США - англійська - NLM (National Library of Medicine)

padagis israel pharmaceuticals ltd - calcipotriene (unii: 143nq3779b) (calcipotriene - unii:143nq3779b), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - calcipotriene and betamethasone dipropionate ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. none. risk summary calcipotriene and betamethasone dipropionate ointment contains calcipotriene and bethamethasone dipropionate. the limited data with calcipotriene and betamethasone dipropionate ointment and calcipotriene use in pregnant women are not sufficient to evaluate a calcipotriene and betamethasone dipropionate ointment-associated or calcipotriene-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of having low birthweight infants with the maternal use of potent or very potent topical corticosteroids (see data ). advise pregnant women that calcipotriene and betamethasone dipropionate ointment may increase the potential risk of having a low birth weight infant and to use calcipotriene and betamethasone dipropionate ointment on the smallest area of skin and for t

США - англійська - NLM (National Library of Medicine)

bryant ranch prepack - calcipotriene (unii: 143nq3779b) (calcipotriene - unii:143nq3779b), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - calcipotriene and betamethasone dipropionate ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. none. risk summary calcipotriene and betamethasone dipropionate ointment contains calcipotriene and bethamethasone dipropionate. the limited data with calcipotriene and betamethasone dipropionate ointment and calcipotriene use in pregnant women are not sufficient to evaluate a calcipotriene and betamethasone dipropionate ointment-associated or calcipotriene-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of having low birthweight infants with the maternal use of potent or very potent topical corticosteroids (see data ). advise pregnant women that calcipotriene and betamethasone dipropionate ointment may increase the potential risk of having a low birth weight infant and to use calcipotriene and betamethasone dipropionate ointment on the smallest area of skin and for the shortest duration possible. in animal reproduction studies, oral administration of calcipotriene to pregnant rats during the period of organogenesis resulted in an increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs (see data ). oral administration of calcipotriene to pregnant rabbits during the period of organogenesis had no apparent effects on embryo-fetal development. subcutaneous administration of betamethasone dipropionate to pregnant rats and rabbits during the period of organogenesis resulted in fetal toxicity, including fetal deaths, reduced fetal weight, and fetal malformations (cleft palate and crooked or short tail) (see data ). the available data do not allow the calculation of relevant comparisons between the systemic exposures of calcipotriene and betamethasone diproprionate observed in animal studies to the systemic exposures that would be expected in humans after topical use of calcipotriene and betamethasone dipropionate ointment. the estimated background risk of major birth defects and miscarriage of the indicated population is unknown. 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 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 embryo-fetal development studies with calcipotriene were performed by the oral route in rats and rabbits. pregnant rats received dosages of 0, 6, 18, or 54 mcg/kg/day (0, 36, 108, and 324 mcg/m2 /day, respectively) on days 6-15 of gestation (the period of organogenesis). there were no apparent effects on maternal survival, behavior, or body weight gain, no effects on litter parameters, and no effects on the incidence of major malformations in fetuses. fetuses from dams dosed at 54 mcg/kg/day exhibited a significantly increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs. pregnant rabbits were dosed daily with calcipotriene at exposures of 0, 4, 12, or 36 mcg/kg/day (0, 48, 144, and 432 mcg/m2 /day, respectively) on days 6-18 of gestation (the period of organogenesis). mean maternal body weight gain was reduced in animals dosed at 12 or 36 mcg/kg/day. the incidence of fetal deaths was increased in the group dosed at 36 mcg/kg/day; reduced fetal weight was also observed in this group. the incidence of major malformations among fetuses was not affected. an increase in the incidence of minor skeletal abnormalities, including incomplete ossification of sternebrae, pubic bones, and forelimb phalanges, was observed in the group dosed at 36 mcg/kg/day. embryo-fetal development studies with betamethasone dipropionate were performed via subcutaneous injection in mice and rabbits. pregnant mice were administered