الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

akorn - calcipotriene hydrate (unii: s7499tyy6g) (calcipotriene - unii:143nq3779b) - calcipotriene 0.05 mg in 1 ml - calcipotriene topical solution, 0.005% (scalp solution), is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. the safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established. calcipotriene topical solution, 0.005% (scalp solution), is contraindicated in those patients with acute psoriatic eruptions or a history of hypersensitivity to any of the components of the preparation. it should not be used by patients with demonstrated hypercalcemia or evidence of vitamin d toxicity.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

cosette pharmaceuticals, inc. - calcipotriene (unii: 143nq3779b) (calcipotriene - unii:143nq3779b) - calcipotriene .05 mg in 1 ml - calcipotriene topical solution, 0.005% (scalp solution) is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. the safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established. calcipotriene topical solution, 0.005% (scalp solution), is contraindicated in those patients with acute psoriatic eruptions or a history of hypersensitivity to any of the components of the preparation. it should not be used by patients with demonstrated hypercalcemia or evidence of vitamin d toxicity.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

sandoz inc. - calcipotriene (unii: 143nq3779b) (calcipotriene - unii:143nq3779b) - calcipotriene 0.05 mg in 1 g - calcipotriene cream, 0.005%, is indicated for the treatment of plaque psoriasis. the safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established. calcipotriene cream, 0.005% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. it should not be used by patients with demonstrated hypercalcemia or evidence of vitamin d toxicity. calcipotriene cream, 0.005% should not be used on the face.

أستراليا - الإنجليزية - 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.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

prasco laboratories - calcipotriene hydrate (unii: s7499tyy6g) (calcipotriene - unii:143nq3779b), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - calcipotriene and betamethasone dipropionate topical suspension is indicated for the topical treatment of plaque psoriasis of the scalp and body in patients 12 years and older. none. risk summary available data with calcipotriene and betamethasone dipropionate topical suspension are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. although there are no available data on use of the calcipotriene component in pregnant women, systemic exposure to calcipotriene after topical administration of calcipotriene and betamethasone dipropionate topical suspension is likely to be low [see clinical pharmacology (12.3)]. observational studies suggest an increased risk of having low birth weight infants with the maternal use of potent or super potent topical corticosteroids (see data ). advise pregnant women that calcipotriene and betamethasone dipropionate topical suspension may increase the potential risk of having a low birth weight infant and

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

taro pharmaceuticals u.s.a., inc. - calcipotriene (unii: 143nq3779b) (calcipotriene - unii:143nq3779b), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - calcipotriene and betamethasone dipropionate topical suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. additional pediatric use information is approved for leo pharma a/s's taclonex® (calcipotriene and betamethasone dipropionate) topical suspension. however, due to leo pharma a/s's marketing exclusivity rights, this drug product is not labeled with that information. none. risk summary available data with calcipotriene and betamethasone dipropionate topical suspension are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. although there are no available data on use of the calcipotriene component in pregnant women, systemic exposure to calcipotriene after topical administration of calcipotriene and betamethasone dipropionate topical suspension is likely to be low [see clinical pharmacology (12.3)].

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

trifluent pharma llc - calcipotriene (unii: 143nq3779b) (calcipotriene - unii:143nq3779b) - calcipotriene foam should not be used by patients with known hypercalcemia. calcipotriene foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. risk summary although there are no available data on the drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes in pregnant women exposed to calcipotriene foam, systemic exposure to calcipotriene is likely to be low [see clinical pharmacology ( 12.2, 12.3)] . in animal reproduction studies, oral administration of calcipotriene to pregnant rats and rabbits during the period of organogenesis resulted in an increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs in rats and an increased incidence of minor skeletal abnormalities, including incomplete ossification of pubic bones and forelimb phalanges in rabbits (see data) . the available data do not allow the calculation of rel

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

padagis israel pharmaceuticals ltd - calcipotriene monohydrate (unii: s7499tyy6g) (calcipotriene - unii:143nq3779b), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - calcipotriene and betamethasone dipropionate topical suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. additional pediatric use information is approved for leo pharma a/s’s taclonex® (calcipotriene and betamethasone dipropionate) topical suspension. however, due to leo pharma a/s’s marketing exclusivity rights, this drug product is not labeled with that information. none. risk summary available data with calcipotriene and betamethasone dipropionate topical suspension are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. although there are no available data on use of the calcipotriene component in pregnant women, systemic exposure to calcipotriene after topical administration of calcipotriene and betamethasone dipropionate topical suspension is likely to be low [see clinical pharmacology (12.3)]

