Betasalin solution for external use (0.5mg+20mg)/1ml 25ml №1

Name:
Betasalin solution dn.prim.(0.5mg + 20mg) 1ml in vial 25ml in pack No. 1
Description:
Transparent colorless or yellowish viscous solution. The main active ingredient Betamethasone + salicylic acid Release form Solution Dosage 25 ml Pharmacological properties Pharmacodynamics Combined drug for external use, the therapeutic effect of which is due to the pharmacological properties of its constituent active substances. Betamethasone is a synthetic fluorinated glucocorticoid that has anti-inflammatory, antipruritic and vasoconstrictive effects. Salicylic acid has a keratolytic, bacteriostatic, fungicidal effect. Pharmacokinetics Penetration and absorption of the drug through the skin depends on the area of the body, skin condition, age, method of application, use of occlusive dressings. Inflammatory and/or other pathological processes in the skin may increase absorption. Occlusive dressings significantly increase the absorption of topical corticosteroids. Under normal conditions, only a portion of the topically applied dose of corticosteroids becomes available systemically. The penetration and absorption of the corticosteroid is enhanced by the salicylic acid contained in the preparation. After absorption through the skin, topical corticosteroids undergo pharmacokinetic pathways similar to those of systemic corticosteroids. Corticosteroids bind to plasma proteins to varying degrees, are metabolized in the liver and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are excreted in the bile. The penetration rate of salicylic acid depends on the site of application and the condition of the skin. Absorption is particularly increased in psoriatic erythroderma or dermatoses associated with inflammatory or erosive changes in the skin. Salicylic acid is metabolized in the liver. The elimination half-life is within the normal dose range of 2 to 3 hours. Indications for use For local treatment of dermatoses sensitive to glucocorticosteroid therapy: seborrheic dermatitis of the scalp; psoriasis of the scalp; psoriatic lesions of other localization; dermatoses accompanied by hyperkeratosis, in which glucocorticosteroid therapy is indicated. Method of administration and doses External (topical application). The frequency and method of application should be prescribed by a doctor. For adults and children over 2 years of age, apply a few drops of the solution to the affected areas, gently massage into the skin or scalp. Usually applied twice a day – morning and evening. In some patients, a satisfactory effect can be achieved with less frequent use of the drug. The use of the drug should not be continued for more than 2 weeks. On the skin of the face, the drug should not be used for more than 5 days. For a week, you can not use more than 20 ml of the drug. In children, do not use this medicinal product under the age of 2 years. For children over 2 years of age, the drug is used with caution, only once a day on small areas of the skin – due to the fact that with a larger area of skin in relation to body weight compared to adults and underdeveloped epidermis in children, absorption is possible. proportionally more betamethasone, and, accordingly, salicylic acid, and, consequently, the manifestation of systemic toxicity. Do not use on the skin of the face in children. Application under diapers (especially plasticized ones) enhances absorption, because. the diaper acts as an occlusive dressing. The duration of use of the drug in children should not exceed 5 days. The surface area of the body to which the drug is applied should not exceed 10% in children. Use during pregnancy and lactation The safety of the use of local corticosteroids in pregnant women has not been established. Since it has not yet been clarified whether local GCS penetrate into mother’s milk, the issue of stopping breastfeeding or the use of the drug should be decided. Precautions If skin irritation or hypersensitivity to the drug occurs during the use of Betasalin, treatment should be discontinued. In case of infection, appropriate therapy should be prescribed. Systemic absorption of corticosteroids and salicylic acid when applied topically will be the higher, the larger the body surface is treated. Appropriate precautions should be taken if long-term use of the drug is expected, especially in children. Application of salicylic acid to an open wound or damaged skin is not allowed. When using Betasalin, do not use closing bandages. If dryness or irritation of the skin occurs, treatment with the drug should be discontinued. With prolonged treatment with the drug, its cancellation is recommended to be carried out gradually. Betasalin solution is not intended for use in ophthalmology. Avoid contact with eyes and mucous membranes. Long-term use on the skin of the face is not recommended. Avoid use in the anogenital area. Topical corticosteroids can be dangerous in psoriasis for a number of reasons, including exacerbation of the disease due to the development of tolerance, the risk of widespread pustular