United States - English - NLM (National Library of Medicine)

bryant ranch prepack - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - (to understand fully the indication for this product, please read the entire indications and usagesection of the labeling.) ciclopirox topical solution, 8% 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% should be used only under medical supervision as desc

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - (to understand fully the indication for this product, please read the entire indications and usage section of the labeling.) ciclopirox topical solution, 8% 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. the results of use of ciclopirox topical solution, 8% in treatment of onychomycosis of the toenail without lunula involvement were obtained from two double-blind, placebo-controlled studies conducted in the united states. in these studies, patients with onychomycosis of the great toenails without lunula involvement were treated with ciclopirox topical solution, 8% in conjun

United States - English - NLM (National Library of Medicine)

encube ethicals private limited - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - (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 ciclopirox topical solution, 8% (nail lacquer) and systemic antifungal agents for onychomycosis, is not recommended. - ciclopirox topical solution, 8% (nail lacquer), should be used

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - superficial dermatophyte infections ciclopirox gel, 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to trichophyton rubrum, trichophyton mentagrophytes, or epidermophyton floccosum . seborrheic dermatitis ciclopirox gel, 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp. ciclopirox gel, 0.77% is contraindicated in individuals who have shown hypersensitivity to any of its components.

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - (to understand fully the indication for this product, please read the entire indication and usage section of the labeling.) ciclopirox topical solution, usp 8% 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 ciclopirox topical solution, 8% and systemic antifungal agents for onychomycosis, is not recommended. - ciclopirox topical solution, 8% should be used only under medical supervision as described above. - the effectiveness and safety of ciclopirox topical solution, 8% in the following populations has not been studied. the clinical trials with use of ciclopirox topical solution, 8% 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% daily for greater than 48 weeks have not been established. clinical trials data the results of use of ciclopirox topical solution, 8% in treatment of onychomycosis of the toenail without lunula involvement were obtained from two double-blind, placebo-controlled studies conducted in the us. in these studies, patients with onychomycosis of the great toenails without lunula involvement were treated with ciclopirox topical solution, 8%, in conjunction with monthly removal of the unattached, infected toenail by the investigator. ciclopirox topical solution, 8% was applied for 48 weeks. at baseline, patients had 20-65% involvement of the target great toenail plate. statistical significance was demonstrated in one of two studies for the endpoint “complete cure” (clear nail and negative mycology) and in two studies for the endpoint “almost clear” ≤10% nail involvement and negative mycology) at the end of study. these results are presented below. *clear nail and negative mycology ** ≤10% nail involvement and negative mycology *** negative koh and negative culture the summary of reported patient outcomes for the itt population at 12 weeks following the end of treatment are presented below. note that post-treatment efficacy assessments were scheduled only for patients who achieved a complete cure. * four patients (from studies 312 and 313) who were completely cured did not have post-treatment week 12 planimetry data. ciclopirox topical solution, 8% is contraindicated in individuals who have shown hypersensitivity to any of its components.

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi-aventis ireland limited t/a sanofi - ciclopirox olamine - cutaneous powder - 1 %w/w

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi-aventis ireland limited t/a sanofi - ciclopirox olamine - cream - 1 %w/w

Israel - English - Ministry of Health

trima israel pharmaceutical products maabarot ltd - ciclopirox olamine; clobetasone butyrate; gentamicin (as sulfate) - cream - ciclopirox olamine 1 %; gentamicin (as sulfate) 0.1 %; clobetasone butyrate 0.05 % - combinations of corticosteroids - combinations of corticosteroids - for local treatment of skin inflammations accompanied by a mycotic and/or bacterial infection.

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - ciclopirox olamine 1% - topical powder - 1 % - active: ciclopirox olamine 1% excipient: colloidal silicon dioxide pregelatinised maize starch

Israel - English - Ministry of Health

trima israel pharmaceutical products maabarot ltd - ciclopirox olamine - solution - ciclopirox olamine 1 % - other antifungals for topical use - broad spectrum antimycotic preparation for topical treatment of fungal infections of the skin.