⚠️ Warnings
Diprosalic must not be used to treat nappy rash.
If hypersensitivity skin reactions (pruritus, erythema) occur on first use, treatment must be discontinued immediately.
If a 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.
Long-term use 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 applied to the genital or anal area.
Owing to the possibility of increased steroid absorption resulting from the keratolytic effect of salicylic acid, occlusive dressings must not be used.
When psoriasis is treated with topical corticosteroids, in certain cases relapse may occur due to the development of tolerance, with a risk of generalised pustular psoriasis and local or 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 may be reported with 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 extensive 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 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 using 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 must be used with great caution and in the smallest amount sufficient for effective therapy.
In small 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 owing to the higher ratio of skin surface area to body weight and the immature stratum corneum. In children treated with the product in the nappy area, tight-fitting nappies or plastic pants must not be used.
