Trionex Drug Information

Indicated for the treatment of plaque psoriasis.

Apply a thin layer of calcipotriene cream to the affected skin 1-2 times daily and rub in gently and completely. The safety and efficacy of calcipotriene cream have been demonstrated in patients treated for eight weeks. Once calcipotriene has been completely rubbed in completely, apply transparent dressing to the affected area as needed as a protectant.

Clinical Trials Experience In controlled clinical trials, the most frequent adverse experiences reported for calcipotriene cream, 0.005% were cases of skin irritation, which occurred in approximately 10 to 15% of patients. Rash, pruritus, dermatitis and worsening of psoriasis were reported in 1 to 10% of patients. 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 cream have been identified post-approval: contact dermatitis, including allergic contact dermatitis.

If pregnant or breast feeding, ask a health professional before use.

Pediatric Use Safety and effectiveness of calcipotriene cream in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of systemic adverse effects when they are treated with topical medication.

Do not use if known hypersensitivity to any of the listed ingredients of any of the components included on the kit.

Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of topical calcipotriene. If elevation in serum calcium should occur, discontinue treatment until normal calcium levels are restored (see PRECAUTIONS ).