Dexamethasone instructions for use: solution for injection and inhalation, tablets and eye drops, ointment

Tradename

Dexamethasone

International non-proprietary name

Dexamethasone

The drug is registered in Ukraine and is sold in the following dosage forms:

• 0.1% eye drops in vials with a dropper (volume 5 or 10 ml) with a dexamethasone content of 1 mg / ml;
• tablets with 0.5, 4, 8, 20 and 40 mg of the hormone;
• solution for parenteral administration (1 ml / 4 mg dexamethasone) in 1 or 2 ml ampoules.

Dosage form (tablets)

0.5 mg tablets

Composition

One tablet contains

active substance - dexamethasone 0.5 mg,

excipients: lactose monohydrate, corn starch, povidone, magnesium stearate, talc, colloidal anhydrous silicon dioxide

Description

Round, flat tablets of white or off-white color, beveled.

Pharmacotherapeutic group

Corticosteroids for systemic use. Glucocorticosteroids. Dexamethasone.

ATX code H02AB02

Pharmacological properties

Pharmacokinetics

Dexamethasone is rapidly and almost completely absorbed when taken orally. The bioavailability of dexamethasone is 80%. After oral administration, Cmax in blood plasma was observed after 1-2 hours; after a single dose, the effect lasts for about 66 hours.

In blood plasma, about 77% of dexamethasone binds to plasma proteins, and most of it is converted to albumin. Only a minimal amount of dexamethasone binds to non-albumin proteins. Dexamethasone is a fat-soluble compound. The drug is initially metabolized in the liver. Small amounts of dexamethasone are metabolized in the kidneys and other organs. The predominant excretion occurs through urine. The half-life (T12) is about 190 minutes.

Pharmacodynamics

Dexamethasone is a synthetic adrenal cortex hormone (corticosteroid) with glucocorticoid action. The drug has a pronounced anti-inflammatory, anti-allergic and desensitizing effect, has immunosuppressive activity.

To date, enough information has been accumulated on the mechanism of action of glucocorticoids to understand how they act at the cellular level. There are two well-defined receptor systems found in the cytoplasm of cells. Through glucocorticoid receptors, corticosteroids exert anti-inflammatory and immunosuppressive effects and regulate glucose homeostasis; through mineralocorticoid receptors, they regulate sodium and potassium metabolism, as well as water and electrolyte balance.

Indications

Systemic connective tissue diseases (systemic lupus erythematosus, scleroderma, periarteritis nodosa, dermatomyositis, rheumatoid arthritis).

Acute and chronic inflammatory diseases of the joints: gouty and psoriatic arthritis, osteoarthritis (including post-traumatic) polyarthritis periarthritis of the shoulder scapula ankylosing spondylitis (ankylosing spondylitis) juvenile arthritis Still's syndrome in adults bursitis nonspecific tendosynovitis synovitis and epicondylitis.

Rheumatic fever, acute rheumatic heart disease.

Acute and chronic allergic diseases: allergic reactions to drugs and food products serum sickness urticaria allergic rhinitis angioedema drug exanthema hay fever.

Skin diseases: pemphigus psoriasis eczema atopic dermatitis diffuse neurodermatitis contact dermatitis (with lesions of a large skin surface) seborrheic toxidermia dermatitis exfoliative dermatitis toxic epidermal necrolysis (Lyell's syndrome) bullous herpetiformis dermatitis malignant exudative erythema (syndrome Stevens-Johnson).

Edema of the brain (only after confirming the symptoms of increased intracranial pressure by the results of magnetic resonance imaging or computed tomography) due to a brain tumor and / or associated with surgery or radiation defeat.

Allergic eye diseases: allergic corneal ulcers, allergic forms of conjunctivitis.

Inflammatory eye diseases: sympathetic ophthalmia; severe, indolent anterior and posterior uveitis; optic neuritis.

Primary or secondary adrenal insufficiency (including a condition after removal of the adrenal glands).

Congenital adrenal hyperplasia.

Kidney disease of autoimmune genesis (including acute glomerulonephritis) nephrotic syndrome.

Subacute thyroiditis.

Diseases of the hematopoietic organs: agranulocytosis panmyelopathy autoimmune hemolytic anemia acute lymphocytic and myeloid leukemia lymphogranulomatosis thrombocytopenic purpura secondary thrombocytopenia in adults erythroblastopenia (erythrocytic anemia) congenital (erythroid) hypoplastic anemia.

Lung diseases: acute alveolitis, pulmonary fibrosis, stage II-III sarcoidosis. Bronchial asthma (with bronchial asthma, the drug is prescribed only in case of severe ineffectiveness or inability to take inhaled GCS). Tuberculous meningitis pulmonary tuberculosis aspiration pneumonia (in combination with specific chemotherapy).

