Beloderm cream for external use 40 g
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Active ingredients
Betamethasone
Release form
Cream
Composition
Cream for external use 0.05% white, homogeneous, without mechanical impurities. 1 g of betamethasone dipropionate 640 mcg, which corresponds to the content of betamethasone 500 mcg. Excipients: chlorocariol, sodium dihydrogen phosphate monohydrate, phosphoric acid, petrolatum, mineral oil, macrogol cetostearate, cetostearyl alcohol (cetyl alcohol 60%, tegdostearate, cetostearyl alcohol (cetyl alcohol 60%, tegrestearate, cetostearyl alcohol (cetyl alcohol 60%, cetotetearate, cetostearyl alcohol (cetyl alcohol 60%, cetotetearate, cetostearyl alcohol) (cetyl alcohol 60%, cetostearate, cetostearyl alcohol (cetyl alcohol 60%, cetotetearate, cetostearyl alcohol (cetyl alcohol, 60%, cetostearate, cetostearyl alcohol) (cetyl alcohol 60%, cetotetearate, cetostearyl alcohol (cetyl alcohol 60%, cetotetearate, cetostearyl alcohol (60% cetyl alcohol, 60% of cetostearate, cetostearyl alcohol water.
Pharmacological effect
GKS. Suppresses the function of leukocytes and tissue macrophages. Limits the migration of leukocytes to the area of inflammation. Violates the ability of macrophages to phagocytosis, as well as the formation of interleukin-1. It contributes to the stabilization of lysosomal membranes, thereby reducing the concentration of proteolytic enzymes in the area of inflammation. Reduces capillary permeability due to histamine release. Suppresses the activity of fibroblasts and the formation of collagen. Inhibits the activity of phospholipase A2, which leads to the suppression of the synthesis of prostaglandins and leukotrienes. Suppresses the release of COX (mainly COX-2), which also helps to reduce the production of prostaglandins. Reduces the number of circulating lymphocytes (T-and B-cells), monocytes, eosinophils and basophils due to their movement from the vascular bed to the lymphoid tissue. inhibits the formation of antibodies. Betamethasone inhibits the release of pituitary ACTH and &. 946.-Lipotropin, but does not reduce the level of circulating & # 946.-Endorphin. It inhibits the secretion of TSH and FSH. With the direct application of the vessels has a vasoconstrictor effect. Betamethasone has a pronounced dose-dependent effect on the metabolism of carbohydrates, proteins and fats. Stimulates gluconeogenesis, promotes the uptake of amino acids by the liver and kidneys and increases the activity of gluconeogenesis enzymes. In the liver, betamethasone enhances the deposition of glycogen, stimulating the activity of glycogen synthetase and the synthesis of glucose from the products of protein metabolism. An increase in blood glucose activates insulin secretion. Betamethasone inhibits glucose uptake by fat cells, which leads to activation of lipolysis. However, due to an increase in insulin secretion, lipogenesis is stimulated, which contributes to the accumulation of fat.It retains sodium ions and water in the body, stimulates the excretion of potassium ions, reduces the absorption of calcium from the gastrointestinal tract, flushes calcium ions from the bones, and increases the excretion of calcium by the kidneys. It has a catabolic effect in the lymphoid and connective tissue, muscles, adipose tissue, skin, bone tissue. Osteoporosis and Itsenko-Cushing syndrome are the main factors limiting long-term therapy of corticosteroids. As a result of the catabolic effect, growth can be suppressed in children. In high doses, betamethasone may increase the excitability of the brain tissue and help lower the threshold of convulsive readiness. Stimulates excessive production of hydrochloric acid and pepsin in the stomach, which leads to the development of peptic ulcers. With systemic use, the therapeutic activity of betamethasone is due to the anti-inflammatory, anti-allergic, immunosuppressive and anti-proliferative effect. When applied topically and locally, the therapeutic activity of betamethasone is due to the anti-inflammatory, antiallergic and anti-exudative (due to the vasoconstrictor effect) action. On anti-inflammatory activity exceeds hydrocortisone 30 times, does not possess mineralocorticoid activity. The presence of fluorine in the molecule enhances the anti-inflammatory activity of betamethasone. Betamethasone dipropionate is characterized by a prolonged action.
