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

zydus lifesciences limited - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.05 g in 1 ml - clobetasol propionate spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (bsa) in patients 18 years of age or older. patients should be instructed to use clobetasol propionate spray, 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 because safety has not been established and because numerically high rates of hpa axis suppression were seen with other clobetasol propionate topical formulations. [see use in specific populations (8.4)] clobetasol propionate spray, 0.05% should not be used on the face, axillae, or groin.  clobetasol propionate spray, 0.05% should not be used if there is atrophy at the treatment site. clobetasol propionate spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis. none. risk summary there are no available data on

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

zydus pharmaceuticals usa inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.05 g in 1 ml - clobetasol propionate spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (bsa) in patients 18 years of age or older. patients should be instructed to use clobetasol propionate spray, 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 because safety has not been established and because numerically high rates of hpa axis suppression were seen with other clobetasol propionate topical formulations. [see use in specific populations (8.4)] clobetasol propionate spray, 0.05% should not be used on the face, axillae, or groin.  clobetasol propionate spray, 0.05% should not be used if there is atrophy at the treatment site. clobetasol propionate spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis. none. risk summary there are no available data on

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

teligent pharma, inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate .05 mg 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

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)

physicians total care, inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.462 mg in 1 ml - clobetasol propionate topical solution is indicated for shortterm 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)

preferred pharmaceuticals, inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 g - clobetasol propionate cream and ointment are super-high potency corticosteroid formulations 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 hypothalamicpituitary- 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 cream and ointment, usp, 0.05% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

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

rebel distributors corp - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 g - clobetasol propionate cream and ointment are super-high potency corticosteroid formulations 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 hypothalamicpituitary- 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 cream and ointment, usp, 0.05% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

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

physicians total care, inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 g - clobetasol propionate foam, 0.05% is a super-potent topical corticosteroid indicated for short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid- responsive dermatoses of the scalp, and for short-term topical treatment of mild to moderate plaque-type psoriasis on non-scalp regions excluding the face and intertriginous areas. treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (hpa) axis. in a controlled pharmacokinetic study, some subjects experienced reversible suppression of the adrenals following 14 days of clobetasol propionate foam, 0.05% therapy (see adverse reactions ). use in children under 12 years of age is not recommended. clobetasol propionate foam, 0.05% is contraindicated in patients who are hypersensitive to clobetasol propionate, to other corticosteroids, or to any ingredient in this preparation.