Health Boards
Sun-18-09-2011, 20:01 PM
Dovobet Ointment
Form & Composition:
Off-white to yellow ointment: One gram of gel contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
Full list of excipients: Paraffin, liquid Polyoxypropylene-15 stearyl ether, Castor oil, hydrogenated, Butylhydroxytoluene (E321), All-rac-α-tocopherol.
Method of administration:
Dovobet ointment should be applied to affected areas once daily. The recommended treatment period is 4 weeks. If it is necessary to continue or restart treatment after this period, treatment should be continued after medical review and under regular medical supervision.
When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g. The body surface area treated with calcipotriol containing medicinal products should not exceed 30 %
Important:
The safety and efficacy of Dovobet ointment in children below 18 years have not been established. The safety and efficacy of Dovobet ointment in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated. Dovobet ointment should not be applied directly to the face or eyes. The hands should be washed after use.
Notes:
Dovobet ointment is contraindicated in erythrodermic, exfoliative and pustular psoriasis.
Due to the content of calcipotriol, Dovobet ointment is contraindicated in patients with known disorders of calcium metabolism.
Due to the content of corticosteroid, Dovobet ointment is contraindicated in the following conditions: Viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, wounds, perianal and genital pruritus.
Dovobet ointment contains a potent group III steroid and concurrent treatment with other steroids must be avoided. Adverse reactions found in connection with systemic corticosteroid treatment, such as adrenocortical suppression or impact on the metabolic control of diabetes mellitus, may occur also during topical corticosteroid treatment due to systemic absorption. Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids. Application on large areas of damaged skin or on mucous membranes or in skin folds should be avoided since it increases the systemic absorption of corticosteroids.
Due to the content of calcipotriol, hypercalcaemia may occur if the maximum daily dose (15 g) is exceeded. Serum calcium is, however, quickly normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the recommendations relevant to calcipotriol are followed. Treatment of more than 30 % of the body surface should be avoided.
Skin of the face and genitals are very sensitive to corticosteroids. The medicinal product should not be used in these areas. Uncommon local adverse reactions (such as eye irritation or irritation of facial skin) were observed, when the medicinal product was accidentally administered in the area of face, or accidentally to the eyes or conjunctives.
The patient must be instructed in correct use of the medicinal product to avoid application and accidental transfer to the face, mouth and eyes. Hands must be washed after each application to avoid accidental transfer to these areas.
When lesions become secondarily infected, they should be treated with antimicrobiological therapy. However, if infection worsens, treatment with corticosteroids should be stopped.
When treating psoriasis with topical corticosteroids, there may be a risk of generalised pustular psoriasis or of rebound effects when discontinuing treatment. Medical supervision should therefore continue in the post-treatment period.
With long-term use there is an increased risk of local and systemic corticosteroid adverse reactions. The treatment should be discontinued in case of adverse reactions related to long-term use of corticosteroid.
There is no experience for the use of Dovobet ointment in guttate psoriasis.
Dovobet ointment for body psoriasis lesions has been used in combination with Dovobet gel for scalp psoriasis lesions, but there is no experience of combination of Dovobet with other topical anti-psoriatic products at the same treatment area, other anti-psoriatic medicinal products administered systemically or with phototherapy.
During Dovobet 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 UVR only if the physician and patient consider that the potential benefits outweigh the potential risks.
Dovobet ointment contains butylated hydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
There are no adequate data from the use of Dovobet ointment in pregnant women. Studies in animals with glucocorticoids have shown reproductive toxicity, but a number of epidemiological studies have not revealed congenital anomalies among infants born to women treated with corticosteroids during pregnancy. The potential risk for humans is uncertain. Therefore, during pregnancy, Dovobet ointment should only be used when the potential benefit justifies the potential risk.
Betamethasone passes into breast milk, but risk of an adverse effect on the infant seems unlikely with therapeutic doses. There are no data on the excretion of calcipotriol in breast milk. Caution should be exercised when prescribing Dovobet ointment to women who breast-feed. The patient should be instructed not to use Dovobet on the breast when breast-feeding.