Indications
For oral administration: primary or secondary insufficiency of adrenal function, congenital adrenal hyperplasia, acute (nonpurulent) and subacute thyroiditis, hypercalcemia due to neoplastic disease, rheumatic diseases, collagen diseases, allergic diseases, symptomatic sarcoidosis, sympathetic sarcoidosis, allergic syndrome, symptomatic sarcoidosis, bifigiosis syndrome, bridiosis, allergic diseases, symptomatic sarcoidosis, bifigiosis syndrome, idiopathic disease, allergic diseases adults, autoimmune hemolytic anemia, erythroblastopenia (erythrocyte anemia), erythroid hypoplastic anemia, transfusion e reactions, palliative therapy of leukemia and lymphoma in adults and acute leukemia in children. ulcerative colitis, Bell's palsy. For parenteral use: shock (including burn, traumatic, operative, toxic, cardiogenic, blood transfusion, anaphylactic). allergic reactions (acute, severe forms), anaphylactoid reactions. swelling of the brain (includingon the background of a brain tumor or associated with surgery, radiation therapy or head injury), increased intracranial pressure. bronchial asthma (severe), asthmatic status. systemic connective tissue diseases (SLE, rheumatoid arthritis). acute adrenal insufficiency, prevention of adrenal insufficiency in patients who have received SCS for a long time. thyrotoxic crisis. acute hepatitis, hepatic coma. poisoning with cauterizing liquids. croup in diphtheria (in combination with appropriate antimicrobial therapy). For intraarticular injection: rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteochondritis, acute gouty arthritis. Soft tissue diseases (including bursitis, fibrositis, tendonitis, tendosynoviitis, myositis). For external use: dermatosis, various types of eczema (including atopic, pediatric, numular), knotty scratches Gaida, simple dermatitis, exfoliative dermatitis, neurodermatitis, solar dermatitis, seborrheic dermatitis, radiation dermatitis, diaper rash, psoriasis (except for extensive plaque psoriasis), cutaneous or anogenital (excluding Candidomycosis) pruritus, discoid lupus erythematosus, as an adjunct in the complex therapy of generalized erythroderma. For local use: diseases of the eye and ear with a pronounced allergic or inflammatory component.
Use during pregnancy and lactation
Use with caution in parasitic and infectious diseases of viral, fungal or bacterial nature (currently or recently transferred, including recent contact with a patient) - herpes simplex, herpes zoster (viraemic phase), chicken pox, measles, amebiasis, strongyloidosis (established or suspect), systemic mycosis. active and latent tuberculosis. Use in severe infectious diseases is permissible only against the background of specific therapy. Use with caution for 8 weeks before and 2 weeks after vaccination), for lymphadenitis after BCG vaccination, for immunodeficiency states (including AIDS or HIV infection). Use with caution in diseases of the gastrointestinal tract: gastric ulcer and duodenal ulcer, esophagitis, gastritis, acute or latent peptic ulcer, a newly created intestinal anastomosis, ulcerative colitis with the threat of perforation or abscess formation, diverticulitis. Use with caution in diseases of the cardiovascular system, incl.after a recent myocardial infarction (patients with acute and subacute myocardial infarction may spread necrosis, slow the formation of scar tissue and, as a result, rupture of the heart muscle), with decompensated chronic heart failure, hypertension, hyperlipidemia), with endocrine diseases - diabetes mellitus ( including violation of tolerance to carbohydrates), thyrotoxicosis, hypothyroidism, Itsenko-Cushing's disease, with severe chronic renal and / or liver failure, nephrourolithiasis, with hypoalbuminemia and conditions predisposing to its occurrence, with systemic osteoporosis, myasthenia, acute psychosis, obesity (III-IV degree), with poliomyelitis (with the exception of the form of bulbar encephalitis), open-and-close-angle glaucoma, gestation, open and closed-angle glaucoma, pregnancy, and, to a wI, to a hearth, to get rid of . If necessary, intra-articular administration should be used with caution in patients with a general serious condition, inefficiency (or short duration) of the effect of 2 previous injections (taking into account the individual properties of the used GCS). When ingestion is necessary to control the level of glucose in the blood, blood pressure, indicators of water and electrolyte balance. In the event of irritation or the onset of symptoms of hypersensitivity to betamethasone, treatment should be discontinued and appropriate therapy should be carried out. When joining a secondary infection, treatment is carried out with appropriate antimicrobial agents. Not indicated for the treatment of neonatal hyaline membrane disease. It should not be used externally for the treatment of primary skin lesions during fungal (eg, candidiasis, trichophytosis) and bacterial (eg impetigo) infections, perianal and anogenital itching.