Beryllium disease Loeffler's syndrome (not amenable to other therapy).

Lung cancer (in combination with cytostatics).

Multiple sclerosis.

Diseases of the gastrointestinal tract: ulcerative colitis Crohn's disease, local enteritis.

Hepatitis.

Prevention of graft rejection reaction as part of complex therapy.

Hypercalcemia against the background of cancer, nausea and vomiting during cytostatic therapy.

Multiple myeloma.

Testing for differential diagnosis of hyperplasia (hyperfunction) and adrenal cortex tumors.

Contraindications

For short-term use for “vital” indications, the only contraindication is hypersensitivity to dexamethasone or auxiliary components of the drug; systemic mycosis; breastfeeding period; the use of live and attenuated vaccines with immunosuppressive doses of the drug.

Dexamethasone-CRKA is contraindicated in patients with lactose intolerance, lactase deficiency and syndrome of glucose-galactose malabsorption, since the drug Dexamethasone-CRKA includes lactose.

Overdose

Increase in dose-dependent side effects is possible, with the exception of allergic reactions. Dexamethasone dose should be reduced.

Treatment: symptomatic.

Pregnancy and lactation

During pregnancy (especially in the first trimester), the drug can be used only for health reasons. During pregnancy, the drug is used only if the potential benefit to the mother outweighs the potential risk to the fetus. With prolonged therapy during pregnancy, the possibility of impaired fetal growth is not excluded. If used in the third trimester of pregnancy, there is a risk of atrophy of the adrenal cortex in the fetus, which may require replacement therapy in the newborn.

If it is necessary to treat with the drug during breastfeeding, then breastfeeding should be discontinued.

Overdose

Increase in dose-dependent side effects is possible, with the exception of allergic reactions. Dexamethasone dose should be reduced.
Treatment: symptomatic.

Interaction with other drugs

Dexamethasone increases the toxicity of cardiac glycosides (due to the resulting hypokalemia, the risk of arrhythmias increases). Accelerates the excretion of acetylsalicylic acid, reduces its concentration in the blood (when dexamethasone is canceled, the concentration of salicylates in the blood increases and the risk of side effects increases). When used simultaneously with live antiviral vaccines and against the background of other types of immunizations, it increases the risk of virus activation and the development of infections. Increases the metabolism of isoniazid, mexiletine (especially in "fast acetylators"), which leads to a decrease in their plasma concentrations. Increases the risk of developing the hepatotoxic effect of paracetamol (induction of liver enzymes and the formation of a toxic metabolite of paracetamol). Increases (with prolonged therapy) the content of folic acid. Hypokalemia. caused by GCS, can increase the severity and duration of muscle blockade against the background of muscle relaxants. In high doses, it reduces the effect of somatropin. Antacids reduce the absorption of GCS funds. Dexamethasone reduces the effect of hypoglycemic drugs: enhances the anticoagulant effect of coumarin derivatives. Weakens the effect of vitamin D on the absorption of calcium ions in the intestinal lumen. Ergocalciferol and parathyroid hormone prevent the development of osteopathy caused by GCS. Reduces the concentration of praziquantel in the blood. Cyclosporine (inhibits metabolism) and ketoconazole (decreases clearance) increase toxicity. Thiazide diuretics, carbonic anhydrase inhibitors, other GCS and amphotericin B increase the risk of hypokalemia, sodium-containing drugs - edema and increased blood pressure. Non-steroidal anti-inflammatory drugs and ethanol increase the risk of ulceration of the gastrointestinal mucosa, bleeding, combination with non-steroidal anti-inflammatory drugs for the treatment of arthritis, it is possible to reduce the dose of GCS due to the summation of the therapeutic effect. Indomethacin, displacing dexamethasone from its association with albumin, increases the risk of developing its side effects. Amphotericin B and carbonic anhydrase inhibitors increase the risk of osteoporosis. The therapeutic effect of GCS decreases under the influence of phenytoin, barbiturates, ephedrine, theophylline, rifampicin and other inducers of "hepatic" microsomal enzymes (an increase in the metabolism). Mitotan and other inhibitors of adrenal cortex function may necessitate an increase in the GCS dose. The clearance of corticosteroids increases against the background of thyroid hormones. Immunosuppressants increase the risk of infections and lymphoma or other lymphoproliferative disorders associated with the Epstein-Barr virus. Estrogens (including oral estrogen-containing contraceptives) reduce the clearance of GCS, lengthen the half-life and their therapeutic and toxic effects. The appearance of hirsutism and acne is facilitated by the simultaneous use of other steroid hormonal drugs - androgens, estrogens, anabolic steroids, oral contraceptives. Tricyclic antidepressants can increase the severity of depression caused by taking dexamethasone (not indicated for the treatment of these side effects). The risk of developing cataracts increases when used against the background of other GCS, antipsychotic drugs (neuroleptics), carbutamide and azathioprine. Simultaneous administration with m-anticholinergics (including antihistamines, tricyclic antidepressants), nitrates contributes to the development of increased intraocular pressure. With simultaneous use with fluoroquinolones, the risk of tendinopathy (mainly Achilles tendon) increases in elderly patients and in patients with tendon diseases. Antimalarial drugs (chloroquine, hydroxychloroquine, mefloquine) in combination with dexamethasone may increase the risk of myopathy and cardiomyopathy. Angiotensin-converting enzyme inhibitors, when administered simultaneously with dexamethasone, can change the composition of peripheral blood.

