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Penlac Generic Name & Formulations
Legal Class
Rx
General Description
Ciclopirox 8%; topical soln (nail lacquer).
Pharmacological Class
Antifungal.
How Supplied
Nail lacquer—6.6mL (w. applicator)
Manufacturer
Penlac Indications
Indications
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).
Penlac Dosage and Administration
Adult
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.
Children
Not recommended.
Penlac Contraindications
Not Applicable
Penlac Boxed Warnings
Not Applicable
Penlac Warnings/Precautions
Warnings/Precautions
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.
Penlac Pharmacokinetics
See Literature
Penlac Interactions
Interactions
Concomitant systemic antifungals for onychomycosis: not recommended. Do not use nail polish or other nail cosmetics on treated nails.
Penlac Adverse Reactions
Adverse Reactions
Rash, nail disorders (e.g., shape change, irritation, ingrown toenail, discoloration), local reactions (e.g., burning sensation, erythema).
Penlac Clinical Trials
See Literature
Penlac Note
Not Applicable
Penlac Patient Counseling
See Literature