Dovobet should not be mixed with other medicinal products, Do not refrigerate. Keep the tube in the outer carton in order to protect from light. Use within 1 year after first opening.
Side Effects:
Common: Pruritus, Rash, Burning sensation of skin.
Uncommon: Eye irritation, Exacerbation of psoriasis, , Skin pain or irritation, Folliculitis, Dermatitis, Erythema, Acne, Dry skin, Rash, Pustular rash.
Adverse reactions include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, eczema, psoriasis aggravated, photosensitivity and hypersensitivity reactions including very rare cases of angioedema and facial oedema.
Systemic effects after topical use may appear very rarely causing hypercalcaemia or hypercalciuria.
Local reactions can occur after topical use, especially during prolonged application, including skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and colloid milia. When treating psoriasis there may be a risk of generalised pustular psoriasis.
Systemic reactions due to topical use of corticosteroids are rare in adults, however they can be severe. Adrenocortical suppression, cataract, infections, impact on the metabolic control of diabetes mellitus and increase of intra-ocular pressure can occur, especially after long term treatment. Systemic reactions occur more frequently when applied under occlusion (plastic, skin folds), when applied on large areas and during long term treatment.
Use above the recommended dose may cause elevated serum calcium which should rapidly subside when treatment is discontinued.
Excessive prolonged use of topical corticosteroids may suppress the pituitary-adrenal functions, resulting in secondary adrenal insufficiency which is usually reversible. In such cases, symptomatic treatment is indicated.
In case of chronic toxicity, the corticosteroid treatment must be discontinued gradually.
It has been reported that due to misuse one patient with extensive erythrodermic psoriasis treated with 240 g of Dovobet ointment weekly (corresponding to a daily dose of approximately 34 g) for 5 months (maximum recommended dose 15 g daily) developed Cushing's syndrome and pustular psoriasis after abruptly stopping treatment.
2 years shelf life. After first opening 1 year.
Form & Composition:
Off-white to yellow ointment: One gram of gel contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
Full list of excipients: Paraffin, liquid Polyoxypropylene-15 stearyl ether, Castor oil, hydrogenated, Butylhydroxytoluene (E321), All-rac-α-tocopherol.
Method of administration:
Dovobet ointment should be applied to affected areas once daily. The recommended treatment period is 4 weeks. If it is necessary to continue or restart treatment after this period, treatment should be continued after medical review and under regular medical supervision.
When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g. The body surface area treated with calcipotriol containing medicinal products should not exceed 30 %
Important:
The safety and efficacy of Dovobet ointment in children below 18 years have not been established. The safety and efficacy of Dovobet ointment in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated. Dovobet ointment should not be applied directly to the face or eyes. The hands should be washed after use.
Notes:
Dovobet ointment is contraindicated in erythrodermic, exfoliative and pustular psoriasis.
Due to the content of calcipotriol, Dovobet ointment is contraindicated in patients with known disorders of calcium metabolism.
Due to the content of corticosteroid, Dovobet ointment is contraindicated in the following conditions: Viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, wounds, perianal and genital pruritus.
Dovobet ointment contains a potent group III steroid and concurrent treatment with other steroids must be avoided. Adverse reactions found in connection with systemic corticosteroid treatment, such as adrenocortical suppression or impact on the metabolic control of diabetes mellitus, may occur also during topical corticosteroid treatment due to systemic absorption. Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids. Application on large areas of damaged skin or on mucous membranes or in skin folds should be avoided since it increases the systemic absorption of corticosteroids.
Due to the content of calcipotriol, hypercalcaemia may occur if the maximum daily dose (15 g) is exceeded. Serum calcium is, however, quickly normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the recommendations relevant to calcipotriol are followed. Treatment of more than 30 % of the body surface should be avoided.