Method of administration and dosage

The dosage regimen of the drug is individual and depends on the indications of the severity of the disease and the patient's response to therapy.

Dexamethasone is administered orally during or after meals once in the morning (small dose) or in 2-3 doses (large dose). The average daily intake for adults ranges from 2-3 mg to 6 mg. The maximum daily dose is 10-15 mg.

After achieving a therapeutic effect, the dose is gradually reduced (usually by 05 mg in 3 days) to a maintenance dose of 2-45 or more mg / day. The most effective dose is 05-1 mg / day.

Children are prescribed 00833-03333 mg / kg or 00025-00001 mg / m2 per day in 3-4 doses, depending on age.

The duration of the use of Dexamethasone depends on the nature of the pathological process and the effectiveness of treatment and ranges from several days to several months or more. The treatment is stopped gradually.

special instructions

Patients requiring long-term dexamethasone therapy may develop withdrawal syndrome after discontinuation of therapy (also without clear signs of adrenal insufficiency): fever, nasal discharge, conjunctival hyperemia, headache, dizziness, drowsiness and irritability, muscle and joint pain, vomiting, weight loss, weakness, convulsions. Therefore, dexamethasone must be discontinued by gradual dose reduction. Rapid drug withdrawal can be fatal.

In patients who received long-term therapy with dexamethasone and were exposed to stress after its withdrawal, it is necessary to resume use dexamethasone, due to the fact that induced adrenal insufficiency can persist for several months after discontinuation drug.

Dexamethasone therapy can mask signs of existing or new infections and signs of bowel perforation in patients with ulcerative colitis. Dexamethasone can aggravate the course of systemic fungal infections, latent amoebiasis, or pulmonary tuberculosis.

For patients with acute pulmonary tuberculosis, dexamethasone can be prescribed (together with anti-tuberculosis drugs) only in the case of a fulminant or severe disseminated process. Patients with inactive pulmonary tuberculosis receiving therapy with dexamethasone, or patients with positive tuberculin tests should simultaneously receive anti-tuberculosis chemoprophylaxis.

Particular attention and careful medical supervision is necessary for patients with osteoporosis, arterial hypertension, heart failure, tuberculosis, glaucoma, hepatic or renal failure, diabetes mellitus, active peptic ulcers, fresh intestinal anastomoses, ulcerative colitis and epilepsy. The drug is prescribed with caution in the first weeks after acute myocardial infarction, to patients with thromboembolism, with myasthenia gravis, glaucoma, hypothyroidism, psychosis or psychoneuroses, as well as patients over 65 years old.

During therapy with dexamethasone, diabetes mellitus decompensation or the transition of latent diabetes mellitus to clinically manifest diabetes is possible.

With long-term treatment, it is necessary to control the level of potassium in the blood serum.

Vaccination with live vaccines is contraindicated during dexamethasone therapy.

Immunization with killed viral or bacterial vaccines does not give the expected increase in the titer of specific antibodies and therefore does not have the necessary protective effect. Dexamethasone-CRKA is usually not given 8 weeks before vaccination and 2 weeks after vaccination.

Patients taking high doses of dexamethasone for a long time should avoid contact with patients with measles; in case of accidental contact, prophylactic treatment with immunoglobulin is recommended.

Care must be taken when treating patients who have recently undergone surgery or bone fracture, as dexamethasone can slow the healing of wounds and fractures.

The effect of glucocorticosteroids is enhanced in patients with liver cirrhosis or hypothyroidism.

Dexamethasone-CRKA is used in children and adolescents only for strict indications. During treatment, strict control of the growth and development of the child or adolescent is required.

Special information about some components of the drug

The composition of the drug Dexamethasone-CRKA contains lactose, and therefore, its use in patients with galactosemia, lactase deficiency and glucose-galactose malabsorption syndrome is contraindicated.

Influence on the ability to drive vehicles and other complex mechanisms

Dexamethasone-KRKA does not affect the ability to drive vehicles and work with technical devices that require concentration of attention and speed of psychomotor reactions.

Precautionary measures

Application for severe infectious diseases is permissible only against the background of specific antimicrobial therapy.

