Calcipotriene

Trade Names:Donovex- Ointment 0.005%- Cream 0.005%- Solution 0.005%

Pharmacology

Calcipotriene, a synthetic vitamin D ₃ analog, regulates skin cell production and development.

Pharmacokinetics

Absorption

Approximately 6% of the topically applied dose is absorbed.

Less than 1% of applied dose is absorbed through the scalp.

Metabolism

Absorbed amount is rapidly converted to an inactive metabolite.

Indications and Usage

Treatment of plaque psoriasis in adults.

Topical treatment of chronic, moderately severe psoriasis of the scalp.

Contraindications

Acute psoriatic eruptions; patients with hypercalcemia or evidence of vitamin D toxicity; history of hypersensitivity to any component of the product. In addition, the cream and ointment should not be used on the face.

Dosage and Administration

Topical Apply thin layer once or twice daily.

Topical Apply twice daily, only to scalp lesions.

General Advice

• For topical use only. Not for ophthalmic, oral, or intravaginal use.
• Do not apply ointment, cream, or scalp solution to face.
• Avoid contact with the eyes or mucus membranes. If medication does come into contact with the eyes, wash them with large amounts of cool water. Notify health care provider if eye irritation occurs.
• Apply ointment or cream 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.
• Scalp solution is flammable. Keep away from open flame.
• Do not cover with occlusive dressing unless ordered by health care provider.

Storage/Stability

Store ointment, cream, and scalp solution at controlled room temperature (59° to 77°F). Protect from freezing. Protect scalp solution from exposure to sunlight.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Dermatologic

Skin irritation (10% to 15%); dermatitis, pruritus, rash, worsening of psoriasis (1% to 10%).

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%).

Transient burning, stinging, and tingling (23%); rash (11%); dry skin, irritation and worsening of psoriasis (1% to 5%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

May experience more severe skin-related adverse reactions when using ointment.

Hypercalcemia

Can develop during therapy. If hypercalcemia occurs, discontinue treatment until normal calcium levels are restored.

Overdosage

Symptoms

Elevated serum calcium.

Patient Information

• Advise patient to review the patient information leaflet carefully before starting therapy and to read and check for new information each time the medication is refilled.
• Caution patient not to apply in greater quantity or more frequently than prescribed by health care provider or for longer than 8 wk.
• Teach patient or caregiver proper technique for applying ointment and cream: wash hands; apply sufficient ointment or cream to cover affected area(s) sparingly then gently massage into skin; wash hands after applying ointment.
• Teach patient or caregiver proper technique for applying scalp solution: wash hands; comb hair to remove scaly debris, part hair, apply a small amount of scalp solution only on lesions, and rub in gently and completely; wash hands after applying scalp solution.
• Caution patient to avoid application of scalp solution to uninvolved scalp lesions.
• Warn patient that scalp solution is flammable and to keep away from open flame.
• Advise patient that if an application is missed, to apply it as soon as remembered and then to continue on regular schedule. If it is almost time for the next application, instruct patient to skip the application and continue on regular schedule. Caution patient not to apply double doses.
• Caution patient not to apply ointment, cream, or scalp solution to face.
• Caution patient not to bandage, cover, or wrap treated skin areas or use cosmetics or other skin products over treated areas unless advised by health care provider.
• Caution patient to avoid contact with the eyes. Advise patient that if medication does come 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.