Israele - inglese - Ministry of Health

trima israel pharmaceutical products maabarot ltd - clobetasol propionate - cream - clobetasol propionate 0.05 %w/w - clobetasol - clobetasol is a very potent topical corticosteroid indicated for adults, elderly and children over 1 year for the short term treatment only of more resistant inflammatory and pruritic manifestations of steroid responsive dermatoses unresponsive to less potent corticosteroids.these include the following:- psoriasis (excluding widespread plaque psoriasis)- recalcitrant dermatoses- lichen planus- discoid lupus erythematosus- other skin conditions which do not respond satisfactorily to less potent steroids.

Stati Uniti - inglese - NLM (National Library of Medicine)

prasco laboratories - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - 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 effects: pregnancy category c. there are no adequate and well-controlled studies in pregnant women. therefore, clobetasol propionate shampoo, 0.05% 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 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. the effect of clobetasol propionate on pregnancy outcome and development of offspring was studied in the rat. clobetasol propionate was administered subcutaneously to female rats twice daily (0, 12.5, 25, and 50 μg/kg/day) from day 7 of presumed gestation through day 25 of lactation or day 24 presumed gestation for those rats that did not deliver a litter. the maternal no-observed-effect-level (noel) for clobetasol propionate was less than 12.5 μg/kg/day due to reduced body weight gain and feed consumption during the gestation period. the reproductive noel in the dams was 25 μg/kg/day (ratio of animal dose to proposed human dose of 0.07 on a mg/m /day basis) based on prolonged delivery at a higher dose level. the no-observed-adverse-effect-level (noael) for viability and growth in the offspring was 12.5 μg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m /day basis) based on incidence of stillbirths, reductions in pup body weights on days 1 and 7 of lactation, increased pup mortality, increases in the incidence of umbilical hernia, and increases in the incidence of pups with cysts on the kidney at higher dose levels during the preweaning period. the weights of the epididymides and testes were significantly reduced at higher dosages. despite these changes, there were no effects on the mating and fertility of the offspring. systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. it is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. because many drugs are excreted in human milk, caution should be exercised when clobetasol propionate shampoo, 0.05%, is administered to a nursing woman. use of clobetasol propionate shampoo, 0.05%, in patients under 18 years old is not recommended due to potential for hpa axis suppression [see warnings and precautions (5.1) ] the effect of clobetasol propionate shampoo, 0.05%, on hpa axis suppression was evaluated in one trial in adolescents 12 to 17 years of age with moderate to severe scalp psoriasis with involvement of at least 25% of the scalp. in this trial, 5 of 12 evaluable subjects developed suppression of their hpa axis following 4 weeks of treatment with clobetasol propionate shampoo, 0.05%, applied once daily for 15 minutes to a dry scalp before lathering and rinsing. only 1 of the 5 subjects who had suppression was tested for recovery of hpa axis, and this subject recovered after 2 weeks. no studies have been performed in patients under the age of 12. because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of hpa axis suppression and cushing’s syndrome when they are treated with topical corticosteroids. they are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. therefore, use is not recommended in patients under the age of 18. hpa axis suppression, cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. ​clinical studies of clobetasol propionate shampoo, 0.05%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. in general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.​

Stati Uniti - inglese - 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

Stati Uniti - inglese - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - 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 eff

Stati Uniti - inglese - NLM (National Library of Medicine)

aleor dermaceuticals limited - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - 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 ef

Stati Uniti - inglese - 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

Stati Uniti - inglese - NLM (National Library of Medicine)

taro pharmaceuticals u.s.a., inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - 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 ef

Stati Uniti - inglese - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - 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

Stati Uniti - inglese - NLM (National Library of Medicine)

northstar rx llc - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - 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 ef

Stati Uniti - inglese - 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.