Pre- and post-vaccination period (8 weeks before and 2 weeks after vaccination), lymphadenitis after BCG vaccination. Immunodeficiency states (including acquired immunodeficiency syndrome or human immunodeficiency virus (HIV infection)).

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

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

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

Severe chronic renal and / or hepatic failure, nephrourolithiasis.

Hypoalbuminemia and conditions predisposing to its occurrence.

Systemic osteoporosis, myasthenia gravis, acute psychosis, poliomyelitis (except for the form of bulbar encephalitis), open and closed angle glaucoma.

The use of the drug in elderly patients (due to the high risk of osteoporosis and arterial hypertension).

Acute psychosis, severe affective disorders (including a history).

Eye infection due to herpes simplex virus (due to the risk of corneal perforation).

During pregnancy.

In children during the period of growth, GCS should be used only for absolute indications and under the particularly careful supervision of the attending physician.

Prescribing dexamethasone for intercurrent infections, septic conditions and tuberculosis, it is necessary to simultaneously treat with specific antibiotic therapy when using the drug in patients with latent tuberculosis, lymphadenitis after BCG vaccination, poliomyelitis, acute and chronic bacterial, parasitic infections; specific therapy in patients with gastric ulcer and / or intestinal ulcer, osteoporosis.

With daily use for 5 months of treatment, atrophy of the adrenal cortex develops.

May mask some symptoms of infections; during treatment, it is useless to carry out immunization.

With a sudden cancellation of corticosteroids, especially in the case of previous use of high doses, there is a "withdrawal" syndrome of corticosteroids (not caused by hypocorticism): decreased appetite, nausea, lethargy, generalized musculoskeletal pain, asthenia, as well as the occurrence of acute adrenal insufficiency (decreased blood pressure, arrhythmia, sweating, weakness, oligoanuria, vomiting, abdominal pain, diarrhea, hallucinations, fainting, coma).

After withdrawal for several months, the relative insufficiency of the adrenal cortex persists. If during this period stressful situations arise, they are prescribed (according to indications) for the time of GCS, if necessary in combination with mineralocorticosteroids.

The dose of dexamethasone must be temporarily increased in stressful situations during therapy (surgery, trauma). A temporary increase in the dose of the drug in stressful situations is necessary both before and after stress.

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.

During treatment with dexamethasone (especially long-term), it is necessary to observe an ophthalmologist, control blood pressure and water-electrolyte balance, as well as pictures of peripheral blood and concentration blood glucose. In order to reduce side effects, you can prescribe anabolic steroids, antacids, and also increase intake of potassium ions into the body (eating food rich in potassium and calcium, or taking potassium, calcium, and vitamin D). Food should be rich in proteins, vitamins, low in fat, carbohydrates and salt.

In children during the period of growth, GCS should be used only for absolute indications and under the particularly careful supervision of the attending physician.

When using dexamethasone, there is a risk of developing severe anaphylactic reactions, bradycardia.

Against the background of drug therapy, the risk of strongyloidosis activation increases.

During drug therapy, careful monitoring of the condition of patients with CHF, uncontrolled arterial hypertension, trauma and ulcerative lesions of the cornea, glaucoma is necessary.

Possible worsening of myasthenia gravis.

Against the background of the use of corticosteroids, a change in sperm motility is possible.

Taking the drug may mask the symptoms of "peritoneal irritation" in patients with perforation of the stomach or intestinal wall.

The effect of the drug is enhanced in patients with liver cirrhosis. It should be borne in mind that in patients with hypothyroidism, the clearance of dexamethasone decreases, and in patients with thyrotoxicosis, it increases.

In patients with diabetes mellitus, blood glucose concentrations should be monitored and, if necessary, the doses of hypoglycemic drugs should be adjusted.

Influence on the ability to drive vehicles and mechanisms

Given the possible side effects during therapy with Dexamethasone, care must be taken when administering transport and work with mechanisms, engaging in other activities that require increased concentration of attention and speed psychomotor reactions.

Shelf life

4 years.

Do not use after the expiration date.

Storage conditions

In a dark place, at a temperature not exceeding 25 ° C

Keep out of the reach of children.

Dosage form (drops)

Dexamethasone

Eye drops 0.1%: vial. 5 ml or 10 ml reg. No: ЛС-001351 dated 05.08.11 - Indefinitely

Release form, packaging and composition of the drug Dexamethasone

Eye drops 0.1%	1 ml
dexamethasone	1 mg

5 ml - polyethylene bottles (1) - cardboard packs.
10 ml - polyethylene bottles (1) - cardboard packs.

