Class: Antipsoriatic agent
- Ointment, topical 0.005%
- Cream, topical 0.005%
- Solution, topical 0.005%
- Foam, topical 0.005%
Calcipotriene, a synthetic vitamin D 3 analog, regulates skin cell production and development.
Plasma concentrations were below the limit of quantitation (10 pg/mL).Ointment
Approximately 6% of the topically applied dose is absorbed.Solution
Less than 1% of applied dose is absorbed through the scalp.
Vitamin D and its metabolites are transported in the blood, bound to specific plasma proteins.
Absorbed amount is rapidly converted to inactive metabolites within 24 h of application.
The active form of the vitamin, 1,25-dihydroxy-vitamin D 3 (calcitriol), is known to be recycled via the liver and excreted in the bile.
Indications and UsageCream, foam, ointment
Treatment of plaque psoriasis in adults (18 y and older).Solution
Topical treatment of chronic, moderately severe psoriasis of the scalp.
Acute psoriatic eruptions (scalp solution); hypersensitivity to any component of the product; patients with hypercalcemia or evidence of vitamin D toxicity; use on the face (cream/ointment).
Dosage and AdministrationAdults
Topical Apply a thin layer to affected skin twice daily.Ointment
Topical Apply a thin layer once or twice daily.Scalp solution
Topical Apply twice daily only to scalp lesions.
- For topical use only. Not for ophthalmic, oral, or intravaginal use.
- Wash hands thoroughly after use, unless treatment area involves the hands.
- Do not apply ointment, cream, or solution to face.
- Avoid contact with the eyes or mucus membranes. If medication comes into contact with the eyes, wash them with large amounts of cool water.
- Apply cream, foam, or ointment sparingly, but in sufficient quantity to cover affected area(s), and rub in gently.
- To treat scalp lesions, comb hair to remove scaly debris, part the hair, apply a small amount of scalp solution only on lesions, and rub in gently and completely. Avoid application of scalp solution to uninvolved scalp lesions and take care to prevent the solution from spreading onto the forehead.
- Foam and scalp solution are flammable. Keep away from open flame. Foam contents are under pressure; do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F.
Store between 59° and 77°F. Protect from freezing. Do not place foam in refrigerator. Protect scalp solution from exposure to sunlight.
None well documented.
Skin irritation (10% to 15%); dermatitis, pruritus, rash, worsening of psoriasis (1% to 10%).Foam
Erythema (more than 1%).Ointment
Burning, itching, skin irritation (10% to 15%); dermatitis, dry skin, erythema, peeling, rash, worsening of psoriasis including development of facial/scalp psoriasis (1% to 10%).Solution
Transient burning, stinging, and tingling (23%); rash (11%); dry skin, irritation and worsening of psoriasis (1% to 5%).
Monitor serum calcium during treatment of large surface areas or during prolonged therapy. Assess skin and scalp condition before initial application and periodically throughout treatment.
Category C .
Safety and efficacy not established.
May experience more severe skin-related adverse reactions when using ointment.
Can develop during therapy. If hypercalcemia occurs, discontinue treatment until normal calcium levels are restored.
Elevated serum calcium.
- Caution patient not to apply in greater quantity or more frequently than prescribed by health care provider.
- Caution patient to avoid application of scalp solution to uninvolved scalp lesions.
- Warn patient that foam and scalp solution are flammable and to keep away from open flame.
- Caution patient not to apply ointment, cream, or scalp solution to face.
- Caution patient to avoid contact with the eyes. Advise patient that if medication comes into contact with the eyes to wash them with large amounts of cool water and to contact health care provider if eye irritation occurs.
- Caution patient to avoid exposing treatment areas to excessive natural or artificial sunlight (eg, tanning booths, sunlamps).
- Advise patient that symptoms should begin to improve within 2 wk after starting treatment and to notify health care provider if condition does not improve, worsens, or if application-site reactions (eg, burning, stinging, redness, itching) develop.
Copyright © 2009 Wolters Kluwer Health.
More about calcipotriene topical
- Calcipotriene (AHFS Monograph)
- Calcipotriene (FDA)
- Calcipotriene Cream (FDA)
- Calcipotriene Ointment (FDA)