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Betamethasone - instructions for use, analogs, reviews and release forms (injections in injectable ampoules, ointment or substance-based gel, Valerat and Dipropionate) for use in adults, children and pregnancy. Composition

Betamethasone - instructions for use, analogs, reviews and release forms (injections in injectable ampoules, ointment or substance-based gel, Valerat and Dipropionate) for use in adults, children and pregnancy. Composition

In this article you can get acquainted with the instructions for the use of a hormonal drug Betamethasone. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Betamethasone in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of betamethasone in the presence of existing structural analogues.Use for the treatment of systemic diseases, shock, rheumatological diseases in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

 

Betamethasone - Glucocorticosteroid (GCS), a hormone. Suppresses the function of white blood cells and tissue macrophages. Limits the migration of leukocytes to the area of ​​inflammation. Violates the ability of macrophages to phagocytosis, as well as to the formation of interleukin-1. Promotes the stabilization of lysosomal membranes, thereby reducing the concentration of proteolytic enzymes in the area of ​​inflammation. Reduces the permeability of capillaries due to the release of histamine. Suppresses the activity of fibroblasts and the formation of collagen.

 

Inhibits the activity of phospholipase A2, which leads to suppression of the synthesis of prostaglandins and leukotrienes. Suppresses the release of COX (mainly COX-2), which also contributes to a decrease in 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 into the lymphoid tissue; suppresses the formation of antibodies.

 

Betamethasone suppresses pituitary release of ACTH and beta-lipotropin, but does not reduce the level of circulating beta-endorphin. Oppresses the secretion of TSH and FSH.

 

With direct application on 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 capture of amino acids by the liver and kidneys and increases the activity of gluconeogenesis enzymes. In the liver, betamethasone enhances the storage of glycogen, stimulating the activity of glycogen synthetase and the synthesis of glucose from protein metabolism products. Increasing the glucose level in the blood activates the release of insulin.

 

Betamethasone suppresses the capture of glucose by fat cells, which leads to activation of lipolysis. However, due to an increase in the secretion of insulin, lipogenesis stimulates, which contributes to the accumulation of fat.

 

It detains sodium ions and water in the body, stimulates the excretion of potassium ions, reduces absorption of calcium from the digestive tract, cleans calcium ions from the bones, increases the excretion of calcium by the kidneys.

 

Has catabolic effect in lymphoid and connective tissue, muscles, fatty tissue, skin, bone tissue.Osteoporosis and Itenko-Cushing's syndrome are the main factors limiting long-term therapy to SCS. As a result of catabolic action, growth can be suppressed in children.

 

In high doses, betamethasone can increase the excitability of brain tissue and helps lower the threshold of convulsive readiness. Stimulates excess production of hydrochloric acid and pepsin in the stomach, which leads to the development of peptic ulcers.

 

In systemic application, the therapeutic activity of betamethasone is due to anti-inflammatory, antiallergic, immunosuppressive and antiproliferative action.

 

With external and local application, the therapeutic activity of betamethasone is due to anti-inflammatory, antiallergic and antiexcudative (due to vasoconstrictor effect) action.

 

For anti-inflammatory activity exceeds Hydrocortisone 30 times, does not have 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.

 

Composition

 

Betamethasone + excipients.

 

Pharmacokinetics

 

Binding to plasma proteins is about 64%. Metabolised 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 with external and with systemic application. Systemic absorption after external application is 12-14%.

 

For 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, can increase the amount of absorption.

 

Indications

 

For oral administration: primary or secondary insufficiency of the adrenal gland function, congenital adrenal hyperplasia, acute (nasal) and subacute thyroiditis, hypercalcemia due to tumor disease, rheumatic diseases, collagen diseases, allergic diseases, symptomatic sarcoidosis, Leffler's syndrome, berylliosis, idiopathic or secondary thrombocytopenia adults, autoimmune hemolytic anemia, erythroblastopenia (red cell anemia), erythroid hypoplastic anemia, transfusion e response, palliative therapy of leukemia and lymphoma in adults and acute leukemia in children; ulcerative colitis, Bell's paralysis.

 

For parenteral administration: shock (including burn, traumatic, operational, toxic, cardiogenic, hemotransfusion, anaphylactic); allergic reactions (acute, severe forms), anaphylactoid reactions; cerebral edema (including on the background of a brain tumor or associated with surgical intervention, radiation therapy or head trauma), increased intracranial pressure; bronchial asthma (severe form), asthmatic status; systemic connective tissue diseases (SLE, rheumatoid arthritis); acute adrenal insufficiency, prevention of insufficiency of the adrenal cortex in patients who received SCS for a long time; thyrotoxic crisis; acute hepatitis, hepatic coma; poisoning cauterizing fluids; cereals 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, tendosinovitis, myositis).