Clinical and pharmacological group: GCS for local use in ophthalmology Pharmaco-therapeutic group: Glucocorticosteroid for local use

pharmachologic effect

What is the drug prescribed for? Dexamethasone is a glucocorticosteroid hormone that is used in ophthalmology as an anti-allergic, anti-inflammatory, anti-exudative agent. The active ingredient of the drug helps to stabilize cell membranes, reduces the permeability of the vascular wall. Antiexudative (decongestant) effect is associated with the stabilization of the membrane membrane of lysosomes.

After instillation, dexamethasone can penetrate through the cornea into the fluid of the anterior chamber of the eyeball, even through the intact epithelial cover. The drug has indications and contraindications

Indications for use

Conjunctivitis (non-purulent and allergic), keratitis, keratoconjunctivitis (without damage to the epithelium), blepharitis, scleritis, episcleritis, retinitis, iritis, iridocyclitis, etc. uveitis of various origins, blepharoconjunctivitis, optic neuritis, retrobulbar neuritis, superficial corneal injuries of various etiologies (after complete epithelialization of the cornea), prevention of inflammation after surgery, sympathetic ophthalmia.

Allergic and inflammatory diseases (including microbial) of the ears: otitis media.

Contraindications

The appointment of dexamethasone is contraindicated in:

• with keratitis, which is caused by the viruses Varicella zoster and Herpes simplex, as well as with viral damage to the conjunctiva and cornea;
• infection of the eye with mycobacteria;
• fungal lesions of the eyeball;
• acute purulent pathologies of the eye;
• violation of the structure of the epithelium of the cornea;
• increased intraocular pressure;
• the presence of individual sensitivity to drops.

Drops "Dexamethasone" may be prescribed to women during the period of gestation and feeding only in special cases where the potential benefit outweighs the threat and harm that can be caused to the fetus or newborn.

How to use: dosage and course of treatment

In acute conditions - in the conjunctival sac, 1-2 drops of a 0.1% solution every 1-2 hours, with a decrease in inflammation - after 4-6 hours. In other cases - 3-4 times a day for 2-5 weeks, depending on the severity of the condition.

3-4 drops in the affected ear 2-3 times a day.

Use in elderly patients

Use with caution in elderly patients in order to avoid the risk of exacerbation of chronic diseases.

Application in children

Not recommended for use in children.

Overdose

If an overdose of "Dexamethasone" eye drops occurs when applied topically, then an increase in the negative effect and the development of side effects are possible.

special instructions

When prescribing to patients with herpetic keratitis, the possibility of corneal perforation should be borne in mind.

During treatment (for more than 2 weeks), it is necessary to monitor the intraocular pressure and the state of the cornea.

When instilling in, soft contact lenses must be removed; they can be put on again no earlier than 15-20 minutes later.

Within 30 minutes after instillation, you must refrain from activities that require increased attention.

Treatment with the drug can mask the picture of a bacterial or fungal infection, therefore, with treatment of infectious diseases of the eyes and ears, the drug should be combined with an adequate antimicrobial therapy.

Influence on the ability to drive vehicles. Wed and fur .:

Taking into account the possibility of lacrimation after instillation of the drug, it should not be used immediately before driving or working with mechanisms.

Within 30 minutes after instillation, it is necessary to refrain from activities requiring increased attention.

Drug interactions

With prolonged use with idoxuridine, it is possible to enhance destructive processes in the corneal epithelium.

Dexamethasone can enhance the action of barbiturates.

The combined use of phenytoin with dexamethasone leads to a decrease in the concentration of the latter.

Warfarin in combination with dexamethasone increases the risk of bleeding.

In the usual regimen of topical application, the dose is insufficient to induce the induction or saturation of hepatic enzymes.

Concomitant use: with diuretics (especially "thiazide" and carbonic anhydrase inhibitors) and amphotericin B can lead to increased excretion of potassium (K +) from the body and an increase in the risk of developing cardiac failure; with cardiac glycosides - their tolerance worsens and the likelihood of developing ventricular extrasystole increases (due to hypokalemia caused); with ethanol and non-steroidal anti-inflammatory drugs (NSAIDs) - the risk of erosive and ulcerative lesions in the gastrointestinal tract increases.

Estrogens and oral estrogen-containing contraceptives reduce the clearance of dexamethasone, which may be accompanied by an increase in the severity of its action.

The combined use of antiarrhythmic drugs with dexamethasone can lead to a decrease in the effect of the latter.

Storage conditions

Store in a dry, dark place at a temperature not exceeding 25 ° C

Keep out of the reach of children!

Dosage form (solution for injection)

Solution for intravenous and intramuscular administration.

