Generic Name and Formulations:
Ciclopirox 8%; topical soln (nail lacquer).
Bausch Health Companies Inc.
Indications for PENLAC:
Mild to moderate onychomycosis of the fingernails and toenails (without lunula involvement) due to Trichophyton rubrum in immunocompetent patients, as part of a comprehensive management program (including professional removal of unattached, infected nails).
Apply thin layer evenly once daily over previous coat(s) to entire nail and surrounding 5mm of skin (preferably at bedtime or 8 hours before washing). If possible, apply to nail bed, hyponychium, and under surface of nail plate when it is free of the nail bed. Remove with alcohol once per week (file and trim nails while nail is free from drug). Repeat this regimen for up to 48 weeks. Improvement may take up to 6 months. Healthcare professional: Remove unattached infected nail as frequently as monthly, trim onycholytic nail, and file excess horny material.
Discontinue if sensitivity or chemical irritation occurs. Immunosuppressed or immunocompromised. HIV positive. Organ transplant recipients. Seizures. Severe plantar (moccasin) tinea pedis. Diabetes, diabetic neuropathy: consider risk of nail care before prescribing. Avoid eyes, mucous membranes. Product is flammable. Pregnancy (Cat.B). Nursing mothers.
Concomitant systemic antifungals for onychomycosis: not recommended. Do not use nail polish or other nail cosmetics on treated nails.
Rash, nail disorders (e.g., shape change, irritation, ingrown toenail, discoloration), local reactions (e.g., burning sensation, erythema).
Nail lacquer—6.6mL (w. applicator)