Dexamethasone tablets: instructions for use. Dexamethasone: instructions, price, analogs and reviews Edema after Dexamethasone

(Dexamethason)

INSTRUCTIONS (information for specialists)

on the medical use of the drug

Registration number P N016061 / 01

Tradename: Dexamethasone

International non-proprietary name: Dexamethasone

Chemical name: 9-fluoro-11 beta, 17,21 -trihydroxy-16alpha-methylpregna-1,4-diene-3,20-dione 21 sodium dihydrogen phosphate

Dosage form: tablets

Compound:

1 tablet contains:

active substance: dexamethasone - 0.0005 g (0.5 mg);

Excipients: refined sugar, potato starch, stearic acid.

Description:

White biconvex tablets.

Pharmacotherapeutic group: Glucocorticosteroid.

The codeATX: Н02АВ02.

Pharmacological properties

Pharmacodynamics.

Synthetic glucocorticosteroid (GCS) is a methylated derivative of fluoroprednisolone. It has anti-inflammatory, anti-allergic, desensitizing, immunosuppressive, anti-shock and antitoxic effects, increases the sensitivity of beta-adrenergic receptors to endogenous catecholamines.

Interacts with specific cytoplasmic receptors (receptors for GCS are present in all tissues, especially there are many in the liver) with the formation of a complex that induces the formation of proteins (including enzymes that regulate vital processes in cells.) Protein metabolism: reduces the amount of globulins in plasma, increases the synthesis of albumin in the liver and kidneys (with an increase in the albumin / globulin ratio); reduces synthesis and enhances protein catabolism in muscle tissue.

Lipid metabolism: increases the synthesis of higher fatty acids and triglycerides, redistributes fat (mobilization from the subcutaneous tissue of the extremities and the accumulation of fat mainly in the shoulder girdle, face, abdomen), leads to the development of hypercholesterolemia.

Carbohydrate metabolism: increases the absorption of carbohydrates from the gastrointestinal tract; increases the activity of glucose-6-phosphatase (increasing the flow of glucose from the liver into the blood); increases the activity of phosphoenolpyruvate carboxylase and the synthesis of aminotransferases (activation of gluconeogenesis); promotes the development of hyperglycemia.

Water-electrolyte metabolism: retains Na + and water in the body, stimulates the excretion of K + (mineralocorticoid activity), reduces the absorption of Ca2 + from the gastrointestinal tract, causes "leaching" of calcium from bones and increases its renal excretion, reduces bone mineralization.

The anti-inflammatory effect is associated with inhibition of the release of inflammatory mediators by eosinophils and mast cells; inducing the formation of lipocortins and reducing the number of mast cells that produce hyaluronic acid; with a decrease in capillary permeability; stabilization of cell membranes (especially lysosomal) and organelle membranes. Acts at all stages of the inflammatory process: inhibits the synthesis of prostaglandins (Pd) at the level of arachidonic acid (lipocortin inhibits phospholipase A2, inhibits the liberation of arachidonic acid and inhibits the biosynthesis of endoperoxides, leicotrienes, which promote inflammation, allergies, etc.), cytokines "pro-inflammatory" interleukin 1, tumor necrosis factor alpha, etc.); increases the resistance of the cell membrane to the action of various damaging factors.

The immunosuppressive effect is caused by the involution of lymphoid tissue caused by the inhibition of the proliferation of lymphocytes (especially T-lymphocytes), suppression of the migration of B-cells and the interaction of T- and B-lymphocytes, inhibition of the release of cytokines (interleukin-1,2; gamma-interferon) from lymphocytes and macrophages and a decrease in the formation of antibodies.

The antiallergic effect develops as a result of a decrease in the synthesis and secretion of allergy mediators, inhibition of the release of histamine and other biologically active substances from sensitized mast cells and basophils, a decrease in the number of circulating basophils, suppression of the development of lymphoid and connective tissue, a decrease in the number of T- and B-lymphocytes, obese cells, a decrease in the sensitivity of effector cells to allergy mediators, inhibition of antibody production, changes in the body's immune response.

In obstructive diseases of the respiratory tract, the action is mainly due to the inhibition of inflammatory processes, the prevention or reduction of the severity of edema of the mucous membranes, a decrease in eosinophilic infiltration of the submucous layer of the bronchial epithelium and the deposition of circulating immune complexes in the bronchial mucosa, as well as inhibition of erosion and desquamation of the mucosa. Increases the sensitivity of the beta-adrenergic receptors of the bronchi of small and medium caliber to endogenous catecholamines and exogenous sympathomimetics, reduces the viscosity of mucus by reducing its production.

It inhibits connective tissue reactions during the inflammatory process and reduces the possibility of scar tissue formation. Suppresses the synthesis and secretion of ACTT and, secondarily, the synthesis of endogenous GCS.

A feature of the action is a significant inhibition of the function of the pituitary gland and an almost complete absence of mineralocorticosteroid activity. Doses of 1-1.5 mg / day inhibit the function of the adrenal cortex; biological half-life - 32-72 hours (duration of inhibition of the hypothalamus-pituitary adrenal gland system).

In terms of the strength of glucocorticoid activity, 0.5 mg of dexamethasone corresponds to approximately 3.5 mg of prednisone (or prednisolone), 15 mg of hydrocortisone, or 17.5 mg of cortisone.

