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

direct_rx - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by trichophyton rubrum, t. mentagrophytes and epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by malassezia furfur (pityrosporum orbiculare); and in the treatment of cutaneous candidiasis caused by candida spp. and in the treatment of seborrheic dermatitis. ketoconazole cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.

Canada - English - Health Canada

apotex inc - ketoconazole - tablet - 200mg - ketoconazole 200mg - azoles

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

a-s medication solutions - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or candida infections. ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid. coadministration of a number of cyp3a4 substrates such as dofetilide, quinidine, cisapride and pimozide is contraindicated with ketoconazole tablets. coadministration with ketoconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects to such an extent tha

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

medimetriks pharmaceuticals, inc. - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole 20 mg in 1 g - ketodan® foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. limitations of use safety and efficacy of ketodan® foam, 2% for treatment of fungal infections have not been established. none. risk summary there are no available data on ketoconazole foam, 2% use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. no reproductive studies in animals have been performed with ketoconazole foam, 2%. in animal reproduction studies with pregnant mice, rats and rabbits both embryotoxic and developmental effects (structural abnormalities) were observed following oral dosing of ketoconazole during organogenesis. assuming equivalent systemic absorption of topical and oral ketoconazole doses and a ketoconazole foam, 2% maximum recommended human dose (mrhd) of 8 grams (equivalent to 160 mg ketoconazole), embryotoxic effects were observed at 0.8 to 2.4 times the mrhd and deve

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

almirall, llc - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole 20 mg in 1 g - xolegel is indicated for the topical treatment of seborrheic dermatitis in immunocompetent adults and children 12 years of age and older. safety and efficacy of xolegel for treatment of fungal infections have not been established. none. risk summary there are no available data on xolegel use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies with pregnant rats, structural abnormalities (syndactylia and oligodactylia) were observed following oral doses of ketoconazole during organogenesis (see data ). the available data do not allow calculation of relevant comparisons between the systemic exposure of ketoconazole observed in animal studies to the systemic exposure observed in humans after topical use of xolegel. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other advers

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

hra pharma uk ltd - ketoconazole - tablet - 200mg

Israel - English - Ministry of Health

devries & co. ltd - ketoconazole - cream - ketoconazole 20 mg/g - ketoconazole - ketoconazole - for topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, tinea cruris, tinea manus and tinea pedis infections due to trichophyton spp, microsporon spp and epidermophyton spp. nizoral cream is also indicated for the treatment of cutaneous candidosis (including vulvitis), tinea (pityriasis) versicolor and seborrhoeic dermatitis caused by malassezia (previously called pityrosporum) spp.

Israel - English - Ministry of Health

j-c health care ltd - ketoconazole - shampoo - ketoconazole 20 mg / 1 g - ketoconazole - ketoconazole - topical treatment of seborrhoeic dermatitis including dandruff resulting from proven fungal infection including pityriasis versicolor.

Israel - English - Ministry of Health

padagis israel pharmaceuticals ltd, israel - ketoconazole - shampoo - ketoconazole 20 mg/g - ketoconazole - ketoconazole - topical treatment of seborrhoeic dermatitis including dandruff resulting from proven fungal infection including pityriasis versicolor.

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

a-s medication solutions - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole cream 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by trichophyton rubrum, t. mentagrophytes and epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by malassezia furfur (pityrosporum orbiculare) ; in the treatment of cutaneous candidiasis caused by candida spp. and in the treatment of seborrheic dermatitis. ketoconazole cream 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.