- betamethasone dipropionate
- calcipotriol monohydrate
POM: Prescription only medicine
This information is intended for use by health professionals
PosologyDovobet ointment should be applied to the affected area once daily. The recommended treatment period is 4 weeks. There is experience with repeated courses of Dovobet 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 section 4.4).
Renal and hepatic impairmentThe safety and efficacy of Dovobet ointment in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.
Paediatric populationThe safety and efficacy of Dovobet ointment in children below 18 years have not been established. Currently available data in children aged 12 to 17 years are described in section 4.8 and 5.1 but no recommendation on a posology can be made.
Method of administrationDovobet 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 Dovobet ointment.
Effects on endocrine systemDovobet 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 (see section 4.8).In a study in patients with both extensive scalp and extensive body psoriasis using a combination of high doses of Dovobet gel (scalp application) and high doses of Dovobet ointment (body application), 5 of 32 patients showed a borderline decrease in cortisol response to adrenocorticotropic hormone (ACTH) challenge after 4 weeks of treatment (see section 5.1).
Effects on calcium metabolismDue 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 (see section 4.2).
Local adverse reactionsDovobet 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 infectionsWhen lesions become secondarily infected, they should be treated with antimicrobiological therapy. However, if infection worsens, treatment with corticosteroids should be stopped (see section 4.3).
Discontinuation of treatmentWhen 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 useWith 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 (see section 4.8).
Unevaluated useThere is no experience with the use of Dovobet in guttate psoriasis.
Concurrent treatment and UV exposureThere is limited experience for the use of this medicinal product on the scalp. Dovobet ointment for body psoriasis lesions has been used in combination with Dovobet gel for scalp psoriasis lesions, but there is limited 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 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 (see section 5.3).
Adverse reactions to excipientsDovobet 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.
PregnancyThere are no adequate data from the use of Dovobet in pregnant women. Studies in animals with glucocorticoids have shown reproductive toxicity (see section 5.3), 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, Dovobet should only be used when the potential benefit justifies the potential risk.
Breast-feedingBetamethasone 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.
FertilityStudies in rats with oral doses of calcipotriol or betamethasone dipropionate demonstrated no impairment of male and female fertility (see section 5.3).
|Infections and infestations|
|Uncommon ≥1/1,000 to <1/100||Skin infection* Folliculitis|
|Rare ≥1/10,000 to <1/1,000||Furuncle|
|Immune system disorders|
|Rare ≥1/10,000 to <1/1,000||Hypersensitivity|
|Metabolism and nutrition disorders|
|Rare ≥1/10,000 and to <1/1,000||Hypercalcaemia|
|Skin and subcutaneous tissue disorders|
|Common ≥1/100 to < 1/10||Skin exfoliation Pruritus|
|Uncommon ≥1/1,000 to <1/100||Skin atrophy Exacerbation of psoriasis Dermatitis Erythema Rash** Purpura or ecchymosis Skin burning sensation Skin irritation|
|Rare ≥1/10,000 to <1/1,000||Pustular psoriasis Skin striae Photosensitivity reaction Acne Dry skin|
|General disorders and administration site conditions|
|Uncommon ≥1/1,000 to <1/100||Application site pigmentation changes Application site pain***|
|Rare ≥1/10,000 to <1/1,000||Rebound effect|
CalcipotriolAdverse 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 (see section 4.4).Betamethasone (as dipropionate)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 with topical corticosteroids 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 (see section 4.4).
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Paediatric populationThe adrenal response to ACTH challenge was measured in an uncontrolled 4-week study in 33 adolescents aged 12-17 years with body psoriasis who used up to 56 g per week of Dovobet ointment. No cases of HPA axis suppression were reported. No hypercalcaemia was reported but one patient had a possible treatment related increase in urinary calcium.
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