Calcipotriene + Betamethasone topical

Calcipotriene + Betamethasone topical is used for: Plaque Psoriasis

Plaque Psoriasis Topical suspension (scalp and body): Apply to affected area(s) once daily for up to 8 weeks; not to exceed 100 g/week Topical ointment: Apply topical layer of ointment to affected area(s) once daily for up to 4 weeks; not to exceed 100 g/week Topical foam: Apply topically to affected area(s) once daily for up to 4 weeks; not to exceed 60 g/4 days Discontinue application earlier if control is is 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) once daily for up to 8 weeks; not to exceed 60 g/week Topical ointment: Apply topically to affected area(s) once daily for up to 4 weeks; not to exceed 60 g/week; Topical foam (scalp and body): Apply to the affected area(s) once daily for up to 4 weeks; not to exceed 60 g/4 days Discontinue application earlier if control is 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 and hypercalciuria have been reported. If it occurs, discontinue treatment until parameters of calcium metabolism normalize Topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome and unmask latent diabetes Systemic absorption may require evaluation for HPA axis suppression Modify use should HPA axis suppression develop Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation and allergic contact dermatitis and may be more likely with occlusive use or more potent corticosteroids Children may be more susceptible to systemic toxicity when treated with topical corticosteroids

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 : >10% Topical cream, adults Headache (20%) Nausea (13%) Topical cream, 7 years and older Enuresis (18%) Nausea (17%) Headache (16%) Vomiting (16%) Weight decreased (12%) Decreased appetite (8%) Dizziness (6%) 1-10% Topical cream Dizziness (10%) Decreased appetite (8%) Parasomnia (6%) Diarrhea (6%) Hyperhidrosis (6%) Anxiety (5%) Vomiting (5%) Fatigue (4%) Dry mouth (4%) Depressed mood (4%) Enuresis (4%) Irritability (3%) Paresthesia (3%) Depression (3%) Tremor (3%) Somnolence (2%) Muscle spasms (2%) Topical suspension Folliculitis (1%) Burning (1%) Topical ointment H4 Pruritus (7.2%) Psoriasis (3.4%) Pruritus (2.8%) Skin atrophy (1.9%) Folliculitis (1.4%) Burning sensation (1.4%) Skin depigmentation (1.4%) Rash scaly (1.2%) Ecchymosis (1%) Erythema (1%) Hand dermatitis (1%) <1% Topical foam, adults Application site irritation (<1%) Application site pruritus (<1%) Folliculitis (<1%) Skin hypopigmentation (<1%) Hypercalcemia (<1%) Urticaria (<1%) Exacerbation of psoriasis (<1%) Topical foam, 12-17 years H4 Acne, erythema, application site pain, and skin reactions (<1%) Topical ointment Application site pruritus (0.5%) Erythema (0.4%) Skin irritation (0.4%) Burning sensation (0.2%) Skin atrophy, telangiectasia and skin hyperpigmentation (0.1%)

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