Version May 2024
Plaque psoriasis: Topical:
Cream: Apply to affected area of skin once daily for up to 8 weeks (maximum dose: 100 g/week). Discontinue therapy when control is achieved.
Foam: Apply to affected area of skin once daily for up to 4 weeks (maximum dose: 60 g every 4 days). Discontinue therapy when control is achieved.
Gel [Canadian product]: Apply once daily to affected area(s) of body for up to 8 weeks or affected area(s) of scalp for up to 4 weeks. Maximum dose: 15 g/day and 100 g/week (including other calcipotriol-containing products). Application to >30% of body surface area (including scalp and body) is not recommended. Following discontinuation, therapy may be reinitiated for recurrence.
Ointment: Apply to affected area of skin once daily for up to 4 weeks (maximum dose: 100 g/week). Application to >30% of body surface area is not recommended. Discontinue therapy when control is achieved.
Suspension: Apply to affected area of skin or scalp once daily for up to 8 weeks (maximum dose: 100 g/week). Discontinue therapy when control is achieved.
There are no dosage adjustments provided in the manufacturer's labeling.
Gel [Canadian product]:
Mild or moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling.
Severe impairment: Use is contraindicated.
There are no dosage adjustments provided in the manufacturer's labeling.
Gel [Canadian product]:
Mild or moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling.
Severe impairment: Use is contraindicated.
Refer to adult dosing.
(For additional information see "Calcipotriol (calcipotriene) and betamethasone: Pediatric drug information")
Note: Use for shortest amount of time necessary and discontinue therapy once control achieved.
Plaque psoriasis:
Children ≥12 years and Adolescents:
Foam: Topical: Apply to affected area of skin once daily for up to 4 weeks; maximum dose: 60 g every 4 days.
Ointment: Topical: Apply to affected area of skin once daily for up to 4 weeks. Application to >30% of BSA is not recommended.
Maximum weekly dose:
Children ≥12 years and Adolescents ≤18 years: 60 g/week.
Adolescents ≥18 years: 100 g/week. Application to >30% of BSA is not recommended.
Suspension: Topical: Apply to affected area of skin or scalp once daily for up to 8 weeks.
Maximum weekly dose:
Children ≥12 years and Adolescents ≤18 years: 60 g/week.
Adolescents ≥18 years: 100 g/week.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also see individual agents.
>10%: Endocrine & metabolic: HPA-axis suppression (3% to 23%)
1% to 10%:
Dermatologic: Burning sensation of skin (1%), ecchymoses (1%), erythema of skin (≤2%), exfoliative dermatitis (1%), folliculitis (≤1%), hand dermatosis (1%), pruritus (4% to 7%), psoriasis (2% to 3%), skin atrophy (≤2%), skin depigmentation (≤1%), skin irritation (1%)
Local: Application site irritation (≤1%)
Nervous system: Headache (2%)
Respiratory: Upper respiratory tract infection (7%)
<1%:
Dermatologic: Acneiform eruption, acne vulgaris, exacerbation of psoriasis, hyperpigmentation, papular rash, psoriasis flare, pustular rash, skin rash, telangiectasia, urticaria
Endocrine & metabolic: Hypercalcemia
Genitourinary: Hypercalciuria
Local: Application site pain, application site pruritus
Ophthalmic: Eye irritation
Postmarketing: Dermatologic: Psoriasis (rebound), pustular psoriasis
There are no contraindications listed within the US manufacturer's labeling.
Canadian labeling: Hypersensitivity to calcipotriene, betamethasone, or any component of the formulation; viral (herpes simplex, varicella, vaccinia), fungal, or bacterial infection of the skin; parasitic infections; tuberculosis of the skin; syphilitic skin infections (gel, ointment only); ophthalmic use (gel, ointment only); calcium metabolism disorders; perioral dermatitis; atrophic skin; striae atrophicae; fragility of skin veins; ichthyosis; acne vulgaris; acne rosacea; rosacea; ulcers; wounds; eruptions following vaccinations (ointment only); perianal and genital pruritus (gel only); guttate, erythrodermic, exfoliative, and pustular psoriasis; severe hepatic disorders (gel only); severe renal insufficiency (gel only).
Concerns related to adverse effects:
• Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children, patients receiving high doses for prolonged period, use over large surface areas, under occlusion, or on altered skin barrier, and use in patients with hepatic failure. HPA axis suppression may lead to adrenal crisis and may occur during treatment or after withdrawal of treatment. If HPA axis suppression occurs, an attempt to withdraw the drug, reduce the application frequency, or substitute a less potent corticosteroid. HPA suppression is usually reversible; if glucocorticoid insufficiency occurs, supplemental systemic steroids may be needed.
