⚠️ Warnings
Diprosalic must not be used to treat nappy rash.
If hypersensitivity skin reactions (pruritus, erythema) occur on first use 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 suppression of adrenal function, may also occur with topical corticosteroids, particularly in children.
Prolonged application to 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 applied to the genital or anal area.
Because the keratolytic effect of salicylic acid may enhance steroid absorption, occlusive dressings must not be used.
During treatment of psoriasis with topical corticosteroids, relapse of the disease may occur in certain cases owing to the development of tolerance, the risk of generalised pustular psoriasis, and local-to-systemic toxicity caused by impairment of the skin barrier function. Careful patient monitoring is therefore important.
Contact with the eyes is hazardous; contact with the eyes and mucous membranes must therefore be avoided.
Visual disturbance
Visual disturbance has been reported with both systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, referral to an ophthalmologist should be considered for evaluation of possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy (CSCR), which has been reported following both systemic and topical corticosteroid administration.
Systemic absorption of betamethasone dipropionate and salicylic acid may be increased, particularly during prolonged treatment of extensive 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 adults to hypothalamic–pituitary–adrenal (HPA) axis suppression induced by topical corticosteroids, and to exogenous corticosteroid effects, owing to greater drug absorption associated with 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 fontanelle, headache, and bilateral papilloedema.
In children, the product should be used with great caution and in the smallest amount required for effective therapy.
In young children, large skin folds and nappies may act as occlusive dressings and increase cutaneous absorption of betamethasone. Furthermore, systemic absorption of betamethasone is increased in children owing to a higher skin surface area to body weight ratio and an incompletely developed stratum corneum. In children treated with the product in the nappy area, tight-fitting nappies or plastic pants must not be used.