doses of 0, 156, 625, or 2500 mcg/kg/day (0, 468, 1875, and 7500 mcg/m2 /day, respectively) on days 7 through 13 of gestation (the period of organogenesis). betamethasone dipropionate induced fetal toxicity, including fetal deaths, reduced fetal weight, malformations (increased incidence of the cleft palate and crooked or short tail), and minor skeletal abnormalities (delayed ossification of vertebra and sternebrae). fetal toxicity was observed at the lowest exposure that was evaluated (156 mcg/kg/day). pregnant rabbits were injected subcutaneously at dosages of 0, 0.625, 2.5, and 10 mcg/kg/day (0, 7.5, 30, and 120 mcg/m2 /day, respectively) on days 6 through 18 of gestation (the period of organogenesis). betamethasone dipropionate induced fetal toxicity, including fetal deaths, reduced fetal weight, external malformations (including malformed ears, cleft palate, umbilical hernia, kinked tail, club foot, and club hand), and skeletal malformations (including absence of phalanges of the first digit and cranial dysplasia) at dosages of 2.5 mcg/kg/day and above. calcipotriene was evaluated for effects on peri- and post-natal development when orally administered to pregnant rats at dosages of 0, 6, 18 or 54 mcg/kg/day (0, 36, 108, and 324 mcg/m2 /day, respectively) from gestation day 15 through day 20 postpartum. no remarkable effects were observed on any parameter, including survival, behavior, body weight, litter parameters, or the ability to nurse or rear pups. betamethasone dipropionate was evaluated for effects on peri- and post-natal development when orally administered to pregnant rats at dosages of 0, 100, 300, and 1000 mcg/kg/day (0, 600, 1800, and 6000 mcg/m2 /day, respectively) from gestation day 6 through day 20 postpartum. mean maternal body weight was significantly reduced on gestation day 20 in animals dosed at 300 and 1000 mcg/kg/day. the mean duration of gestation was slightly, but statistically significantly, increased at 100, 300, and 1000 mcg/kg/day. the mean percentage of pups that survived to day 4 was reduced in relation to dosage. on lactation day 5, the percentage of pups with a reflex to right themselves when placed on their back was significantly reduced at 1000 mcg/ kg/day. no effects on the ability of pups to learn were observed, and the ability of the offspring of treated rats to reproduce was not affected. risk summary there is no information regarding the presence of topically administered calcipotriene and betamethasone dipropionate in human milk, the effects on the breastfed infant, or the effects on milk production. it is not known whether topically administered calcipotriene or corticosteroids 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 calcipotriene and betamethasone dipropionate ointment and any potential adverse effects on the breastfed child from calcipotriene and betamethasone dipropionate ointment or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use calcipotriene and betamethasone dipropionate ointment on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply calcipotriene and betamethasone dipropionate ointment directly to the nipple and areola to avoid direct infant exposure [see use in specific populations (8.4)] . safety and effectiveness of the use of calcipotriene and betamethasone dipropionate ointment in pediatric patients under the age of 12 years have not been established. the safety and effectiveness of calcipotriene and betamethasone dipropionate ointment for the treatment of plaque psoriasis have been established in the age group 12 to 17 years. in a prospective, uncontrolled trial, 33 pediatric subjects ages 12-17 years with plaque psoriasis on the body were treated with calcipotriene and betamethasone dipropionate ointment for 4 weeks up to a maximum of 55.8 g per week. subjects were assessed for hpa axis suppression and effects on calcium metabolism. no adverse effects on adrenal suppression were observed. no hypercalcemia was observed but one subject had a possible treatment-related increase in urinary calcium [see clinical pharmacology (12.2)] . 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 [see warnings and precautions (5.2)] . 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. of the total number of subjects in the clinical studies of calcipotriene and betamethasone dipropionate ointment, approximately 14% were 65 years and older and approximately 3% were 75 years and over. no overall differences in safety or effectiveness of calcipotriene and betamethasone dipropionate ointment were observed between these subjects and younger subjects. all other reported clinical experience has not identified any differences in response between elderly and younger patients. however, greater sensitivity of some older individuals cannot be ruled out.

