ABD - İngilizce - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - hydrocortisone butyrate (unii: 05rmf7ypwn) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone butyrate lotion, 0.1% is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.   none. pregnancy category c. there are no adequate and well-controlled studies in pregnant women. therefore, hydrocortisone butyrate lotion 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 in laboratory animals.   note: the animal multiples of human exposure calculations in this label were based on body surface area comparisons for an adult (i.e., mg/m2 /day dose comparisons) assuming 100% human percutaneous absorption of a maximum topical human dose (mthd) for hydrocortisone butyrate lotion (25 g lotion).   systemic embryofetal development studies were conducted in rats and rabbits.   sub

ABD - İngilizce - NLM (National Library of Medicine)

mayne pharma inc. - hydrocortisone butyrate (unii: 05rmf7ypwn) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone butyrate lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. none. pregnancy category c. there are no adequate and well-controlled studies in pregnant women. therefore, hydrocortisone butyrate lotion 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 in laboratory animals. note: the animal multiples of human exposure calculations in this label were based on body surface area comparisons for an adult (i.e., mg/m2 /day dose comparisons) assuming 100% human percutaneous absorption of a maximum topical human dose (mthd) for hydrocortisone butyrate lotion (25 g lotion). systemic embryofetal development studies were conducted in rats and rabbits. subcutaneous doses

ABD - İngilizce - NLM (National Library of Medicine)

rebel distributors corp - hydrocortisone butyrate (unii: 05rmf7ypwn) (hydrocortisone butyrate - unii:05rmf7ypwn) - hydrocortisone butyrate cream usp, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

ABD - İngilizce - NLM (National Library of Medicine)

