Daivobet

/ Dexcel

Daivobet ointment should be applied to the affected area once daily.
The recommended treatment period is 4 weeks. There is experience with repeated courses of Daivobet up to 52 weeks. If it is necessary to continue or restart treatment after 4 weeks, 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% (see special precautions).
Special populations:
Renal and hepatic impairment
The safety and efficacy of Daivobet ointment in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.
Pediatric population
The safety and efficacy of Daivobet ointment in children below 18 years have not been established. Currently available data in children aged 12 to 17 years. No recommendation on a posology can be made.
Method of administration:
Daivobet ointment should be applied to the affected area. In order to achieve optimal effect, it is not recommended to take a shower or bath immediately after application of Daivobet ointment.

Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy.

Hypersensitivity to the active substances or to any of the excipients.
Daivobet ointment is contraindicated in erythrodermic, exfoliative and pustular psoriasis.
Due to the content of calcipotriol, Daivobet ointment is contraindicated in patients with known disorders of calcium metabolism .
Due to the content of corticosteroid, Daivobet 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, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wounds.

Effects on endocrine system:
Daivobet 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 and under occlusive dressings or on mucous membranes or in skin folds should be avoided since it increases the systemic absorption of corticosteroids.
In a study in patients with both extensive scalp and extensive body psoriasis using a combination of high doses of Daivobet gel (scalp application) and high doses of Daivobet ointment (body application), 5 of 32 patients showed a borderline decrease in cortisol response to adrenocorticotropic hormone (ACTH) challenge after 4 weeks of treatment.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for a referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Effects on calcium metabolism:
Due to the content of calcipotriol, hypercalcaemia may occur if the maximum daily dose (15 g) is exceeded. Serum calcium is 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.
Local adverse reactions:
Daivobet ointment contains a potent group III-steroid and concurrent treatment with other steroids on the same treatment area must be avoided. Skin of the face and genitals are very sensitive to corticosteroids. The medicinal product should not be used in these areas. 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.
Concomitant skin infections:
When lesions become secondarily infected, they should be treated with antimicrobiological therapy. However, if infection worsens, treatment with corticosteroids should be stopped.
Discontinuation of treatment:
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.
Long-term use:
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.
Unevaluated use:
There is no experience with the use of Daivobet ointment in guttate psoriasis.
Concurrent treatment and UV exposure:
There is limited experience for the use of this medicinal product on the scalp. Daivobet ointment for body psoriasis lesions has been used in combination with Daivobet gel for scalp psoriasis lesions, but there is limited experience of combination of Daivobet with other topical anti-psoriatic products at the same treatment area, other anti-psoriatic medicinal products administered systemically or with phototherapy.
During Daivobet ointment treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial light. Topical calcipotriol should be used with UVR only if the physician and patient consider that the potential benefits outweigh the potential risks.
Adverse reactions to excipients:
Daivobet ointment contains butylhydroxytoluene (E321) as an excipient, which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

Skin exfoliation, pruritus, pustular psoriasis and hypercalcaemia.
See prescribing information for full details.

No interaction studies have been performed with Daivobet.

Pregnancy: There are no adequate data from the use of this  ointment in pregnant women. Studies in animals with glucocorticoids have shown reproductive toxicity, but a number of epidemiological studies (less than 300 pregnancy outcomes) 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, this drug ointment should only be used when the potential benefit justifies the potential risk.
Lactation: 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 this ointment to women who breast-feed. The patient should be instructed not to use this  ointment on the breast when breast-feeding.
See prescribing information for full details.

Use above the recommended dose may cause elevated serum calcium which subsides when treatment is discontinued. The symptoms of hypercalcaemia include polyuria, constipation, muscle weakness, confusion and coma. 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 the  ointment weekly (corresponding to a daily dose of approximately 34 g) for 5 months (maximum recommended dose 15 g daily) developed Cushing’s syndrome during treatment and then pustular psoriasis after abruptly stopping treatment.