LEO Pharma


Full Prescribing Info
Daivonex ointment contains 50μg/g (0.005% w/w) calcipotriol.
Daivonex is a topical formulation of the vitamin D derivative, calcipotriol, which induces differentiation and suppresses proliferation of skin cell (keratinocytes). Daivonex thus normalises abnormal cell proliferation and differentiation in psoriatic skin.
Pharmacology: Pharmacokinetics: An open single dose trial was conducted on 6 psoriatic patients at doses of 1 gm of tritium labelled calcipotriol ointment applied without occlusions. Serum, urine and faeces were collected at different times between 72 - 96 hours after its application and concentrations of activity were measured by liquid scintillating counter.
Results showed that within 6 hours of administration, the level of radioactivity in serum was near the peak value equivalent to 52.6 pgm calcipotriol/ml serum. The maximum level of radioactivity observed was equivalent to calcipotriol concentration of the same order of magnitude as circulating levels of 1,25 dihydroxy vitamin D3 in man.
In urine, the radioactivity was detectable between 0-3 hours, maximal between 6-24 hours and maintained thereafter till 90 hours. Total urinary excretion of radioactivity over 72 hours was below 0-0.45%. Thus, maximally 1% of calcipotriol is absorbed systemically after single dose application to 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.
Psoriasis vulgaris.
Dosage/Direction for Use
Daivonex ointment 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 100g.
Excessive use (more than 100g Daivonex ointment weekly) may cause elevated serum calcium, which rapidly subsides when the treatment is discontinued.
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.
Do not store above 30°C.
ATC Classification
D05AX02 - calcipotriol ; Belongs to the class of other antipsoriatics for topical use.
Oint 50 mcg/g (off white to yellowish white translucent) x 30 g.
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