Health Boards
Sun-18-09-2011, 19:59 PM
Dovonex Scalp Solution
Form & Composition:
Colourless, slightly viscous solution: Calcipotriol 50 micrograms per ml (as the hydrate)
Full list of excipients: Hydroxypropyl cellulose, isopropyl alcohol, levomenthol, sodium citrate, propylene glycol, purified water.
Method of administration:
Adults: Dovonex Scalp Solution should be applied twice daily (morning and evening) to the affected areas. Maximum weekly dose should not exceed 60 ml.
When used together with Dovonex Cream or Ointment, the total dose of calcipotriol should not exceed 5mg in any week, e.g. 60 ml of Scalp Solution plus 30g of Cream or Ointment, or 30ml of Scalp Solution plus 60g of Cream or Ointment.
Children: Not recommended as there is no experience of the use of Dovonex Scalp Solution in children.
Notes:
Dovonex Scalp Solution is contraindicated in patients with known disorders of calcium metabolism and patients with severe liver and kidney disease. As with other topical preparations, Dovonex Scalp Solution is contraindicated in patients with hypersensitivity to the active substance or any of the excipients.
Application of Dovonex to the face may cause local irritation. Dovonex Scalp Solution should not therefore be applied directly to the face. Patients should be advised to wash their hands after applying the scalp solution 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 Scalp Solution 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 rapidly subsides when the treatment is discontinued.
Dovonex should not be mixed with other medicinal products, store below 25°C. Warning The alcohol base is flammable.
Side Effects:
Very rare: allergic reactions (including angioedema) hypercalcaemia, hypercalciuria, especially if the total recommended dose is exceeded.
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 nothing found.
Form & Composition:
Colourless, slightly viscous solution: Calcipotriol 50 micrograms per ml (as the hydrate)
Full list of excipients: Hydroxypropyl cellulose, isopropyl alcohol, levomenthol, sodium citrate, propylene glycol, purified water.
Method of administration:
Adults: Dovonex Scalp Solution should be applied twice daily (morning and evening) to the affected areas. Maximum weekly dose should not exceed 60 ml.
When used together with Dovonex Cream or Ointment, the total dose of calcipotriol should not exceed 5mg in any week, e.g. 60 ml of Scalp Solution plus 30g of Cream or Ointment, or 30ml of Scalp Solution plus 60g of Cream or Ointment.
Children: Not recommended as there is no experience of the use of Dovonex Scalp Solution in children.
Notes:
Dovonex Scalp Solution is contraindicated in patients with known disorders of calcium metabolism and patients with severe liver and kidney disease. As with other topical preparations, Dovonex Scalp Solution is contraindicated in patients with hypersensitivity to the active substance or any of the excipients.
Application of Dovonex to the face may cause local irritation. Dovonex Scalp Solution should not therefore be applied directly to the face. Patients should be advised to wash their hands after applying the scalp solution 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 Scalp Solution 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 rapidly subsides when the treatment is discontinued.
Dovonex should not be mixed with other medicinal products, store below 25°C. Warning The alcohol base is flammable.
Side Effects:
Very rare: allergic reactions (including angioedema) hypercalcaemia, hypercalciuria, especially if the total recommended dose is exceeded.
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 nothing found.