Embedded Files
Pharmacologic Category
Corticosteroid, Topical; Vitamin D Analog
Dosing: Adult
Plaque psoriasis: Topical:
Foam: Apply to affected area of skin once daily for up to 4 weeks (maximum dose: 60 g every 4 days).
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: 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.
Suspension: Apply to affected area of skin or scalp once daily for up to 8 weeks (maximum dose: 100 g/week)
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment: Adult
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.
Dosing: Hepatic Impairment: Adult
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.
Dosing: Pediatric
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.
Dosing: Renal Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling.
Dosing: Hepatic Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling.
Use: Labeled Indications
Plaque psoriasis:
Foam: Treatment of plaque psoriasis in children ≥12 years of age, adolescents, and adults
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 children ≥12 years of age, adolescents, and adults
Suspension: Treatment of plaque psoriasis of the scalp and body in children ≥12 years of age, adolescents, and adults
Administration: 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.
Foam: Shake before use. Rub into affected area gently.
Gel [Canadian product]: Shake bottle before use. If using applicator, assemble per manufacturer instructions (refer to labeling) and then prime before initial use. After priming, the applicator delivers the product in 0.05 g actuations. 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.
Ointment: Rub into affected area gently and completely.
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.
Administration: Pediatric
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.
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.
Storage/Stability
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Do not refrigerate suspension, and discard 6 months from date opened. Keep suspension bottle in outer carton when not in use.
Foam: Contents under pressure. Avoid heat, flame, or smoking during use. Do not puncture or incinerate container. Do not expose to heat or store at temperatures >49°C (120°F); do not freeze. Use within 6 months after opening.
Gel [Canadian product]: Store at 15°C to 30°C (59°F to 86°F). Do not refrigerate. Protect bottle from light. Use within 6 months after opening bottle or assembling applicator, or before expiration date.
Medication Patient Education with HCAHPS Considerations
What is this drug used for?
• It is used to treat plaque psoriasis.
• It may be given to you for other reasons. Talk with the doctor.
Frequently reported side effects of this drug
• Itching
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
• High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit
• High calcium like weakness, confusion, fatigue, headache, nausea and vomiting, constipation, or bone pain
• Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss
• Cushing syndrome like weight gain in upper back or abdomen; moon face; severe headache; or slow healing
• Skin changes like acne, stretch marks, slow healing, or hair growth
• Severe skin irritation
• Skin breakdown at application site
• Skin discoloration
• Vision changes
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Contraindications
There are no contraindications listed within the manufacturer's labeling.
Canadian labeling: Additional contraindications (not in US 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; ophthalmic use; calcium metabolism disorders; perioral dermatitis; atrophic skin; striae atrophicae; fragility of skin veins; ichthyosis; acne vulgaris; acne rosacea; rosacea; ulcers; wounds; perianal and genital pruritus; guttate, erythrodermic and pustular psoriasis; severe hepatic disorders (gel only); severe renal insufficiency (gel only).
Warnings/Precautions
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 (foam, ointment) or 8 weeks (suspension) 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.
Warnings: Additional Pediatric Considerations
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.
Pregnancy Considerations
The treatment of psoriasis in pregnancy is initiated with conservative treatment as in nonpregnant females. When a topical steroid is needed, low to moderate potency corticosteroids are preferred initially, followed by moderate to high potency agents. High potency topical steroids should be used only when clearly needed and after the first trimester (Bae 2012). Information related to the use of calcipotriene in pregnancy has not been located (Bae 2012; Bangsgaard 2015); until additional information is available, some sources do not recommend use in pregnant females with psoriasis (Bae 2012), while others recommend limiting exposure to ≤50 g/week for ≤3 to 4 weeks) (Rademaker 2018).
Also refer to the Betamethasone (Topical) monograph for additional information.
Breast-Feeding Considerations
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) monograph for additional information.
Briggs' Drugs in Pregnancy & Lactation
Adverse Reactions
Also see individual agents.
>10%: Endocrine & metabolic: HPA-axis suppression (≤18%)
1% to 10%: Dermatologic: Pruritus (4% to 7%), psoriasis (2% to 3%), erythema of skin (≤2%), skin atrophy (≤2%), burning sensation of skin (1%), ecchymoses (1%), exfoliative dermatitis (1%), hand dermatosis (1%), skin irritation (1%), folliculitis (≤1%), skin depigmentation (≤1%)
<1%, postmarketing, and/or case reports: Acneiform eruption, acne vulgaris, application site irritation, application site pain, application site pruritus, exacerbation of psoriasis, eye irritation, hypercalcemia, hypercalciuria, hyperpigmentation, papular rash, psoriasis flare, psoriasis (rebound), pustular psoriasis, pustular rash, skin rash, telangiectasia, urticaria, xeroderma
Allergy and Idiosyncratic Reactions
Toxicology
Metabolism/Transport Effects
None known.
Drug Interactions Open Interactions
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Risk X: Avoid combination
Aluminum Hydroxide: Vitamin D Analogs may increase the serum concentration of Aluminum Hydroxide. Specifically, the absorption of aluminum may be increased, leading to increased serum aluminum concentrations. Risk X: Avoid combination
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
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor therapy
Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy
Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Risk D: Consider therapy modification
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
Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. 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
Sucralfate: Vitamin D Analogs may increase the serum concentration of Sucralfate. Specifically, the absorption of aluminum from sucralfate may be increased, leading to an increase in the serum aluminum concentration. Risk X: Avoid combination
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
Test Interactions
See individual agents.
