Brand name: Daivonex
Active ingredient (generic name): Calcipotriol
Manufacturer: Leo Pharma
Importer: Behestan Behdasht
Pharmacotherapeutic group: Anti- psoriasis
Pharmaceutical form: 50mcg Ointment
Pharmacodynamic:
Calcipotriol is a non-steroidal antipsoriatic agent, derived from vitamin D. Calcipotriol exhibits a vitamin D-like effect by competing for the 1,25(OH)2D3 receptor. Calcipotriol is as potent as 1,25(OH)2D3, the naturally occurring active form of vitamin D, in regulating cell proliferation and cell differentiation, but much less active than 1,25(OH)2D3 in its effect on calcium metabolism. Calcipotriol induces differentiation and suppresses proliferation (without any evidence of a cytotoxic effect) of keratinocytes, thus reversing the abnormal keratinocyte changes in psoriasis. The therapeutic goal envisaged with calcipotriol is thus a normalization of epidermal growth.
Pharmacokinetic:
Data from a single study containing 5 evaluable patients with psoriasis treated with 0.3 - 1.7g of a 50 micrograms/g tritium labelled calcipotriol ointment suggested that less than 1% of the dose was absorbed. However, total recovery of the tritium label over a 96 hour period ranged from 6.7 to only 32.6%, figures maximised by uncorrected chemiluminescence. There were no data on 3H tissue distribution or excretion from the lungs.
Therapeutic indication:
Daivonex Ointment is indicated for the topical treatment of plaque psoriasis (psoriasis vulgaris) amenable to topical therapy.
Dosage and administration:
These dose recommendations are based on extensive experience in adults. In respect of children, clinical experience in children has shown Daivonex to be safe and effective over eight weeks at a mean dose of 15g per week but with wide variability in dose among patients. Individual dose requirement depends on the extent of psoriasis but should not exceed the above recommendations. There is no experience of use of Daivonex in combination with other therapies in children. |
Contraindications:
Daivonex is contra-indicated in patients with known disorders of calcium metabolism and patients with severe liver and kidney disease. As with other topical preparations, Daivonex is contra-indicated in patients with hypersensitivity to the active substance or any of the excipients.
Adverse reaction:
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Approximately 10% of the patients treated with Daivonex could experience an adverse reaction. These reactions are usually mild. |
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Very rare: |
allergic reactions (including angioedema). |
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Very rare: |
hypercalcaemia, hypercalciuria, especially if the total recommended dose is exceeded (see section 4.2). |
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Very common: |
skin irritation |
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Common: |
rash*, burning sensation, stinging sensation, dry skin, pruritus, erythema, contact dermatitis including facial and perioral. |
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Uncommon: |
psoriasis aggravated, eczema |
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Unknown frequency: |
transient changes in skin pigmentation, transient photosensitivity, urticaria, angioedema, periorbital or face oedema. |
*Various types of rash reactions such as scaly, erythematous, maculo-papular, pustular, bullous have been reported.
Pharmacokinetic interactions:
There is no experience of concomitant therapy with other antipsoriatic products applied to the same skin area at the same time.
Special warnings:
Daivonex should not be used on the face. Patients should be advised to wash their hands after applying the ointment and to avoid inadvertent transfer to other body areas, especially the face.
The risk of hypercalcaemia is minimal when the dosage recommendations are followed. Hypercalcaemia may occur if the maximum weekly dose is exceeded. Care should be exercised in patients with other types of psoriasis, since hypercalcaemia has been reported in patients with generalized pustular or erythrodermic exfoliative psoriasis. However, serum calcium is quickly normalized when treatment is discontinued.
During treatment with Daivonex 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 .
Pregnancy and lactation:
The safety of the use of calcipotriol during human pregnancy has not been established, and studies in animals have shown reproductive toxicity when calcipotriol was administered orally. Calcipotriol should not be used during pregnancy unless clearly necessary.
It is not known whether calcipotriol is excreted in breast milk. A decision on whether to abstain from breast-feeding or to abstain from therapy with Dovonex® should be made taking into account the benefit of breast-feeding to the newborn/infant and the benefit of Dovonex® therapy to the woman.
Storage temperature:
Do not store above 25°C.
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