Endocrine diseases (acute insufficiency of the adrenal cortex, primary or secondary insufficiency of the adrenal cortex, congenital hyperplasia of the adrenal cortex, subacute thyroiditis);
- shock resistant to standard therapy; anaphylactic shock;
- cerebral edema (with a brain tumor, traumatic brain injury, neurosurgical intervention, cerebral hemorrhage, encephalitis, meningitis, radiation injury);
- asthmatic status; severe bronchospasm (exacerbation of bronchial asthma, chronic obstructive bronchitis);
- severe allergic reactions;
- rheumatic diseases;
- systemic connective tissue diseases;
- acute severe dermatoses;
- malignant diseases (palliative treatment of leukemia and lymphoma in adult patients; acute leukemia in children; hypercalcemia in patients with malignant tumors, if oral treatment is impossible);
- diagnostic study of adrenal hyperfunction;
- blood diseases (acute hemolytic anemia, agranulocytosis, idiopathic thrombocytopenic purpura in adults);
- severe infectious diseases (in combination with antibiotics);
- intra-articular and intra-synovial administration: arthritis of various etiologies, osteoarthritis, acute and subacute bursitis, acute tendovaginitis, epicondylitis, synovitis;
- local application (in the field of pathological education): keloids, discoid lupus erythematosus, annular granuloma.

For intra-articular administration: previous arthroplasty, pathological bleeding (endogenous or caused by the use of anticoagulants), intra-articular bone fracture, infectious (septic) inflammatory process in the joint and periarticular infections (including in history), as well as a general infectious disease, pronounced periarticular osteoporosis, no signs of inflammation in the joint (the so-called "dry" joint, for example, in osteoarthritis without synovitis), pronounced bone destruction and deformation of the joint (sharp narrowing of the joint space, ankylosis), joint instability as an outcome of arthritis, aseptic necrosis of the epiphyses of the bones forming the joint.

Post-vaccination period (a period lasting 8 weeks before and 2 weeks after vaccination), lymphadenitis after BCG vaccination. Immunodeficiency states (including AIDS or HIV infection).

Diseases of the gastrointestinal tract (peptic ulcer and 12 duodenal ulcer, esophagitis, gastritis, acute or latent peptic ulcer, recently created intestinal anastomosis, ulcerative colitis with the threat of perforation or abscess formation, diverticulitis).

Diseases of the cardiovascular system, incl. recent myocardial infarction (in patients with acute and subacute myocardial infarction, it is possible to spread the focus of necrosis, slow down the formation of scar tissue and, as a result, rupture of the heart muscle), decompensated chronic heart failure, arterial hypertension, hyperlipidemia.

Endocrine diseases - diabetes mellitus (including impaired carbohydrate tolerance), thyrotoxicosis, hypothyroidism, Itsenko-Cushing's disease.

Severe chronic renal and / or hepatic failure, nephrourolithiasis. Hypoalbuminemia and conditions predisposing to its occurrence.

Systemic osteoporosis, myasthenia gravis, acute psychosis, obesity (III-IV grade), poliomyelitis (except for the form of bulbar encephalitis), open and closed angle glaucoma, pregnancy, lactation.

For intra-articular administration: the general serious condition of the patient, the ineffectiveness (or short duration) of the action of 2 previous injections (taking into account the individual properties of the glucocorticosteroids used).

Method of administration and dosage:

Intramuscularly or intravenously - 0.5-9 mg / day.

For the treatment of cerebral edema - 10 mg in the first injection, then 4 mg intramuscularly every 6 hours until the symptoms disappear. The dose can be reduced after 2-4 days with gradual cancellation within 5-7 days after the elimination of cerebral edema. The maintenance dose is 2 mg 3 times / day.

For the treatment of shock - intravenously 20 mg in the first injection, then 3 mg / kg over 24 hours in the form of intravenous infusion or intravenous stream - from 2 to 6 mg / kg in the form of a single injection or 40 mg in the form of a single injection, given every 2 6 hours; possible intravenous administration of 1 mg / kg once. Shock therapy should be canceled as soon as the patient's condition stabilizes, the usual duration is no more than 2-3 days.

Allergic diseases - intramuscularly in the first injection of 4-8 mg. Further treatment is carried out with oral dosage forms.

In case of nausea and vomiting, during chemotherapy - intravenously 8-20 mg 5-15 minutes before the chemotherapy session. Further chemotherapy should be given with oral dosage forms.

For the treatment of respiratory distress syndrome of newborns - intramuscularly 4 injections of 5 mg every 12 hours for two days.

The maximum daily dose is 80 mg.

For children: for the treatment of adrenal insufficiency - intramuscularly at 23 μg / kg (0.67 mg / sq. M) every 3 days, or 7.8-12 μg / kg (0.23-0.34 mg / sq. M.) m / day), or 28-170 μg / kg (0.83-5 mg / sq. m) every 12-24 hours.

Precautions for use

Overdose

Side effect

From the side of metabolism: retention of sodium and water in the body; hypokalemia; hypokalemic alcolosis; negative nitrogen balance caused by increased protein catabolism, increased appetite, weight gain.

On the part of the cardiovascular system: a higher risk of thrombus formation (especially in immobilized patients), arrhythmias, increased blood pressure, development or worsening of chronic heart failure, myocardial dystrophy, steroid vasculitis.

