Daivonex

Daivonex

calcipotriol

Manufacturer:

LEO Pharma

Distributor:

DKSH
Full Prescribing Info
Contents
Calcipotriol.
Description
Daivonex ointment contains 50 μg/g (0.005% w/w) calcipotriol.
Action
Pharmacology: Daivonex is a topical formulation of the vitamin D derivative, calcipotriol, which induces differentiation and suppresses proliferation of skin cells (keratinocytes). Daivonex thus normalises abnormal cell proliferation and differentiation in psoriatic skin.
Toxicology: Preclinical Safety Data: The effect on the calcium metabolism is approximately 100 times less than that of the hormonally active form of vitamin D3.
A dermal carcinogenicity study in mice revealed no special hazard to humans.
In a study where albino hairless mice were repeatedly exposed to both ultraviolet (UV) radiation and dermally administered calcipotriol for 40 weeks at dose levels corresponding to 9, 30 and 90 μg/m2/day (equivalent to 0.25, 0.84, 2.5 times the maximum recommended daily dose for a 60 kg adult, respectively), a reduction in the time required for UV radiation to induce the formation of skin tumours was observed (statistically significant in males only), suggesting that calcipotriol may enhance the effect of UV radiation to induce skin tumours. The clinical relevance of this finding is unknown.
Indications/Uses
Psoriasis vulgaris.
Dosage/Direction for Use
Scalp Solution: Apply twice daily. Weekly dose should not exceed 60 mL. When used together with Daivonex ointment or cream, the total dose of calcipotriol should not exceed 5 mg/week corresponding to 100 g of Daivonex cream or ointment.
Cream/Ointment: Daivonex should be applied to the affected area twice daily. For some patients adequate maintenance therapy may be achieved with less frequent application. The weekly dose should not exceed 100 g.
Overdosage
Excessive use (more than 100 g Daivonex ointment weekly) may cause elevated serum calcium, which rapidly subsides when the treatment is discontinued.
Contraindications
Hypersensitivity to any of the constituents of Daivonex ointment.
Known disorder of calcium metabolism.
Special Precautions
Daivonex ointment should not be used in the face since the ointment formulation may give rise to irritation of the facial skin. Careful handwashing after use is recommended.
During Daivonex ointment treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. Topical calcipotriol should be used with UV radiation only if the physician and patient consider that the potential benefits outweigh the potential risks.
Use in children: Safety and efficacy in the treatment of children have not yet been established.
Use In Pregnancy & Lactation
Although studies in experimental animals have not shown any teratogenic effect, the safety of Daivonex in human pregnancy has not been established.
Side Effects
Minor adverse effects such as transient local irritation and, very rarely, facial dermatitis may occur.
Drug Interactions
Concurrent treatment with topical preparations containing salicylic acid should be avoided as salicylic acid may inactivate calcipotriol.
Caution For Usage
Incompatibilities: Daivonex ointment is a ready-for-use preparation and should therefore, not be mixed with other ingredients of preparations.
Storage
Do not store above 30°C.
ATC Classification
D05AX02 - calcipotriol ; Belongs to the class of other antipsoriatics for topical use.
Presentation/Packing
Scalp soln 50 mcg/mL x 30 mL. Oint (smooth, white, preservative-free) 50 mcg/g x 30 g.
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