oceanside pharmaceuticals - hydrocortisone butyrate (unii: 05rmf7ypwn) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone butyrate lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. none. risk summary there are no controlled or large-scale epidemiologic studies with hydrocortisone butyrate lotion in pregnant women, and available data on hydrocortisone butyrate use in pregnant women have not identified a drug associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. in animal reproduction studies, when administered subcutaneously or topically to pregnant rats, rabbits, and mice, hydrocortisone butyrate induced adverse reproductive and developmental outcomes, including abortion, fetal death, malformation, delayed ossification, decrease in fetal weight, and delay in sexual maturation (see data) . the available data do not allow the calculation of relevant comparisons between the systemic exposure of hydrocortisone butyrate observed in animal studies and the systemic exposure that would be expected in humans after topical use of hydrocortisone butyrate lotion. 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data systemic embryofetal development studies were conducted in rats and rabbits. subcutaneous doses of 0.6, 1.8, and 5.4 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats during gestation days 6 – 17. in the presence of maternal toxicity, fetal effects noted at 5.4 mg/kg/day included increased ossification variations and unossified sternebra. no treatment-related embryofetal toxicity or malformation were noted at 5.4 and 1.8 mg/kg/day, respectively. subcutaneous doses of 0.1, 0.2 and 0.3 mg/kg/day hydrocortisone butyrate were administered to pregnant female rabbits during gestation days 7 – 20. increased abortion was noted at 0.3 mg/kg/day. in the absence of maternal toxicity, a dose-dependent decrease in fetal body weight was noted at doses ≥0.1 mg/kg/day. embryofetal toxicities (reduction in litter size, decreased number of viable fetuses, and increased post-implantation loss) were noted at doses ≥0.2 mg/kg/day. additional fetal effects included delayed ossification noted at doses ≥0.1 mg/kg/day and increased fetal malformations (primarily skeletal malformations) noted at doses ≥0.2 mg/kg/day. a dose at which no embryofetal toxicity or malformation was observed was not established in this study. additional systemic embryofetal development studies were conducted in rats and mice. subcutaneous doses of 0.1 and 9 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats during gestation days 9 – 15. in the presence of maternal toxicity, an increase in fetal death and fetal resorption and an increase in ossification of caudal vertebrae were noted at 9 mg/kg/day. no treatment-related embryofetal toxicity or malformation was noted at 0.1 mg/kg/day. subcutaneous doses of 0.2 and 1 mg/kg/day hydrocortisone butyrate were administered to pregnant female mice during gestation days 7 – 13. in the absence of maternal toxicity, an increased number of cervical ribs and one fetus with clubbed legs were noted at 1 mg/kg/day. no treatment-related embryofetal toxicity or malformation was noted at 1 and 0.2 mg/kg/day. no topical embryofetal development studies were conducted with hydrocortisone butyrate lotion. however, topical embryofetal development studies were conducted in rats and rabbits with a hydrocortisone butyrate ointment formulation. topical doses of 1% and 10% hydrocortisone butyrate ointment were administered to pregnant female rats during gestation days 6 – 15 or pregnant female rabbits during gestation days 6 – 18. a dose-dependent increase in fetal resorption was noted in rabbits and fetal resorptions were noted in rats at the 10% hydrocortisone butyrate ointment dose. no treatment-related embryofetal toxicity was noted at the 1% hydrocortisone butyrate ointment dose in rats. a dose at which no embryofetal toxicity was observed in rabbits after topical administration of hydrocortisone butyrate ointment was not established. no treatment-related malformation was noted at a dose of 10% hydrocortisone butyrate ointment in rats or rabbits. a peri- and post-natal development study was conducted in rats. subcutaneous doses of 0.6, 1.8 and 5.4 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats from gestation day 6 to lactation day 20. in the presence of maternal toxicity, a dose-dependent decrease in fetal weight was noted at doses ≥1.8 mg/kg/day. no treatment-related fetal toxicity was noted at 0.6 mg/kg/day. a delay in sexual maturation was noted at 5.4 mg/kg/day. no treatment-related effects on sexual maturation were noted at 1.8 mg/kg/day. no treatment-related effects on behavioral development or subsequent reproductive performance were noted at 5.4 mg/kg/day. risk summary there are no data on the presence of hydrocortisone butyrate in human or animal milk, effects on the breastfed infant, or effects on milk production. 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 hydrocortisone butyrate lotion 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 hydrocortisone butyrate lotion and any potential adverse effects on the breastfed infant from hydrocortisone butyrate lotion or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use hydrocortisone butyrate lotion on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women to wash off prior to breastfeeding any hydrocortisone butyrate lotion that has been applied to the areas at risk for direct infant contact. the safety and effectiveness of hydrocortisone butyrate lotion for the topical treatment of mild to moderate atopic dermatitis have been established in pediatric patients 3 months of age and older. use of hydrocortisone butyrate lotion for this indication is supported by evidence from an adequate and well-controlled trial in 284 pediatric patients 3 months to 18 years of age with mild to moderate atopic dermatitis. the safety and effectiveness of hydrocortisone butyrate lotion have not been established in pediatric patients younger than 3 months of age. endocrine adverse reactions eighty-four (84) pediatric subjects (3 months to less than 18 years of age) with moderate to severe atopic dermatitis affecting at least 25% of body surface area (bsa) treated with hydrocortisone butyrate lotion three times daily for up to 4 weeks were assessed for hpa axis suppression. the disease severity (moderate to severe atopic dermatitis) and the dosing regimen (three times daily) in this hpa axis trial were different from the subject population (mild to moderate atopic dermatitis) and the dosing regimen (twice daily) for which hydrocortisone butyrate lotion is indicated. seven of the 82 evaluable subjects (8.5%) demonstrated laboratory evidence of hpa axis suppression, where the criterion for defining hpa axis suppression was a serum cortisol level of less than or equal to 18 mcg/dl after cosyntropin stimulation. subjects with hpa axis suppression ranged from 1 to 12 years of age and, at the time of enrollment, had 35% to 90% bsa involvement. these subjects did not develop any other signs or symptoms of hpa axis suppression. at the first follow-up visit, approximately 1 month after the conclusion of treatment, cosyntropin stimulation results of all subjects had returned to normal, with the exception of one subject. this last subject recovered adrenal function by the second post-treatment visit, 55 days post-treatment [see clinical pharmacology (12.2)] . because of higher skin-surface-to-body-mass ratios, pediatric patients are at a greater risk than adults of hpa axis suppression when they are treated with topical corticosteroids [see warnings and precautions (5.1)] . they are therefore also at a greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of cushing’s syndrome while on treatment. cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. manifestations of adrenal suppression in pediatric patients include low plasma cortisol levels to an absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. clinical trials of hydrocortisone butyrate lotion did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects.