From the musculoskeletal system:muscle weakness, steroid myopathy, decrease in muscle mass, osteoporosis, compression fractures of the vertebrae, aseptic necrosis of the femoral head and humerus, pathological fractures of the long bones.

From the digestive system:nausea, vomiting, erosive and ulcerative lesions of the gastrointestinal tract (which can cause perforations and bleeding), hepatomegaly, pancreatitis, ulcerative esophagitis.

Dermatological reactions: thinning and fragility of the skin, petechiae and subcutaneous hemorrhages, ecchymosis, striae, steroid acne, delayed wound healing, increased sweating.

From the central nervous system:increased fatigue, dizziness, headache, mental disorders, seizures and false symptoms of a brain tumor (increased intracranial pressure with congestive optic nerve head).

From the endocrine system:decreased glucose tolerance, "steroid" diabetes mellitus or manifestation of latent diabetes mellitus, suppression of adrenal function, Itsenko-Cushing's syndrome (moon face, pituitary obesity, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia gravis, striae), delayed development in children.

From the side of the organs of vision: posterior subcapsular cataract, increased intraocular pressure, exophthalmos.

Side effects associated with immunosuppressive effects: more frequent occurrence of infections and aggravation of the severity of their course.

Others:allergic reactions.

Local reactions (at the injection site): hyperpigmentation and leukoderma, atrophy of the subcutaneous tissue and skin, aseptic abscess, hyperemia at the injection site, arthropathy.

Interaction with other medicinal products

Possibilities and features of the use of the drug during pregnancy

The effect of the drug on the ability to drive vehicles, mechanisms

Release form:

Shelf life:

Storage conditions:

Pharmacy dispensing conditions:

Name, address of the manufacturer and address of the place of manufacture of the medicinal product / organization accepting claims

Release form: Liquid dosage forms. Injection.

General characteristics. Composition:

Pharmacological properties:

Indications for use:

Important! Check out the treatment,

Method of administration and dosage:

Application features:

Interaction with other medicinal products:

Contraindications:

Overdose:

Storage conditions:

Storage conditions. Keep out of the reach of children, protected from light at a temperature not exceeding 25° C.

Shelf life is 2 years.

Vacation conditions:

On prescription

Packaging:

GKS. Suppresses the function of leukocytes and tissue macrophages.
Drug: DEXAMETAZONE
The active substance of the drug: dexamethasone
ATX coding: H02AB02
KFG: GCS for injection
Registration number: P No. 014442 / 01-2002
Date of registration: 11.10.02
Owner reg. ID: SHREYA LIFE SCIENCES Pvt. Ltd. (India)

Release form Dexamethasone (solution for injection), drug packaging and composition.

1 amp.

4 mg

1 ml - dark glass ampoules (25) - cardboard boxes.
1 ml - dark glass bottles (25) - cardboard boxes.

Solution for injection is clear, colorless or pale yellow.

1 ml
1 amp.
dexamethasone sodium phosphate (calculated as dexamethasone phosphate)
4 mg
8 mg

Excipients: methylparaben, propylparaben, sodium metabisulfite, disodium edetate, sodium hydroxide, water d / i.

2 ml - dark glass ampoules (25) - cardboard boxes.
2 ml - dark glass bottles (25) - cardboard boxes.

DESCRIPTION OF THE ACTIVE SUBSTANCE.
All the information given is presented only for familiarization with the drug, you should consult your doctor about the possibility of use.

Pharmacological action Dexamethasone (solution for injection)

GKS. Suppresses the function of leukocytes and tissue macrophages. Limits the migration of leukocytes to the area of \u200b\u200binflammation. Violates the ability of macrophages to phagocytosis, as well as the formation of interleukin-1. Promotes the stabilization of lysosomal membranes, thereby reducing the concentration of proteolytic enzymes in the area of \u200b\u200binflammation. Reduces capillary permeability due to the release of histamine. Suppresses fibroblast activity and collagen formation.

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 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 into the lymphoid tissue; inhibits the formation of antibodies.

Dexamethasone suppresses the release of ACTH and β-lipotropin by the pituitary gland, but does not reduce the level of circulating β-endorphin. Inhibits the secretion of TSH and FSH.

When applied directly to the vessels, it has a vasoconstrictor effect.

Dexamethasone 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, increases the activity of gluconeogenesis enzymes. In the liver, dexamethasone enhances the storage 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 the release of insulin.

Dexamethasone inhibits the uptake of glucose by fat cells, which leads to the activation of lipolysis. However, due to the increase in insulin secretion, lipogenesis is stimulated, which leads to the accumulation of fat.

It has a catabolic effect in lymphoid and connective tissue, muscles, adipose tissue, skin, bone tissue. Osteoporosis and Itsenko-Cushing's syndrome are the main factors limiting long-term GCS therapy. As a result of the catabolic effect, growth suppression in children is possible.

In high doses, dexamethasone can increase the excitability of brain tissue and help lower the seizure threshold. Stimulates excess production of hydrochloric acid and pepsin in the stomach, which contributes to the development of peptic ulcers.

With systemic use, the therapeutic activity of dexamethasone is due to its anti-inflammatory, antiallergic, immunosuppressive and antiproliferative effects.