Skin of the face and genitals are very sensitive to corticosteroids. The medicinal product should not be used in these areas. Uncommon local adverse reactions (such as eye irritation or irritation of facial skin) were observed, when the medicinal product was accidentally administered in the area of face, or accidentally to the eyes or conjunctives.
The patient must be instructed in correct use of the medicinal product to avoid application and accidental transfer to the face, mouth and eyes. Hands must be washed after each application to avoid accidental transfer to these areas.
When lesions become secondarily infected, they should be treated with antimicrobiological therapy. However, if infection worsens, treatment with corticosteroids should be stopped.
When treating psoriasis with topical corticosteroids, there may be a risk of generalised pustular psoriasis or of rebound effects when discontinuing treatment. Medical supervision should therefore continue in the post-treatment period.
With long-term use there is an increased risk of local and systemic corticosteroid adverse reactions. The treatment should be discontinued in case of adverse reactions related to long-term use of corticosteroid.
There is no experience for the use of Dovobet ointment in guttate psoriasis.
Dovobet ointment for body psoriasis lesions has been used in combination with Dovobet gel for scalp psoriasis lesions, but there is no experience of combination of Dovobet with other topical anti-psoriatic products at the same treatment area, other anti-psoriatic medicinal products administered systemically or with phototherapy.
During Dovobet 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 UVR only if the physician and patient consider that the potential benefits outweigh the potential risks.
Dovobet ointment contains butylated hydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
There are no adequate data from the use of Dovobet ointment in pregnant women. Studies in animals with glucocorticoids have shown reproductive toxicity, but a number of epidemiological studies have not revealed congenital anomalies among infants born to women treated with corticosteroids during pregnancy. The potential risk for humans is uncertain. Therefore, during pregnancy, Dovobet ointment should only be used when the potential benefit justifies the potential risk.
Betamethasone passes into breast milk, but risk of an adverse effect on the infant seems unlikely with therapeutic doses. There are no data on the excretion of calcipotriol in breast milk. Caution should be exercised when prescribing Dovobet ointment to women who breast-feed. The patient should be instructed not to use Dovobet on the breast when breast-feeding.
Dovobet should not be mixed with other medicinal products, Do not refrigerate. Keep the tube in the outer carton in order to protect from light. Use within 1 year after first opening.
Side Effects:
Common: Pruritus, Rash, Burning sensation of skin.
Uncommon: Eye irritation, Exacerbation of psoriasis, , Skin pain or irritation, Folliculitis, Dermatitis, Erythema, Acne, Dry skin, Rash, Pustular rash.
Adverse reactions include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, eczema, psoriasis aggravated, photosensitivity and hypersensitivity reactions including very rare cases of angioedema and facial oedema.
Systemic effects after topical use may appear very rarely causing hypercalcaemia or hypercalciuria.
Local reactions can occur after topical use, especially during prolonged application, including skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and colloid milia. When treating psoriasis there may be a risk of generalised pustular psoriasis.
Systemic reactions due to topical use of corticosteroids are rare in adults, however they can be severe. Adrenocortical suppression, cataract, infections, impact on the metabolic control of diabetes mellitus and increase of intra-ocular pressure can occur, especially after long term treatment. Systemic reactions occur more frequently when applied under occlusion (plastic, skin folds), when applied on large areas and during long term treatment.
Use above the recommended dose may cause elevated serum calcium which should rapidly subside when treatment is discontinued.
Excessive prolonged use of topical corticosteroids may suppress the pituitary-adrenal functions, resulting in secondary adrenal insufficiency which is usually reversible. In such cases, symptomatic treatment is indicated.
In case of chronic toxicity, the corticosteroid treatment must be discontinued gradually.
It has been reported that due to misuse one patient with extensive erythrodermic psoriasis treated with 240 g of Dovobet ointment weekly (corresponding to a daily dose of approximately 34 g) for 5 months (maximum recommended dose 15 g daily) developed Cushing's syndrome and pustular psoriasis after abruptly stopping treatment.
2 years shelf life. After first opening 1 year.