カナダ - 英語 - Health Canada

bausch health, canada inc. - halobetasol propionate - ointment - 0.05% - halobetasol propionate 0.05% - anti-inflammatory agents

カナダ - 英語 - Health Canada

bausch health, canada inc. - halobetasol propionate - cream - 0.05% - halobetasol propionate 0.05% - anti-inflammatory agents

カナダ - 英語 - Health Canada

mylan pharmaceuticals ulc - clobetasol propionate - ointment - 0.05% - clobetasol propionate 0.05% - anti-inflammatory agents

カナダ - 英語 - Health Canada

mylan pharmaceuticals ulc - clobetasol propionate - lotion - 0.05% - clobetasol propionate 0.05% - anti-inflammatory agents

カナダ - 英語 - Health Canada

galderma canada inc - clobetasol propionate - lotion - 0.05% - clobetasol propionate 0.05% - anti-inflammatory agents

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

prasco laboratories - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone 0.5 mg in 1 g - augmented betamethasone dipropionate ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. augmented betamethasone dipropionate ointment is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. risk summary there are no available data on augmented betamethasone dipropionate ointment 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 infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women that augmented betamethasone dipropionate ointment may increase the risk of having a low birthweight infant and to use augmented betamethasone dipropionate ointment on the smallest

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone dipropionate ointment usp (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. betamethasone dipropionate ointment (augmented) is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. risk summary there are no available data on betamethasone dipropionate ointment (augmented) 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 infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women that betamethasone dipropionate ointment (augmented) may increase the risk of having a low birthweight infant and to use betamethasone dipropionate ointment (augmented) on

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

aurobindo pharma limited - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone dipropionate ointment (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. betamethasone dipropionate ointment (augmented) is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. risk summary there are no available data on betamethasone dipropionate ointment (augmented) 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 infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women that betamethasone dipropionate ointment (augmented) may increase the risk of having a low birthweight infant and to use betamethasone dipropionate ointment (augmented) on the smallest area of skin and for the shortest duration possible. in animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits. the available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate in animal studies to the systemic exposure that would be expected in humans after topical use of betamethasone dipropionate ointment (augmented) (see data) . the 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 animal data betamethasone dipropionate has been shown to cause malformations in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. the abnormalities observed included umbilical hernias, cephalocele, and cleft palate. risk summary there are no data regarding the presence of betamethasone dipropionate in human milk, the effects on the breastfed infant, or the effects on milk production after topical application of betamethasone dipropionate ointment (augmented) to women who are breastfeeding. it is possible that topical administration of betamethasone dipropionate 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 betamethasone dipropionate ointment (augmented) and any potential adverse effects on the breastfed infant from betamethasone dipropionate ointment (augmented) or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use betamethasone dipropionate ointment (augmented) on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply betamethasone dipropionate ointment (augmented) directly to the nipple and areola to avoid direct infant exposure [see use in specific populations (8.4)] . use of betamethasone dipropionate ointment (augmented) in pediatric patients younger than 13 years of age is not recommended due to the potential for hpa axis suppression [see warnings and precautions (5.1)] . in an open-label hpa axis safety trial in subjects 3 months to 12 years of age with atopic dermatitis, diprolene af cream 0.05% was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 95%). in 19 of 60 (32%) evaluable subjects, adrenal suppression was indicated by either a ≤5 mcg/dl pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤18 mcg/dl and/or an increase of <7 mcg/dl from the baseline cortisol. out of the 19 subjects with hpa axis suppression, 4 subjects were tested 2 weeks after discontinuation of diprolene af cream, and 3 of the 4 (75%) had complete recovery of hpa axis function. the proportion of subjects with adrenal suppression in this trial was progressively greater, the younger the age group. 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 treated with topical drugs. they are, therefore, also at greater risk of hpa axis suppression and adrenal insufficiency upon the use of topical corticosteroids. rare systemic effects 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 skin atrophy have also been reported with use of topical corticosteroids in pediatric patients. avoid use of betamethasone dipropionate ointment (augmented) in the treatment of diaper dermatitis. clinical trials of betamethasone dipropionate ointment (augmented) included 225 subjects who were 65 years of age and over and 46 subjects who were 75 years of age and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. however, greater sensitivity of some older individuals cannot be ruled out.