When applied topically and locally, the therapeutic activity of dexamethasone is due to its anti-inflammatory, antiallergic and antiexudative (due to the vasoconstrictor effect) action.

In terms of anti-inflammatory activity, hydrocortisone is 30 times higher, does not have mineralocorticoid activity.

Pharmacokinetics of the drug.

Plasma protein binding - 60-70%. Penetrates through histohematogenous barriers. It is excreted in small amounts in breast milk.

Metabolized in the liver.

T1 / 2 is 2-3 hours. It is excreted by the kidneys.

When applied topically in ophthalmology, it is absorbed through the cornea with intact epithelium into the moisture of the anterior chamber of the eye. With inflammation of the tissues of the eye or damage to the mucous membrane and cornea, the rate of absorption of dexamethasone significantly increases.

Indications for use:

For oral administration: Addison-Birmer disease; acute and subacute thyroiditis, hypothyroidism, progressive ophthalmopathy associated with thyrotoxicosis; bronchial asthma; rheumatoid arthritis in the acute phase; NNC; connective tissue diseases; autoimmune hemolytic anemias, thrombocytopenia, aplasia and hypoplasia of hematopoiesis, agranulocytosis, serum sickness; acute erythroderma, pemphigus (normal), acute eczema (at the beginning of treatment); malignant tumors (as palliative therapy); congenital adrenogenital syndrome; edema of the brain (usually after prior parenteral administration of GCS).

For parenteral administration: shock of various origins; edema of the brain (with a brain tumor, traumatic brain injury, neurosurgical intervention, cerebral hemorrhage, encephalitis, meningitis, radiation injury); asthmatic status; severe allergic reactions (Quincke's edema, bronchospasm, dermatosis, acute anaphylactic reaction to drugs, serum transfusion, pyrogenic reactions); acute hemolytic anemia, thrombocytopenia, acute lymphoblastic leukemia, agranulocytosis; severe infectious diseases (in combination with antibiotics); acute insufficiency of the adrenal cortex; spicy croup; joint diseases (periarthritis of the shoulder scapula, epicondylitis, styloiditis, bursitis, tendovaginitis, compression neuropathy, osteochondrosis, arthritis of various etiologies, osteoarthritis).

For use in ophthalmic practice: non-purulent and allergic conjunctivitis, keratitis, keratoconjunctivitis without damage to the epithelium, iritis, iridocyclitis, blepharoconjunctivitis, blepharitis, episcleritis, scleritis, inflammation after eye injuries and surgical interventions, sympathetic.

Dosage and method of administration of the drug.

Individual. Inside for severe diseases, at the beginning of treatment, up to 10-15 mg / day is prescribed, the maintenance dose may be 2-4.5 mg or more per day. The daily dose is divided into 2-3 doses. In small doses, take 1 time / day in the morning.

For parenteral administration, it is injected into / in a slow stream or drip (in acute and urgent conditions); i / m; periarticular and intraarticular injection is also possible. During the day, you can enter from 4 to 20 mg of dexamethasone 3-4 times. The duration of parenteral administration is usually 3-4 days, then they switch to maintenance therapy with the oral form. In the acute period for various diseases and at the beginning of treatment, dexamethasone is used in higher doses. When the effect is achieved, the dose is reduced at intervals of several days until a maintenance dose is reached or until treatment is discontinued.

When used in ophthalmology in acute conditions, 1-2 drops are instilled into the conjunctival sac every 1-2 hours, then, with a decrease in inflammation, every 4-6 hours.The duration of treatment is from 1-2 days to several weeks, depending on the clinical course diseases.

Side effect of Dexamethasone (solution for injection):

From the endocrine system: decreased glucose tolerance, steroid diabetes mellitus or manifestation of latent diabetes mellitus, suppression of adrenal function, Itsenko-Cushing's syndrome (moon-shaped face, pituitary obesity, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia gravis, striae) sexual development in children.

From the side of metabolism: increased excretion of calcium ions, hypocalcemia, increased body weight, negative nitrogen balance (increased protein breakdown), increased sweating, hypernatremia, hypokalemia.

From the side 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 side of the cardiovascular system: arrhythmias, bradycardia (up to cardiac arrest); development (in predisposed 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 the focus of necrosis, slowing down the formation of scar tissue, which can lead to rupture of the heart muscle; with intracranial administration - epistaxis.

From the digestive system: nausea, vomiting, pancreatitis, steroid ulcers of the stomach and duodenum, erosive esophagitis, bleeding and perforation of the gastrointestinal tract, increased or decreased appetite, flatulence, hiccups; rarely - increased activity of hepatic transaminases and alkaline phosphatase.

From the sensory organs: posterior subcapsular cataract, increased intraocular pressure with possible damage to the optic nerve, a tendency to develop secondary bacterial, fungal or viral eye infections, trophic changes in the cornea, exophthalmos.

From 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 humerus and femur head), muscle tendon rupture, steroid myopathy, decreased muscle mass (atrophy).

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

Allergic reactions: generalized (skin rash, itching of the skin, anaphylactic shock) and when applied topically.

Effects associated with immunosuppressive action: the development or exacerbation of infections (the appearance of this side effect is facilitated by jointly used immunosuppressive drugs and vaccination).

