Ciclopirox Nail Lacquer is indicated for the topical treatment of mild to moderate fungal infections (onychomycosis) of fingernails and toenails in immunocompetent patients, specifically those caused by Trichophyton rubrum, without involvement of the lunula.

Ciclopirox is a synthetic antifungal agent. The nail lacquer formulation is a clear, colorless to slightly yellowish solution intended for application on affected nails and surrounding skin. Unlike azole antifungals, the exact mechanism of action of ciclopirox is not fully defined; however, it is believed to interfere with fungal cell metabolism by inhibiting key enzymes such as catalase and peroxidase, leading to disruption of essential cellular processes.

• Before starting treatment, any loose nail or nail material should be removed using nail clippers or nail files. If one has diabetes or problems with numbness in toes or fingers, he/she should talk to the health care provider before trimming the nails or removing any nail material
• Ciclopirox Nail Lacquer should be applied evenly over the entire nail plate once daily (preferably at bedtime or eight hours before washing) to all affected nails with the applicator brush provided. If possible, it should be applied to the underside of the nail and to the skin beneath it. The nail lacquer should be allowed to dry approximately 30 seconds before putting on socks or stockings
• Ciclopirox Nail Lacquer should be applied daily over the previous coat
• Once a week, Ciclopirox Nail Lacquer should be removed with an alcohol pad (nail polish remover). Using scissors, clippers, or nail files, the damaged nail should be removed as much as possible.
• This cycle (steps 2 through 4) should be repeated throughout the duration of therapy (6 months to 48 weeks).

There are no adequate studies to determine whether ciclopirox affects the efficacy of systemic antifungal therapy. Therefore, the concurrent use of Ciclopirox 8% topical solution with systemic antifungal agents for nail infections is generally not recommended.

Ciclopirox Nail Lacquer should not be used in patients with known hypersensitivity to ciclopirox or any of its formulation components.

Local reactions such as redness, burning sensation, or changes in nail color or shape may occur. Severe allergic reactions are rare.

Pregnancy Category B. Adequate and well-controlled studies in pregnant women are lacking. Ciclopirox Nail Lacquer should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus. It is not known whether ciclopirox is excreted in human breast milk; therefore, caution should be exercised when used in nursing mothers.

If signs of sensitivity or irritation occur during treatment, the medication should be discontinued. Use in patients with insulin-dependent diabetes mellitus or diabetic neuropathy requires careful consideration, particularly regarding removal of infected nail tissue.

Ciclopirox Nail Lacquer is for external use only and should not be applied to the eyes, mouth, or intravaginally. It should be used only on the nails and the surrounding skin.

Use in Children: Considered safe for children aged 12 years and above; however, clinical studies in pediatric patients are limited.

Other preparations

Store below 30°C. Keep the bottle tightly closed and protect from heat and light. Keep out of reach of children.