Pharmacokinetics

After oral administration, it is rapidly and completely absorbed. The maximum concentration in the blood is reached after 1-2 hours. In the blood it binds (60-70%) with a specific carrier protein - transcortin. Easily passes through the histohematogenous barriers (including through the hemato-encephalic and placental). It is metabolized in the liver (mainly by conjugation with glucuronic and sulfuric acids) to inactive metabolites. It is excreted in the urine (a small part by the lactating glands). The half-life is 3-5 hours.

Indications for use

• Primary and secondary adrenal insufficiency (usually in combination with mineralocorticoids);
• congenital hyperplasia of the adrenal cortex;
• subacute thyroiditis;
• hypercalcemia in malignant neoplasms;
• bronchial asthma;
• rheumatoid arthritis in the acute phase;
• systemic connective tissue diseases (systemic lupus erythematosus, scleroderma, etc.);
• skin diseases (psoriasis, eczema, dermatitis, pemphigus, acute erytoderma, etc.);
• nonspecific ulcerative colitis;
• diseases of the hematopoietic organs: agranulocytosis, panmyelopathy, autoimmune hemolytic anemia, acute lymphocytic and myeloid leukemias, lymphogranulomatosis, thrombocytopenic purpura, secondary thrombocytopenia in adults, erythroblastopenia (erythrocytic anemia), congenital anemia;
• cerebral edema (usually after prior parenteral administration of a glucocorticosteroid);
• conducting a test in the differential diagnosis of hyperplasia (hyperfunction) and tumors of the adrenal cortex.

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. With caution, the drug should be prescribed for the following diseases and conditions:

Application during pregnancy and breastfeeding

During pregnancy (especially in the first trimester), the drug can be used only for health reasons. 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 carry out drug treatment during breastfeeding, then breastfeeding should be discontinued.

Method of administration and dosage

The dosage regimen of the drug is individual and depends on the indications, 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 0.5 mg every 3 days) to a maintenance dose of 2-4.5 or more mg / day. The minimum effective dose is 0.5-1 mg / day. Children are prescribed 0.0833-0.3333 mg / kg or 0.0025-0.0001 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. Treatment is stopped gradually.

Side effect

Dexamethasone is usually well tolerated. It has low mineralocorticoid activity, i.e. its effect on water-electrolyte metabolism is insignificant. As a rule, low and medium doses of Dexamethasone do not cause sodium and water retention in the body, increased potassium excretion. The following side effects have been described:

From the endocrine system: decreased glucose tolerance, steroidal diabetes mellitus or manifestation of latent diabetes mellitus, inhibition of adrenal function, Itsenko-Cushing's syndrome (moon face, pituitary obesity, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, muscle weakness, stretch marks), delay ...

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, indigestion, flatulence, hiccups. In rare cases - an increase in the activity of "hepatic" transaminases and alkaline phosphatase.

On the part of the cardiovascular system: arrhythmias, bradycardia (up to cardiac arrest); development (in predisposed patients) or increased severity of 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.

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

Due to mineralocorticoid activity- fluid and sodium retention (peripheral edema), hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).

From the side of the musculoskeletal system: growth retardation and ossification processes in children (premature closure of the epiphyseal growth zones), osteoporosis (very rarely - pathological bone fractures, aseptic necrosis of the humerus and femur head), muscle tendon rupture, steroid myopathy, decreased muscle mass (atrophy).

On the part of the skin and mucous membranes: delayed wound healing, petechiae, ecchymosis, thinning of the skin, hyper- or hypopigmentation, acne, striae, a tendency to develop pyoderma and candidiasis.

Allergic reactions: skin rash, itching, anaphylactic shock.

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

Overdose

An increase in the side effects described above is possible. It is necessary to reduce the dose of Dexamethasone. Treatment is symptomatic.

Interaction with other medicinal products

Simultaneous appointment of Dexamethasone with:

inducers of "hepatic" microsomal enzymes(phenobarbital, rifampicin, phenytoin, theofipline, ephedrine) leads to a decrease in its concentration;

diuretics(especially "thiazide" and carbonic anhydrase inhibitors) and amphotericin B can lead to increased excretion of K + from the body; with sodium-containing drugs - the development of edema and increased blood pressure;

amphotericin B - the risk of developing heart failure increases;

cardiac gpicosides- their tolerance worsens and the likelihood of developing ventricular extrasystole (due to induced hypokalemia) increases;

indirect anticoagulants weakens (less often enhances) their effect (dose adjustment is required);

anticoagulants and thrombolytics- the risk of bleeding from ulcers in the gastrointestinal tract increases;

ethanol and non-steroidal anti-inflammatory drugs(NSAIDs) - the risk of erosive and ulcerative lesions in the gastrointestinal tract and the development of bleeding increases (in combination with NSAIDs in the treatment of arthritis, it is possible to reduce the dose of glucocorticosteroids due to the summation of the therapeutic effect);

paracetamol the risk of developing hepatotoxicity increases (induction of liver enzymes and the formation of a toxic metabolite of paracetamol);

acetylsapicylic acid accelerates its excretion and reduces the concentration in the blood (when dexamethasone is canceled, the level of salicylates in the blood increases and the risk of side effects increases);

insulin and oral hypoglycemic drugs, antihypertensive drugs- their effectiveness decreases.

vitamin D- its effect on the absorption of Ca2 + in the intestine decreases.

growth hormone reduces the effectiveness of the latter, and with praziquantel - its concentration;

M-anticholinergics(including antihistamines and tricyclic antidepressants) and nitrates helps to increase intraocular pressure;

isoniazid and mexelitine increases their pletabolism (especially in "slow" acetylators), which leads to a decrease in their plasma concentrations.