Composition

1 ml of solution contains:

Active substance:

Dexamethasone sodium phosphate 4.75 mg (equivalent to 4.00 mg dexamethasone phosphate);

Excipients:

Sodium phosphate disubstituted dodecahydrate 12.60 mg

Methyl para-hydroxybenzoate 1.80 mg

Propyl para-hydroxybenzoate 0.20 mg

Sodium metabisulfite 1.00 mg

Sodium chloride 2.00 mg

Sodium citrate dihydrate 2.28 mg

Disodium edetate 1.00 mg

Water for injection up to 1.0 ml

Description of the dosage form

Transparent colorless or slightly yellowish liquid.

Pharmacotherapeutic group

Systemic corticosteroids. Glucocorticosteroids. Dexamethasone.

ATX code Н02АВ02

Pharmacological properties

Pharmacokinetics

With intravenous (IV) administration, the effect of dexamethasone occurs quickly, but relatively shortly. With intramuscular (i / m) administration, it acts more slowly, but longer. Therefore, intravenous administration of the initial dose is recommended for life-threatening conditions, intramuscular injections are applicable for subsequent monitoring of the patient's condition.

Plasma protein binding is proportional to dosage; at very high doses, most dexamethasone remains unbound. Easily penetrates the blood-brain barriers (including the blood-brain and placental barriers). Dexamethasone is metabolized mainly in the liver, mainly by conjugation with glucuronic and sulfuric acids. It is excreted in the urine, mainly in the form of inactive metabolites, in small quantities in breast milk.

Renal failure does not affect the elimination of dexamethasone, while severe hepatic failure increases the half-life.

Pharmacodynamics

Dexamed is a glucocorticosteroid, a methylated derivative of fluoroprednisolone. It has anti-inflammatory, anti-allergic, anti-shock, anti-toxic, desensitizing and immunosuppressive effects. Suppresses all 3 phases of inflammation and almost all links of the allergic reaction.

Competitively affects mineralocorticoid activity, inhibits antibody synthesis, inhibits the function of eosinophils, basophils, plasma and mast cells, prevents platelet aggregation, stabilizes cell membranes by blocking phospholipase A2, which leads to a decrease in the synthesis of prostaglandins and thromboxanes, leukotrienes and MRSA. Increases the content of cAMP and reduces the content of cGMP in the cell, which leads to a decrease in the release of allergy mediators, prevents the formation of kinins, and reduces the synthesis of serotonin and histamine due to blocking of specific decarboxylases, reduces the formation of free oxygen radicals, activates the synthesis of protease inhibitors, inhibits the activity collagenase.

Indications of the active substances of the drug Dexamed

Shock of various origins; cerebral edema (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).

Open the list of ICD-10 codes

ICD-10 code	Indication
C80	Malignant neoplasm without specifying localization
C91.0	Acute lymphoblastic leukemia [ALL]
D59	Acquired hemolytic anemia
D59.0	Drug-induced autoimmune hemolytic anemia
D59.1	Other autoimmune hemolytic anemias
D59.9	Acquired hemolytic anemia, unspecified
D61.9	Aplastic anemia, unspecified
D69.3	Idiopathic thrombocytopenic purpura
D69.6	Thrombocytopenia, unspecified
D70	Agranulocytosis
E03	Other forms of hypothyroidism
E06	Thyroiditis
E25	Adrenogenital Disorders
E27.1	Primary adrenal insufficiency
E27.2	Addison's crisis
G58.9	Unspecified mononeuropathy
G93.6	Cerebral edema
H06.2	Exophthalmos in thyroid dysfunction (E05.-)
J05.0	Acute obstructive laryngitis [croup]
J45	Asthma
J46	Status asthmaticus
K51	Ulcerative colitis
L10	Pemphigus [pemphigus]
L20.8	Other atopic dermatitis (neurodermatitis, eczema)
L30.0	Coin eczema
L53.9	Erythematous condition, unspecified
M05	Seropositive rheumatoid arthritis
M13.9	Arthritis, unspecified
M15	Polyarthrosis
M19.9	Unspecified arthrosis
M30	Polyarteritis nodosa and related conditions
M32	Systemic lupus erythematosus
M33	Dermatopolymyositis
M34	Systemic sclerosis
M42	Osteocondritis of the spine
M45	Ankylosing spondylitis
M47	Spondylosis
M65	Synovitis and tenosynovitis
M70	Soft tissue diseases associated with stress, overload and pressure
M71	Other bursopathies
M75.0	Adhesive capsulitis of the shoulder
M77	Other enthesopathies (epicondylitis)
R57.0	Cardiogenic shock
R57.1	Hypovolemic shock
R57.2	Septic shock
R57.8	Other types of shock
T78.2	Anaphylactic shock, unspecified
T78.3	Angioedema (Quincke's edema)
T79.4	Traumatic shock
T80.5	Anaphylactic shock associated with serum administration
T80.6	Other serum reactions
T88.7	Unspecified pathological reaction to a drug or medication
Z51.5	Palliative care

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Contraindications

The only contraindication for short-term use for health reasons is hypersensitivity to dexamethasone or drug components.

