 2% with the negative control, but all were reactions of mild transient erythema. There was no evidence of allergic contact sensitization for either the Onylac Topical Solution, 8%, (Nail Lacquer), or the vehicle base. In a separate study of the photosensitization potential of Onylac Topical Solution, 8%, (Nail Lacquer), in a maximized test design that included the occluded application of sodium lauryl sulfate, no photoallergic reactions were noted. In four subjects localized allergic contact reactions were observed. In the vehicle-controlled studies, one patient treated with Onylac Topical Solution, 8%, (Nail Lacquer), discontinued treatment due to a rash, localized to the palm (causal relation to test material undetermined).
Use of Onylac Topical Solution, 8%, (Nail Lacquer), for 48 additional weeks was evaluated in an open-label extension study conducted in patients previously treated in the vehicle-controlled studies. Three percent (9/281) of subjects treated with Onylac Topical Solution, 8%, (Nail Lacquer), experienced at least one TEAE that the investigator thought was causally related to the test material. Mild rash in the form of periungual erythema (1% [2/281]) and nail disorders (1% [4/281]) were the most frequently reported. Four patients discontinued because of TEAEs. Two of the four had events considered to be related to test material: one patient’s great toenail “broke away” and another had an elevated creatine phosphokinase level on Day 1 (after 48 weeks of treatment with vehicle in the previous vehicle-controlled study).
To report SUSPECTED ADVERSE REACTIONS, contact G&W Laboratories, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
DOSAGE AND ADMINISTRATION
Onylac 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 Onylac Topical Solution, 8%, (Nail Lacquer), is removed with alcohol.
Onylac 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 Onylac Topical Solution, 8%, (Nail Lacquer), should be applied evenly over the entire nail plate.
If possible, Onylac 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 Onylac 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.
HOW SUPPLIED
Onylac Topical Solution, 8%, (Nail Lacquer), is supplied in 3.3 mL (NDC 0713-0317-87) and 6.6 mL (NDC 0713-0317-88) glass bottles with screw caps which are fitted with brushes.
Protect from light (e.g., store the bottle in the carton after every use.)
STORAGE AND HANDLING
Onylac Topical Solution, 8%, (Nail Lacquer), should be stored at room temperature between 59° and 86° F (15° and 30° C).
CAUTION: Flammable. Keep away from heat and flame.
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
G&W Laboratories, Inc.
South Plainfield, NJ 07080
8-0317GW3
Rev. 03/2015
PATIENT PACKAGE INSERT
Onylac
Topical Solution, 8%,
(Nail Lacquer)
Patient Information and Instructions
Patients should have detailed instructions regarding the use of Onylac 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 Onylac Topical Solution, 8%, (Nail Lacquer), as directed by your health care professional.
- Onylac 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 Onylac 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 Onylac 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 Onylac Topical Solution, 8%, (Nail Lacquer), daily over the previous coat.
4. Once a week, remove the Onylac 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.
G&W Laboratories, Inc.
South Plainfield, NJ 07080
8-0317GW3
Rev. 03/2015
NDC 0713-0317-88
Onylac Topical Solution, 8% (Nail Lacquer)
FOR DERMATOLOGIC USE ONLY
NOT FOR USE IN EYES
Rx Only
One 6.6 mL Bottle
Each gram of Onylac Topical Solution, 8%, (Nail Lacquer), contains 80 mg Onylac in a solution base consisting of ethylacetate, NF; isopropyl alcohol,USP; and butyl monoester of poly[methylvinyl ether/maleic acid] in isopropyl alcohol.
Usual
Dosage: Apply to the affected nails once daily. See package insert for full prescribing information.
WARNING: Keep out of reach of children.
Important: This package is not child resistant.
Store at room temperature between 59-86°F (15-30°c). Protect bottle from light.
CAUTION: Flammable. Keep away from heat and flame.
Store bottle in carton after every use.
Onylac pharmaceutical active ingredients containing related brand and generic drugs:
Onylac available forms, composition, doses:
Onylac destination | category:
Onylac Anatomical Therapeutic Chemical codes:
Onylac pharmaceutical companies:
References
- Dailymed."CICLOPIROX (CICLOPIROX) SOLUTION [G&W LABORATORIES, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
- Dailymed."CICLOPIROX: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
- "CICLOPIROX". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
Frequently asked Questions
Can i drive or operate heavy machine after consuming Onylac?Depending on the reaction of the Onylac after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Onylac not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Onylac addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Review
sdrugs.com conducted a study on Onylac, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Onylac consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.Visitor reports
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The information was verified by Dr. Rachana Salvi, MD Pharmacology