Carbonic anhydrase inhibitors and loop diuretics may increase the risk of developing osteoporosis.

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

ACTH enhances the effect of Dexamethasone.

Ergocalciferol and parathyroid hormone prevent the development of osteopathy caused by Dexamethasone.

Cyclosporine and ketoconazole, slowing down the metabolism of Dexamethasone, may in some cases increase its toxicity.

The simultaneous administration of androgens and steroid anabolic drugs with Dexamethasone contributes to the development of peripheral edema and hirsutism, the appearance of acne.

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

Mitotan and other inhibitors of adrenal cortex function may necessitate an increase in the dose of Dexamethasone.

When used simultaneously with live antiviral vaccines and against the background of other types of immunization, it increases the risk of virus activation and the development of infections.

Antipsychotics (neuroleptics) and azathioprine increase the risk of developing cataracts when dexamethasone is prescribed.

The simultaneous administration of antacids reduces the absorption of Dexamethasone.

With simultaneous use with antithyroid drugs, it decreases, and with thyroid hormones, the clearance of Dexamethasone increases.

Special instructions. Before starting treatment, the patient should be examined to identify possible contraindications. Clinical examination should include examination of the cardiovascular system, X-ray examination of the lungs, examination of the stomach and duodenum, urinary system, organs of vision; control of blood count, glucose and electrolytes in blood plasma. During treatment with Dexamethasone (especially long-term), it is necessary to observe an ophthalmologist, control blood pressure and the state of water and electrolyte balance. as well as pictures of peripheral blood and blood glucose levels.

In order to reduce side effects, antacids can be prescribed, as well as to increase the intake of K + into the body (diet, potassium preparations). Food should be rich in proteins, vitamins, with limited content of fats, carbohydrates and table salt.

The effect of the drug is enhanced in patients with hypothyroidism and liver cirrhosis. The drug can exacerbate existing emotional instability or psychotic disturbances. If a history of psychosis is indicated, Dexamethasone in high doses is prescribed under the strict supervision of a physician.

In stressful situations during supportive treatment (for example, surgery, trauma or infectious diseases), the dose of the drug should be adjusted due to the increased need for glucocorticosteroids.

With daily use for 5 months. treatment develops atrophy of the adrenal cortex. The patient should be carefully monitored for a year after the end of long-term therapy with Dexamethasone due to the possible development of relative adrenal insufficiency. If during this period stressful situations arise, they are prescribed (according to indications) at the time of GCS, if necessary in combination with mineralocorticoids.

With a sudden cancellation, especially in the case of previous use of high doses, it is possible to develop a withdrawal syndrome (anorexia, nausea, lethargy, generalized musculoskeletal pain, general weakness), as well as exacerbation of the disease, for which Dexamethasone was prescribed.

During treatment with Dexamethasone, vaccination should not be carried out due to a decrease in its effectiveness (immune response).

Prescribing Dexamethasone for intercurrent infections, septic conditions and tuberculosis, it is necessary to simultaneously treat with antibiotics with bactericidal action.

Dexamethasone can mask some of the symptoms of infections.

In children, during long-term treatment with Dexamethasone, 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. In patients with diabetes mellitus, blood glucose should be monitored and, if necessary, therapy should be corrected. X-ray control of the osteoarticular system is shown (images of the spine, hand).

In patients with latent infectious diseases of the kidneys and urinary tract, Dexamethasone can cause leukocyturia, which may be of diagnostic value.

Dexamethasone increases the content of 11- and 17-oxyketocorticosteroid metabolites.

Release form

0.5 mg tablets. 50 tablets in polypropylene cases. The pencil case, together with the instructions for use, is placed in a cardboard box.

Best before date

3 years. Do not use after the expiration date printed on the package.

Storage conditions

B. Slisok. Store in a dry, protected by light place, out of reach of children, at a temperature of 15 to 25 ° C.

Conditions of dispensing from pharmacies

On prescription.

LLC "Experimental Plant" GNTSLS ", Ukraine

Consumer claims should be sent to the manufacturer.

Dexamethasone is a hormonal drug that is considered in modern medicine as one of the vital pharmaceuticals belonging to the group of synthetic glucocorticosteroids. Dexamethasone is able to penetrate into the tissues of all organs and systems, including the brain and nervous system, and affect the entire body. In severe conditions - shock, acute systemic allergies, severe inflammation, pathological immune reactions, the medicine can save lives.

For the treatment of various types of diseases, Dexamethasone is produced in 4 dosage forms, the therapeutic basis of which is sodium phosphate of dexamethasone.

This substance is a synthetic analogue of the natural steroid hormone that the adrenal glands produce in the body.

Basic forms:

1. Tablets of 0.5 mg (0.5 mg of the active ingredient) in a pack of 10 units.
2. Injection solution (0.4%) in 1 ml ampoules, containing 4 mg of active ingredient (5 or 25 units per package). It is used for injection into a muscle, vein (jet or drip), into the joint, into the soft tissues surrounding it, into the fiber of the eyeball.
3. Dexamethasone eye drops (ear) 10 ml with an active substance concentration of 0.1% (1 mg in 1 ml).
4. Eye ointment - 2.5 g tube.