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

mayne pharma - calcipotriene (unii: 143nq3779b) (calcipotriene - unii:143nq3779b) - calcipotriene foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. calcipotriene foam should not be used by patients with known hypercalcemia. risk summary although there are no available data on the drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes in pregnant women exposed to calcipotriene foam, systemic exposure to calcipotriene is likely to be low [see clinical pharmacology (12.2, 12.3)] . in animal reproduction studies, oral administration of calcipotriene to pregnant rats and rabbits during the period of organogenesis resulted in an increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs in rats and an increased incidence of minor skeletal abnormalities, including incomplete ossification of pubic bones and forelimb phalanges in rabbits (see data) . the available data do not allow the calculation of relevant comparisons between the systemic exposure of calcipotriene observed in animal studies to the systemic exposure that would be expected in humans after topical use of calcipotriene foam. 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 animal data embryofetal development studies were conducted with calcipotriene after oral administration in rats and rabbits. pregnant rats received daily oral administration of calcipotriene during the period of organogenesis. fetuses from dams dosed with 54 mcg/kg/day (318 mcg/m2 /day) exhibited a significantly increased incidence of minor skeletal abnormalities consisting primarily of enlarged fontanelles and extra ribs. the enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. there were no effects on the incidence of major malformations in fetuses. pregnant rabbits received daily oral administration of calcipotriene during the period of organogenesis. increased rabbit maternal and fetal toxicity was noted at 12 mcg/kg/day (132 mcg/m2 /day). fetuses from does dosed with 36 mcg/kg/day (396 mcg/m2 /day) exhibited a significantly increased incidence of minor skeletal abnormalities including incomplete ossification of pubic bones and forelimb phalanges. there were no effects on the incidence of major malformations in fetuses. risk summary there are no data on the presence of topically administered calcipotriene in human or animal milk, the effects on the breastfed infant, or the effects on milk production. after topical administration of calcipotriene foam, concentrations of calcipotriene in plasma are low, and therefore, concentrations in human milk are likely to be low [see clinical pharmacology (12.3)] . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for and any potential adverse effects on the breastfed child from calcipotriene foam or from the underlying maternal condition. the safety and effectiveness of calcipotriene foam have been established in pediatric patients age 4 years and older for topical treatment of plaque psoriasis of the scalp and body. use of calcipotriene foam in this age group is supported by two adequate and well controlled 8-week trials in adults and adolescents 12 years of age and older, with additional data from a 15-day open-label safety and pharmacokinetics (pk) study conducted in 19 subjects 12 to less than 17 years of age; and an 8-week open-label safety and pk study in 36 subjects 4 to 11 years of age with psoriasis. data from 19 subjects aged 12 to less than 17 years and 18 subjects aged 5 to 11 years showed no significant effects on indices of calcium metabolism. systemic concentrations of calcipotriene were not quantifiable in the two studies in subjects aged 7 years to less than 17 years. [see clinical studies (14), clinical pharmacology (12.2, 12.3) and adverse reactions (6.1)] . the safety and effectiveness of calcipotriene foam in pediatric patients less than 4 years of age have not been established. clinical trials of calcipotriene foam did not include sufficient numbers of subjects aged 65 years 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. read this instructions for use before you start using calcipotriene foam and each time you get a refill. there may be new information. this information does not take the place of talking with your healthcare provider about your medical condition or treatment. important information: - calcipotriene foam is for use on the skin only (topical use). do not use calcipotriene foam in your mouth, eyes, or vagina. - avoid getting calcipotriene foam on your face or in your eyes. if you accidentally get calcipotriene foam on your face or in your eyes, rinse well with water. how to apply calcipotriene foam to your body: follow your healthcare providers instructions on how much calcipotriene foam to use and where to use it. wash your hands after applying calcipotriene foam unless you are treating areas on your hands. step 1. before applying calcipotriene foam for the first time, break the tiny plastic piece at the base of the can's rim by gently pushing back (away from the piece) on the nozzle. see figure a.   figure a step 2: shake the can of calcipotriene foam before use. see figure b.   figure b step 3: turn the can of calcipotriene foam upside down and press the nozzle. see figure c.   figure c step 4. dispense a small amount of calcipotriene foam into the palm of your hand. see figure d.   figure d step 5. use enough calcipotriene foam to cover the affected area with a thin layer. gently rub the foam into the affected area until it disappears into the skin. see figures e and f   figure e   figure f how to apply calcipotriene foam to your scalp: step 6 . apply calcipotriene foam to your scalp when your hair is dry. part your hair and apply directly on the affected area. see figure g. wash your hands after applying calcipotriene foam.   figure g this instructions for use has been approved by the u.s. food and drug administration. distributed by: mayne pharma , greenville, nc 27834 revised: 12/2020

