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

e. fougera & co. a division of fougera pharmaceuticals inc. - ciclopirox olamine (unii: 50md4sb4ap) (ciclopirox - unii:19w019zdrj) - ciclopirox 7.7 mg in 1 g - ciclopirox 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 cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

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

fougera pharmaceuticals inc. - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - ciclopirox 10 mg in 0.96 ml - ciclopirox shampoo 1% is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. none. teratogenic effects: pregnancy category b there are no adequate or well-controlled studies in pregnant women. therefore, ciclopirox shampoo 1% 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

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

actavis pharma, inc. - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - ciclopirox 10 mg in .96 ml - ciclopirox shampoo 1% is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. none. teratogenic effects: pregnancy category b there are no adequate or well-controlled studies in pregnant women. therefore, ciclopirox shampoo 1% 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 administere

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

padagis israel pharmaceuticals ltd - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - ciclopirox 1 g in 100 ml - ciclopirox shampoo, 1% is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. none. teratogenic effects: pregnancy category b there are no adequate or well-controlled studies in pregnant women. therefore, ciclopirox shampoo, 1% 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 highest doses of 92 mg/kg/day and 77 mg/kg/day ciclopirox in rats and rabbits, respectively (approximately 31 and 54 times the maximum recommended human dose based on body surface area comparisons, respectively). it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when ciclopirox shampoo, 1% is administered to a nursing woman. no clinical trials have been conducted in subjects younger than 16 years. in clinical trials, the safety and tolerability of ciclopirox shampoo, 1% in the population 65 years and older was comparable to that of younger subjects. results of the efficacy analysis in those subjects 65 years and older showed effectiveness in 25 of 85 (29%) subjects treated with ciclopirox shampoo, 1%, and in 15 of 61 (25%) subjects treated with the vehicle; due to the small sample size, a statistically significant difference was not demonstrated. other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity to adverse effects in some older individuals cannot be ruled out.

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

taro pharmaceuticals, inc. - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - ciclopirox 10 mg in 0.96 ml - ciclopirox shampoo is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. ciclopirox shampoo is contraindicated in individuals who have shown hypersensitivity to any of its components.

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

versapharm incorporated - 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. 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 wi

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

akorn - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - ciclopirox 71.3 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% (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 tricho-phyto 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% (nail lacquer) 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 onchomycosis of the great toenails without lunula involvement were treated with ciclopirox topical solu

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

preferred 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. 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)

cosette 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%, (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 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis, is not recommended.     • ciclopirox topical solution, 8%, (nail lacquer),

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

taro pharmaceuticals u.s.a., inc. - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - ciclopirox 10 mg in 0.96 ml - none. teratogenic effects: pregnancy category b there are no adequate or well-controlled studies in pregnant women. therefore, ciclopirox shampoo 1% 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