All forms of medication as auxiliary components contain substances that are necessary to stabilize, shape and transport dexamethasone to the painful focus, as well as preservatives and additives that facilitate the absorption of the drug.

Each therapeutic form has its own purposefulness in use, certain indications and contraindications, therefore, you should not engage in treatment on your own - only a specialist is able to develop the necessary therapy regimen, calculate the doses and frequency of use.

The drug is a prescription drug, where the name of the drug is Latin for Dexamethasoni.

Pharmacological properties and pharmacokinetics

Medicinal properties

The mechanism of the drug's therapeutic action is based on its ability to create a high concentration of the component in the blood and inflammation foci, penetrate into all tissues and exert an effect at the cellular level.

This allows the active substance to work in the brain and nerve tissues, relieve cerebral and lung edema in case of hemorrhage, poisoning, injuries, tumors, removing the patient from a life-threatening state of shock, inhibiting the course of cancer processes, and eliminating the manifestations of acute allergies.

Glucocorticosteroid activates a series of processes that lead to a decrease in the permeability of the vascular walls, strengthening the protection of cell membranes and blocking inflammation at any stage of development.

By suppressing an acute reaction of the immune system to allergens, the drug stops the development of an allergic reaction, including anaphylactic shock, reduces the degree of edema of the mucous membranes of the respiratory organs, bronchi, restoring the flow of air in case of laryngeal edema or asthmatic attack.

At the same time, the drug inhibits the production of histamine, stopping the pathological manifestations of allergies.

Slows down the formation of cicatricial changes in the tissues of various organs.

Absorption and excretion from the body

The corticosteroid is actively and almost completely absorbed not only after injection, but also after internal administration. The bioavailability or amount of the medicinal substance reaching the focus of exposure is 77 - 79%, due to which the therapeutic effect of the drug is maximized.

In the blood, 65 - 70% of dexamethasone binds to the transport protein transcortin, which provides a high concentration of the drug in the blood. With the blood flow, the protein delivers dexamethasone throughout the body, penetrating into the intracellular spaces of tissues.

The largest amount of active substance in the blood, providing the maximum therapeutic effect, is observed within 40 to 90 minutes, depending on the method of application.

The active substance is processed by liver enzymes to inactive intermediates. It is removed from the body along with urine and in small quantities (about 10%) is excreted by the intestines. A small amount of dexamethasone penetrates into human milk, which should be taken into account when prescribing the drug to a nursing mother.

What is the drug prescribed for?

The action of the drug is used in many diseases of internal organs, systemic, autoimmune pathologies, in diseases of the joints, eyes, skin and in many other fields of medicine.

The list of pathological conditions that require injections or Dexamethasone tablets include:

• life-threatening shock conditions of all forms, including painful shock, toxic, cardiogenic, allergic, postoperative, blood transfusion (after blood transfusions);
• swelling of brain tissue (with hemorrhage, meningitis, tumor, encephalitis, trauma, surgery);
• an attack of bronchial asthma or long-term status asthma;
• lung pathologies: beryllium disease, tuberculosis, alveolitis, pneumonia, Leffler's syndrome (resistant to other medicines);
• allergic reactions: urticaria, Quincke's edema, hay fever, allergy to drugs and food, serum sickness;
• endocrine disorders - adrenal insufficiency, thyroid disease, thyrotoxic crisis, thyroiditis, adrenogenital syndrome;
• autoimmune diseases - rheumatic heart disease, multiple sclerosis, systemic lupus erythematosus, pemphigus, scleroderma, systemic vasculitis;
• pain with inflammation of the reproductive organs, including prostatitis; various types of myositis;
• intractable skin diseases - eczema, dermatitis of various types, psoriasis, toxidermia, Lyell and Stevens-Johnson syndromes, discoid lupus erythematosus, keloid scars (topical application);
• eye lesions of an allergic and inflammatory nature: scleritis, corneal ulcer, various types of conjunctivitis (except purulent), uveitis, keratitis, blepharitis, inflammation of the optic nerve, ophthalmopathy against the background of diabetes mellitus;
• swelling of the larynx and glottis with acute croup;
• joint inflammation of various courses: arthritis of various forms, osteoarthritis, polyarthritis, ankylosing spondylitis, bursitis, tendosynovitis and others;
• hematopoietic disorders: Addison's disease, lymphoma, agranulocytosis, anemia of various origins, thrombocytopenia;
• critical conditions with damage to the gastrointestinal system: enteritis, including granulomatous, hepatitis and hepatic coma, ulcerative colitis;
• allergic-toxic reaction with massive helminthic aggression;
• lesions of the esophagus and stomach in case of alkali, acid poisoning to suppress inflammation and prevent cicatricial narrowing;
• acute renal pathologies - glomerulonephritis, nephrotic syndrome;
• malignant processes in the lungs, leukemia, lymphocytic leukemia, multiple myeloma;
• nausea and vomiting while taking cytostatics.

Instructions for the use of Dexamethasone

The treatment regimen with Dexamethasone and the dosage regimen is established only by the attending physician in order to obtain the maximum therapeutic effect with a minimum risk of unwanted side reactions.

