Health Boards
Sun-18-09-2011, 19:58 PM
Dovonex Ointment
Form & Composition:
Slightly translucent white to yellowish ointment: Calcipotriol 50 micrograms per g (as the hydrate)
Full list of excipients: Disodium edetate, disodium phosphate dihydrate, DL-α-tocopherol, liquid paraffin, macrogol (2) stearyl ether, propylene glycol, purified water and white soft paraffin.
Method of administration:
Adults: Dovonex Ointment should be applied to the affected area once or twice daily. For maximum benefit use the ointment twice daily. Maximum weekly dose should not exceed 100g.
Children over 12 years: Dovonex Ointment should be applied to the affected area twice daily. Maximum weekly dose should not exceed 75g.
Children aged 6 to 12 years: Dovonex Ointment should be applied to the affected area twice daily. Maximum weekly dose should not exceed 50g.
Children under 6 years: There is limited experience of the use of Dovonex Ointment in this age group. A maximum safe dose has not been established.
These dose recommendations are based on extensive experience in adults. In respect of children, clinical experience in children has shown Dovonex 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 Dovonex in combination with other therapies in children.
Notes:
Dovonex Ointment is contra-indicated in patients with known disorders of calcium metabolism and patients with severe liver and kidney disease. As with other topical preparations, Dovonex Ointment is contra-indicated in patients with hypersensitivity to the active substance or any of the excipients.
Dovonex Ointment 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 generalised pustular or erythrodermic exfoliative psoriasis. However, serum calcium is quickly normalised when treatment is discontinued.
During treatment with Dovonex Ointment 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.
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.
Use above the recommended dose may cause elevated serum calcium which quickly subsides when treatment is discontinued.
Dovonex should not be mixed with other medicinal products, store below 25°C.
Side Effects:
Very rare: allergic reactions (including angioedema).
Very common: skin irritation.
Common: rash, burning sensation, stinging sensation, dry skin, pruritus, erythema, contact dermatitis including facial and perioral.
Uncommon: psoriasis aggravated, eczema.
Unknown frequency: transient changes in skin pigmentation, transient photosensitivity, urticaria, angioedema, periorbital or face oedema.
2 years shelf life. After first opening 6 months.
Form & Composition:
Slightly translucent white to yellowish ointment: Calcipotriol 50 micrograms per g (as the hydrate)
Full list of excipients: Disodium edetate, disodium phosphate dihydrate, DL-α-tocopherol, liquid paraffin, macrogol (2) stearyl ether, propylene glycol, purified water and white soft paraffin.
Method of administration:
Adults: Dovonex Ointment should be applied to the affected area once or twice daily. For maximum benefit use the ointment twice daily. Maximum weekly dose should not exceed 100g.
Children over 12 years: Dovonex Ointment should be applied to the affected area twice daily. Maximum weekly dose should not exceed 75g.
Children aged 6 to 12 years: Dovonex Ointment should be applied to the affected area twice daily. Maximum weekly dose should not exceed 50g.
Children under 6 years: There is limited experience of the use of Dovonex Ointment in this age group. A maximum safe dose has not been established.
These dose recommendations are based on extensive experience in adults. In respect of children, clinical experience in children has shown Dovonex 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 Dovonex in combination with other therapies in children.
Notes:
Dovonex Ointment is contra-indicated in patients with known disorders of calcium metabolism and patients with severe liver and kidney disease. As with other topical preparations, Dovonex Ointment is contra-indicated in patients with hypersensitivity to the active substance or any of the excipients.
Dovonex Ointment 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 generalised pustular or erythrodermic exfoliative psoriasis. However, serum calcium is quickly normalised when treatment is discontinued.
During treatment with Dovonex Ointment 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.
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.
Use above the recommended dose may cause elevated serum calcium which quickly subsides when treatment is discontinued.
Dovonex should not be mixed with other medicinal products, store below 25°C.
Side Effects:
Very rare: allergic reactions (including angioedema).
Very common: skin irritation.
Common: rash, burning sensation, stinging sensation, dry skin, pruritus, erythema, contact dermatitis including facial and perioral.
Uncommon: psoriasis aggravated, eczema.
Unknown frequency: transient changes in skin pigmentation, transient photosensitivity, urticaria, angioedema, periorbital or face oedema.
2 years shelf life. After first opening 6 months.