Pharmacotherapeutic group: Corticosteroids, potent, other combinations
ATC code: D07XC01
Diprosalic is a dermatological preparation combining the glucocorticoid anti-inflammatory agent betamethasone with salicylic acid.
Betamethasone is a synthetic, fluorinated corticosteroid for topical use in dermatology, with potent anti-inflammatory, immunosuppressive, and antiproliferative activity. It is a synthetic derivative of prednisolone, possessing high corticosteroid activity and negligible mineralocorticoid effect.
The exact mechanism of action of topical corticosteroids is unknown, but it is believed to involve a combination of anti-inflammatory, immunosuppressive, and antiproliferative effects, of which the anti-inflammatory action is the most important. Corticosteroids inhibit the formation, release, and activity of chemical mediators of inflammation (kinins, histamine, lysosomal enzymes, prostaglandins). They also inhibit the migration of leukocytes and macrophages — whose presence is required from the very onset of the immune response — to the affected site, reduce vasodilation, and increase the permeability of blood vessels at the site of inflammation. This vasoconstrictive effect reduces serum extravasation and oedema formation. Corticosteroids also exert an immunosuppressive effect on type III and type IV hypersensitivity reactions by inhibiting the toxic activity of antigen-antibody complexes deposited in the vascular wall, which give rise to allergic cutaneous vasculitis, and by inhibiting lymphokine activity together with the activity of target cells and macrophages, which together mediate allergic reactions such as allergic contact dermatitis. Corticosteroids also prevent sensitised T-lymphocytes and macrophages from reaching their target cells. Fluorination enhances the anti-inflammatory activity of betamethasone, placing it among the potent topical corticosteroids.
Salicylic acid acts as a keratolytic, facilitating penetration of the corticosteroid through the skin, and additionally exerts squamolytic, antibacterial, and antifungal effects while restoring the acidic surface of the skin.
⚠️ 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.