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

bryant ranch prepack - calcipotriene hydrate (unii: s7499tyy6g) (calcipotriene - unii:143nq3779b), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - calcipotriene and betamethasone dipropionate topical suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. additional pediatric use information is approved for leo pharma a/s’s taclonex® (calcipotriene and betamethasone dipropionate) topical suspension. however, due to leo pharma a/s’s marketing exclusivity rights, this drug product is not labeled with that information. none. risk summary available data with calcipotriene and betamethasone dipropionate topical suspension are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. although there are no available data on use of the calcipotriene component in pregnant women, systemic exposure to calcipotriene after topical administration of calcipotriene and betamethasone dipropionate topical suspension is likely to be low [see clinical pharmacology (12.3)] . observational studies suggest an increased risk of having low birth weight infants with the maternal use of potent or super potent topical corticosteroids (see data) . advise pregnant women that calcipotriene and betamethasone dipropionate topical suspension may increase the potential risk of having a low birth weight infant and to use calcipotriene and betamethasone dipropionate topical suspension 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 dipropionate observed in animal studies to the systemic exposures that would be expected in humans after topical use of calcipotriene and betamethasone dipropionate topical suspension. the estimated background risk of major birth defects and miscarriage of 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 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 super potent topical corticosteroids exceeded 300 grams 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. concentrations of calcipotriene in plasma are low after topical administration, and therefore, concentrations in human milk are likely to be low [see clinical pharmacology (12.3)] . it is not known whether topical administration of large amounts of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk (see clinical considerations). the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for calcipotriene and betamethasone dipropionate topical suspension and any potential adverse effects on the breastfed child from calcipotriene and betamethasone dipropionate topical suspension or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use calcipotriene and betamethasone dipropionate topical suspension on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply calcipotriene and betamethasone dipropionate topical suspension directly to the nipple and areola to avoid direct infant exposure [see use in specific populations (8.4)] . the safety and effectiveness of calcipotriene and betamethasone dipropionate topical suspension for the treatment of plaque psoriasis of the scalp have been established in pediatric patients age 12 to 17 years. the use of calcipotriene and betamethasone dipropionate topical suspension for this indication is supported by evidence from adequate and well-controlled trials in adults and from uncontrolled trials in pediatric subjects that enrolled 109 adolescents with moderate psoriasis of the scalp. after 4 weeks of once daily treatment with calcipotriene and betamethasone dipropionate topical suspension, hpa axis suppression was observed in 3% of adolescents with psoriasis of the scalp and 16% of adolescents with psoriasis of the scalp and body. [see warnings and precautions (5.2), adverse reactions (6.1), and 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 corticosteroids. pediatric patients are, therefore, also at greater risk of hpa axis suppression and adrenal insufficiency with the use of topical corticosteroids including calcipotriene and betamethasone dipropionate topical suspension [see clinical pharmacology (12.2)] . 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. the safety and effectiveness of calcipotriene and betamethasone dipropionate topical suspension in pediatric patients less than 12 years of age have not been established. additional pediatric use information is approved for leo pharma a/s’s taclonex® (calcipotriene and betamethasone dipropionate) topical suspension. however, due to leo pharma a/s’s marketing exclusivity rights, this drug product is not labeled with that information. clinical studies of calcipotriene and betamethasone dipropionate topical suspension in plaque psoriasis on non-scalp areas included 124 subjects who were 65 years of age or older, and 36 were 75 years of age or older. clinical studies of calcipotriene and betamethasone dipropionate topical suspension in subjects with psoriasis of the scalp included 334 subjects who were 65 years or older and 84 subjects who were 75 years or older. no overall differences in safety or effectiveness of calcipotriene and betamethasone dipropionate topical suspension were observed between these subjects and younger subjects, and other reported clinical experience has not identified any differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. calcipotriene (kal-si-poe-try-een) and betamethasone (bay-ta-meth-a-sone) dipropionate topical suspension, 0.005%/0.064% important: calcipotriene and betamethasone dipropionate topical suspension is for use on skin only (topical). do not get calcipotriene and betamethasone dipropionate topical suspension near or in your mouth, eyes or vagina. read this instructions for use before you start using calcipotriene and betamethasone dipropionate topical suspension and each time you get a refill. there may be new information. this information does not take the place of talking with your healthcare provider about your medical condition or treatment. how to apply calcipotriene and betamethasone dipropionate topical suspension to your body: follow your healthcare provider’s instructions of how much calcipotriene and betamethasone dipropionate topical suspension to use and where to use it. apply calcipotriene and betamethasone dipropionate topical suspension directly to areas affected by plaque psoriasis and gently rub in. wash your hands after applying calcipotriene and betamethasone dipropionate topical suspension, unless you are treating areas on your hands. how to apply calcipotriene and betamethasone dipropionate topical suspension to your scalp: you do not need to wash your hair before you apply calcipotriene and betamethasone dipropionate topical suspension step 1: shake the bottle before use. remove the cap from the bottle. (see figure a). step 2: locate the area to treat using your fingers and part your hair. (see figure b). step 3: squeeze a drop of calcipotriene and betamethasone dipropionate topical suspension to your fingertip. (see figure c). step 4: use your fingers to apply the drop of calcipotriene and betamethasone dipropionate topical suspension directly to scalp affected by plaque psoriasis. gently rub in. (see figure d). step 5: after applying calcipotriene and betamethasone dipropionate topical suspension, put the cap back on the bottle. step 6: wash your hands after applying calcipotriene and betamethasone dipropionate topical suspension. do not wash your hair right after you apply calcipotriene and betamethasone dipropionate topical suspension to your scalp. how should i store calcipotriene and betamethasone dipropionate topical suspension? keep calcipotriene and betamethasone dipropionate topical suspension and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured by padagis® , yeruham, israel rev 08-2023