Calcipotriene + Betamethasone topical

Calcipotriene + Betamethasone topical is used for: Plaque Psoriasis

Plaque Psoriasis Topical suspension (scalp and body): Apply to affected area(s) qDay for up to 8 weeks; not to exceed 100 g/week Topical ointment: Apply topical layer of ointment to affected area(s) qDay for up to 4 weeks; not to exceed 100 g/week Topical foam: Apply topically to affected area(s) qDay for up to 4 weeks; not to exceed 60 g/4 days Discontinue application earlier if control achieved

Plaque Psoriasis Indicated for plaque psoriasis of the scalp and body <12 years: Safety and efficacy not established >12 years Topical suspension: Apply to affected area(s) qDay for up to 8 weeks; not to exceed 60 g/week Topical ointment: Apply topically to affected area(s) qDay for up to 4 weeks; not to exceed 60 g/week; Topical foam (scalp and body): Apply to affected area(s) qDay for up to 4 weeks; not to exceed 60 g/4 days Discontinue application earlier if control achieved

Do not apply to face, axillae, or groin, or if skin atrophy is present at treatment site Wash hands after application Topical ointment Rub ointment into skin gently and completely Do not treat >30% of body surface area Topical suspension Shake bottle prior to use Do not use with occlusive dressings unless directed by a physician Do not apply to scalp within 12 hr before or after any chemical treatment to the hair

Hypersensitivity Known or suspected disorders of calcium metabolism Erythrodermic, exfoliative, and/or pustular psoriasis

Hypercalcemia observed with use of calcipotriene Discontinue if irritation develops Do not apply to on face, axillae, or groin Do not apply to areas of pre-existing skin atrophy If concomitant skin infection present/develops, apply appropriate antifungal or antibacterial agent Use of topical corticosteroids may increase risk of posterior subcapsular cataracts and glaucoma; avoid contact with eyes; may cause eye irritation; instruct patients to report visual symptoms to physician Systemic absorption of topical corticosteroids Avoid application over large surface areas, prolonged use, and occlusive dressings that may increase risk for corticosteroid adverse effects Pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs and at greater risk of HPA axis suppression and adrenal insufficiency upon topical corticosteroid use Excessive systemic absorption may cause HPA axis suppression, Cushing syndrome, hyperglycemia, glucosuria

Pregnancy The limited data on use in pregnant women are not sufficient to evaluate 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; advise pregnant women that therapy may increase potential risk of having a low birth weight infant and to use product on smallest area of skin and for shortest duration possible; in animal reproduction studies Animal data Oral administration to pregnant rats during period of organogenesis resulted in an increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs; 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 period of organogenesis resulted in fetal toxicity, including fetal deaths, reduced fetal weight, and fetal malformations (cleft palate and crooked or short tail); available data do not allow calculation of relevant comparisons between systemic exposures of calcipotriene and betamethasone diproprionate observed in animal studies to systemic exposures that would be expected in humans after topical use of product Lactation There is no information regarding presence of topically administered calcipotriene and betamethasone dipropionate in human milk, effects on breastfed infant, or on milk production; not known whether topically administered calcipotriene or corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition; to minimize potential exposure to breastfed infant via breast milk, use drug on smallest area of skin and for shortest duration possible while breastfeeding; advise breastfeeding women not to apply drug directly to nipple and areola to avoid direct infant exposure

Side effects of Calcipotriene + Betamethasone topical : 1-10% Pruritus (7.2%) Worsening psoriasis (3.4%) Skin atrophy (1.9%) Folliculitis (1.4%) Burning sensation (1.4%) Skin depigmentation (1.4%) Ecchymosis (1%) Erythema (1%) Hand dermatitis (1%)

Calcipotriene: In vitro evidence suggests drug is roughly equipotent to natural vitamin D in its effects on proliferation & differentiation of various cell types Betamethasone: Corticosteroid; elicits anti-inflammatory, antipruritic, and vasoconstrictive properties