США - англійська - NLM (National Library of Medicine)

bryant ranch prepack - calcipotriene (unii: 143nq3779b) (calcipotriene - unii:143nq3779b), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - calcipotriene and betamethasone dipropionate ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. none. risk summary calcipotriene and betamethasone dipropionate ointment contains calcipotriene and bethamethasone dipropionate. the limited data with calcipotriene and betamethasone dipropionate ointment and calcipotriene use in pregnant women are not sufficient to evaluate a calcipotriene and betamethasone dipropionate ointment-associated or calcipotriene-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of having low birthweight infants with the maternal use of potent or very potent topical corticosteroids ( see data ). advise pregnant women that calcipotriene and betamethasone dipropionate ointment may increase the potential risk of having a low birth weight infant and to use calcipotriene and betamethasone dipropionate ointment on the smallest area of skin and

США - англійська - NLM (National Library of Medicine)

bryant ranch prepack - calcipotriene (unii: 143nq3779b) (calcipotriene - unii:143nq3779b), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - calcipotriene and betamethasone dipropionate ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. none. risk summary calcipotriene and betamethasone dipropionate ointment contains calcipotriene and bethamethasone dipropionate. the limited data with calcipotriene and betamethasone dipropionate ointment and calcipotriene use in pregnant women are not sufficient to evaluate a calcipotriene and betamethasone dipropionate ointment-associated or calcipotriene-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of having low birthweight infants with the maternal use of potent or very potent topical corticosteroids (see data ). advise pregnant women that calcipotriene and betamethasone dipropionate ointment may increase the potential risk of having a low birth weight infant and to use calcipotriene and betamethasone dipropionate ointment on the smallest area of skin and for the shortest duration possible. in animal reproduction studies, oral administration of calcipotriene to pregnant rats during the period of organogenesis resulted in an increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs (see data ). oral administration of calcipotriene to pregnant rabbits during the period of organogenesis had no apparent effects on embryo-fetal development. subcutaneous administration of betamethasone dipropionate to pregnant rats and rabbits during the period of organogenesis resulted in fetal toxicity, including fetal deaths, reduced fetal weight, and fetal malformations (cleft palate and crooked or short tail) (see data ). the available data do not allow the calculation of relevant comparisons between the systemic exposures of calcipotriene and betamethasone diproprionate observed in animal studies to the systemic exposures that would be expected in humans after topical use of calcipotriene and betamethasone dipropionate ointment. the estimated background risk of major birth defects and miscarriage of the indicated population is unknown. 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 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 embryo-fetal development studies with calcipotriene were performed by the oral route in rats and rabbits. pregnant rats received dosages of 0, 6, 18, or 54 mcg/kg/day (0, 36, 108, and 324 mcg/m2 /day, respectively) on days 6-15 of gestation (the period of organogenesis). there were no apparent effects on maternal survival, behavior, or body weight gain, no effects on litter parameters, and no effects on the incidence of major malformations in fetuses. fetuses from dams dosed at 54 mcg/kg/day exhibited a significantly increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs. pregnant rabbits were dosed daily with calcipotriene at exposures of 0, 4, 12, or 36 mcg/kg/day (0, 48, 144, and 432 mcg/m2 /day, respectively) on days 6-18 of gestation (the period of organogenesis). mean maternal body weight gain was reduced in animals dosed at 12 or 36 mcg/kg/day. the incidence of fetal deaths was increased in the group dosed at 36 mcg/kg/day; reduced fetal weight was also observed in this group. the incidence of major malformations among fetuses was not affected. an increase in the incidence of minor skeletal abnormalities, including incomplete ossification of sternebrae, pubic bones, and forelimb phalanges, was observed in the group dosed at 36 mcg/kg/day. embryo-fetal development studies with betamethasone dipropionate were performed via subcutaneous injection in mice and rabbits. pregnant mice were administered doses of 0, 156, 625, or 2500 mcg/kg/day (0, 468, 1875, and 7500 mcg/m2 /day, respectively) on days 7 through 13 of gestation (the period of organogenesis). betamethasone dipropionate induced fetal toxicity, including fetal deaths, reduced fetal weight, malformations (increased incidence of the cleft palate and crooked or short tail), and minor skeletal abnormalities (delayed ossification of vertebra and sternebrae). fetal toxicity was observed at the lowest exposure that was evaluated (156 mcg/kg/day). pregnant rabbits were injected subcutaneously at dosages of 0, 0.625, 2.5, and 10 mcg/kg/day (0, 7.5, 30, and 120 mcg/m2 /day, respectively) on days 6 through 18 of gestation (the period of organogenesis). betamethasone dipropionate induced fetal toxicity, including fetal deaths, reduced fetal weight, external malformations (including malformed ears, cleft palate, umbilical hernia, kinked tail, club foot, and club hand), and skeletal malformations (including absence of phalanges of the first digit and cranial dysplasia) at dosages of 2.5 mcg/kg/day and above. calcipotriene was evaluated for effects on peri- and post-natal development when orally administered to pregnant rats at dosages of 0, 6, 18 or 54 mcg/kg/day (0, 36, 108, and 324 mcg/m2 /day, respectively) from gestation day 15 through day 20 postpartum. no remarkable effects were observed on any parameter, including survival, behavior, body weight, litter parameters, or the ability to nurse or rear pups. betamethasone dipropionate was evaluated for effects on peri- and post-natal development when orally administered to pregnant rats at dosages of 0, 100, 300, and 1000 mcg/kg/day (0, 600, 1800, and 6000 mcg/m2 /day, respectively) from gestation day 6 through day 20 postpartum. mean maternal body weight was significantly reduced on gestation day 20 in animals dosed at 300 and 1000 mcg/kg/day. the mean duration of gestation was slightly, but statistically significantly, increased at 100, 300, and 1000 mcg/kg/day. the mean percentage of pups that survived to day 4 was reduced in relation to dosage. on lactation day 5, the percentage of pups with a reflex to right themselves when placed on their back was significantly reduced at 1000 mcg/ kg/day. no effects on the ability of pups to learn were observed, and the ability of the offspring of treated rats to reproduce was not affected. risk summary there is no information regarding the presence of topically administered calcipotriene and betamethasone dipropionate in human milk, the effects on the breastfed infant, or the effects on milk production. it is not known whether topically administered calcipotriene or corticosteroids 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 calcipotriene and betamethasone dipropionate ointment and any potential adverse effects on the breastfed child from calcipotriene and betamethasone dipropionate ointment or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use calcipotriene and betamethasone dipropionate ointment on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply calcipotriene and betamethasone dipropionate ointment directly to the nipple and areola to avoid direct infant exposure [see use in specific populations (8.4)] . safety and effectiveness of the use of calcipotriene and betamethasone dipropionate ointment in pediatric patients under the age of 12 years have not been established. the safety and effectiveness of calcipotriene and betamethasone dipropionate ointment for the treatment of plaque psoriasis have been established in the age group 12 to 17 years. in a prospective, uncontrolled trial, 33 pediatric subjects ages 12-17 years with plaque psoriasis on the body were treated with calcipotriene and betamethasone dipropionate ointment for 4 weeks up to a maximum of 55.8 g per week. subjects were assessed for hpa axis suppression and effects on calcium metabolism. no adverse effects on adrenal suppression were observed. no hypercalcemia was observed but one subject had a possible treatment-related increase in urinary calcium [see clinical pharmacology (12.2)] . 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 [see warnings and precautions (5.2)] . 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. of the total number of subjects in the clinical studies of calcipotriene and betamethasone dipropionate ointment, approximately 14% were 65 years and older and approximately 3% were 75 years and over. no overall differences in safety or effectiveness of calcipotriene and betamethasone dipropionate ointment were observed between these subjects and younger subjects. all other reported clinical experience has not identified any differences in response between elderly and younger patients. however, greater sensitivity of some older individuals cannot be ruled out.

