Ciclopirox Kit
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Questions & Answers
Side Effects & Adverse Reactions
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.)
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 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.
- Ciclopirox Topical Solution, 8% (Nail Lacquer) should be used only under medical supervision as described above.
- The effectiveness and safety of Ciclopirox Topical Solution, 8% (Nail Lacquer) in the following populations has not been studied. The clinical trials with use of Ciclopirox Topical Solution, 8% (Nail Lacquer) excluded patients who: were pregnant or nursing, planned to become pregnant, had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex), were HIV seropositive, received organ transplant, required medication to control epilepsy, were insulin dependent diabetics or had diabetic neuropathy. Patients with severe plantar (moccasin) tinea pedis were also excluded.
- The safety and efficacy of using Ciclopirox Topical Solution, 8% (Nail Lacquer) daily for greater than 48 weeks have not been established.
History
There is currently no drug history available for this drug.
Other Information
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 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. 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
Ciclopirox Kit Manufacturers
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Acella Pharmaceuticals, Llc
![Ciclopirox Kit [Acella Pharmaceuticals, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ciclopirox Kit | Acella Pharmaceuticals, Llc
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).
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Acella Pharmaceuticals, Llc
Ciclopirox Kit | Acella Pharmaceuticals, Llc
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).
![Ciclopirox Kit [Acella Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2c67dd09-ab1f-4ccf-97b5-421356f64f22&name=2c67dd09-ab1f-4ccf-97b5-421356f64f22-02.jpg)
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