Daivobet Ointment Calcipotiol Beamethasone
Each g contains:
(as hydrate 52.2 mcg)
Betamethasone Ph. Eur. 0.5 mg
(as dipropionate 0.643 mg)
One gram of Daivobet®ointment contains 50 micrograms of calcipotriol (as monohydrate) and 500 micrograms of betamethasone (as dipropionate).
Daivobet®ointment is indicated for the once daily topical treatment of plaque-type psoriasis vulgaris amenable to topical therapy in adult patients 18 years and older.
Dosage and method of administration
Daivobet®ointment is indicated FOR TOPICAL USE ONLY and NOT FOR OPHTHALMIC USE.
All psoriasis-affected areas treated with Daivobet ®should be, where possible, protected from direct sunlight and UV-light with items of clothing. Topical calcipotriol should only beused with UV radiation if the physician and patient consider that the potential benefits outweigh the potential risks. The potential phototoxic effects of Daivobet®over long term exposure have notbeen fully investigated.
Daivobet®ointment should be applied topically to the affected area once daily. The maximum daily dose should not exceed 15 grams.
The maximum recommended weekly dose of Daivobet®ointment is 100 g/week.
The treated area should not be more than 30% of the body surface.The recommended treatment period of Daivobet®ointment is 4 weeks. At the completion ofthe treatment period, repeated treatment with Daivobet®ointment can be initiated under medical supervision. There is no clinical experience with Daivobet®Ointment beyond 52 weeks
Daivobet®ointment is not recommended for use in children and adolescents below the age of 18 years.
Special warnings and special precautionsfor use
FOR EXTERNAL USE ONLY
Effects on endocrine systemAdverse 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 of Daivobet®ointment to large areas of damaged skin, under occlusive dressings, to mucous membranes, or in skin folds should be avoided as these conditions increase the systemic absorption of both corticosteroids and calcipotriol. Elevated systemic absorption of calcipotriol could result in hypercalcaemia in some patients
In a trial in patients with both extensive scalp and extensive body psoriasis vulgaris 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 may be reported with systemic and topical corticosteroid use. If apatient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as centralserous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroid.
Effects on calcium metabolism
In view of the risk of hypercalcaemia secondary to excessive absorption of calcipotriol when there is extensive skin involvement, Daivobet®ointment should not be used on more than 30% of the body surface area.
The risk of hypercalcaemia is minimal when the recommendations relevant to calcipotriol are observed. In adults, the maximum daily dose of 15 g or the maximum weekly doseof 100g ointment should not be exceeded.
Treatment with Daivobet®ointment in adults in the recommended amounts up to 100 g per week does not generally result in changes in laboratory values.Serum calcium and renal functionshould be monitored at 3 monthly intervals during periods of usage of topical calcipotriol, including that in Daivobet® ointment. If the serum calcium level is elevated, treatment withDaivobet®ointment should be discontinued and the condition should be treated appropriately. The levels of serum calcium should be measured once weekly until the serum calcium levels return to normal values
Successful treatment of refractory chronic hand eczema with calcipotriol/betamethasone ointment: A report of three cases