 

For external use: dermatoses, various types of specimens (incl.atopic, pediatric, numeral), gnawing pruritus Gaida, simple dermatitis, exfoliative dermatitis, neurodermatitis, sun dermatitis, seborrheic dermatitis, radiation dermatitis, diaper rash, psoriasis (except for extensive plaque psoriasis), cutaneous or anogenital (excluding candidemycosis) itching, discoid red lupus, as an aid in the treatment of generalized erythroderma.

 

For topical application: eye and ear diseases with a pronounced allergic or inflammatory component.

 

Forms of release

 

Solution for intravenous, intraarticular and intramuscular injection (injections in ampoules for injection).

 

Pills.

 

It is used as an active ingredient in various ointments, creams and gels (Celestoderm B, Beloderm and others).

 

Instructions for use and dosing regimen

 

The dose is set individually.

 

At intake the daily dose for adults makes 0.25-8 mg, for children - 17-250 mkg / kg. After long-term use, the abolition of betamethasone should be carried out gradually, reducing the dose by 250 micrograms every 2-3 days.

 

For intravenous administration (struino slowly or drip), a single dose is 4-8 mg, if necessary, an increase of up to 20 mg is possible; the maintenance dose is usually 2-4 mg.A single dose for intramuscular injection is 4-6 mg.

 

For intraarticular administration and administration directly to the lesion in soft tissue disorders, depending on joint size and lesion area size, a single dose of 0.4-6 mg.

 

Subconjunctivalally single dose - 2 mg.

 

For external application, apply a thin layer on the affected area of ​​the skin 2-6 times a day before clinical improvement, then apply 1-2 times a day. When using betamethasone in children, as well as in patients with facial lesions, the course of treatment should not exceed 5 days.

 

Side effect

 

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 , stria), delayed sexual development in children.

 

Metabolism: increased excretion of calcium ions, hypocalcemia, increase of body weight, negative Nitrogen balance (increased protein breakdown), increased sweating, fluid retention and sodium ions (peripheral edema), hypernatremia, hypokalemic syndrome (includinghypokalemia, 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, pseudotumor cerebellum, headache, convulsions.

 

From the cardiovascular system: arrhythmias, bradycardia (up to cardiac arrest); development (in predisposed patients) or increased severity of chronic heart failure, ECG changes typical of hypokalemia, increased blood pressure, hypercoagulation, thrombosis. In patients with acute and subacute myocardial infarction - the spread of the focus of necrosis, slowing the formation of scar tissue, which can lead to rupture of the heart muscle; when intracranial introduction - nosebleeds.

 

From the digestive system: nausea, vomiting, pancreatitis, steroid stomach ulcers and duodenal ulcers, 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.

 

From the senses: sudden loss of vision (with parenteral administration in the region of the head, neck, nasal concha, scalp may precipitate crystals of the drug in the vessels of the eye), posterior subcapsular cataracts, increased intraocular pressure with possible damage to the optic nerve, propensity to develop secondary bacterial , fungal or viral infections of the eyes, trophic changes in the cornea, exophthalmos.

 

From the musculoskeletal system: slowing growth 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 thigh bone), rupture of muscle tendons, steroid myopathy, (atrophy); with intra-articular injection - increased pain in the joint.

 

Dermatological reactions: delayed healing of wounds, petechiae, ecchymosis, thinning of the skin, hyper- or hypopigmentation, steroid acne, striae, propensity to develop pyoderma and candidiasis.

 

Allergic reactions: generalized (skin rash, skin itching, anaphylactic shock), local allergic reactions.

 

Local reactions: with parenteral administration - burning, numbness, pain, paresthesia and infection at the injection site, rarely - necrosis of surrounding tissues, scar formation at the injection site; when intramuscular introduction (especially in the deltoid muscle) - atrophy of the skin and subcutaneous tissue.

 

Other: development or exacerbation of infections (the appearance of this side effect is promoted by jointly used immunosuppressants and vaccination), leukocyturia, withdrawal syndrome.

 

With intravenous injection - arrhythmia, "tides" of blood to the face, convulsions.

 

With external application: rarely - itching, hyperemia, burning, dryness, folliculitis, acne, hypopigmentation, perioral dermatitis, allergic dermatitis, skin maceration, secondary infection, skin atrophy, striae, sweating. With prolonged use or application to large areas of the skin, it is possible to develop systemic side effects characteristic of GCS.