Local reactions: with parenteral administration - tissue necrosis.

When applied externally: rarely - itching, hyperemia, burning, dryness, folliculitis, acne, hypopigmentation, perioral dermatitis, allergic dermatitis, skin maceration, secondary infection, skin atrophy, striae, prickly heat. With prolonged use or application to large areas of the skin, the development of systemic side effects characteristic of GCS is possible.

Contraindications to the drug:

For short-term use for health reasons - hypersensitivity to dexamethasone.

For intra-articular injection and injection directly into the lesion: previous arthroplasty, pathological bleeding (endogenous or caused by the use of anticoagulants), intra-articular bone fracture, an infectious (septic) inflammatory process in the joint and periarticular infections (including a history), and general infectious disease, pronounced periarticular osteoporosis, no signs of inflammation in the joint ("dry" joint, for example, in osteoarthritis without synovitis), pronounced bone destruction and joint deformation (sharp narrowing of the joint space, ankylosis), joint instability as an outcome of arthritis, aseptic necrosis of the the joint of the epiphyses of the bones.

For external use: bacterial, viral, fungal skin diseases, skin tuberculosis, skin manifestations of syphilis, skin tumors, post-vaccination period, violation of the integrity of the skin (ulcers, wounds), children's age (up to 2 years, with itching in the anus - up to 12 years), rosacea, acne vulgaris, perioral dermatitis.

For use in ophthalmology: bacterial, viral, fungal eye diseases, tuberculous eye disease, violation of the integrity of the ocular epithelium, an acute form of purulent eye infection in the absence of specific therapy, diseases of the cornea, combined with epithelial defects, trachoma, glaucoma.

Application during pregnancy and lactation.

During pregnancy (especially in the first trimester), as well as during lactation, dexamethasone is used taking into account the expected therapeutic effect and negative effect on the fetus. With prolonged therapy during pregnancy, the possibility of fetal growth disorders is not excluded. If used at the end of pregnancy, there is a risk of atrophy of the adrenal cortex in the fetus, which may require replacement therapy in the newborn.

Special instructions for the use of Dexamethasone (solution for injection).

Use with caution within 8 weeks before and 2 weeks after vaccination, with lymphadenitis after BCG vaccination, with immunodeficiency conditions (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, 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 (in patients with acute and subacute myocardial infarction, it is possible to spread the focus of necrosis, slow down the formation of scar tissue and, as a result, rupture of the heart muscle), with decompensated chronic heart failure, arterial hypertension, hyperlipidemia), with endocrine diseases - diabetes mellitus ( including impaired tolerance to carbohydrates), thyrotoxicosis, hypothyroidism, Itsenko-Cushing's disease, with severe chronic renal and / or hepatic failure, nephrourolithiasis, with hypoalbuminemia and conditions predisposing to its occurrence, with systemic osteoporosis, psychosis, , obesity (III-IV degree), with poliomyelitis (except for the form of bulbar encephalitis), open and closed angle glaucoma.

If necessary, intra-articular administration should be used with caution in patients with a general severe condition, ineffectiveness (or short duration) of the action of 2 previous injections (taking into account the individual properties of the GCS used).

Before and during GCS therapy, it is necessary to monitor a complete blood count, blood glucose levels and plasma electrolytes.

With intercurrent infections, septic conditions and tuberculosis, it is necessary to simultaneously carry out antibiotic therapy.

Dexamethasone-induced relative adrenal insufficiency may persist for several months after withdrawal. Taking this into account, in stressful situations that arise during this period, hormonal therapy is resumed with the simultaneous administration of salts and / or mineralocorticoids.

When using dexamethasone in patients with corneal herpes, the possibility of corneal perforation should be borne in mind. During treatment, it is necessary to monitor intraocular pressure and the condition of the cornea.

With the sudden cancellation of dexamethasone, especially in the case of previous use in high doses, the so-called withdrawal syndrome occurs (not caused by hypocorticism), manifested by anorexia, nausea, lethargy, generalized musculoskeletal pain, general weakness. After discontinuation of dexamethasone, a relative insufficiency of the adrenal cortex may persist for several months. If during this period stressful situations arise, they are prescribed (according to indications) for the time of GCS, if necessary in combination with mineralocorticoids.

During the treatment period, monitoring of blood pressure, water-electrolyte balance, peripheral blood picture and glycemic level, as well as observation of an ophthalmologist is required.

In children, during long-term treatment, careful monitoring of the dynamics of growth and development is necessary. Children who, during the period of treatment, were in contact with patients with measles or chickenpox, are prophylactically prescribed specific immunoglobulins.

Interaction of Dexamethasone (solution for injection) with other drugs.

With simultaneous use with antipsychotics, bukarban, azathioprine, there is a risk of developing cataracts; with drugs that have an anticholinergic effect - the risk of developing glaucoma.

With simultaneous use with dexamethasone, the effectiveness of insulin and oral hypoglycemic drugs decreases.

With simultaneous use with hormonal contraceptives, androgens, estrogens, anabolic steroids, hirsutism, acne are possible.

With simultaneous use with diuretics, it is possible to increase the excretion of potassium; with NSAIDs (including acetylsalicylic acid) - the incidence of erosive and ulcerative lesions and bleeding from the gastrointestinal tract increases.

