Ciclopirox is the generic equivalent of the brand-name drug Ciclopirox. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Ciclopirox through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
INDICATIONS AND USAGE (To understand fully the indication for this product, please read the entireINDICATIONS 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…
Important Warnings
WARNINGS Ciclopirox Topical Solution, 8% (Nail Lacquer) is not for ophthalmic, oral, or intravaginal use. For use on nails and immediately adjacent skin only.
Adverse Reactions
ADVERSE REACTIONS In the vehicle-controlled clinical trials conducted in the US, 9% (30/327) of patients treated with Ciclopirox 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/…
Dosage & Administration
DOSAGE AND ADMINISTRATION 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 ).
Patient Counseling Information
Information for Patients: Patients should have detailed instruction regarding the use of Ciclopirox 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: Use Ciclopirox Topical Solution, 8% (Nail Lacquer) as directed by a health care professional. Avoid contact with eyes and mucous membranes. Contactwith skin other than skin immediately surrounding the treated nail(s) should be avoided. Ciclopirox Topical Solution, 8% (Nail Lacquer) is for extern…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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