Tablets

Usually prescribed for the chronic course of the pathology or after the removal of an acute condition.

The dose is determined for each patient separately, taking into account the nature and severity of the disease, the planned duration of the course, age, drug tolerance and patient response.

The usual minimum effective dose for adults per day is 0.5 to 9 mg. A small dose is taken at a time, a large dose is divided into 3 - 4 doses. The largest amount of dexamethasone per day should not exceed 10-15 mg.

The average maintenance dose per day is 0.5 - 3 mg.

With long-term use of the drug in a large dose, taking the drug is combined with food. In this case, between meals, it is advisable to use agents that reduce gastric acidity (antacids).

After the patient's condition improves, the dose should be gradually reduced - every 3 days by 0.5 mg to a maintenance dose.

The duration of the course of application ranges from 3 - 5 days to several months.

It is unacceptable to abruptly stop treatment with Dexamethasone, so as not to cause withdrawal syndrome,

which is expressed in an exacerbation of the underlying disease and painful manifestations of withdrawal symptoms (weakness, weight loss, vomiting, diarrhea, drop in blood sugar and pressure, muscle pain, fever).

Dosing for children

Young patients are prescribed in accordance with body weight or body area, age and severity of the pathological process.

The approximate children's dose per day is 0.0833 - 0.333 mg per 1 kilogram of the child's body weight. Thus, according to the calculation, a child weighing 25 kg can receive a maximum of 0.333 x 25 = 8.36 mg of the drug per day, divided into 3-4 doses. The minimum dose that will give a therapeutic effect for a small patient with such a weight is 0.0833 x 25 = 2.08 mg.

More precisely, the child's dose is calculated by the surface area of ​​the child's body at the rate of 0.0025 - 0.0001 mg per 1 square meter per day in 3 - 4 doses, depending on age.

Injections

Dexamethasone injections for systemic diseases are given inside the muscles, or injected intravenously, which is preferable in life-threatening situations when there is a high risk to the patient's life. The solution enters the bloodstream immediately, providing a quick therapeutic effect.

For urgent short-term or one-time use of the drug, only intolerance to any of the substances in Dexamethasone is considered a contraindication. In critical situations, the side effects of the medication are neglected.

Adults in acute and urgent conditions can be administered 3 - 4 times 4 - 20 mg per day. In the acute phase of the pathology, as well as at the beginning of therapy, higher doses of a corticosteroid are used. The highest dose is 80 mg, but in critical cases it is higher.

Children's doses for intramuscular administration are calculated by the weight of the child at the rate of 0.02776 - 0.16665 mg per kilogram of body weight after 12 - 24 hours.

The duration of the injection with a gradual dose reduction usually does not exceed 3-4 days, after which the patient is transferred to taking pills in a maintenance dose.

Eye and ear drops

In acute inflammation, patients over 12 years of age are dripped 4 - 5 times a day ophthalmic solution into the lower eyelid, 1 - 2 drops, for 48 hours. When the degree of inflammation decreases, the treatment is continued for another 4 - 6 days, reducing the frequency of instillation to 3 times a day.

In chronic processes, the agent is used twice a day for no longer than 20 - 40 days.

In case of allergic eye damage, similar doses are used up to 5 times a day for 48 hours, then the frequency of instillation is gradually reduced to 2 times a day and treatment is canceled for 7 to 12 days.

For patients 6 - 12 years old, to eliminate inflammatory and allergic phenomena, 1 drop is administered per eyelid up to 4 times a day for no longer than 10 days.

The solution is used from the 8th day after surgery to eliminate cataracts, retinal detachment, strabismus up to 4 times a day for 2 to 4 weeks.

In case of ear inflammation (otitis media) of a non-viral nature, 3-4 drops (for children 1 - 2) are instilled into the sore ear in a warm form three times a day.

Lenses are removed before instilling the product. You can put them on only after 15 minutes.

Dexamethasone eye ointment

It is used for the same indications as ophthalmic drops in patients from 6 years old. A strip of ointment 10-15 mm long is carefully placed behind the lower eyelid 3 times a day. The maximum duration of treatment is no more than 20 days.

Use during pregnancy and lactation

In a study on small mammals, it was revealed that Dexamethasone, like many other hormonal agents, crosses the placenta into the embryonic tissue and can lead to early fetal death and fetal malformations. The class of action of the drug on the fetus is C (according to FDA).

Therefore, Dexamethasone is used during pregnancy only if there is a threat to the mother's life.

If the pregnant woman received Dexamethasone, the baby's health should be monitored after childbirth - since the baby may be diagnosed with adrenal dysfunction, which requires immediate intensive treatment.

Since the drug passes into human milk, breastfeeding mothers need to switch to artificial feeding or refuse the drug.

With long-term use of ointment or drops, the drug is partially absorbed into the bloodstream. Therefore, these dosage forms are allowed to be used by expectant mothers only after 12 weeks of gestation, in very short courses up to 3 days and in minimal doses.

During lactation, treatment with ointment and drops for no longer than 7 to 10 days is permissible.

Can I drink alcohol while taking the drug?

Dexamethasone treatment is incompatible with alcohol consumption, otherwise the consequences of concurrent use will be very serious.

There is a high probability of such severe manifestations as:

• indomitable diarrhea;
• partial loss of vision;
• abdominal pain, vomiting;
• acute soreness at the injection site;
• redness of the skin on the chest, hives, acne on the face;
• ulceration of the mucous membrane of the digestive organs;
• internal bleeding.