Side effects
From endocrine system: reduction of glucose tolerance, steroid diabetes or a manifestation of latent diabetes mellitus, adrenal suppression, Cushing's syndrome (including moon face, obesity, pituitary type, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia gravis , striae), delayed sexual development in children. On the part of metabolism: increased excretion of calcium ions, hypocalcemia, increased body weight, negative nitrogen balance (increased protein breakdown), increased sweating, fluid retention and sodium ions (peripheral edema), hypernatremia, hypokalemic syndrome (including hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue.CNS: delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure, nervousness or anxiety, insomnia, dizziness, vertigo, cerebellar pseudo-tumor, headache, convulsions. Since the cardiovascular system: arrhythmias, bradycardia (up to cardiac arrest). development (in susceptible patients) or increased severity of chronic heart failure, ECG changes characteristic of hypokalemia, increased blood pressure, hypercoagulation, thrombosis. In patients with acute and subacute myocardial infarction - the spread of necrosis, slowing the formation of scar tissue, which can lead to rupture of the heart muscle. with intracranial administration - nosebleeds. On the part of the digestive system: nausea, vomiting, pancreatitis, steroid gastric and duodenal ulcer, erosive esophagitis, bleeding and perforation of the gastrointestinal tract, increased or decreased appetite, flatulence, hiccups. In rare cases - increased activity of hepatic transaminases and alkaline phosphatase. On the part of the senses: a sudden loss of vision (when parenterally administered in the head, neck, nasal conchaeta, scalp may be deposited crystals of the drug in the eye vessels), posterior subcapsular cataract, increased intraocular pressure with possible damage to the optic nerve, a tendency to develop secondary bacterial , fungal or viral infections of the eyes, trophic changes of the cornea, exophthalmos. On the part of the musculoskeletal system: growth retardation and ossification processes in children (premature closure of the epiphyseal growth zones), osteoporosis (very rarely - pathological bone fractures, aseptic necrosis of the head of the humerus and femur), muscle tendon rupture, steroid myopathy, muscle mass reduction (atrophy). with intra-articular injection - increased pain in the joint. Dermatological reactions: delayed wound healing, petechiae, ecchymosis, thinning of the skin, hyper- or hypopigmentation, steroid acne, stretch marks, tendency to the development of pyoderma and candidiasis. Allergic reactions: generalized (skin rash, itchy skin, anaphylactic shock), local allergic reactions.Local reactions: with parenteral administration - burning, numbness, pain, paresthesias and infections at the injection site, rarely - necrosis of surrounding tissues, scarring at the injection site. with intramuscular injection (especially in the deltoid muscle), atrophy of the skin and subcutaneous tissue. Others: the development or exacerbation of infections (the joint use of immunosuppressants and vaccination contribute to the occurrence of this side effect), leukocyturia, withdrawal syndrome. With a / in the introduction - arrhythmias, "flushes" of blood to the face, convulsions. When applied topically: rarely - itching, hyperemia, burning, dryness, folliculitis, acne, hypopigmentation, perioral dermatitis, allergic dermatitis, skin maceration, secondary infection, skin atrophy, stria, strep. With prolonged use or application to large areas of skin may develop systemic side effects characteristic of GCS.
special instructions
From endocrine system: reduction of glucose tolerance, steroid diabetes or a manifestation of latent diabetes mellitus, adrenal suppression, Cushing's syndrome (including moon face, obesity, pituitary type, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia gravis , striae), delayed sexual development in children. On the part of metabolism: increased excretion of calcium ions, hypocalcemia, increased body weight, negative nitrogen balance (increased protein breakdown), increased sweating, fluid retention and sodium ions (peripheral edema), hypernatremia, hypokalemic syndrome (including hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue. CNS: delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure, nervousness or anxiety, insomnia, dizziness, vertigo, cerebellar pseudo-tumor, headache, convulsions. Since the cardiovascular system: arrhythmias, bradycardia (up to cardiac arrest). development (in susceptible patients) or increased severity of chronic heart failure, ECG changes characteristic of hypokalemia, increased blood pressure, hypercoagulation, thrombosis. In patients with acute and subacute myocardial infarction - the spread of necrosis, slowing the formation of scar tissue, which can lead to rupture of the heart muscle. with intracranial administration - nosebleeds.On the part of the digestive system: nausea, vomiting, pancreatitis, steroid gastric and duodenal ulcer, erosive esophagitis, bleeding and perforation of the gastrointestinal tract, increased or decreased appetite, flatulence, hiccups. In rare cases - increased activity of hepatic transaminases and alkaline phosphatase. On the part of the senses: a sudden loss of vision (when parenterally administered in the head, neck, nasal conchaeta, scalp may be deposited crystals of the drug in the eye vessels), posterior subcapsular cataract, increased intraocular pressure with possible damage to the optic nerve, a tendency to develop secondary bacterial , fungal or viral infections of the eyes, trophic changes of the cornea, exophthalmos. On the part of the musculoskeletal system: growth retardation and ossification processes in children (premature closure of the epiphyseal growth zones), osteoporosis (very rarely - pathological bone fractures, aseptic necrosis of the head of the humerus and femur), muscle tendon rupture, steroid myopathy, muscle mass reduction (atrophy). with intra-articular injection - increased pain in the joint. Dermatological reactions: delayed wound healing, petechiae, ecchymosis, thinning of the skin, hyper- or hypopigmentation, steroid acne, stretch marks, tendency to the development of pyoderma and candidiasis. Allergic reactions: generalized (skin rash, itchy skin, anaphylactic shock), local allergic reactions. Local reactions: with parenteral administration - burning, numbness, pain, paresthesias and infections at the injection site, rarely - necrosis of surrounding tissues, scarring at the injection site. with intramuscular injection (especially in the deltoid muscle), atrophy of the skin and subcutaneous tissue. Others: the development or exacerbation of infections (the joint use of immunosuppressants and vaccination contribute to the occurrence of this side effect), leukocyturia, withdrawal syndrome. With a / in the introduction - arrhythmias, "flushes" of blood to the face, convulsions. When applied topically: rarely - itching, hyperemia, burning, dryness, folliculitis, acne, hypopigmentation, perioral dermatitis, allergic dermatitis, skin maceration, secondary infection, skin atrophy, stria, strep. With prolonged use or application to large areas of skin may develop systemic side effects characteristic of GCS.