When used simultaneously with oral anticoagulants, the anticoagulant effect may be weakened.

With simultaneous use with cardiac glycosides, it is possible to impair the tolerance of cardiac glycosides due to potassium deficiency.

With simultaneous use with aminoglutethimide, it is possible to reduce or inhibit the effects of dexamethasone; with carbamazepine - it is possible to reduce the effect of dexamethasone; with ephedrine - increased excretion of dexamethasone from the body; with imatinib - it is possible to reduce the concentration of imatinib in the blood plasma due to the induction of its metabolism and increased excretion from the body.

With simultaneous use with itraconazole, the effects of dexamethasone are enhanced; with methotrexate - an increase in hepatotoxicity is possible; with praziquantel - a decrease in the concentration of praziquantel in the blood is possible.

With simultaneous use with rifampicin, phenytoin, barbiturates, the effects of dexamethasone may be weakened due to an increase in its excretion from the body.

Description

Transparent colorless or yellowish solution.

Composition

For one ampoule: active substance - dexamethasone phosphate (in the form of dexamethasone sodium phosphate) - 4.0 mg (ampoule 1 ml) and 8.0 mg (ampoule 2 ml); excipients: glycerin, disodium phosphate dihydrate, disodium edetate, water for injection.

Pharmacotherapeutic group

Systemic corticosteroids. Glucocorticoids.
ATC code: Н02АВ02.

pharmachologic effect

Dexamethasone is a synthetic fluorinated glucocorticosteroid that has anti-inflammatory, antiallergic, immunosuppressive effects, has antiexudative and antifibroblastogenic properties, and practically does not have a mineralocorticosteroid effect. Interacts with specific cytoplasmic receptors and forms a complex that penetrates the cell nucleus and stimulates the synthesis of mRNA; the latter induces the formation of proteins that mediate cellular effects, including lipocortin, which inhibits phospholipase A2, inhibits the liberation of arachidonic acid, and inhibits the biosynthesis of endoperoxides, prostaglandins, leukotrienes, which promote inflammation, allergies, etc. Dexamethasone inhibits the expression of proteins involved in the development of inflammatory reactions. Interferes with the release of inflammatory mediators from eosinophils and mast cells. Inhibits the activity of hyaluronidase, collagenase and proteases. Suppresses fibroblast activity and collagen formation. Reduces capillary permeability, stabilizes cell membranes, including lysosomal, inhibits the release of cytokines from lymphocytes and macrophages.

Indications for use

Diseases requiring the administration of a fast-acting glucocorticosteroid, as well as cases when oral administration of the drug is not possible. Addison's disease, congenital adrenal hyperplasia, adrenal insufficiency (usually in combination with mineralocorticoids), adrenogenital syndrome, subacute thyroiditis, tumor hypercalcemia, shock (anaphylactic, post-traumatic, postoperative, cardiogenic, hemotransfusional rheumatoid arthritis) , collagenosis (rheumatic diseases - as an additional therapy for short-term treatment of exacerbation of the disease, disseminated lupus erythematosus, etc.), joint diseases (post-traumatic osteoarthritis, acute gouty arthritis, psoriatic arthritis, synovitis in osteoarthritis, acute nonspecific tendosynovitis, bursitis, epithelium Bekhterev, etc.), bronchial asthma, status asthmaticus, anaphylactoid reactions, incl. caused by drugs; edema of the brain (with tumors, traumatic brain injury, neurosurgical intervention, cerebral hemorrhage, encephalitis, meningitis); ulcerative colitis, sarcoidosis, beryllium disease, disseminated tuberculosis (only in combination with anti-tuberculosis drugs), Loeffler's disease, and other severe respiratory diseases; anemia (autoimmune, hemolytic, congenital, hypoplastic, idiopathic, erythroblastopenia), idiopathic thrombocytopenic purpura (in adults), secondary thrombocytopenia, lymphoma (Hodgkin's and non-Hodgkin's), leukemia, lymphocytic leukemia (acute, chronic) , acute infectious laryngeal edema (adrenaline is the drug of first choice), trichinosis with damage to the nervous system or involvement of the myocardium, nephrotic syndrome, severe inflammatory processes after eye injuries and operations, skin diseases: pemphigus, Stevens-Johnson syndrome, exfoliative dermatitis, bullous herpetiform dermatitis , severe seborrheic dermatitis, severe psoriasis, atopic dermatitis.

