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CALCIPOTRIENE

Brand and Other Names: Dovonex, Sorilux
Mechanism of Action:
Indications:

Calcipotriene ointment, 0.005%, is indicated for the treatment of plaque psoriasis in adults. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.

Route: TOPICAL
Dose:

Apply a thin layer of calcipotriene ointment once or twice daily and rub in gently and completely.

Adverse Reactions:

Clinical Trials Experience
In controlled clinical trials, the most frequent adverse experiences reported for calcipotriene were burning, itching and skin irritation, which occurred in approximately 10 to 15% of patients. Erythema, dry skin, peeling, rash, dermatitis, worsening of psoriasis including development of facial/scalp psoriasis were reported in 1 to 10% of patients. Other experiences reported in less than 1% of patients included skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis. Once daily dosing has not been shown to be superior in safety to twice daily dosing.

Postmarketing Experience
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions associated with the use of calcipotriene ointment have been identified post-approval: contact dermatitis, including allergic contact dermatitis.

Contraindication:

Calcipotriene is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity. Calcipotriene should not be used on the face.

Warnings and Precautions:
  • Contact dermatitis, including allergic contact dermatitis, has been observed with the use of calcipotriene.
  • Use of calcipotriene may cause irritation of lesions and surrounding uninvolved skin. If irritation develops, calcipotriene should be discontinued.
  • For external use only.
  • Keep out of the reach of children.
  • Always wash hands thoroughly after use.
  • Transient, rapidly reversible elevation of serum calcium has occurred with use of calcipotriene. If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored.
See package insert for full prescribing information.