Dipsotrex B Special Precautions

Adverse effects 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.
If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid.
Due to the content of calcipotriol, hypercalcemia may occur if the maximum weekly dose (100 g) is exceeded. Serum calcium is, however, quickly normalized when treatment is discontinued. The risk of hypercalcemia is minimal when the recommendations relevant to calcipotriol are followed.
Efficacy and safety of use of this product on areas other than the scalp have not been established. Treatment of more than 30% of the body surface should be avoided. Application on large areas of damaged skin or in mucous membranes or in skin folds should be avoided since it increases the systemic absorption of corticosteroids. Skin of the face and genitals are very sensitive to corticosteroids. These areas should only be treated with weaker corticosteroids. Uncommon local adverse reactions (such as eye irritation or irritation of facial skin) were observed, when the drug 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 product to avoid application and accidental transfer to the face, mouth and eyes.
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 generalized 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 undesirable effects. The treatment should be discontinued in case of undesirable effects related to long-term use of corticosteroid.
There is no experience with concurrent use of other anti-psoriatic products administered systemically or with phototherapy.
During Calcipotriol + Betamethasone (Dipsotrex B) 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.
Calcipotriol + Betamethasone (Dipsotrex B) may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Use in the elderly: All other reported clinical experience has not identified any differences in response between elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.