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

nucare pharmaceuticals,inc. - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - ciclopirox 80 mg in 1 ml - (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. - 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

Malta - English - Malta Medicines Authority

stiefel laboratories (ireland) ltd finisklin business park, sligo, famar nederland bv, industrieweg 1,5531 ad bladel, ireland - ciclopirox olamine - cutaneous liquid - ciclopirox olamine 1.5 % (w/w) - antifungals for dermatological use

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

sincerus florida, llc - salicylic acid (unii: o414pz4lpz) (salicylic acid - unii:o414pz4lpz), ciclopirox olamine (unii: 50md4sb4ap) (ciclopirox - unii:19w019zdrj), clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) -

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pierre fabre benelux sa-nv - ciclopirox olamine 1 g/100 g - cream - 10 mg/g - ciclopirox olamine 10 mg/g - ciclopirox

New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - ciclopirox 8%{relative} - nail lacquer - 8% w/w - active: ciclopirox 8%{relative} excipient: ethyl acetate gantrez es-435 isopropyl alcohol - apo-ciclopirox is indicated for the topical treatment of fungal infections of the nails, caused by dermatophytes, yeasts or moulds, including tinea pedis, tinea cruris and tinea corporis due to trichophyton rubrum, trichophyton mentagrophytes, epidermophyton floccosum and microsporumcanis, candidiasis due to candida albicans and tinea (pityriasis) versicolor due to malassezia furfur.

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

acella pharmaceuticals, llc - 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 solution - 10 %v/v

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

e. fougera & co. a division of fougera pharmaceuticals inc. - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - none. teratogenic effects: pregnancy category b there are no adequate or well-controlled studies in pregnant women. therefore, ciclopirox shampoo should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral embryofetal developmental studies were conducted in mice, rats, rabbits and monkeys. ciclopirox or ciclopirox olamine was orally administered during the period of organogenesis. no maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 77, 125, 80 and 38.5 mg/kg/day ciclopirox in mice, rats, rabbits and monkeys, respectively (approximately 13, 42, 54 and 26 times the maximum recommended human dose based on body surface area comparisons, respectively). dermal embryofetal developmental studies were conducted in rats and rabbits with ciclopirox olamine dissolved in peg 400. ciclopirox olamine was topically administered during the period of organogenesis. no maternal toxicity, embryotoxicity or teratogenicity were noted at the hig

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

harris pharmaceutical, inc. - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - ciclopirox 80 mg in 1 ml

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

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