Method of administration and dosage

It is intended for intravenous (i / v), intramuscular (i / m), intra-articular, periarticular and retrobulbar administration. The dosage regimen is individual and depends on the indications, the patient's condition and his response to therapy. In order to prepare a solution for intravenous drip infusion, an isotonic sodium chloride solution or 5% dextrose solution should be used. The administration of high doses of dexamethasone can be continued only until the patient's condition has stabilized, which usually does not exceed 48 to 72 hours. Adults in acute and urgent conditions are injected intravenously slowly, by stream or drip, or intramuscularly at a dose of 4-20 mg 3-4 times a day. The maximum daily dose is 80 mg. The maintenance dose is 0.2-9 mg per day. The course of treatment is 3-4 days, then they switch to oral administration of Dexamethasone.
In shock, adults - 20 mg IV once, then 3 mg / kg for 24 hours as a continuous infusion or once 2-6 mg / kg IV, or 40 mg IV every 2-6 hours.
With cerebral edema (adults) - 10 mg IV, then 4 mg every 6 hours IM until symptoms are eliminated; the dose is reduced after 2-4 days and gradually - within 5-7 days - treatment is stopped.
In case of an acute allergic reaction or exacerbation of a chronic allergic disease, dexamethasone should be prescribed according to the following schedule, taking into account parenteral and oral administration: 1 day - intravenous solution for injection 4 mg / ml at a dose of 1-2 ml (4-8 mg); 2 and 3 days - orally 1 mg (2 tablets 0.5 mg) 2 times a day; 4 and 5 days - inside, 0.5 mg (1 tablet, 0.5 mg) 2 times a day; 6 and 7 days - orally once 1 tablet of 0.5 mg; on day 8, the effectiveness of therapy is assessed.
For injection into the joint, the recommended doses are between 0.4 mg and 4 mg. The dose depends on the size of the affected joint:
- large joints (for example, knee joint): 2-4 mg;
- small (for example, interphalangeal, temporal joint): 0.8-1 mg. If re-introduction is necessary, it is possible not earlier than in 3-4 weeks.
The insertion into the same joint can be performed three or four times throughout life. More frequent intra-articular injection can damage articular cartilage and cause bone necrosis.
The dose of dexamethasone, which is injected into the synovial bag, is usually 2-3 mg, in the tendon sheath - 0.4-1 mg. Dexamethasone can be injected simultaneously into no more than two lesions. Doses for administration to soft tissues (around the joint) are 2-6 mg.
Children
In case of adrenal cortex insufficiency, the dose for children during replacement therapy is 0.0233 mg / kg (0.67 mg / m2 body surface area) IM, divided into 3 injections every 3rd day, or 0.00776 - 0, 01165 mg / kg (0.233 - 0.335 mg / m 2 body surface area) daily.
When used for other indications, the recommended dose is 0.02776 - 0.16665 mg / kg (0.833 - 5 mg / m 2 body surface area) every 12-24 hours.

Side effect

The incidence of side effects is given in the following gradation: very frequent (≥1 / 10); frequent (≥1 / 100,<1/10); нечастые (≥1/1000, <1/100); редкие (≥1/10000, <1/1000); очень редкие (<1/10000); неизвестные (по имеющимся данным определить частоту встречаемости не представляется возможным). Частота нежелательных эффектов зависит от дозы и продолжительности лечения.
Side effects associated with short-term treatment with dexamethasone include:
From the immune system: infrequent - hypersensitivity reactions.
: frequent - transient adrenal insufficiency.
: frequent - decreased carbohydrate tolerance, increased appetite and weight gain; infrequent - hypertriglyceridemia.
Psychiatric disorders: frequent - mental disorders.
: infrequent - peptic ulcers and acute pancreatitis.
Side effects associated with long-term dexamethasone treatment include:
From the immune system: infrequent - decreased immune response and increased susceptibility to infections.
From the endocrine system: frequent - long-term adrenal insufficiency, stunted growth in children and adolescents.
Metabolic and nutritional disorders: frequent - upper type of obesity.
Violation of the organ of vision: infrequent - cataract, glaucoma.
: infrequent - arterial hypertension.
: frequent - thinning and fragility of the skin.
: frequent - muscle atrophy, osteoporosis; infrequent - aseptic bone necrosis.
The following side effects associated with dexamethasone treatment may occur (presented in decreasing order of importance).
From the lymphatic system and the hematopoietic system: rare - thromboembolic complications, a decrease in the number of monocytes and / or lymphocytes, leukocytosis, eosinophilia (like other glucocorticoids), thrombocytopenia and non-thrombocytopenic purpura.
From the immune system: rare - rash, bronchospasm, anaphylactic reactions; very rare - angioedema.
From the sidehearts: very rare - polyfocal ventricular extrasystoles, transient bradycardia, heart failure, myocardial rupture after a recent acute infarction.
From the vascular system: infrequent - hypertensive encephalopathy.
Psychiatric disorders: infrequent - changes in personality and behavior, which are most often manifested by euphoria, insomnia, irritability, hyperkinesia, depression; rarely - psychosis.
From the endocrine system: often - adrenal insufficiency and atrophy (decreased response to stress), Itsenko-Cushing's syndrome, irregularity of the menstrual cycle, hirsutism.
Metabolic and nutritional disorders: rarely - the transition of latent diabetes mellitus to clinically manifest, increased need for insulin or oral hypoglycemic drugs in patients with diabetes mellitus, sodium and water retention, increased potassium loss; very rarely - hypokalemic alkalosis, negative nitrogen balance due to protein catabolism.
From the digestive system: infrequent - nausea, hiccups, stomach ulcers or 12 duodenal ulcers; very rarely - esophagitis, perforation of ulcers and bleeding of the gastrointestinal tract (hematomesis, melena), pancreatitis, perforation of the gallbladder and intestines (especially in patients with chronic inflammatory diseases of the large intestine).
On the part of the musculoskeletal system and connective tissue: frequent - muscle weakness, steroid myopathy (muscle weakness due to catabolism of muscle tissue); very rare - compression fractures of the vertebrae, tendon ruptures (especially with the combined use of some quinolones), necrosis of the cartilage tissue of the joint and bones (with frequent intra-articular injections).
On the part of the skin and subcutaneous tissue: frequent - delayed healing of wounds, striae, petechiae and ecchymosis, increased sweating, acne, suppression of skin reactions during allergological tests; very rarely - allergic dermatitis, urticaria.
Violation of the organ of vision: infrequent - increased intraocular pressure; very rarely - exophthalmos.
From the reproductive system and mammary glands: rarely - impotence.
General violations and violations at the injection site: very rare - edema, hyper- and hypopigmentation of the skin, atrophy of the skin or subcutaneous tissue, sterile abscess and skin redness.
Signs and symptoms of glucocorticosteroid withdrawal syndrome.
If a patient who has been taking glucocorticosteroids for a long time, quickly reduce the dose of the drug, signs of adrenal insufficiency, arterial hypotension, and death may develop.
In some cases, withdrawal symptoms may be similar to symptoms and signs of exacerbation or recurrence of the disease for which the patient was receiving treatment. If severe adverse events develop, treatment should be discontinued.
In the event of the above adverse reactions or adverse reactions that are not specified in these instructions for medical use of the medicinal product, you should consult a doctor.