If the patient has a serious alcohol dependence and is unable to refuse alcohol during therapy, other drugs are required.

Drug interactions with other drugs

The combination of Dexamethasone and non-hormonal anti-inflammatory pharmaceuticals (Aspirin, Paracetamol) increases the likelihood of formation or deepening of ulcers of the digestive organs.

The effect of the corticosteroid is reduced when used in parallel:

• antacids, which reduce the absorption of the medicinal substance in the stomach;
• somatotropin;
• drugs from the series of inducers of the CYP3A4 isoenzyme (for example, phenobarbital, phenobarbital, rifabutin, rifampicin, carbamazepine);
• aminoglutethimide and ephedrine.

When used in parallel, Dexamethasone is capable of:

• to reduce the therapeutic effects of Insulin, hypoglycemic drugs, drugs for high blood pressure, Praziquantel and diuretic-natriuretics;
• enhance the effect of Heparin, Albendazole.
• increase the excretion of potassium when combined with diuretics; influence the action of coumarin-based anticoagulants;

Antifungal agents based on ketoconazole, contraceptive pills, macrolide antibiotics can lengthen the time for excretion of dexamethasone in the urine and increase the frequency and degree of adverse reactions.

The combination of a medication with Thalidomide can provoke the development of Lyell's syndrome, with anticholinergics - glaucoma, with antipsychotics and Azathioprine - cataracts; with cardiac glycosides - arrhythmias.

The combination with anabolic steroids, androgens, contraceptives, estrogens can cause increased hair growth of the face, breasts, edema, and the development of acne.

The use of antiviral vaccines in parallel with Dexamethasone therapy increases viral aggressiveness against a background of decreased immunity.

Contraindications, side effects and overdose

Contraindications

If Dexamethasone is urgently required to save life, all contraindications (except for drug intolerance) and possible adverse reactions are ignored.

For any severe infections, Dexamethasone injections and tablets can be prescribed only with the simultaneous specific treatment of these diseases.

Contraindications for intra-articular injections:

• bleeding tendency;
• intra-articular bone fracture;
• infection, osteoporosis, instability, deformity in the joint area, bone destruction, ankylosis;
• surgical intervention (arthroplasty);
• articular bone necrosis;
• low efficiency after 2 previous injections.

Contraindications for local forms (ointment, drops):

• damage to the eyes with a tubercle bacillus, fungus, viruses, including herpes;
• glaucoma;
• acute suppuration of the structures of the eye (if antibiotic treatment is not carried out);
• trauma and corneal ulcer, the period after removal of a foreign object;
• hole in the eardrum.

Important! Dexamethasone ointment and drops can reduce the severity of manifestations in the development of bacterial and fungal infections of the ears and eyes.

Therefore, after clarifying the diagnosis and detecting infection, the drug should be used with appropriate antimicrobial treatment.

Side effects

The hormonal agent has a profound effect on all body systems. The task of the attending physician is to minimize the risk, frequency and severity of adverse reactions with a high therapeutic effect of the drug.

Undesirable manifestations depend on the duration of the course, dosages, age and condition of the patient.

Basic side effects:

• allergic rashes, pruritus, urticaria, facial edema, respiratory distress, bronchospasm, anaphylactic shock;
• anxiety, disorientation, depressive, paranoid, or euphoric states;
• double vision, visual disturbances, pain in the head due to an increase in intracranial pressure, characteristic of a rapid dose reduction;
• insomnia, dizziness;
• persistent increase in blood pressure;
• weakening of the myocardium, arrhythmias;
• potassium deficiency and heart problems associated with hypokalemia;
• decreased adrenal function, development of diabetes mellitus, Itsenko-Cushing's syndrome, excessive hair growth, disorder of the monthly cycle, developmental delay in children;
• a sharp increase in blood viscosity and thrombus formation;
• nausea, bouts of vomiting, ulceration of the digestive organs, gastritis, pancreatitis, colitis;
• frequent infections against the background of suppression of immunity;
• osteoporosis, abnormal fractures, joint and muscle pain, femoral head necrosis, tendon rupture;
• acne, sweating, dry skin, slow healing of damage;
• swelling of the limbs, weight gain;
• a sharp deterioration in vision (with injections in the area of ​​the face, neck and head);
• increased pain when injected into the joint;
• burning, itching of the mucous membranes and skin (ointment and drops), with treatment longer than 20 days, allergies, glaucoma and cataracts may develop, and decreased visual function.

Drivers of vehicles and workers from whom increased concentration is required should be careful when treating with Dexamethasone, as concentration of attention is impaired when it is taken.

Overdose

Excessive doses of a corticosteroid or long-term treatment can lead to overdose, which manifests itself in an increase in unwanted side reactions.

The drug is immediately canceled and the symptoms of an overdose are eliminated with the help of drugs that can relieve certain manifestations.

Long-term therapy requires constant monitoring of the development of children, periodic examination of the organs of vision, control of intraocular, intracranial pressure, sugar and blood clotting, functions of the adrenal glands and the hypothalamic-pituitary system.

Dexamethasone analogs

Synonyms - drugs with the same active ingredient as Dexamethasone, and a similar therapeutic effect: Dexamethasone-Vial, Dexamethasone-Ferein, eye drops - Dexamethasonlong, Maxidex, Oftan Dexamethasone, Ozurdex.

