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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)

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

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

unit dose services - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 g - clobetasol propionate gel, 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 per 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 gel, cream and ointment 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)

a-s medication solutions - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate gel, 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 per 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 gel, cream and ointment 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)

a-s medication solutions - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - 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 grams per 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 is 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)

a-s medication solutions - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate cream, usp 0.05% 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 per 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 is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. safety and effectiveness of clobetasol propionate cream in pediatric patients has not been established. use in children under 12 years of age is not recommended. because of a higher ratio of skin

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

a-s medication solutions - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate topical solution 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)

taro pharmaceuticals u.s.a., inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate gel, 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 per 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 gel, cream and ointment 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)

taro pharmaceuticals u.s.a., inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate topical 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. the total dosage should not exceed 50 g (59 ml or 2 fl. oz.) per week. do not use more than 26 sprays per application or 52 sprays per day. treatment should be limited to 4 consecutive weeks. patients should be instructed to use clobetasol propionate topical 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. clobetasol propionate topical spray, 0.05% should not be used on the face, axillae, or groin. clobetasol propionate topical spray, 0.05% should not be used if there is atr

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

glenmark pharmaceuticals inc., usa - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - 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 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 clobetasol propionate spray use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight in infants with the maternal use of potent or very potent topical corticosteroids (see data ). advise pregnant women that clobetasol propionate spray may increase the risk of having a low birth weight infant and to use clobetasol propionate spray on the smallest area of skin and for the shortest duration possible. animal reproduction studies have not been conducted with clobetasol propionate spray. in an animal reproduction study, subcutaneous administration of clobetasol propionate to pregnant rats at doses greater than 12.5 mcg/kg/day during the period of organogenesis caused an increase in malformations (increased incidence of umbilical hernia) (see data ). the available data do not allow calculation of relevant comparisons between the systemic exposure of clobetasol propionate in animal studies to the systemic exposure that would be expected in humans after topical use of clobetasol propionate spray. 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency. however, when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 g during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants. animal data clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it caused malformations in both the rabbit and the mouse. clobetasol propionate has greater potential for adverse developmental effects 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 mcg/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-adverse-effect-level (noael) for clobetasol propionate was less than 12.5 mcg/kg/day due to reduced body weight gain and feed consumption during the gestation period. the reproductive noael in the dams was 25 mcg/kg/day based on prolonged delivery at 50 mcg/kg/day. the noael for viability and growth in the offspring was 12.5 mcg/kg/day 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. risk summary there is no information regarding the presence of clobetasol propionate in human milk or its effects on the breastfed infant or on milk production. 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 spray and any potential adverse effects on the breastfed infant from clobetasol propionate spray or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use clobetasol propionate spray on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply clobetasol propionate spray directly to the nipple and areola to avoid direct infant exposure [see use in specific populations (8.4) ]. 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. safety and effectiveness in pediatric patients treated with clobetasol propionate spray, 0.05% have not been established [see warnings and precautions (5.1) ]. because of 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 glucocorticosteroid 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. 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 absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. clinical studies of clobetasol propionate spray, 0.05% did not include sufficient numbers of patients aged 65 and over to adequately determine whether they respond differently than younger patients. in two randomized, vehicle controlled clinical trials, 21 of the 240 patients (9%) were over the age of 65. 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. clobetasol propionate (kloh-bay-tuh-sall proh-pee-uh-nate) spray important: for use on skin only. do not get clobetasol propionate spray near or in your eyes, mouth or vagina. read the instructions for use that comes with clobetasol propionate spray before you start using it and each time you get a refill. there may be new information. this information does not take the place of talking with your doctor about your medical condition or your treatment. parts of clobetasol propionate spray (see figure a). when you receive clobetasol propionate spray the directional spray nozzle is in the “locked” position with the nozzle pointing downwards (see figure b). how to apply clobetasol propionate spray: step 1: to unlock the directional spray nozzle, hold the clobetasol propionate spray bottle and sides of the pump top with one hand. use your other hand to turn the directional spray nozzle to either the right or the left (see figure c). the spray will come out through the opening at the end of the directional spray nozzle. step 2: to apply clobetasol propionate spray, point the directional spray nozzle to the affected area. to spray, push down on the pump top. apply clobetasol propionate spray to the affected area as instructed by your doctor (see figure d) . step 3: spray only enough clobetasol propionate spray to cover the affected area, for example, the elbow (see figure e). rub in clobetasol propionate spray gently and completely. step 4: after applying clobetasol propionate spray, return the directional spray nozzle to the “locked” position (see figure g). step 5: wash your hands after applying clobetasol propionate spray. this patient information and instructions for use have been approved by the u.s. food and drug administration. manufactured by: glenmark pharmaceuticals limited baddi, himachal pradesh 173205, india manufactured for: glenmark pharmaceuticals inc., usa mahwah, nj 07430 questions? 1 (888) 721-7115 www.glenmarkpharma-us.com september 2020