Local treatment of skin diseases with excessive hyperkeratosis, dryness and inflammation, reacting to local corticosteroid treatment.
Composition:
1 g Ointment contains 0.5 mg betamethasone in the form of betamethasone dipropionate and 30 mg salicylic acid. 1 g of liquid on the skin contains 0.5 mg of betamethasone in the form of betamethasone dipropionate and 20 mg of salicylic acid.
Action:
Preparation for topical application with combined effect of betamethasone and salicylic acid. Betamethasone is a synthetic fluorinated corticosteroid with a strong action for topical use. It has a strong anti-inflammatory, antipruritic and decongestant effect on blood vessels. Salicylic acid as a result of keratolytic activity exfoliates and facilitates the penetration of the corticosteroid into the skin. When administered on the skin, corticosteroids are absorbed in 12-14%. Approx. 64% of betamethasone is bound to plasma proteins. It is metabolised in the liver, and its metabolites are excreted primarily in the urine. Salicylic acid, when applied to the skin under an occlusive wrap, reaches its maximum plasma concentration within 5 hours. Approximately 6% of absorbed salicylic acid is excreted in unchanged form in the urine. The largest amount of salicylic acid is excreted as metabolites.
Contraindications:
Hypersensitivity to the active substances or to any of the excipients. Skin tuberculosis. Viral infection of the skin (eg herpes simplex, bovine chickenpox, chickenpox). Acne, dermatitis around the mouth, rosacea. Do not use around the anus and genitals. Diaper dermatitis. Fungal or bacterial skin infections unless proper causal treatment has been instituted.
Precautions:
If a skin allergic reaction occurs after applying the preparation, it should be immediately discontinued. Avoid contact of the preparation with eyes and mucous membranes. Do not use on eyes or around eyes. It is not recommended for the face, due to the risk of dermatitis (similar to acne-like lesions), dermatitis, skin disappearance and acne. The ointment preparation should not be used on the scalp. In case of skin infection, antibacterial or antifungal agents should be used. Due to the risk of systemic side effects of corticosteroids (including adrenal suppression) and salicylic acid, the drug should be avoided for large areas of the body, damaged skin, use in high doses, and long-term use in patients with impaired liver function and in children. Use only the absolutely necessary cases for the skin of the armpits and groin, due to the increased absorption. Particularly caution should be used in patients with psoriasis, because topical use of corticosteroids in psoriasis can be dangerous, including due to the recurrence of the disease caused by the development of tolerance, the risk of generalized pustular psoriasis and general toxic effects caused by skin dysfunction. It is not recommended for use in children below 12 years of age due to the risk of suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome and increase in intracranial pressure after topical use of potent corticosteroids.
Pregnancy and lactation:
The use of the drug during pregnancy is only allowed in cases where the benefit for the mother outweighs the risk to the fetus. Use should be short-lived and limited to a small area of the body. A decision should be made whether to discontinue breast-feeding or discontinue the preparation, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother. The preparations should not be applied to the breast skin before breast-feeding.
Side effects:
Local application of betamethasone dipropionate may cause atrophic skin changes, irreversible stretch marks, dry skin, small arterioles, folliculitis, hypertrichosis, acne-like lesions, allergic contact dermatitis (burning, swelling and inflammatory blisters on the skin), dermatitis around the mouth, itching, discoloration of the skin, inhibition of sweat glands (prickly) and the occurrence of secondary infections. Topical use of salicylic acid can cause dermatitis. As a result of the absorption of active substances into the blood, general side effects of betamethasone and salicylic acid may also occur.General side effects are rare, especially in the case of long-term use of the drug, use on a large area of the skin, under closed composure and use in children and usually disappear after discontinuation of the preparation.
Dosage:
Outwardly. Adults and children over 12 years: lightly rub the thin layer of the preparation into diseased areas twice a day. In lighter cases, less frequent use is sufficient. Do not use for more than 14 days. Do not use compresses and closed (occlusive) dressings.
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