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

lupin pharmaceuticals, inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate cream usp is 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 50g/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 cream 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)

akorn - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - 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)

nucare pharmaceuticals,inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate cream usp is 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 50g/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 cream 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)

remedyrepack inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - 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

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

viona pharmaceuticals inc - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - 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)

preferred pharmaceuticals, inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - 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

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

synerrv sdn bhd - clobetasol propionate -

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

alembic pharmaceuticals inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - 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 animal exposure with human exposure was computed. 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 adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality. however, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants [adjusted rr, 7.74 (95% ci, 1.49 to 40.11)]. in addition, a small cohort study, in which 28 sub-saharan women using potent topical corticosteroids (27/28 used clobetasol propionate 0.05%) for skin lightening during pregnancy, noted a higher incidence of low birth weight infants in the exposed group. the majority of exposed subjects treated large areas of the body (a mean quantity of 60 g/month (range, 12 to170 g) over long periods of time. animal data embryofetal development studies conducted with clobetasol propionate in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and malformations at all dose levels tested down to 0.03 mg/kg. malformations seen included cleft palate and skeletal abnormalities. in an embryofetal development study in rabbits, subcutaneous administration of clobetasol propionate resulted in malformations at doses of 0.003 and 0.01 mg/kg. malformations seen included cleft palate, cranioschisis, and other skeletal abnormalities. risk summary there is no information regarding the presence of clobetasol propionate in breast milk or its effects on the breastfed infant or on milk production. systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. it is not known whether topical administration of clobetasol propionate could result in sufficient systemic absorption to produce detectable quantities in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clobetasol propionate foam and any potential adverse effects on the breastfed infant from clobetasol propionate foam or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use clobetasol propionate foam on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply clobetasol propionate foam directly to the nipple and areola to avoid direct infant exposure. safety and effectiveness of clobetasol propionate foam in patients younger than 12 years of age have not been established; therefore, use in children younger than 12 years is not recommended. because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when they are treated with topical drugs. they are, therefore, also at greater risk of adrenal insufficiency upon the use of topical corticosteroids. rare systemic toxicities such as cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients especially those with prolonged exposure to large doses of high potency topical corticosteroids. local adverse reactions including striae have also been reported with use of topical corticosteroids in pediatric patients. avoid use of clobetasol propionate foam in the treatment of diaper dermatitis. clinical studies of clobetasol propionate foam did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

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

bryant ranch prepack - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - 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. no comparison of animal exposure with human exposure was computed. 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 adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality. however, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants [adjusted rr, 7.74 (95% ci, 1.49–40.11)]. in addition, a small cohort study, in which 28 sub-saharan women using potent topical corticosteroids (27/28 used clobetasol propionate 0.05%) for skin lightening during pregnancy, noted a higher incidence of low birth weight infants in the exposed group. the majority of exposed subjects treated large areas of the body (a mean quantity of 60 g/month [range, 12–170g]) over long periods of time. animal data embryofetal development studies conducted with clobetasol propionate in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and malformations at all dose levels tested down to 0.03 mg/kg. malformations seen included cleft palate and skeletal abnormalities. in an embryofetal development study in rabbits, subcutaneous administration of clobetasol propionate resulted in malformations at doses of 0.003 and 0.01 mg/kg. malformations seen included cleft palate, cranioschisis, and other skeletal abnormalities. risk summary there is no information regarding the presence of clobetasol propionate in breast milk or its effects on the breastfed infant or on milk production. systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. it is not known whether topical administration of clobetasol propionate could result in sufficient systemic absorption to produce detectable quantities in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for clobetasol propionate foam, 0.05% and any potential adverse effects on the breastfed infant from clobetasol propionate foam, 0.05% or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use clobetasol propionate foam, 0.05% on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply clobetasol propionate foam, 0.05% directly to the nipple and areola to avoid direct infant exposure. safety and effectiveness of clobetasol propionate foam, 0.05% in patients younger than 12 years of age have not been established; therefore, use in children younger than 12 years is not recommended. because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when they are treated with topical drugs. they are, therefore, also at greater risk of adrenal insufficiency upon the use of topical corticosteroids. rare systemic toxicities such as cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients especially those with prolonged exposure to large doses of high potency topical corticosteroids. local adverse reactions including striae have also been reported with use of topical corticosteroids in pediatric patients. avoid use of clobetasol propionate foam, 0.05% in the treatment of diaper dermatitis. clinical studies of clobetasol propionate foam, 0.05% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range. clobetasol propionate foam, 0.05% important: clobetasol propionate foam, 0.05% is for use on the skin only. do not get clobetasol propionate foam, 0.05% in your eyes, mouth, or vagina. how to apply clobetasol propionate foam, 0.05%: step 1: remove the cap and save for further use. figure a step 2: before applying clobetasol propionate foam, 0.05% for the first time, break the tiny plastic piece at the base of the can’s rim by gently pushing back (away from the piece) on the nozzle. (see figure a ) figure b step 3: turn the can upside down. push the button to dispense a small amount of clobetasol propionate foam, 0.05% into the cap of the can, or on your affected skin area. (see figure b ) this amount should be no more than 1 ½ capfuls, about the size of a golf ball. figure c figure d step 4: using your fingertips, gently massage a thin layer of clobetasol propionate foam, 0.05% into the affected areas until the foam disappears. (see figures c and d ) figure e step 5: if you are treating areas with hair, such as the scalp, move any hair away so that the foam can be applied directly to the affected areas. (see figure e ) keep the foam away from your eyes, as it will sting and may cause eye problems if there is frequent contact with your eyes. if the foam gets in your eyes, rinse them well with cold water right away. if the stinging continues, contact your healthcare provider right away. figure f step 6: wash your hands after applying clobetasol propionate foam, 0.05%. (see figure f ) this instructions for use has been approved by the u.s. food and drug administration.

Kenya - English - Pharmacy and Poisons Board

atco laboratories limited b-18, site. karachi-75700, pakistan - clobetasol propionate, neomycin sulphate, nystatin - ointment - clobetasol propionate 0.05% w/w, neomycin… - clobetasol