ABD - İngilizce - NLM (National Library of Medicine)

the j. molner company llc - hydrocortisone butyrate (unii: 05rmf7ypwn) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone butyrate lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. none. risk summary there are no controlled or large-scale epidemiologic studies with hydrocortisone butyrate lotion in pregnant women, and available data on hydrocortisone butyrate use in pregnant women have not identified a drug associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. in animal reproduction studies, when administered subcutaneously or topically to pregnant rats, rabbits, and mice, hydrocortisone butyrate induced adverse reproductive and developmental outcomes, including abortion, fetal death, malformation, delayed ossification, decrease in fetal weight, and delay in sexual maturation (see data) . the available data do not allow the calculation of relevant comparisons between the systemic exposure of hydrocortisone butyrate observed in animal studies and the systemic exposure that would be expected in humans

ABD - İngilizce - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - hydrocortisone (unii: wi4x0x7bpj) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone 1 mg in 1 g - hydrocortisone butyrate cream, 0.1% (lipophilic) is indicated for: none. there are no adequate and well-controlled studies in pregnant women. therefore, hydrocortisone butyrate cream 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 in laboratory animals. note: the animal multiples of human exposure calculations in this label were based on body surface area comparisons for an adult (i.e., mg/m2 /day dose comparisons) assuming 100% human percutaneous absorption of a maximum topical human dose (mthd) for hydrocortisone butyrate cream (25 g). systemic embryofetal development studies were conducted in rats and rabbits. subcutaneous doses of 0.6, 1.8 and 5.4 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats during gestation days 6 to 17. in the presence of maternal toxicity, fetal effects noted at 5.4 mg/kg/day (2x mthd) included an increased incidence of ossification variations and unossified sternebra. no treatment-related effects on embryofetal toxicity or teratogenicity were noted at doses of 5.4 and 1.8 mg/kg/day, respectively (2x mthd and 0.7x mthd, respectively). subcutaneous doses of 0.1, 0.2 and 0.3 mg/kg/day hydrocortisone butyrate were administered to pregnant female rabbits during gestation days 7 to 20. an increased incidence of abortion was noted at 0.3 mg/kg/day (0.2x mthd). in the absence of maternal toxicity, a dose-dependent decrease in fetal body weight was noted at doses ≥0.1 mg/kg/day (0.1x mthd). additional indicators of embryofetal toxicity (reduction in litter size, decreased number of viable fetuses, increased post-implantation loss) were noted at doses ≥0.2 mg/kg/day (0.2x mthd). additional fetal effects noted in this study included delayed ossification noted at doses ≥0.1 mg/kg/day and an increased incidence of fetal malformations (primarily skeletal malformations) noted at doses ≥0.2 mg/kg/day. a dose at which no treatment-related effects on embryofetal toxicity or teratogenicity were observed was not established in this study. additional systemic embryofetal development studies were conducted in rats and mice. subcutaneous doses of 0.1 and 9 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats during gestation days 9 to 15. in the presence of maternal toxicity, an increase in fetal deaths and fetal resorptions and an increase in the number of ossifications in caudal vertebrae were noted at a dose of 9 mg/kg/day (3x mthd). no treatment-related effects on embryofetal toxicity or teratogenicity were noted at 0.1 mg/kg/day (0.1x mthd). subcutaneous doses of 0.2 and 1 mg/kg/day hydrocortisone butyrate were administered to pregnant female mice during gestation days 7 to 13. in the absence of maternal toxicity, an increased number of cervical ribs and one fetus with clubbed legs were noted at a dose of 1 mg/kg/day (0.2x mthd). no treatment-related effects on embryofetal toxicity or teratogenicity were noted at doses of 1 and 0.2 mg/kg/day, respectively (0.2x mthd and 0.1x mthd, respectively). no topical embryofetal development studies were conducted with hydrocortisone butyrate cream. however, topical embryofetal development studies were conducted in rats and rabbits with a hydrocortisone butyrate ointment formulation. topical doses of 1% and 10% hydrocortisone butyrate ointment were administered to pregnant female rats during gestation days 6 to 15 or pregnant female rabbits during gestation days 6 to 18. a dose-dependent increase in fetal resorptions was noted in rabbits (0.2 to 2x mthd) and fetal