Dovobet And Dovonex (What's the difference ?)

[Fred]

A question often asked by psoriasis sufferers is "what is the difference between Dovobet and Dovonex"

Both products are made by Leo Pharma and are Cream/Ointment/Solution/Gel treatments for psoriasis. there is a big difference between the two products, and this thread is intended to give you some answers. so please take time to familiarize yourself with the two products.

Dovonex also called Daivonex in some countries comes in Blue & White tubes and is Calcipotriol based. (Calcipotriol is a vitamin D derivative)

Dovobet also called Daivobet in some counties comes in Red & White tubes and is Betamethasone & Calcipotriol based. (Betamethasone is a potent glucocorticoid steroid)

Please scroll down or click your choice below.

Dovonex Cream

Dovonex Ointment

Dovonex Scalp Solution

Dovobet Ointment

Dovobet Gel

[Fred]

Dovonex Cream

Form & Composition:
Soft White Cream: Calcipotriol 50 micrograms per g (as the hydrate)
Full list of excipients: macrogol cetostearyl ether, cetostearyl alcohol, chloroallylhexaminium chloride, disodium edetate, disodium phosphate dihydrate, glycerol 85%, liquid paraffin, sodium hydroxide, purified water, white soft paraffin.

Method of administration:
Adults: Dovonex Cream should be applied to the affected area once or twice daily. For maximum benefit use the cream twice daily. Maximum weekly dose should not exceed 100g.
Children over 12 years: Dovonex Cream should be applied to the affected area twice daily. Maximum weekly dose should not exceed 75g.
Children aged 6 to 12 years: Dovonex Cream 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 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 Cream 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 Cream is contra-indicated in patients with hypersensitivity to the active substance or any of the excipients.

Dovonex Cream should not be used on the face. Patients should be advised to wash their hands after applying the cream 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, which rapidly reversed on cessation of treatment, has been reported in patients with generalized pustular or erythrodermic exfoliative psoriasis. However, serum calcium is quickly normalised when treatment is discontinued.

During treatment with Dovonex Cream 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.

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 nothing found.

[Fred]

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.

[Fred]

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.

[Fred]

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.

[Fred]

Dovobet Gel

Form & Composition:
An almost clear, colourless to slightly off-white gel: 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 gel should be applied to affected areas once daily. The recommended treatment period is 4 weeks for scalp areas and 8 weeks for “non-scalp” areas. 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 %

If used on the scalp: All the affected scalp areas may be treated with Dovobet gel. Usually an amount between 1 g and 4 g per day is sufficient for treatment of the scalp (4 g corresponds to one teaspoon).

Important:
The safety and efficacy of Dovobet gel in children below 18 years have not been established. No data are available. The bottle should be shaken before use and Dovobet gel applied to the affected area. Dovobet gel should not be applied directly to the face or eyes. The hands should be washed after use.

Notes:
Dovobet gel is contraindicated in erythrodermic, exfoliative and pustular psoriasis.

Due to the content of calcipotriol, Dovobet gel is contraindicated in patients with known disorders of calcium metabolism.

Due to the content of corticosteroid, Dovobet gel 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 gel 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 gel 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 gel 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 gel 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 gel 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 gel 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 gel 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 bottle in the outer carton in order to protect from light. Use within 3 months after first opening.

Side Effects:
Common: Pruritus.
Uncommon: Eye irritation, Exacerbation of psoriasis, Burning sensation of skin, 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.

2 years shelf life. Bottle: After first opening: 3 months. Applicator: After first opening: 6 months.

[Fred]

I will make this topic sticky in Prescribed treatments and lock it. if anyone has more information on Dovonex or Dovobet that you think could be helpful in this thread please let me know.

You are also welcome to start you're own topics in the "Prescribed Section" about Dovonex / Dovobet.

Thank you.

Fred.