США - англійська - NLM (National Library of Medicine)

padagis israel pharmaceuticals ltd - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 g - clobetasol propionate foam, 0.05% (emulsion) is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older. none. risk summary there are no available data on clobetasol propionate foam, 0.05% (emulsion) use in pregnant women to inform of a drug associated risk for adverse developmental outcomes. published data report a significantly increased risk of low birth weight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women of the potential risk to a fetus and to use clobetasol propionate foam, 0.05% (emulsion) on the smallest area of skin and for the shortest duration possible (see data ). in animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. no comparison of animal exposure with human exposure was compu

США - англійська - NLM (National Library of Medicine)

padagis israel pharmaceuticals ltd - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 g - clobetasol propionate foam, 0.05% is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older. none. risk summary there are no available data on clobetasol propionate foam, 0.05% use in pregnant women to inform of a drug-associated risk for adverse developmental outcomes. published data report a significantly increased risk of low birth weight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women of the potential risk to a fetus and to use clobetasol propionate foam, 0.05% on the smallest area of skin and for the shortest duration possible (see data ). in animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits.

США - англійська - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 g - clobetasol propionate ointment is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (hpa) axis. use in pediatric patients under 12 years of age is not recommended. as with other highly active corticosteroids, therapy should be discontinued when control has been achieved. if no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. clobetasol propionate ointment, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

США - англійська - NLM (National Library of Medicine)

renaissance pharma, inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 g - clobetasol propionate foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older. none. there are no adequate and well-controlled studies in pregnant women. clobetasol propionate foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically. some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals. clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously, it was a significant teratogen in both the rabbit and the mouse. clobetasol propionate has greater teratogenic potential than steroids that are less potent. teratogenicity studi

США - англійська - NLM (National Library of Medicine)

akorn - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate .5 mg in 1 ml - clobetasol propionate shampoo, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. treatment should be limited to 4 consecutive weeks. the total dosage should not exceed 50 g (50 ml or 1.75 fl. oz.) per week. patients should be instructed to use clobetasol propionate shampoo, 0.05%, for the minimum time period necessary to achieve the desired results [see dosage and administration (2) ]. use in patients younger than 18 years of age is not recommended due to numerically high rates of hypothalamic-pituitary-adrenal (hpa) axis suppression [see warnings and precautions (5.1) and use in specific populations (8.4) ]. clobetasol propionate shampoo, 0.05%, should not be used on the face, groin or axillae. avoid any contact of the drug product with the eyes and lips. in case of contact, rinse thoroughly with water all parts of the body that came in contact with the shampoo. none teratogenic e

США - англійська - NLM (National Library of Medicine)

e. fougera & co. a division of fougera pharmaceuticals inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 g - clobetasol propionate cream, 0.05% (emollient) is a super-high potency corticosteroid indicated for: clobetasol propionate cream, 0.05% (emollient) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age and older. treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 grams per week. clobetasol propionate cream, 0.05% (emollient) is indicated for the topical treatment of moderate to severe plaque-type psoriasis. treatment beyond 4 consecutive weeks is not recommended. use in pediatric patients under 16 years of age is not recommended. clobetasol propionate cream, 0.05% (emollient) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. the total dosage should not exceed 50 grams per week. avoid use if skin atrophy is present at the treatment site. none pregnancy category c. there are no adequate and well-controlled

Португалія - португальська - INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde)

ratiopharm - comércio e indústria de produtos farmacêuticos, lda. - clobetasol - pomada - 0.5 mg/g - clobetasol, propionato 0.5 mg/g - clobetasol - genérico - duração do tratamento: curta ou média duração

Португалія - португальська - INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde)

ratiopharm - comércio e indústria de produtos farmacêuticos, lda. - clobetasol - pomada - 0.5 mg/g - clobetasol, propionato 0.5 mg/g - clobetasol - genérico - duração do tratamento: curta ou média duração

Португалія - португальська - INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde)

ratiopharm - comércio e indústria de produtos farmacêuticos, lda. - clobetasol - creme - 0.5 mg/g - clobetasol, propionato 0.5 mg/g - clobetasol - genérico - duração do tratamento: curta ou média duração

Португалія - португальська - INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde)

ifc skincare portugal - produtos dermatológicos, unip., lda. - clobetasol - champô - 0.5 mg/g - clobetasol, propionato 0.5 mg/g - clobetasol - n/a - duração do tratamento: curta ou média duração