In children during the period of growth, GCS should be used only for absolute indications and under the particularly careful supervision of the attending physician.

Dosage regimen

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Individual. For parenteral administration, it is injected into / in a slow stream or drip (in acute and urgent conditions); i / m. 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.

Carefully

With the following diseases and conditions:

- 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.

- Parasitic and infectious diseases of a viral, fungal or bacterial nature (currently occurring or recently transferred, including recent contact with the patient) - herpes simplex, herpes zoster (viremic phase), varicella smallpox, measles; amebiasis, strongyloidosis; systemic mycosis; active and latent tuberculosis. Application for severe infectious diseases is permissible only against the background of specific therapy.

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

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

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

- Severe chronic renal and / or hepatic failure, nephrourolithiasis.

- Hypoalbuminemia and conditions predisposing to its occurrence (cirrhosis of the liver, nephrotic syndrome).

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

- Pregnancy.

Interaction

Pharmaceutically incompatible with others. PP (can form insoluble compounds).

Dexamethasone increases the toxicity of cardiac glycosides (due to the resulting hypokalemia, the risk of arrhythmias increases).

Accelerates the excretion of ASA, reduces its level in the blood (when dexamethasone is canceled, the concentration of salicylates in the blood increases and the risk of side effects increases).

With simultaneous use with live antiviral vaccines and against the background of others. types of immunizations increase the risk of virus activation and infection.

Increases the metabolism of isoniazid, mexiletine (especially in "fast acetylators"), which leads to a decrease in their plasma concentrations.

Increases the risk of developing hepatotoxic effects of paracetamol (induction of "liver" enzymes and the formation of a toxic metabolite of paracetamol).

Increases (with prolonged therapy) the content of folic acid.

Hypokalemia caused by GCS can increase the severity and duration of muscle blockade against the background of muscle relaxants.

In high doses, it reduces the effect of somatropin.

Antacids reduce the absorption of corticosteroids.

Dexamethasone reduces the effect of hypoglycemic drugs; enhances the anticoagulant effect of coumarin derivatives.

Weakens the effect of vitamin D on the absorption of Ca2 + in the intestinal lumen. Ergocalciferol and parathyroid hormone prevent the development of osteopathy caused by GCS.

Reduces the concentration of praziquantel in the blood.

Cyclosporine (inhibits metabolism) and ketoconazole (decreases clearance) increase toxicity.

Thiazide diuretics, carbonic anhydrase inhibitors, etc. GCS and amphotericin B increase the risk of hypokalemia, Na + -containing drugs - edema and increased blood pressure.

NSAIDs and ethanol increase the risk of ulceration of the gastrointestinal tract mucosa of bleeding; in combination with NSAIDs for the treatment of arthritis, it is possible to reduce the GCS dose due to the summation of the therapeutic effect.

Indomethacin, displacing dexamethasone from its association with albumin, increases the risk of developing its side effects.

Amphotericin B and carbonic anhydrase inhibitors increase the risk of osteoporosis.

The therapeutic effect of GCS is reduced under the influence of phenytoin, barbiturates, ephedrine, theophylline, rifampicin, etc. inducers of "hepatic" microsomal enzymes (increase in metabolic rate).

Mitotan et al. inhibitors of the function of the adrenal cortex may necessitate an increase in the dose of corticosteroids.

The clearance of corticosteroids increases against the background of thyroid hormones.

Immunosuppressants increase the risk of infections and lymphoma or others. lymphoproliferative disorders associated with the Epstein-Barr virus.

Estrogens (including oral estrogen-containing contraceptives) reduce the clearance of GCS, lengthen T1 / 2 and their therapeutic and toxic effects.

The appearance of hirsutism and acne is facilitated by the simultaneous use of others. steroid hormonal drugs - androgens, estrogens, anabolic steroids, oral contraceptives.

Tricyclic antidepressants can increase the severity of depression caused by taking GCS (not indicated for the treatment of these side effects).

The risk of developing cataracts increases when used against a background of others. GCS, antipsychotic drugs (neuroleptics), carbutamide and azathioprine.

Simultaneous administration with m-anticholinergics (including antihistamines, tricyclic antidepressants), nitrates contributes to the development of an increase in intraocular pressure.

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.

Application for violations of liver function

It should be used with caution in severe chronic hepatic failure.

Application for impaired renal function

It should be used with caution in severe chronic renal failure.

