Properties
What is it?
International Nonproprietary Name (Active Substance): betamethasone, gentamicine Composition and Dosage Form Ointment: 15 g tube 1 g contains: Betamethasone (as dipropionate). . . . . . . 0.5 mg Gentamicin (as sulfate). . . . . . . … . . . 1 mg Excipients: Liquid paraffin, lanolin alcohol, cetostearyl alcohol, butylated hydroxytoluene, butylated hydroxyanisole, white petrolatum. Clinical-Pharmacological Group Glucocorticoid agent for external use. Pharmacological Properties The active ingredients in Betaderm exhibit a combined action in the treatment of inflammatory skin changes with excessive keratinization, allergic signs, and secondary bacterial infection. Betamethasone dipropionate: A synthetic hydrocortisone fluoride derivative. It easily penetrates the skin and exhibits a strong anti-inflammatory, antipruritic, and antiallergic effect. It suppresses the causes of inflammatory processes, prevents histamine release, and the manifestation of local allergy symptoms. Due to its local vasoconstrictive effect, it reduces exudative reactions. Betamethasone dipropionate is not biotransformed in the skin. After penetration into the body from the skin, it is metabolized in the liver and excreted mainly with urine and in smaller amounts with bile. Absorption of betamethasone dipropionate from the skin increases in areas of folds, on delicate skin, on damaged epidermis, or on skin affected by inflammatory processes. Additionally, absorption increases with frequent application or application to a significant skin surface. Absorption of betamethasone dipropionate from the skin is more pronounced in younger individuals than in adults. Gentamicin sulfate: Belongs to broad-spectrum antibiotics. It exhibits antibacterial activity against Gram-negative and some Gram-positive bacteria. Indications for its use in ointment form include secondary infections in skin diseases if the infection is caused by gentamicin-sensitive bacteria, as well as in cases of suspected such infection. Gentamicin sulfate is not absorbed after topical application to intact skin, but it may be systemically absorbed after application to traumatized, burned, or bruised skin. Gentamicin sulfate is not biotransformed in the body and is excreted unchanged with urine. Indications Betaderm is used topically for dry, inflammatory skin conditions (dermatoses), especially those of allergic origin, complicated by recurrent bacterial infection and characterized by excessive keratinization, itching, or severe allergic reactions, mainly in the following conditions: atopic dermatitis, seborrheic dermatitis, chronic simple lichen, hyperkeratotic eczema, psoriasis, allergic contact dermatitis, discoid lupus erythematosus, polymorphous erythema. Dosage Regimen Apply topically, a small amount of ointment should be applied to the affected skin surface 1-2 times a day. The ointment should not be used under an occlusive dressing. If a dressing is absolutely necessary, an air-permeable dressing should be used, and a tight cellophane dressing should not be used. Treatment should not exceed 2 weeks without interruption. It is not recommended to use more than 45 g of ointment per week. Side Effects The patient should report any side effects that develop during the use of the medication to the doctor. Prolonged use of the preparation beyond the doctor's recommendation is not allowed, as prolonged use over a large body surface area increases its absorption and the frequency of side effects such as edema, hypertension, increased blood glucose levels, and decreased immunity. In case of increased infection at the site of ointment application, the doctor may prescribe additional antimicrobial and antifungal treatment. The recommendation not to use the preparation on facial skin should be considered due to the risk of side effects such as prolonged dilation of small blood vessels, atrophy of subcutaneous tissue in the lip area, even with short-term use. Contraindications Hypersensitivity to corticosteroids, gentamicin, or any component of the ointment base. Viral, fungal, or tuberculous skin diseases, skin neoplasms, rosacea and juvenile acne, chickenpox, phlebitis, and tropical ulcers. It should not be used on extensive skin lesions, especially those with damaged skin integrity, such as burns. It should not be used for prolonged periods due to the development of bacterial resistance. It should not be used on facial skin. The preparation is not used in children under 12 years of age. Pregnancy and Lactation The use of Betaderm during pregnancy and lactation is not recommended. Special Instructions After applying the ointment to the skin, a cellophane dressing should not be applied, as it can lead to increased skin moisture and temperature. Use with caution in pre-existing atrophic conditions of subcutaneous tissue, especially in elderly individuals. Effect on Ability to Drive and Operate Machinery: The preparation does not limit mental capacity, ability to drive, or operate machinery. Interaction with Other Drugs Vaccination against chickenpox is not recommended during treatment with glucocorticosteroids. Other types of immunization should also not be carried out during treatment. Storage Conditions and Shelf Life Store the preparation at a temperature not exceeding 25°C, in a place protected from children, freezing is not allowed. Shelf life - 3 years. Dispensing Conditions from Pharmacy: The preparation is dispensed without a prescription.