Canada - English - Health Canada

leo pharma inc - calcipotriol (calcipotriol monohydrate); betamethasone (betamethasone dipropionate) - gel - 50mcg; 0.5mg - calcipotriol (calcipotriol monohydrate) 50mcg; betamethasone (betamethasone dipropionate) 0.5mg - anti-inflammatory agents

Australia - English - Department of Health (Therapeutic Goods Administration)

leo pharma pty ltd - calcipotriol -

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - calcipotriol monohydrate, betamethasone dipropionate - ointment - calcipotriol monohydrate 50 microgram(s)/gram ; betamethasone dipropionate 0.5 milligram(s) - antipsoriatics

United States - English - 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

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

prasco laboratories - calcipotriene monohydrate (unii: s7499tyy6g) (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 betamethasone 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

United States - English - 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

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

northstar rx llc - calcipotriene (unii: 143nq3779b) (calcipotriene - unii:143nq3779b) - 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 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 should not be used on the face.

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

novel laboratories, inc. - calcipotriene (unii: 143nq3779b) (calcipotriene - unii:143nq3779b) - 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.

United States - English - 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

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

ayurax - 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 betwee