• Contact dermatitis: Allergic contact dermatitis can occur; it is usually diagnosed by failure to heal rather than clinical exacerbation. Further evaluation (eg, patch testing) may be necessary.
• Hypercalcemia/hypercalciuria: Use with caution in patients with known or suspected disorders of calcium metabolism; may cause transient increases in serum and urinary calcium (reversible); if hypercalcemia or hypercalciuria occurs, discontinue treatment until levels return to normal. The effects on calcium metabolism following treatment durations of longer than 4 weeks (ointment), 8 weeks (suspension), or 56 weeks (foam) have not been evaluated.
• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).
• Local effects: Local adverse reactions may occur, including atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. These reactions are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids; some reactions may be irreversible.
• Ocular effects: Glaucoma and posterior subcapsular cataracts have been reported with topical corticosteroids; avoid contact with eyes and monitor for visual symptoms.
• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing's syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.
Disease related concerns:
• Diabetes mellitus: Hyperglycemia and unmasking of latent diabetes mellitus may result from systemic absorption of topical corticosteroids.
• Photosensitivity: Avoid excessive exposure of treated skin to natural or artificial sunlight (eg, tanning booths, sun lamps) and phototherapy.
• Skin infections: Use appropriate antibacterial or antifungal agents to treat concomitant skin infections; if infection persists, discontinue use of calcipotriene and betamethasone until infection has resolved.
Special populations:
• Pediatric: Children may be at higher risk of systemic side effects due to a greater skin surface area:body weight ratio. Children may absorb proportionally larger amounts of corticosteroids after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity and delay weight gain; growth should be routinely monitored in pediatric patients.
Dosage form specific issues:
• Flammable contents: Foam contains flammable propellants. Avoid fire, flame, and smoking during and immediately following administration.
Other warnings/precautions:
• Appropriate use: Do not use on the face, axillae, groin, or in the presence of preexisting skin atrophy at the treatment site. Not for oral, ophthalmic, or intravaginal use. Avoid exposure of suspension to the eyes; irritation may occur. Do not use occlusive dressings unless directed by a health care provider; discontinue use if irritation occurs.
The extent of percutaneous steroid absorption is dependent on several factors, including epidermal integrity (intact vs abraded skin), formulation, age of the patient, prolonged duration of use, and the use of occlusive dressings. Percutaneous absorption of topical steroids is increased in pediatric patients compared to adults, particularly in neonates (especially preterm neonates), infants, and young children. Younger pediatric patients (ie, infants and small children) may be more susceptible to hypothalamic pituitary adrenal axis suppression, intracranial hypertension, Cushing syndrome, or other systemic toxicities due to larger skin surface area to body mass ratio. After 4 weeks of treatment with topical calcipotriene/betamethasone suspension in patients 12 to 17 years, adrenal suppression was observed in 3% of patients with moderate scalp psoriasis and 16% of patients with scalp and body psoriasis. In a similar study of patients aged 12 to 17 years with plaque psoriasis, 4 weeks of ointment application (<55.8 g/week) was not associated adrenal suppression.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External:
Wynzora: Calcipotriene 0.005% and betamethasone dipropionate 0.064% (5 g, 60 g) [contains isopropyl alcohol, peg-40 hydrog castor oil(cremophor rh40), trolamine (triethanolamine)]
Foam, External:
Enstilar: Calcipotriene 0.005% and betamethasone dipropionate 0.064% (60 g)
Ointment, External:
Taclonex: Calcipotriene 0.005% and betamethasone dipropionate 0.064% (60 g [DSC], 100 g [DSC])
Generic: Calcipotriene 0.005% and betamethasone dipropionate 0.064% (60 g, 100 g)
Suspension, External:
Taclonex: Calcipotriene 0.005% and betamethasone dipropionate 0.064% (4 g [DSC], 60 g, 120 g)
Generic: Calcipotriene 0.005% and betamethasone dipropionate 0.064% (60 g, 120 g)
May be product dependent
Cream (Wynzora External)
0.005-0.064% (per gram): $25.12
Foam (Enstilar External)
0.005-0.064% (per gram): $26.55
Ointment (Calcipotriene-Betameth Diprop External)
0.005-0.064% (per gram): $7.69 - $13.70
Suspension (Calcipotriene-Betameth Diprop External)
0.005-0.064% (per gram): $10.02 - $20.93
Suspension (Taclonex External)
0.005-0.064% (per gram): $26.04
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Foam, External:
Enstilar: Calcipotriene 0.005% and betamethasone dipropionate 0.064% (60 g)
Gel, External:
Dovobet: Calcipotriene 0.005% and betamethasone dipropionate 0.05% (30 g, 60 g)
Generic: Calcipotriene 0.005% and betamethasone dipropionate 0.05% (60 g)
Ointment, External:
Dovobet: Calcipotriene 0.005% and betamethasone dipropionate 0.05% (30 g, 60 g, 120 g)
Generic: Calcipotriene 0.005% and betamethasone dipropionate 0.05% (30 g, 60 g, 120 g)
Topical: Wash hands before and after use. Do not apply to face, axillae, or groin or in the presence of preexisting skin atrophy at the treatment site; not for oral, ophthalmic, or intravaginal use. Avoid use of occlusive dressings over treated areas unless directed by a health care provider.