 

Contraindications

  • increased sensitivity to betamethasone;
  • previous arthroplasty;
  • pathological hemorrhage (endogenous or caused by the use of anticoagulants);
  • intra-articular bone fracture;
  • infectious (septic) inflammatory process in the joint and periarticular infections (including in the anamnesis), as well as general infectious disease;
  • pronounced near-joint osteoporosis;
  • absence of signs of inflammation in the joint ("dry" joint, for example, with osteoarthritis without synovitis);
  • severe bone destruction and joint deformity (a sharp narrowing of the joint space, ankylosis);
  • joint instability as the outcome of arthritis;
  • aseptic necrosis of the joints forming the epiphyses of bones;
  • rosacea;
  • acne and common (youthful) acne;
  • primary viral skin infections (including chicken pox).

 

Application in pregnancy and lactation

 

The use of betamethasone in pregnancy is possible in exceptional cases on strict indications.

 

If it is necessary to use lactation, breastfeeding should be discontinued.

 

Use in children

 

Outer is contraindicated in children and adolescents under the age of 1 year, then on strict indications.

 

special instructions

 

Use with caution in case of parasitic and infectious diseases of a viral, fungal or bacterial nature (currently or recently transferred,including recent contact with a patient) - herpes simplex, herpes zoster (viremicheskaya phase), chicken pox, measles, amoebiasis, strongyloidiasis (or suspected), systemic mycosis; active and latent tuberculosis. The use in severe infectious diseases is permissible only against the background of specific therapy.

 

Be wary of over 8 weeks before and 2 weeks post vaccination), at lymphadenitis after BCG vaccination with immunodeficiency (including AIDS or HIV infection).

 

Be wary of in diseases of the gastrointestinal tract: gastric ulcer and duodenal ulcers, esophagitis, gastritis, acute or latent peptic ulcer, recently established intestinal anastomosis, ulcerative colitis, with the threat of perforation or abscess, diverticulitis.

 

It is necessary to monitor the function of the hypothalamic-pituitary-adrenal system in patients receiving betamethasone preparations. For this purpose it is expedient to use such laboratory diagnostic methods, the stimulation of the adrenal cortex adrenocorticotropic hormone (ACTH), determination of free cortisol level in the urine.

 

With caution apply for diseases of the cardiovascular system, incl. after a recent myocardial infarction (in patients with acute and subacute myocardial infarction it is possible to spread the necrosis foci, slow the formation of scar tissue and, as a result, rupture of the heart muscle), with decompensated chronic heart failure, hypertension, hyperlipidemia), endocrine diseases - diabetes mellitus including violation of tolerance to carbohydrates), thyrotoxicosis, hypothyroidism, Itenko-Cushing's disease, with severe chronic renal and / or hepatic insufficiency, nephrourolythiasis, hypoalbuminemia and conditions predisposing to its occurrence, with systemic osteoporosis, myasthenia gravis, acute psychosis, obesity (grade 3-4), poliomyelitis (except for the form of bulbar encephalitis), open and closed angle glaucoma, pregnancy, lactation .

 

If necessary, intraarticular administration should be used with caution in patients with a general severe condition, ineffectiveness (or short-term) of the effect of the previous 2 injections (taking into account the individual properties of the SCS used).

 

When ingesting it is necessary to monitor blood glucose, blood pressure, electrolyte balance. In case of irritation or the appearance of symptoms of hypersensitivity to betamethasone treatment should be stopped and appropriate therapy should be carried out. When secondary infection is attached, appropriate antimicrobial agents are treated.

 

Not indicated for the treatment of hyaline membranes of newborns.

 

Do not use topically to treat primary skin lesions in fungal (eg, candidiasis, trichophytosis) and bacterial (eg, impetigo) infection, perianal and anogenital itching.

 

Drug Interactions

 

With simultaneous use with cardiac glycosides, their action is enhanced; with diuretics - the excretion of potassium increases; with hypoglycemic drugs, oral anticoagulants - weakening of their action; with non-steroidal anti-inflammatory drugs (NSAIDs) - the risk of erosive and ulcerative lesions and bleeding from the gastrointestinal tract increases.

 

Analogs of the drug Betamethasone

 

Structural analogs for the active substance:

  • Acriderm;
  • Beloderm;
  • Betazon;
  • Betamethasone Darnitsa;
  • Betamethasone sodium phosphate;
  • Betamethasone valerate;
  • Betamethasone dipropionate;
  • Betliben;
  • Betnoveit;
  • Diprospan;
  • Kuterid;
  • Flosteron;
  • Celestoderm B;
  • Celeston.

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