Calcipotriene / Betamethasone Dipropionate

Pronunciation: kal-sih-POE-try-een/BAY-tah-METH-uh-zone die-PRO-pee-oh-NATE
Class: Antipsoriatic combination

Trade Names

Taclonex
- Ointment 0.005% calcipotriene and 0.064% betamethasone dipropionate

Pharmacology

Calcipotriene, a synthetic vitamin D 3 analog, regulates skin cell production and development. Betamethasone has anti-inflammatory, antipruritic, and vasoconstrictive actions.

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Indications and Usage

Treatment of psoriasis vulgaris in adults.

Contraindications

Patients with known or suspected disorders of calcium metabolism; erythrodermic, exfoliative, and pustular psoriasis; history of hypersensitivity to any component of the product.

Dosage and Administration

Adults

Topical Apply once daily for up to 4 wk. (Max weekly dose, 100 g).

General Advice

  • For topical use only. Not for ophthalmic, oral, or intravaginal use.
  • Do not apply to face, groin, or axillae. Do not treat more than 30% of body surface area.
  • Apply medication sparingly, but in sufficient quantity to cover affected area(s), and rub in gently.
  • Do not cover with occlusive dressing unless ordered by health care provider.
  • Avoid contact with eyes. If medication comes into contact with eyes, wash them with large amounts of cool water. Notify health care provider if eye irritation occurs.

Storage/Stability

Store ointment at controlled room temperature (59° to 86°F). Keep tube tightly closed.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache (3%).

Dermatologic

Pruritus (3%); psoriasis, scaly rash (1%).

EENT

Nasopharyngitis (2%).

Precautions

Monitor

Monitor serum calcium during treatment of large surface area with ointment. Assess and document skin condition before initial application and periodically throughout treatment. Inform health care provider if condition does not improve, worsens, or if application site reactions develop. Periodically evaluate patient applying medication to a large surface area, or to areas under occlusion, for evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (eg, adrenocorticotropic hormone [ACTH] stimulation, A.M. plasma cortisol, urinary free cortisol tests). If HPA axis suppression is noted, ensure attempts are made to discontinue the drug, reduce frequency of application, or substitute a less potent corticosteroid. Be prepared to supplement with systemic corticosteroids if symptoms of glucocorticosteroid insufficiency occur.


Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Concomitant skin infection

Ensure that appropriate antifungal or antibacterial therapy is used in patient who has a concomitant skin infection.

Hypercalcemia

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

Systemic effects

Systemic absorption of topical corticosteroids may produce reversible HPA axis suppression, manifestations of Cushing syndrome, hyperglycemia, and glucosuria. Prolonged application or application to a large surface areas or areas under occlusion increase risk of systemic effects.

Skin atrophy

Do not apply to treatment sites with pre-existing skin atrophy.

Overdosage

Symptoms

Chronic overdosage may produce reversible HPA axis suppression and manifestations of Cushing syndrome, glucosuria, hypercalcemia, hyperglycemia.

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.
  • Advise patient to apply medication once daily to affected areas.
  • Caution patient not to apply in greater quantity or more frequently than prescribed by health care provider or for longer than 4 wk.
  • Teach patient or caregiver proper technique for applying ointment: wash hands; apply sufficient ointment to cover affected area(s) sparingly then gently massage into skin; wash hands after applying ointment.
  • Advise patient that if an application is missed, to apply it as soon as remembered and then 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 to face, underarms, or groin area.
  • 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 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 fairly soon 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.

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