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

actavis pharma, inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.05 g in 100 ml - clobetasol propionate lotion, 0.05% is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older. treatment should be limited to 2 consecutive weeks. for moderate to severe plaque psoriasis, treatment may be extended for an additional 2 weeks for localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment. any additional benefits of extending treatment should be weighed against the risk of hypothalamic-pituitary-adrenal (hpa) axis suppression before prescribing for more than 2 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 lotion, 0.05% for the minimum amount of time necessary to achieve the desired results [see dosage and administration (2)]. use in patients under 18 years of age is not recommended due to n

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

paddock laboratories, llc - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 ml - clobetasol propionate lotion, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older. treatment should be limited to 2 consecutive weeks. for moderate to severe plaque psoriasis, treatment may be extended for an additional 2 weeks for localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment. any additional benefits of extending treatment should be weighed against the risk of hypothalamic-pituitary-adrenal (hpa) axis suppression before prescribing for more than 2 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 lotion, 0.05%, for the minimum amount of time necessary to achieve the desired results [see dosage and administration (2) ]. use in patients under 18 years of age is not recommended due

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

taro pharmaceuticals u.s.a., inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 ml - clobetasol propionate lotion, 0.05% is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older. treatment should be limited to 2 consecutive weeks. for moderate to severe plaque psoriasis, treatment may be extended for an additional 2 weeks for localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment. any additional benefits of extending treatment should be weighed against the risk of hypothalamic-pituitary-adrenal (hpa) axis suppression before prescribing for more than 2 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 lotion, 0.05% for the minimum amount of time necessary to achieve the desired results [see dosage and administration (2) ]. use in patients under 18 years of age is not recommended due to

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

ingenus pharmaceuticals, llc - 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. risk summary there are no available data on clobetasol propionate foam use in pregnant women to inform of a drug-associated risk for adverse developmental outcomes. published data report a significantly increased risk of low birthweight 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 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 anim

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

lupin pharmaceuticals,inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 ml - clobetasol propionate topical solution, usp is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 ml/week because of the potential for the drug to suppress the hpa axis. this product is not recommended for use in pediatric patients under 12 years of age. clobetasol propionate topical solution is contraindicated in patients with primary infections of the scalp, or in patients who are hypersensitive to clobetasol propionate, other corticosteroids, or any ingredient in this preparation.

United States - English - 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 emulsion foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older. none. teratogenic effects. pregnancy category c. there are no adequate and well-controlled studies of clobetasol propionate emulsion foam in pregnant women. clobetasol propionate emulsion 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 at relatively low dosage levels. 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 a

United States - English - 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

United States - English - 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.

United States - English - 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

United States - English - 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