Analogues with similar action, but different composition:

• drops with Dexamethasone and other active ingredients: Sofradex, Dexon;
• Prednisolone is a corticosteroid medication with a similar but weaker therapeutic effect.

Expiry date from the date of manufacture

Product description

Tablets

pharmachologic effect

Glucocorticosteroid (GCS) - a methylated derivative of fluoroprednisolone, inhibits the release of interleukin-1 and interleukin-2, interferon gamma from lymphocytes and macrophages. It has anti-inflammatory, anti-allergic, desensitizing, anti-shock, anti-toxic and immunosuppressive effects.
Suppresses the release of adrenocorticotropic hormone (ACTH) and beta-lipotropin by the pituitary gland, but does not reduce the content of circulating beta-endorphin. Inhibits the secretion of thyroid-stimulating hormone (TSH) and follicle-stimulating hormone (FSH).
Increases the excitability of the central nervous system (CNS), reduces the number of lymphocytes and eosinophils, increases - erythrocytes (stimulates the production of erythropoietins).
Interacts with specific cytoplasmic receptors, forms a complex that penetrates the cell nucleus, stimulates the synthesis of mRNA, which induces the formation of proteins, incl. lipocortin, which mediate cellular effects. Lipocortin inhibits phospholipase A2, inhibits the release of arachidonic acid and inhibits the synthesis of endoperoxides, Pg, leukotrienes, which promote inflammation, allergies, etc.
Protein metabolism: reduces the amount of protein in the plasma (due to globulins) with an increase in the albumin / globulin ratio, increases the synthesis of albumin in the liver and kidneys; enhances protein catabolism in muscle tissue.
Lipid metabolism: increases the synthesis of higher fatty acids and triglycerides (TG), redistributes fat (fat accumulation mainly in the shoulder girdle, face, abdomen), leads to the development of hypercholesterolemia.
Carbohydrate metabolism: increases the absorption of carbohydrates from the gastrointestinal tract (GIT); increases the activity of glucose-6-phosphatase, leading to an increase in the flow of glucose from the liver into the blood; increases activity
phosphoenolpyruvate carboxylases and the synthesis of aminotransferases leading to the activation of gluconeogenesis.
Water-electrolyte metabolism: detains Na + and water in the body, stimulates the excretion of K + (MCS activity), reduces the absorption of Ca2 + from the gastrointestinal tract, "flushes" Ca2 + from the bones, increases the excretion of Ca2 + by the kidneys.
The anti-inflammatory effect is associated with inhibition of the release of inflammatory mediators by eosinophils; inducing the formation of lipocortin and reducing the number of mast cells that produce hyaluronic acid; with a decrease in capillary permeability; stabilization of cell membranes and membranes of organelles (especially lysosomal).
The antiallergic effect develops as a result of suppression of the synthesis and secretion of allergy mediators, inhibition of the release of histamine and other biologically active substances from sensitized mast cells and basophils, a decrease in the number of circulating basophils, suppression of the development of lymphoid and connective tissue, a decrease in the number of T- and B-lymphocytes, obese cells, a decrease in the sensitivity of effector cells to allergy mediators, inhibition of antibody production, changes in the body's immune response.
In chronic obstructive pulmonary disease (COPD), the action is mainly based on inhibition of inflammatory processes, inhibition of the development or prevention of edema of the mucous membranes, inhibition of eosinophilic infiltration of the submucous layer of the bronchial epithelium, deposition of circulating immune complexes in the mucous membrane of the bronchi, as well as inhibition of erosion and desquamation ... Increases the sensitivity of small and medium-sized bronchial beta-adrenergic receptors to endogenous catecholamines and exogenous sympathomimetics, reduces the viscosity of mucus by inhibiting or reducing its production.
The anti-shock and antitoxic effect is associated with an increase in blood pressure (due to an increase in the concentration of circulating catecholamines and restoration of the sensitivity of adrenergic receptors to them, as well as vasoconstriction), a decrease in vascular wall permeability, membrane-protective properties, activation of liver enzymes involved in the metabolism of endo- and xenobiotics.
The immunosuppressive effect is due to inhibition of the release of cytokines (interleukin1, interleukin2; interferon gamma) from lymphocytes and macrophages.
Suppresses the synthesis and secretion of ACTH, and secondarily - the synthesis of endogenous GCS. It inhibits connective tissue reactions during the inflammatory process and reduces the possibility of scar tissue formation.
A feature of the action is a significant inhibition of the function of the pituitary gland and an almost complete absence of ISS activity. Doses of 1-1.5 mg / day inhibit the adrenal cortex; biological T1 / 2 - 32-72 hours (duration of inhibition of the hypothalamus-pituitary-adrenal cortex).

Pharmacokinetics

Dexamethasone is rapidly and almost completely absorbed after oral administration. The bioavailability of dexamethasone tablets is approximately 80%. Cmax in blood plasma and the maximum effect after oral administration is achieved after 1-2 hours; after taking a single dose, the effect persists for about 2.75 days.