Contraindications

Hypersensitivity to the active substance or other ingredients of the drug, acute viral, bacterial and systemic fungal infections (without appropriate treatment), amoebic infections, infections of the joints and periarticular soft tissues, active forms of tuberculosis, the period before and after prophylactic vaccinations (especially antiviral), glaucoma, acute purulent eye infection (retrobulbar injection), Cushing's syndrome, vaccination with a live vaccine, intramuscular administration is contraindicated in patients with severe disorders of the blood coagulation system.

Overdose

There are isolated reports of cases of acute overdose or death due to acute overdose. Overdose usually manifests itself only after a few weeks of excessive doses and can cause most of the undesirable effects listed in the "adverse reactions" section, primarily Cushing's syndrome.
There is no known specific antidote. Treatment is supportive and symptomatic. Hemodialysis is ineffective in accelerating the elimination of dexamethasone from the body.

Precautions

Limited for use in: peptic ulcers of the gastrointestinal tract, gastric ulcer and duodenal ulcer, esophagitis, gastritis, intestinal anastomosis (in the closest history); congestive heart failure, arterial hypertension, thrombosis, diabetes mellitus, osteoporosis, Itsenko-Cushing's disease, acute renal and / or liver failure, psychosis, convulsive conditions, myasthenia gravis, open-angle glaucoma, AIDS, pregnancy, breastfeeding. With long-term treatment (more than 3 weeks) in high doses (more than 1 mg of Dexamethasone per day) for the prevention of secondary adrenal insufficiency, Dexamethasone is withdrawn gradually. This condition can last for several months, therefore, if stress occurs (including against the background of general anesthesia, surgery or trauma), an increase in the dose or administration of Dexamethasone is necessary. Topical application of Dexamethasone can lead to systemic effects. With intra-articular administration, it is necessary to exclude local infectious processes (septic arthritis). Frequent intra-articular administration can lead to joint tissue damage and osteonecrosis. Patients are not recommended to overload the joints (despite the decrease in symptoms, the inflammatory processes in the joint continue).
Care should be taken when prescribing against the background of ulcerative colitis, intestinal diverticulitis, hypoalbuminemia. The appointment in the case of intercurrent infections, tuberculosis, septic conditions requires preliminary and then simultaneous antibiotic therapy. GCS can increase the susceptibility or mask the symptoms of infectious diseases. Chickenpox, measles, and other infections can be more difficult and even fatal in non-immunized individuals. Immunosuppression often develops with prolonged use of GCS, but it can also occur with short-term treatment. Against the background of concomitant tuberculosis, it is necessary to carry out adequate antimycobacterial chemotherapy. The simultaneous use of high doses of dexamethasone with inactivated viral or bacterial vaccines may not give the desired result. Immunization against the background of GCS replacement therapy is permissible. It is necessary to take into account the increased action in hypothyroidism and cirrhosis of the liver, aggravation of psychotic symptoms and emotional lability at their high initial level, masking of some symptoms of infection, the likelihood of persisting for several months (up to 1 year) relative adrenal insufficiency after discontinuation of Dexamethasone (especially in the case of prolonged use ). With a long course, the dynamics of the growth and development of children is carefully monitored, an ophthalmological examination is systematically carried out, the state of the hypothalamic-pituitary-adrenal system, and the level of glucose in the blood are monitored. Discontinue therapy only gradually. It is recommended to be careful when carrying out any kind of operations, the occurrence of infectious diseases, injuries, avoid immunization, exclude the use of alcoholic beverages. In case of contact with patients with measles, chickenpox and other infections, concomitant prophylactic therapy is prescribed.
In rare cases, anaphylactoid reactions may occur in patients receiving parenteral corticosteroids. Appropriate precautions should be taken in patients prior to administration, especially if the patient has a history of allergy to any drug.
Corticosteroids can worsen the course of systemic fungal infections and, therefore, should not be used in the presence of such infections.
Corticosteroids can activate latent amebiasis. Therefore, it is recommended that latent or active amebiasis be ruled out prior to initiating corticosteroid therapy.
Medium to high doses of cortisone or hydrocortisone can cause high blood pressure, salt and water retention, and increased potassium excretion. However, it may be necessary to limit salt and potassium. All corticosteroids increase calcium excretion.
Use corticosteroids with great caution in patients with recent myocardial infarction due to the risk of ventricular wall rupture.
Corticosteroids should be used with caution in patients with herpes simplex eye infections due to the risk of corneal perforation.
Aspirin should be used with caution in combination with corticosteroids because of the risk of hypoprothrombinemia.
In some patients, steroids can increase or decrease motility and sperm count.
You can observe:
- loss of muscle mass;
- pathological fractures of the long bones;
- compression fractures of the vertebrae;
- aseptic necrosis of the femoral head and humerus.
During treatment with dexamethasone, a worsening of the course of diabetes mellitus or the transition of latent diabetes to a form with clinical manifestations is possible.
The drug contains 0.0196 mmol (0.045 mg) sodium per dose.
Children
In children, in order to avoid overdose, the dose is calculated based on the surface area of \u200b\u200bthe body. Dexamethasone is used in children and adolescents only under strict indications. During treatment with dexamethasone, the growth and development of children and adolescents must be carefully monitored.
Premature infants: There is evidence of a negative effect on subsequent neurological development of early use (<96 часов) в начальных дозах 0,25 мг/ кг два раза в день у недоношенных детей с бронхолегочной дисплазией.
Elderly patients
The unwanted effects of systemic corticosteroids, such as hypokalemia, osteoporosis, hypertension, diabetes mellitus, increased susceptibility to infections, and thinning of the skin, may have more serious consequences in older patients. Clinical observation is recommended to avoid life-threatening adverse reactions.

