Local treatment of inflammatory and pruritic skin diseases that respond to treatment with corticosteroids.
Composition:
1 g of cream or 1 g of Ointment contains 0.5 mg of betamethasone in the form of betamethasone dipropionate. The cream formulation contains cetostearyl alcohol and chlorocresol.
Action:
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. When applied to the skin, betamethasone is absorbed in 12-14%. Approx. 64% bound to plasma proteins. It is metabolised in the liver, and its metabolites are excreted primarily in the urine.
Contraindications:
Hypersensitivity to the active substance 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. It is not recommended for the face, due to the risk of dermatitis (similar to acne-like lesions), dermatitis, skin disappearance and acne. Avoid contact of the preparation with eyes and mucous membranes. Do not use on eyes or around eyes. In the case of skin infection, treatment with antimicrobial or antifungal drugs should be used. The preparation should not be used to treat varicose veins in the lower leg. Due to the risk of systemic side effects of corticosteroids (including adrenal suppression), 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. The skin of the armpits and groin can be used only in cases of absolute necessity, due to the increased absorption. The drug should be used with particular caution 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 under 12 years of age, due to frequent reports of hypothalamic-pituitary-adrenal axis inhibition, Cushing's syndrome and increase in intracranial pressure after topical use of potent corticosteroids. The cream formulation contains cetostearyl alcohol, which can cause a local skin reaction (e.g., contact dermatitis) and chlorocresol, which can cause allergic reactions.
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. When breast-feeding, consider whether to stop breastfeeding or use, taking into account the possibility of side effects in children 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 secondary infections. In addition, allergic reactions may occur. As a result of absorption of the active substance into the blood, there may also be general adverse reactions of betamethasone, characteristic of corticosteroids.General side effects are rare, especially in long-term use, for large areas of the skin, under the closed poultice, and in children, and usually disappear after discontinuation.
Dosage:
Outwardly. Adults and children over 12 years of age: lightly rub the thin layer of the preparation into diseased areas on the skin 1 or 2 times a day. Do not use a closed (occlusive) dressing. Treatment should not last longer than 14 days. Do not use more than 50 g of preparation per week.
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