Вірменія - англійська - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

krka d.d. - betamethasone (betamethasone dipropionate), betamethasone (betamethasone sodium phosphate) - suspension for injection - 5mg/ml+ 2mg/ml

США - англійська - NLM (National Library of Medicine)

e. fougera & co. a division of fougera pharmaceuticals inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone 0.5 mg in 1 ml - betamethasone dipropionate lotion (augmented), 0.05% 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 lotion (augmented), 0.05% 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 lotion (augmented), 0.05% 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 lotion (augmented), 0.05% may increase the risk of having a low birthweight infant and to use betamethasone dipropionate lotion

США - англійська - NLM (National Library of Medicine)

teligent pharma, inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone dipropionate  lotion 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 lotion 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 lotion 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 lotion may increase the risk of having a low birthweight infant and to use betamethasone dipropionate lotion on the smallest area of skin and for the shortest duration possible.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - calcipotriol, quantity: 52.2 microgram/g; betamethasone dipropionate, quantity: 643 microgram/g (equivalent: betamethasone, qty microgram/g) - ointment - excipient ingredients: dl-alpha-tocopherol; oleyl alcohol; liquid paraffin; white soft paraffin - indicated for the once daily topical treatment of plaque-type psoriasis vulgaris amenable to topical therapy.

США - англійська - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone dipropionate cream, 0.05% (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 cream, 0.5% (augmented)is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. teratogenic effects: pregnancy category c there are no adequate and well-controlled studies in pregnant women. betamethasone dipropionate cream, 0.5% (augmented)should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. betamethasone dipropionate has been shown to be teratogenic 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. systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous

США - англійська - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone dipropionate cream usp (augmented), 0.05% 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 cream usp (augmented), 0.05% 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 cream usp (augmented), 0.05% 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 cream usp (augmented), 0.05% may increase the risk of having a low birthweight infant and to use betamethasone dipropionate cream usp (augmented), 0.05% 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 cream usp (augmented), 0.05% (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 excretion of betamethasone dipropionate in breast milk, the effects on the breastfed infant, or the effects on milk production after topical application of betamethasone dipropionate cream usp (augmented), 0.05% to women who are breastfeeding. it is possible that topical administration of large amounts 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 cream usp (augmented), 0.05% and any potential adverse effects on the breastfed infant from betamethasone dipropionate cream usp (augmented), 0.05% or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use betamethasone dipropionate cream usp (augmented), 0.05% on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply betamethasone dipropionate cream usp (augmented), 0.05% directly to the nipple and areola to avoid direct infant exposure [see use in specific populations (8.4) ]. use of betamethasone dipropionate cream usp (augmented), 0.05% 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, betamethasone dipropionate cream (augmented), 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 betamethasone dipropionate cream (augmented), 0.05%, 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 cream usp (augmented), 0.05% in the treatment of diaper dermatitis. clinical trials of betamethasone dipropionate cream (augmented), 0.05% included 104 subjects who were 65 years of age and over and 8 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.