Medicinal Products

DAIVONEX 50 μg / g

Generic drug of the therapeutic class: Dermatology
active ingredients: Calcipotriol
laboratory: Leo

Cream
120 g tube
All forms

Indication

Topical treatment of plaque psoriasis (psoriasis vulgaris) affecting up to 40% of body surface area.

Dosage DAIVONEX 50 μg / g Cream Tube of 120 g

- An application morning and evening at the level of lesions. In maintenance treatment and depending on the results, the frequency of applications can be reduced to once a day.
- The maximum dose to apply is 100 g of cream per week.
- If concomitant use of DAIVONEX ointment, this maximum dose of 100 g per week should take into account the amount of ointment used.
- Calcipotriol cream can be usefully combined with local corticosteroids, and in larger forms of psoriasis, with phototherapy, ciclosporin or acitretin, respecting the maximum dose of 100 g of cream per week and, in applying on a body surface less than 40%.
- In case of association with the local corticosteroids, one of the treatments will be applied in the morning, the other in the evening.
- In children, clinical efficacy and safety data are very limited. In clinical studies, DAIVONEX was only used in 79 children aged 6 to 12 years and 19 children over 12 years of age for 6 to 8 weeks. The average dose per week (approximately 15 grams) was often lower than the maximum allowable dose in clinical studies (50 grams for ages 6 to 12 years and 75 grams for ages 12 to 16 years). Under these conditions, the treatment was well tolerated.
- The possible impact on bone growth of prolonged treatment with topical calcipotriol is not known.

Against indications

CONTRAINDICATED:
- History of allergy to calcipotriol or any of the excipients.
- Hypercalcemia whatever its origin.
- The cream should not be applied on the face.
NOT RECOMMENDED :
- In the absence of clinical data, the use of calcipotriol in other forms of psoriasis is not recommended (pustular psoriasis, gout, erythrodermic).
- Breast-feeding: The passage of calcipotriol into breast milk is not known.

Daivonex side effects

- irritation at the application site may occur after application; it is usually reversible upon discontinuation of treatment.
- Facial or peri-oral dermatitis can be observed: it is rare if the application conditions of the cream are respected (see warnings).
- At the usual doses of calcipotriol (up to 100 g of cream per week), no change in calcemia was observed. However, for high doses hypercalcemia, generally moderate, may occur. It is reversible in a few days when the treatment is stopped.

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