⚠️ Warnings
Diprosalic must not be used to treat nappy rash.
If hypersensitivity skin reactions (pruritus, erythema) occur on first use, the product must be discontinued immediately.
If a secondary infection develops, appropriate anti-infective therapy must be initiated without delay.
Any of the adverse reactions reported following systemic corticosteroid use, including suppression of adrenal function, may also occur with topical corticosteroids, particularly in children.
Prolonged use on the facial skin is not recommended because of the possible risk of rosacea-like dermatitis, perioral dermatitis, skin atrophy or acne. The product should not be applied to the genital or anal area.
Owing to the potential for increased steroid absorption resulting from the keratolytic action of salicylic acid, occlusive dressings must not be used.
During the treatment of psoriasis with topical corticosteroids, disease relapse may occur in certain cases due to the development of tolerance, with a risk of generalised pustular psoriasis and local and systemic toxicity caused by impaired skin barrier function. Close monitoring of patients is therefore important.
Contact with the eyes is hazardous; contact with the eyes and mucous membranes must therefore be avoided.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient develops symptoms such as blurred vision or other visual disturbances, referral to an ophthalmologist should be considered for evaluation of possible causes, which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR), which has been reported following the use of systemic and topical corticosteroids.
Systemic absorption of betamethasone dipropionate and salicylic acid may be increased, particularly during prolonged treatment of large areas or skin folds, or with high steroid doses. In such cases appropriate safety precautions must be observed, especially when treating infants and children.
If Diprosalic causes irritation or an allergic reaction, treatment must be interrupted or discontinued.
Paediatric population:
Children are more susceptible than adult patients to topical corticosteroid–induced suppression of the hypothalamic–pituitary–adrenal (HPA) axis and to the exogenous effects of corticosteroids, owing to greater drug absorption resulting from a higher body surface area–to–body weight ratio.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children treated with topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol concentrations and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches and bilateral papilloedema.
In children the product should be used with great caution, in the smallest amount required for effective therapy.
In young children, large skin folds and nappies may act as an occlusive dressing and increase cutaneous absorption of betamethasone. In addition, systemic absorption of betamethasone is increased in children because of their higher skin surface area–to–body weight ratio and incompletely developed stratum corneum. In children treated with the product in the nappy area, tight-fitting nappies or plastic pants must not be used.