resorptions were noted in rats at the 10% hydrocortisone butyrate ointment dose (80x mthd). no treatment-related effects on embryofetal toxicity were noted at the 1% hydrocortisone butyrate ointment dose in rats (8x mthd). a dose at which no treatment-related effects on embryofetal toxicity were observed in rabbits after topical administration of hydrocortisone butyrate ointment was not established in this study. no treatment-related effects on teratogenicity were noted at a dose of 10% hydrocortisone butyrate ointment in rats or rabbits (80x mthd and 2x mthd, respectively). a peri- and post-natal development study was conducted in rats. subcutaneous doses of 0.6, 1.8 and 5.4 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats from gestation day 6 to lactation day 20. in the presence of maternal toxicity, a dose-dependent decrease in fetal weight was noted at doses ≥1.8 mg/kg/day (0.7x mthd). no treatment-related effects on fetal toxicity were noted at 0.6 mg/kg/day (0.2x mthd). a delay in sexual maturation was noted at 5.4 mg/kg/day (2x mthd). no treatment-related effects on sexual maturation were noted at 1.8 mg/kg/day. no treatment-related effects on behavioral development or subsequent reproductive performance were noted at 5.4 mg/kg/day. 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 hydrocortisone butyrate cream is administered to a nursing woman. safety and efficacy in pediatric patients below 3 months of age have not been established. because of higher skin surface-to-body-mass ratios, pediatric patients are at a greater risk than adults of hpa axis suppression when they are treated with topical corticosteroids [see warnings and precautions (5.1)] . they are therefore also at a greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of cushing’s syndrome while on treatment. eighty-six (86) pediatric subjects (between 5 months and 18 years of age) with moderate to severe atopic dermatitis affecting at least 25% of body surface area (bsa) treated with hydrocortisone butyrate cream three times daily for up to 4 weeks were assessed for hpa axis suppression in two separate studies. the disease severity (moderate to severe atopic dermatitis) and the dosing regimen (three times daily) in these hpa axis studies were different from the subject population (mild to moderate atopic dermatitis) and the dosing regimen (two times daily) for which hydrocortisone butyrate cream is indicated in this population. five of the 82 evaluable subjects (6.1%) demonstrated evidence of suppression, where the criterion for defining hpa axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter after cosyntropin stimulation. suppressed subjects ranged in age from 5 months to 16 years and, at the time of enrollment, had 25% to 95% bsa involvement. these subjects did not demonstrate any clinical signs or symptoms despite evidence of hpa axis suppression. at the first follow up visit, approximately one month after the conclusion of treatment, cosyntropin stimulation results of all subjects had returned to normal, with the exception of one subject. this last subject recovered adrenal function by 65 days post-treatment. cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have also been reported in pediatric patients receiving topical corticosteroids. manifestations of adrenal suppression in pediatric patients include low plasma cortisol levels to an absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. clinical studies of hydrocortisone butyrate cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

ABD - İngilizce - NLM (National Library of Medicine)

bausch health us, llc - hydrocortisone butyrate (unii: 05rmf7ypwn) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone butyrate 1 mg in 1 g - locoid (hydrocortisone butyrate) cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. none.

ABD - İngilizce - NLM (National Library of Medicine)

bausch health us, llc - hydrocortisone butyrate (unii: 05rmf7ypwn) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone butyrate 1 mg in 1 ml - locoid (hydrocortisone butyrate) solution, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of seborrheic dermatitis. none.

Yeni Zelanda - İngilizce - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - hydrocortisone butyrate 0.1%{relative} - topical cream - 0.1 % - active: hydrocortisone butyrate 0.1%{relative} excipient: butyl hydroxybenzoate cetomacrogol 1000 cetostearyl alcohol citric acid light liquid paraffin propyl hydroxybenzoate purified water sodium citrate white soft paraffin

Yeni Zelanda - İngilizce - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - hydrocortisone butyrate 0.1%{relative} - topical ointment - 0.1 % - active: hydrocortisone butyrate 0.1%{relative} excipient: plastibase