Interaction Dexamed solution for injection 4mg / ml 5ml

Reduce the therapeutic and toxic effects of barbiturates, phenytoin, rifampicin (accelerate metabolism), growth hormone, antacids (reduce absorption), increase - estrogen-containing oral contraceptives, the risk of arrhythmias and hypokalemia - cardiac glycosides and diuretics, the likelihood of edema and arterial hypertension - sodium-containing drugs or supplements, severe hypokalemia, heart failure and osteoporosis - amphotericin B and carbonic anhydrase inhibitors, the risk of erosive ulcerative lesions and bleeding from the gastrointestinal tract - NSAIDs. With simultaneous use with live antiviral vaccines and against the background of others. types of immunizations increase the risk of viral activation and the development of infections. Reduces the hypoglycemic activity of insulin and oral antidiabetic agents, anticoagulation - coumarins, diuretic - diuretics, immunotropic - vaccination (suppresses antibody formation). It impairs the tolerance of cardiac glycosides (causes potassium deficiency), reduces the concentration of salicylates and praziquantel in the blood.

Due to its wide range of action: antihistamine (anti-allergic), anti-shock, anti-toxic, anti-inflammatory Dexamethasone is used as an emergency measure and for treatment dangerous diseases. Inhalations with the drug are often used in pulmonology.

For what diseases is it used

The properties of Dexamethasone make it possible to prescribe it for pathologies:

• with spastic cough with attacks of suffocation;
• for respiratory diseases of viral and bacterial etiology (laryngitis, pharyngitis, tracheitis);
• with pneumonia in the convalescent stage;
• respiratory pathology of fungal origin;
• with pulmonary tuberculosis;
• bronchial asthma;
• with systemic damage to the respiratory system (cystic fibrosis).

The use of the inhalation method helps to reduce the inflammatory process, relaxes the muscles of the larynx, reduces the formation of mucus and promotes its excretion from the body.

Instructions for use

The introduction of nebulizers into medical practice made it possible to expand the range of drugs used for nebulization. Modern devices convert precisely metered amounts of drugs into aerosols. This is of great importance for hormones, an overdose of which is fraught with serious complications, up to and including death.

The following types of inhalers are commercially available:

1. Compressor.
2. Ultrasonic.
3. Mesh inhalers.

According to the instructions, compressor and Mesh inhalers spray a wide range of drugs, including hormones and antibiotics.

Stages of treatment with a nebulizer:

• cleaning hands with detergents;
• assembly of removable parts according to the data sheet and instructions;
• dilution of components and filling of the drug container;
• connecting the main unit (compressor) to the nebulizer and transferring the key from the off state. "0" to the working position "I";
• after the end of the session, the device turns off in the reverse order.

It should be borne in mind that the hormone can be used on the recommendation of the attending physician.

How to dilute - dosage

The hormone for manipulation must be diluted with saline. The recommended proportion is 1: 6. 6 ml of saline is added to 1 ml of the hormone. The resulting composition is added to the drug compartment. Do not use undiluted hormonal preparations.

How to inhale with a nebulizer

When organizing a session with Dexamethasone in a nebulizer, the following recommendations must be followed:

1. Schedule the procedure between meals (1-1.5 hours).
2. You should not read or talk during the session.
3. Dilute Dexamethasone with a sterile syringe before starting each procedure.
4. Medicines should have a temperature between 20 and 25 ° C.
5. Smooth, unhurried breathing with the mouth is recommended for tracheitis, laryngitis.
6. Inhaling aerosol vapors through the nose should be in case of pneumonia, bronchitis, asthma. Breathe out through the mouth after a minute delay in the lungs.
7. After the procedure, you need to wash, rinse your mouth.

The process ends with a wet treatment of the inhaler.

How to carry out the procedure

Having understood how to correctly apply "Dexamethasone" in ampoules for inhalation, you need to understand the specifics of the event itself.

It is important to plan the procedure in the interval between meals, it should be 1-1.5 hours. It is necessary to dilute the composition with a special sterile syringe before starting each procedure. It is important that the components are kept at a temperature of 20-25 ° C.

It is necessary to try to maintain even and unhurried breathing, evenly inhaling and exhaling the drug, even if it is given with difficulty due to swelling or coughing. As a rule, this procedure lasts 7-10 minutes.

At the end of the procedure, you should wash your face and rinse your mouth thoroughly.

Treatment of children

You also need to talk about how to carry out procedures for babies, since we are talking about the instructions for "Dexamethasone" in ampoules. Doctors often prescribe inhalations for children. One procedure takes 0.5 ml of the drug and 2-3 ml of saline. Specific appointments are made by the attending physician, depending on the disease and the severity of the condition.

Inhalations need to be carried out twice a day. The parent is obliged to carefully monitor the child's breathing - it should be even and relaxed. The doctor may allow the infant to be inhaled while sleeping. The procedure is effective, since the relief of the condition occurs already on the third day.

Analogs

Dexamed's analogs are: Dexamethasone, Dexamethasonlong, Maxidex, Dexapos, Megadexan, Dexoftan, Ozurdex, etc.