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Calcipotriene and Betamethasone

Pronunciation

(kal si POE try een & bay ta METH a sone)

Index Terms

  • Betamethasone Dipropionate and Calcipotriene Hydrate
  • Calcipotriene/Betamethasone
  • Calcipotriol and Betamethasone Dipropionate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Foam, topical:

Enstilar: Calcipotriene 0.005% and betamethasone dipropionate 0.064% (60 g)

Ointment, topical:

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, topical:

Taclonex: Calcipotriene 0.005% and betamethasone dipropionate 0.064% (60 g, 120 g) [contains castor oil]

Brand Names: U.S.

  • Enstilar
  • Taclonex

Pharmacologic Category

  • Corticosteroid, Topical
  • Vitamin D Analog

Pharmacology

See individual agents.

Use: Labeled Indications

Plaque psoriasis:

Foam: Treatment of plaque psoriasis in patients 18 years and older.

Gel [Canadian product]: Treatment of mild to moderate plaque psoriasis of the body or moderate to severe psoriasis of the scalp in patients 18 years and older.

Ointment: Treatment of plaque psoriasis in patients 12 years and older.

Suspension: Treatment of plaque psoriasis of the scalp (patients 12 years and older) and body (adults).

Contraindications

There are no contraindications listed within the manufacturer's labeling.

Canadian labeling: Additional contraindications (not in U.S. 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, exfoliative and pustular psoriasis; severe hepatic disorders (gel only); severe renal insufficiency (gel only).

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: Pediatric

Plaque psoriasis: Children ≥12 years and Adolescents: Topical:

Ointment: Apply to affected area of skin once daily for up to 4 weeks (maximum dose: 60 g/week). Application to >30% of body surface area is not recommended.

Suspension: Apply to affected area of the scalp once daily for up to 8 weeks (maximum dose: 60 g/week).

Dosing: Renal Impairment

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

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.

Administration

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 within 12 hours of chemical hair treatment. Do not wash hair directly after use.

Storage

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.

Drug Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. 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. Avoid combination

Calcium Salts: May enhance the adverse/toxic effect of Vitamin D Analogs. Monitor therapy

Cardiac Glycosides: Vitamin D Analogs may enhance the arrhythmogenic effect of Cardiac Glycosides. Monitor therapy

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. 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. 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. 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. Consider therapy modification

Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Vitamin D Analogs. Avoid combination

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Vitamin D Analogs. Avoid combination

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. Avoid combination

Thiazide and Thiazide-Like Diuretics: May enhance the hypercalcemic effect of Vitamin D Analogs. Monitor therapy

Vitamin D Analogs: May enhance the adverse/toxic effect of other Vitamin D Analogs. Avoid combination

Test Interactions

See individual agents.

Adverse Reactions

Also see individual agents.

1% to 10%: Dermatologic: Pruritus (4% to 7%), psoriasis (2% to 3%), erythema (1% to 2%), skin atrophy (≤2%), burning sensation of skin (1%), ecchymoses (1%), exfoliative dermatitis (1%), hand dermatosis (1%), skin depigmentation (1%), skin irritation (1%), folliculitis (≤1%)

<1% (Limited to important or life-threatening): Acneiform eruption, application site irritation, application site pruritus, contact dermatitis, exacerbation of psoriasis, eye irritation, facial edema, HPA-axis suppression, hypercalcemia, hypercalciuria, hyperpigmentation, hypopigmentation, otitis externa, papular rash, psoriasis flare, psoriasis (rebound), pustular psoriasis, pustular rash, skin pain, skin rash, telangiectasia, urticaria, xeroderma

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypercorticism 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.

• 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.

Monitoring Parameters

Baseline serum calcium levels and then periodically during treatment in patients at risk for hypercalcemia

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted with this topical combination. See individual agents.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience itching, burning, or redness. Have patient report immediately to prescriber signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), signs of high calcium (weakness, confusion, feeling tired, headache, nausea and vomiting, constipation, or bone pain), signs of skin changes (pimples, stretch marks, slow healing, or hair growth), severe skin irritation, skin discoloration, thinning of skin, weight gain, constipation, muscle weakness, or muscle pain (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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