⚠️ Warnings
Diprosalic must not be used to treat nappy rash.
If hypersensitivity skin reactions (pruritus, erythema) occur on first application of the product, treatment must be discontinued immediately.
If secondary infection develops, appropriate anti-infective therapy must be initiated without delay.
Any of the adverse reactions reported with systemic corticosteroid use, including adrenal suppression, may also occur with topical corticosteroids, particularly in children.
Long-term use of the product on the face is not recommended owing to the potential risk of rosacea-like dermatitis, perioral dermatitis, skin atrophy, or acne. The product should not be used in the genital or anal region.
Because of the potential for increased steroid absorption due to the keratolytic action of salicylic acid, occlusive dressings must not be used.
During treatment of psoriasis with topical corticosteroids, relapse of the disease may occur in certain cases as a result of the development of tolerance, the risk of generalised pustular psoriasis, and local and systemic toxicity due to impaired skin barrier function. Careful patient monitoring is essential.
Contact of the product with the eyes is hazardous. Contact with the eyes and mucous membranes must therefore be avoided.
Visual disturbance
Visual disturbance has been reported with systemic and topical use of corticosteroids. If a patient presents with symptoms such as blurred vision or other visual disturbance, referral to an ophthalmologist for evaluation of possible causes should be considered, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy (CSCR), which have been reported following systemic and topical corticosteroid use.
Systemic absorption of betamethasone dipropionate and salicylic acid may be increased, particularly with prolonged treatment of large areas or skin folds or with high steroid doses. In such cases, appropriate 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, headache, and bilateral papilloedema.
In children, the product should be used with great caution and in the smallest amount required for effective therapy.
In small 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 the higher skin-surface-area to body-weight ratio and the underdeveloped stratum corneum. In children treated with the product in the nappy area, tight-fitting nappies or plastic pants must not be used.