eruptions, and local systemic toxicity due to impaired skin barrier function. Careful observation of patients is recommended. Application in pediatrics. Children are more at risk of suppression of the function of the hypothalamic-pituitary-adrenal system due to the use of local corticosteroids than adults, due to their greater ratio of body surface area and weight and, accordingly, increased absorption of the drug. Suppression of the function of the hypothalamic-pituitary-adrenal system in children is determined by low plasma cortisol levels and lack of response to adrenocorticotropic hormone stimulation. An increase in intracranial pressure is manifested by a protrusion of the fontanel, headaches, bilateral edema of the optic nerve head. Interaction with other drugs During treatment with the drug, it is contraindicated to carry out vaccinations and immunizations due to the immunosuppressive effect of the drug. It should not be given in combination with other topical drugs. With systemic absorption of the drug, GCS reduces the effect of insulin, oral hypoglycemic agents, antihypertensive drugs, anticoagulants, and reduces the concentration of praziquantel in the blood serum. Increases the risk of side effects of the combination of betasalin with the following drugs: androgens, estrogens, oral contraceptives, anabolic steroids (hirsutism, acne), antipsychotics, bucarban, azathioprine (cataract), anticholinergics, antihistamines, tricyclic antidepressants, nitrates (glaucoma) , diuretics (hypokalemia), cardiac glycosides (digitalis intoxication). Contraindications hypersensitivity to any of the components of the drug; children’s age up to 2 years; pregnancy; lactation period; rosacea; perioral dermatitis; perianal itching; acne bacterial, viral or fungal infection of the skin (pyoderma, syphilis, skin tuberculosis, Herpes simplex, chicken pox, Herpes zoster, actinomycosis, blastomycosis, sporotrichosis); trophic ulcers against the background of chronic venous insufficiency; skin tumors (skin cancer, nevus, atheroma, epithelioma, melanoma, hemangioma, xanthoma, sarcoma); post-vaccination skin reactions; diaper dermatitis; itching in the vulva; on large areas of the skin, especially with damage to the skin, such as burns. With caution: children under 12 years of age; liver failure; long-term therapy. Composition 1 ml of the solution contains as active ingredients betamethasone (in the form of betamethasone dipropionate) 0.5 mg and salicylic acid 20 mg. Excipients: isopropyl alcohol, disodium edetate, hypromellose, sodium hydroxide, purified water. OverdoseSymptoms: Excessive or prolonged use of topical corticosteroids can lead to suppression of the function of the pituitary-adrenal system, which can lead to the development of secondary adrenal insufficiency and the appearance of symptoms of hypercoticism, including Cushing’s disease. Excessive or prolonged use of topical preparations containing salicylic acid may cause symptoms of salicylism. Treatment: Appropriate symptomatic treatment is indicated. Acute symptoms of hypercortisolism are usually reversible. If necessary, correction of electrolyte imbalance is indicated. In case of chronic toxic effects, slow withdrawal of corticosteroids is recommended. Treatment of salicylism is symptomatic. Take measures to more quickly remove salicylates from the body. Orally, sodium bicarbonate is used to alkalinize urine and increase diuresis. Side effects At the beginning of treatment Immune system: hypersensitivity reactions. Skin: skin irritation, burning, itching, dryness. Longer use Skin: skin atrophy, telangiectasias (risk is high especially on the face), skin hemorrhages, striae, acne, occurrence or exacerbation of rosacea, perioral dermatitis, hypertrichosis, depigmentation, pustular rash. Topical corticosteroids can cause delayed wound healing, pressure sores, and leg ulcers. When used on large surfaces and / or with prolonged use under an occlusive dressing Infections: infections. Endocrine system: suppression of the synthesis of endogenous corticosteroids, hypercoticism with edema. Metabolism: diabetes mellitus (manifestation of a latent disease). Skin: stretch marks. Musculoskeletal system: osteoporosis, growth retardation in children General disorders and reactions at the site of application: edema. With prolonged or excessive use of local glucocorticosteroids, it is possible to suppress the pituitary-adrenal function with the development of secondary adrenal insufficiency and the appearance of symptoms of hypercorticism, including Cushing’s disease. Prolonged or excessive use of topical corticosteroids with salicylic acid may lead to symptoms of salicism. Long-term use of salicylic acid preparations can cause dermatitis. In the event of the listed adverse reactions, as well as reactions not listed in the instructions for use, you should consult a doctor. Storage conditions In a place protected from light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Betasalin solution for external use (0.5mg + 20mg) / 1ml 25ml No. 1 external use (0.5mg+20mg)/1ml 25ml №1