Cream/ointment: Rub into affected area gently and completely.
Foam: Shake before use. Rub into affected area gently.
Gel [Canadian product]: Shake bottle before use. If applying to the scalp, do not apply within 12 hours of chemical hair treatment. Do not shower/bathe or wash hair directly after use.
Suspension: Shake well before use. If applying to the scalp, do not apply 12 hours before or after chemical hair treatment. Do not bathe/shower or wash hair directly after use.
Topical: Topical use only; not for oral, ophthalmic, or intravaginal use. Wash hands before and after use. Do not apply to face, axillae, or groin or in the presence of preexisting skin atrophy at the treatment site. Avoid use of occlusive dressings over treated areas unless directed by a health care provider.
Foam: Shake before use. Rub into affected area gently. Keep away from flame or smoking during or immediately following application; propellants are flammable.
Ointment: Rub into affected area gently and completely. Avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.).
Suspension: Shake well before use. If applying to the scalp, do not apply within 12 hours of chemical hair treatment. Do not wash hair or take a bath or shower directly after use.
Plaque psoriasis:
Cream: Treatment of plaque psoriasis in adults.
Foam: Treatment of plaque psoriasis in patients ≥12 years of age.
Gel [Canadian product]: Treatment of mild to moderate plaque psoriasis of the body or moderate to severe psoriasis of the scalp in adults.
Ointment: Treatment of plaque psoriasis in patients ≥12 years of age.
Suspension: Treatment of plaque psoriasis of the scalp and body in patients ≥12 years of age.
KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Calcium Salts: May enhance the adverse/toxic effect of Vitamin D Analogs. Risk C: Monitor therapy
Cardiac Glycosides: Vitamin D Analogs may enhance the arrhythmogenic effect of Cardiac Glycosides. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Betamethasone (Topical). Risk C: Monitor therapy
Hydrocortisone (Topical): May diminish the therapeutic effect of Calcipotriene. Management: Monitor for reduced calcipotriene efficacy if combined with hydrocortisone valerate. Consider separating the administration of these agents by 10 to 12 hours to minimize the risk of this potential interaction. Risk C: Monitor therapy
Lactic Acid: May diminish the therapeutic effect of Calcipotriene. Management: Monitor for reduced calcipotriene efficacy if combined with lactic acid. Consider separating the administration of these agents by 10 to 12 hours to minimize the risk of this potential interaction. Risk C: Monitor therapy
Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Vitamin D Analogs. Risk X: Avoid combination
Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Vitamin D Analogs. Risk X: Avoid combination
Nirmatrelvir and Ritonavir: May increase the serum concentration of Corticosteroids (Topical). Risk C: Monitor therapy
Salicylic Acid: May diminish the therapeutic effect of Calcipotriene. Management: Monitor for reduced calcipotriene efficacy if combined with salicylic acid. Consider separating the administration of these agents by 10 to 12 hours to minimize the risk of this potential interaction. Risk C: Monitor therapy
Thiazide and Thiazide-Like Diuretics: May enhance the hypercalcemic effect of Vitamin D Analogs. Risk C: Monitor therapy
Vitamin D Analogs: May enhance the adverse/toxic effect of other Vitamin D Analogs. Risk X: Avoid combination
Topical agents are recommended for the treatment of psoriasis in pregnancy; however, this combination should only be used when clearly necessary (AAD-NPF [Elmets 2021]; Maul 2021; Simionescu 2021).
Refer to the Betamethasone (Topical) and Calcipotriene monographs for additional information.
It is not known if calcipotriene or betamethasone are present in breast milk following topical application.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Do not apply directly to the nipple or areola if breastfeeding.
Also refer to the Betamethasone (Topical) and Calcipotriene monographs for additional information.
Baseline serum calcium levels and then periodically during treatment in patients at risk for hypercalcemia
See individual agents.
See individual agents.
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