Monitoring Parameters
Baseline serum calcium levels and then periodically during treatment in patients at risk for hypercalcemia
Advanced Practitioners Physical Assessment/Monitoring
Obtain baseline serum calcium periodically in patients at risk for hypercalcemia. When applied to large areas of skin or for extensive periods of time, assess for adverse skin or systemic reactions.
Nursing Physical Assessment/Monitoring
Check ordered labs and report abnormalities. When applied to large areas of skin or for extensive periods of time, monitor for adverse skin or systemic reactions.
Dosage Forms: US
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)
Ointment, External:
Taclonex: Calcipotriene 0.005% and betamethasone dipropionate 0.064% (60 g, 100 g)
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, 60 g, 120 g)
Generic: Calcipotriene 0.005% and betamethasone dipropionate 0.064% (60 g)
Dosage Forms: Canada
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)
Ointment, External:
Dovobet: Calcipotriene 0.005% and betamethasone dipropionate 0.05% (30 g, 60 g, 120 g)
Anatomic Therapeutic Chemical (ATC) Classification
- D05AX52
Generic Available (US)
May be product dependent
Pricing: US
Foam (Enstilar External)
0.005-0.064% (per gram): $22.27
Ointment (Calcipotriene-Betameth Diprop External)
0.005-0.064% (per gram): $13.15 - $13.70
Ointment (Taclonex External)
0.005-0.064% (per gram): $21.78
Suspension (Calcipotriene-Betameth Diprop External)
0.005-0.064% (per gram): $20.93
Suspension (Taclonex External)
0.005-0.064% (per gram): $22.27
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.
Mechanism of Action
See individual agents.
Pharmacodynamics/Kinetics
See individual agents.
Local Anesthetic/Vasoconstrictor Precautions
No information available to require special precautions
Effects on Dental Treatment
No significant effects or complications reported
Effects on Bleeding
No information available to require special precautions
Related Information
Index Terms
Betamethasone Dipropionate and Calcipotriene Hydrate; Calcipotriene/Betamethasone; Calcipotriol and Betamethasone Dipropionate
FDA Approval Date
January 09, 2006
References
Bae YS, Van Voorhees AS, Hsu S, et al.; National Psoriasis Foundation. Review of treatment options for psoriasis in pregnant or lactating women: from the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol. 2012;67(3):459-477. doi: 10.1016/j.jaad.2011.07.039.[PubMed 22018758]
Bangsgaard N, Rørbye C, Skov L. Treating Psoriasis During Pregnancy: Safety and Efficacy of Treatments. Am J Clin Dermatol. 2015;16(5):389-398. doi: 10.1007/s40257-015-0137-5.[PubMed 26149091]
Dovobet (calcipotriene/betamethasone dipropionate) gel [product monograph]. Thornhill, Ontario, Canada: LEO Pharma Inc; March 2016.
Dovobet (calcipotriene/betamethasone dipropionate) ointment [product monograph]. Thornhill, Ontario, Canada: LEO Pharma Inc; April 2016.
Enstilar (calcipotriene/betamethasone dipropionate) ointment [prescribing information]. Madison, NJ: Leo Pharma Inc; July 2019.
Enstilar (calcipotriene/betamethasone dipropionate) ointment [product monograph]. Thornhill, Ontario, Canada: LEO Pharma Inc; September 2016.
Enstilar (calcipotriene/betamethasone dipropionate) aerosol foam [product monograph]. Thornhill, Ontario, Canada: LEO Pharma Inc; January 2020.
Goedert JJ, Vitale F, Lauria C, et al, “Risk Factors for Classical Kaposi's Sarcoma,” J Natl Cancer Inst, 2002, 94(22):1712-8.[PubMed 12441327]
Rademaker M, Agnew K, Andrews M, et al. Psoriasis in those planning a family, pregnant or breast-feeding. The Australasian Psoriasis Collaboration. Australas J Dermatol. 2018;59(2):86-100. doi: 10.1111/ajd.12641.[PubMed 28543445]
Taclonex (calcipotriene and betamethasone dipropionate) ointment [prescribing information]. Madison, NJ: Leo Pharma Inc; December 2018.
Taclonex (calcipotriene and betamethasone dipropionate) suspension [prescribing information]. Madison, NJ: Leo Pharma Inc; July 2019.
Brand Names: International
Daivobet (AE, AU, BG, BH, BR, CH, CL, CN, CO, CZ, DE, DK, EC, EE, EG, ES, FI, FR, HK, HU, ID, IL, IS, JO, KR, KW, LB, LT, LV, MT, MX, MY, NO, NZ, PH, PK, PL, PT, QA, RO, SA, SE, SG, SI, SK, TH, TW, VN); Dovobet (BE, GB, GR, IE, IT, JP, NL); Dyvon Plus (BD, LK); Enstilar (IE); Xamiol (AT, BE, BG, CH, CN, CY, CZ, DE, DK, EE, EG, ES, FI, FR, GR, HK, IL, IT, JO, KR, LB, LT, LU, LV, MT, MY, NL, PH, PL, PT, QA, SE, SG, SI, SK, TH, TW, VN)
Last Updated 3/14/20
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