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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: Daivonex should be applied to the affected skin lesions twice daily. For some patients, the maintenance therapy may be achieved with less frequent application. The weekly dose should not exceed 100 g.
Ointment: 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 100 g.
Cream: Daivonex should be applied to the affected skin lesions twice daily. For some patients, the maintenance therapy may be achieved with less frequent application. The weekly dose should not exceed 100 g.
Ointment: 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 100 g.
Overdosage
Excessive use (more than 100 g Daivonex weekly) may cause elevated serum calcium, which rapidly subsides when the treatment is discontinued.
Contraindications
Hypersensitivity to any constituents of Daivonex.
Known disorder of calcium metabolism.
Known disorder of calcium metabolism.
Special Precautions
Daivonex should not be used on the face since it may give rise to irritation of the facial skin. Careful handwashing after use is recommended.
Ointment: 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 Pregnancy: Although studies in experimental animals have not shown any teratogenic effect, the safety of Daivonex in human pregnancy has not been established.
Use in Children: Safety and efficacy in the treatment of children have not yet been established.
Ointment: 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 Pregnancy: Although studies in experimental animals have not shown any teratogenic effect, the safety of Daivonex in human pregnancy has not been established.
Use in Children: Safety and efficacy in the treatment of children have not yet been established.
Use In Pregnancy & Lactation
Use in Pregnancy: Although studies in experimental animals have not shown any teratogenic effect, the safety of Daivonex in human pregnancy has not been established.
Adverse Reactions
Minor adverse effects such as transient local irritation and, very rarely, facial dermatitis may occur.
Drug Interactions
Ointment: No interaction studies have been performed with Daivonex 50 mcg/g ointment.
Daivonex 50mcg/g ointment should not be used concurrently with calcium or vitamin D supplements, or drugs which enhance the systemic availability of calcium.
Daivonex 50mcg/g ointment should not be used concurrently with calcium or vitamin D supplements, or drugs which enhance the systemic availability of calcium.
Storage
Ointment: Do not store above 30°C.
Action
Pharmacology: Pharmacodynamics and Pharmacokinetics: 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.
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 90μg/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.
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 90μg/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.
MedsGo Class
Psoriasis, Seborrhea & Ichthyosis Preparations
Features
Dosage
50 mcg / g (0.005%)
Ingredients
- Calcipotriol
Packaging
Ointment 30g
Generic Name
Calcipotriol
Registration Number
DR-XY15290
Classification
Prescription Drug (RX)
Product Questions
Questions