Application during pregnancy and lactation

Glucocorticoids cross the placenta and can reach high concentrations in the fetus. Dexamethasone is less extensively metabolized in the placenta than, for example, with prednisolone, so high concentrations of dexamethasone can be determined in the fetus. Therapeutic doses of glucocorticoids can increase the risk of placental insufficiency, oligohydramnios, fetal growth and development retardation or intrauterine death, increase the number of leukocytes (neutrophils) in a child, as well as the risk of developing adrenal insufficiency. Use during pregnancy is allowed if the expected effect of therapy outweighs the potential risk to the fetus. During treatment, breastfeeding should be discontinued. Infants born to mothers who have received significant doses of corticosteroids during pregnancy should be closely monitored for signs of adrenal hypofunction.

Influence on the ability to drive a car and other potentially dangerous mechanisms

During treatment, you should not drive vehicles and engage in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Interaction with other medicinal products

The therapeutic and toxic effects of Dexamethasone are reduced by barbiturates, phenytoin, rifabutin, carbamazepine, ephedrine and aminoglutethimide, rifampicin (accelerate metabolism); somatotropin; antacids (reduce absorption), enhance - estrogen-containing oral contraceptives. Concomitant use with cyclosporine increases the risk of seizures in children. The risk of arrhythmias and hypokalemia is increased by cardiac glycosides and diuretics, the likelihood of edema and arterial hypertension - sodium-containing drugs and nutritional supplements, severe hypokalemia, heart failure and osteoporosis - amphotericin B and carbonic anhydrase inhibitors; risk of erosive and ulcerative lesions and bleeding from the gastrointestinal tract - non-steroidal anti-inflammatory drugs. When used simultaneously with live antiviral vaccines and against the background of other types of immunization, it increases the risk of virus activation and infection. Simultaneous use with thiazide diuretics, furosemide, ethacrynic acid, carbonic anhydrase inhibitors, amphotericin B can lead to severe hypokalemia, which can increase the toxic effects of cardiac glycosides and non-depolarizing muscle relaxants. Weakens the hypoglycemic activity of insulin and oral antidiabetic agents; anticoagulant - coumarins; diuretic - diuretic diuretics; immunotropic - vaccination (suppresses antibody production). It impairs the tolerance of cardiac glycosides (causes potassium deficiency), reduces the concentration of salicylates and praziquantel in the blood. May increase the concentration of glucose in the blood, which requires a dose adjustment of hypoglycemic drugs, sulfonylurea derivatives, asparaginase. GCS increase the clearance of salicylates, therefore, after discontinuation of Dexamethasone, it is necessary to reduce the dose of salicylates. When used concomitantly with indomethacin, the Dexamethasone suppression test may give false negative results.
The combined use of dexamethasone and drugs that inhibit the activity of the CYP ZA4 enzyme (ketoconazole, macrolides) may cause an increase in the concentration of dexamethasone in serum. Dexamethasone is a moderate inducer of CYP ZA4. Concomitant use with drugs that are metabolized by CYP ZA4 (indinavir, erythromycin) can increase their clearance, which leads to a decrease in serum concentration.
The simultaneous use of dexamethasone and thalidomide can cause toxic epidermal necrolysis.
The simultaneous use of ritodrin and dexamethasone is contraindicated during childbirth, as this can lead to the death of the woman in labor due to pulmonary edema.
During the treatment period, the simultaneous use of drugs and food with a high sodium content is not recommended.

Storage conditions

In a dark place at a temperature not exceeding 25 ° C.
Keep out of the reach of children.