⚠️ 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 a secondary infection develops, appropriate anti-infective therapy must be initiated promptly.
Any of the adverse reactions reported with systemic corticosteroid use, including adrenal suppression, may also occur with topical corticosteroids, particularly in children.
Long-term application to the face is not recommended due 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 areas.
Because of the potential for increased steroid absorption due to the keratolytic action of salicylic acid, occlusive dressings must not be used.
When psoriasis is treated with topical corticosteroids, relapse may occur in certain cases due to the development of tolerance, the risk of generalised pustular psoriasis, and local-to-systemic toxicity caused by impaired skin barrier function. Careful patient monitoring is essential.
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, which may include cataract, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR), which has been reported following systemic and topical corticosteroid administration.
Systemic absorption of betamethasone dipropionate and salicylic acid may be increased, particularly during prolonged treatment of large surface 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 adults to topical corticosteroid-induced suppression of the hypothalamic–pituitary–adrenal (HPA) axis and to exogenous corticosteroid effects, 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 receiving 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 young children, large skin folds and nappies may act as occlusive dressings and increase cutaneous absorption of betamethasone. In addition, systemic absorption of betamethasone is increased in children due to a higher skin surface area to body weight ratio and an immature stratum corneum. In children treated in the nappy area, tightly fitting nappies or plastic pants must not be used.
