Beloderm express spray vneshn. 20ml
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Active ingredients
Betamethasone
Release form
Spray
Composition
Betamethasone dipropionate 0.640 mg, which corresponds to the content of betamethasone 0.5 mg. Adjuvants: isopropanol 400 mg, carbomer 934P 2.5 mg, water 596.86 mg, sodium hydroxide q.s.
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 ACTH pituitary and β-lipotropin, but does not reduce the level of circulating β-endorphin. Inhibits the secretion of TSH and FSH. When directly applied to the vessels, it 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 the activation of lipolysis. However, due to an increase in insulin secretion, lipogenesis is stimulated, which contributes to the accumulation of fat. Detains sodium 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, increases the excretion of calcium by the kidneys. connective tissue, muscle, 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 action, growth inhibition in children is possible. In high doses, betamethasone can increase the excitability of 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 anti-inflammatory, antiallergic, immunodepressive and anti-proliferative effects. effect) by action. By anti-inflammatory active STI than hydrocortisone 30 times, has no mineralocorticoid activity. The presence of fluorine in the molecule enhances the anti-inflammatory activity of betamethasone. Betamethasone in the form of dipropionate is characterized by a prolonged action.
Pharmacokinetics
Plasma protein binding is about 64%, Vd - 84 l. Metabolized in the liver. Metabolites are excreted mainly by the kidneys, a small part - with bile. When absorbed through the skin, betamethasone is characterized by similar pharmacokinetic properties, both when applied externally and systemically. Systemic absorption after external use is 12-14%. In case of local and external use with intact skin, absorption may be negligible. The presence of an inflammatory process, as well as the use of an occlusive dressing, may increase the amount of suction.
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, Bella palsy. For parenteral use: shock (includingburn, traumatic, operational, toxic, cardiogenic, blood transfusion, anaphylactic); allergic reactions (acute, severe forms), anaphylactoid reactions; swelling of the brain (including against 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 received GCS 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 administration: rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteochondritis, acute gouty arthritis. Diseases of soft tissues (including bursitis, fibrositis, tendonitis, tendosynoviitis, myositis). For external use: dermatosis, various types of eczema (including atopic, pediatric, numular), knotty rude Gaida, simple dermatitis, exfoliative dermatitis, neurodermatitis, sun dermatitis, seborrheic dermatitis, radiation dermatitis, diaper rash, psoriasis (except for extensive plaque psoriasis), skin or anogenital (excluding candidomycosis), pruritus, discoid lupus erythematosus, as an adjuvant in complex therapy eneralizovannoy eritrodermii.Dlya topical application: the eyes and ears with severe allergic or inflammatory component.
Contraindications
For short-term use for vital reasons - hypersensitivity to betamethasone. For intra-articular administration and administration directly into the lesion: anterior arthroplasty, abnormal bleeding (endogenous or caused by the use of anticoagulants), intra-articular fracture of the bone, infectious (septic) inflammation in the joint and periartikulykulyarku (including in history), as well as a common infectious disease, marked periarticular osteoporosis, no signs of inflammation Lenia in the joint (dry joint, such as osteoarthritis without synovitis)severe bone destruction and deformity of the joint (sharp narrowing of the joint space, ankylosis), joint instability as an outcome of arthritis, aseptic necrosis of the epiphysis of the bones forming the joint. For external use: acne rosacea, acne and common (youth) acne; primary viral infections of the skin (including chicken pox).
Precautionary measures
Application for violations of liver functionWith caution in severe chronic hepatic insufficiency. Use for disorders of renal functionWith caution in severe chronic renal failure, nephrorolithiasis.
Use during pregnancy and lactation
Use during pregnancy is possible in exceptional cases under strict indications. If necessary, use during lactation breastfeeding should be stopped.
Dosage and administration
The dose is set individually. When taken orally, the daily dose for adults is 0.25-8 mg, for children - 17-250 mcg / kg. After prolonged use, the abolition of betamethasone should be made gradually, reducing the dose by 250 mcg every 2-3 days. For intravenous injection (jet slow or drip), a single dose is 4-8 mg, if necessary, an increase to 20 mg is possible; maintenance dose is usually 2-4 mg. A single dose for intramuscular administration is 4-6 mg. For intra-articular injection and introduction directly into the lesion in diseases of soft tissues, depending on the size of the joint and the size of the lesion, a single dose is 0.4-6 mg. Subconjunctival single dose - 2 mg. When applied topically, apply a thin layer on the affected skin 2-6 times / day until clinical improvement, then apply 1-2 times / day. When using betamethasone in children, as well as in patients with lesions of the face, the course of treatment should not exceed 5 days.
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 side of metabolism: increased excretion of calcium ions, hypocalcemia, increased body weight, negative nitrogen balance (increased protein breakdown), increased sweating, ass rzhka fluids and sodium ions (peripheral edema), hypernatremia, hypokalemic syndrome (includinghypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue) For part of the central nervous system: delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure, nervousness or anxiety, insomnia, dizziness, vertigo, cerebellar pseudotumor, headache, convulsions. From 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; for intracranial administration - nasal bleeding. From 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 membrane cells. From the sensory organs: sudden loss of vision (when administered parenterally in the head, neck, nasal conchaea, scalp, it is possible the deposition of 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 eye, trophic changes of the cornea, exophthalmos. From the musculoskeletal system: slow of growth and ossification processes in children (premature closure of the epiphyseal growth zones), osteoporosis (very rarely - pathological bone fractures, aseptic necrosis of the humeral head and the femur), the gap muscle tendons, steroid myopathy, loss of muscle mass (atrophy); with intra-articular injection - increased pain in the joint. Dermatological reactions: delayed wound healing, petechiae, ecchymosis, skin thinning, hyper or hypopigmentation, steroid acne, stria, a tendency to develop 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 (jointly used immunosuppressants and vaccination contribute to the occurrence of this side effect), leukocyturia, withdrawal syndrome. hot flushes, convulsions. When applied topically: rarely - itching, hyperemia, burning, dryness, folliculitis, acne, hypopigmentation, perioral dermatitis, allergic dermatitis, skin maceration, secondary infection, skin atrophy, stria, streak. With prolonged use or application to large areas of skin may develop systemic side effects characteristic of GCS.
Interaction with other drugs
With simultaneous use with cardiac glycosides, their action is enhanced; with diuretics - excretion of potassium increases; with hypoglycemic drugs, oral anticoagulants - weakening of their action; with NSAIDs - increases the risk of erosive and ulcerative lesions and bleeding from the gastrointestinal tract.
special instructions
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 on 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). С use with caution in gastrointestinal diseases: gastric ulcer and duodenal ulcer, esophagitis, gastritis, acute or latent peptic ulcer, newly created intestinal anastomosis, ulcerative colitis with the threat of perforation or abscess ation, divertikulite.S wary of in diseases of the cardiovascular system, includingafter 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 it is necessary to use intra-articular administration 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). Birmingham into the need to control the level of blood glucose, 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 attaching a secondary infection, treatment is carried out with appropriate antimicrobial agents. It is not indicated for the treatment of hyaline membrane disease in newborns. It should not be used topically to treat primary skin lesions during fungal (eg, candidiasis, trichophytosis) and bacterial (eg, impetigo) infections, perianal and anogenital itch .