USA - engelsk - NLM (National Library of Medicine)

rpk pharmaceuticals, inc. - ciclopirox olamine (unii: 50md4sb4ap) (ciclopirox - unii:19w019zdrj) - ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to trichophyton rubrum , trichophyton mentagrophytes , epidermophyton floccosum , and microsporum canis ; candidiasis (moniliasis) due to candida albicans ; and tinea (pityriasis) versicolor due to malassezia furfur . ciclopirox olamine cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

Canada - engelsk - Health Canada

sterimax inc - ciclopirox - solution - 8% - ciclopirox 8% - hydroxypyridones

USA - engelsk - NLM (National Library of Medicine)

bryant ranch prepack - ciclopirox olamine (unii: 50md4sb4ap) (ciclopirox - unii:19w019zdrj) - ciclopirox olamine topical suspension usp, 0.77% (w/w) (lotion) is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris and tinea corporis due to trichophyton rubrum, trichophyton mentagrophytes, epidermophyton floccosum, and microsporum canis; cutaneous candidiasis (moniliasis) due to candida albicans; and tinea (pityriasis) versicolor due to malassezia furfur . ciclopirox olamine topical suspension usp, 0.77% (w/w) (lotion) is contraindicated in individuals who have shown hypersensitivity to any of its components.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - ciclopirox 8%{relative} - nail lacquer - 8% w/w - active: ciclopirox 8%{relative} excipient: butyl ester of pvm/ma copolymer ethyl acetate isopropyl alcohol - the treatment of fungal infections of the nails, caused by dermatophytes, yeasts and moulds.

Israel - engelsk - Ministry of Health

perrigo israel agencies ltd - ciclopirox - lacque - ciclopirox 8 %w/w - ciclopirox - treatment of fungal infections of the nails.

USA - engelsk - NLM (National Library of Medicine)

medimetriks pharmaceuticals, inc. - ciclopirox olamine (unii: 50md4sb4ap) (ciclopirox - unii:19w019zdrj) - ciclopirox 7.7 mg in 1 g

USA - engelsk - 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.

USA - engelsk - NLM (National Library of Medicine)

sincerus florida, llc - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj), fluconazole (unii: 8vzv102jfy) (fluconazole - unii:8vzv102jfy), terbinafine (unii: g7riw8s0xp) (terbinafine - unii:g7riw8s0xp) -

USA - engelsk - NLM (National Library of Medicine)

sincerus florida, llc - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj), clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) -

USA - engelsk - NLM (National Library of Medicine)

sincerus florida, llc - ciclopirox olamine (unii: 50md4sb4ap) (ciclopirox - unii:19w019zdrj), salicylic acid (unii: o414pz4lpz) (salicylic acid - unii:o414pz4lpz) -