Cnl8
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Questions & Answers
Side Effects & Adverse Reactions
CNL8 (ciclopirox topical solution, 8%) nail lacquer is not for ophthalmic, oral, or intravaginal use. For use on nails and immediately adjacent skin only.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)
CNL8 (ciclopirox topical solution,8%) nail lacquer as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Tricho-phyto 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.CNL8 (ciclopirox topical solution, 8%) nail lacquer should be used only under medical supervision as described above.
The effectiveness and safety of CNL8 (ciclopirox topical solution, 8%) nail lacquer in the following populations have not been studied. The clinical trials with use of CNL8 (ciclopirox topical solution, 8%) nail lacquer excluded patients who: were pregnant or nursing, planned to become pregnant, had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of derma-tomycoses, 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 CNL8 (ciclopirox topical solution, 8%) nail lacquer daily for greater than 48 weeks have not been established.
History
There is currently no drug history available for this drug.
Other Information
CNL8 (ciclopirox topical solution, 8%) nail lacquer.
For use on fingernails and toenails and immediately adjacent skin only.
Not for use in eyes.
CNL8 (ciclopirox topical solution, 8%) nail lacquer contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin.
Each gram of CNL8 (ciclopirox topical solution, 8%) nail lacquer 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.
CNL8 (ciclopirox topical solution, 8%) nail lacquer 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 molecular formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is 29342-05-0. The chemical structure is:
Sources
Cnl8 Manufacturers
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Innocutis Holdings Llc
![Cnl8 (Ciclopirox ) Solution [Innocutis Holdings Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Cnl8 | Innocutis Holdings Llc
CNL8 (ciclopirox topical solution, 8%) nail lacquer should be used as a component of a comprehensive management program for onychomycosis. Removal of the unattached, infected nail, as frequently as monthly, by a health care professional, weekly trimming by the patient, and daily application of the medication are all integral parts of this therapy. Careful consideration of the appropriate nail management program should be given to patients with diabetes (see PRECAUTIONS).
Nail Care By Health Care Professionals: Removal of the unattached, infected nail, as frequently as monthly, trimming of onycholytic nail, and filing of excess horny material should be performed by professionals trained in treatment of nail disorders.
Nail Care By Patient: Patients should file away (with emery board) loose nail material and trim nails, as required, or as directed by the health care professional, every seven days after CNL8 (ciclopirox topical solution, 8%) nail lacquer is removed with alcohol. CNL8 (ciclopirox topical solution, 8%) nail lacquer should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails with the applicator brush provided. CNL8 (ciclopirox topical solution, 8%) nail lacquer should be applied evenly over the entire nail plate.
If possible, CNL8 (ciclopirox topical solution, 8%) nail lacquer should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis).
CNL8 (ciclopirox topical solution, 8%) nail lacquer should not be removed on a daily basis. Daily applications should be made over the previous coat and removed with alcohol every seven days. This cycle should be repeated throughout the duration of therapy.
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