Indications for use

From the endocrine system: replacement therapy of primary and secondary (pituitary) adrenal insufficiency, congenital adrenal hyperplasia, subacute thyroiditis and severe forms of postradiation thyroiditis. Rheumatic diseases: rheumatoid arthritis (including juvenile chronic arthritis) and extra-articular lesions in rheumatoid arthritis (lungs, heart, eyes, cutaneous vasculitis).
Systemic connective tissue diseases, vasculitis and amyloidosis (as part of combination therapy): systemic lupus erythematosus (treatment of polyserositis and lesions of internal organs), Sjogren's syndrome (treatment of lung, kidney and brain lesions), systemic sclerosis (treatment of myositis, pericarditis and alveolitis) , polymyositis, dermatomyositis, systemic vasculitis, amyloidosis (replacement therapy for adrenal insufficiency), scleroderma.
Skin diseases: pemphigoid, bullous dermatitis, dermatitis herpetiformis, exfoliative dermatitis, exudative erythema (severe forms), erythema nodosum, seborrheic dermatitis (severe forms), psoriasis (severe forms), lichen, fungoid mycoses, asthma edema, bronchial contact , atopic dermatitis, serum sickness, allergic rhinitis, drug disease (hypersensitivity to drugs), urticaria after blood transfusion, systemic immune diseases (sarcoidosis, temporal arteritis).
Eye diseases: proliferative changes in the orbit (endocrine ophthalmopathy, pseudotumors), sympathetic ophthalmia, immunosuppressive therapy in corneal transplantation.
Diseases of the gastrointestinal tract: ulcerative colitis (severe exacerbations), Crohn's disease (severe exacerbations), chronic autoimmune hepatitis, rejection reaction after liver transplantation.
Blood diseases: congenital or acquired acute pure aplastic anemia, autoimmune hemolytic anemia, secondary thrombocytopenia in adults, erythroblastopenia, acute lymphoblastic leukemia (induction therapy), myelodysplastic syndrome, angioimmunoblastic malignant T-cell lymphoma (in combination with plastic with cytostatics), anemia after myelofibrosis with myeloid metaplasia or lymphoplasmacytoid immunocytoma, systemic histiocytosis (systemic process).
Kidney diseases: primary and secondary glomerulonephritis (Goodpasture's syndrome), kidney damage in systemic connective tissue diseases (systemic lupus erythematosus, Sjogren's syndrome), systemic vasculitis (usually in combination with cyclophosphamide), glomerulonephritis in polyarteritis nodosa, Charg-Strauss syndrome, granulomatosegren's syndrome Schonlein-Genoch purpura, mixed cryoglobulinemia, kidney damage in Takayasu arteritis, interstitial nephritis, immunosuppressive therapy after kidney transplantation, induction of diuresis or reduction of proteinemia in idiopathic nephrotic syndrome (without uremia) and kidney damage associated with systemic lupus erythematosus.
Malignant diseases: palliative therapy of leukemia and lymphoma in adults, acute leukemia in children, hypercalcemia in malignant neoplasms.
Other indications: tuberculous meningitis with subarachnoid blockade (in combination with adequate anti-tuberculosis therapy), trichinosis with neurological or myocardial manifestations.

Application during pregnancy and lactation

During pregnancy (especially in the first trimester), Dexamethasone can be used only when the expected therapeutic effect outweighs the potential risk to the fetus. With prolonged therapy with dexamethasone during pregnancy, the possibility of impaired fetal growth is not excluded. In the case of using the drug Dexamethasone in the last 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 a woman received glucocorticosteroids during pregnancy, additional use of glucocorticosteroids is recommended during childbirth. If labor is delayed or a caesarean section is planned, it is recommended to inject 100 mg of hydrocortisone intravenously every 8 hours during the peripartum period.
If necessary, therapy with the drug Dexamethasone breastfeeding should be discontinued.

special instructions

In patients requiring long-term therapy with dexamethasone, after stopping therapy, a "withdrawal" syndrome may develop (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 should be canceled by gradual dose reduction. Rapid withdrawal of the drug 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 the use of dexamethasone, due to the fact that induced adrenal insufficiency can persist for several months after discontinuation of the drug.
Dexamethasone therapy may 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 amebiasis, 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.
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 need special attention and close medical supervision. The drug is prescribed with caution in the first weeks after acute myocardial infarction, to patients with thromboembolism, myasthenia gravis, glaucoma, hypothyroidism, psychosis or psychoneuroses, as well as to patients over 65 years of age.
During therapy with dexamethasone, diabetes mellitus decompensation or the transition of latent diabetes 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 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 is used in children and adolescents only under 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 includes lactose, and therefore, its use in patients with galactosemia, lactase deficiency and glucose-galactose malabsorption syndrome is contraindicated.

With care (Precautions)

Contraindicated in severe chronic liver failure.
Contraindicated in severe chronic renal failure, nephrourolithiasis.
Dexamethasone is used in children and adolescents only under strict indications. During treatment, strict control of the growth and development of the child or adolescent is required.

Method of administration and dosage

Doses are set individually for each patient, depending on the nature of the disease, the expected duration of treatment, drug tolerance and the patient's response to the therapy.
The recommended starting dose for adults is 0.5 mg to 9 mg / day.
The usual maintenance dose is 0.5 mg to 3 mg / day.
The minimum effective daily dose is 0.5-1 mg.
The maximum daily dose is 10-15 mg.
The daily dose can be divided into 2-4 doses.
After reaching a therapeutic effect, the dose is gradually reduced (usually by 0.5 mg every 3 days until a maintenance dose is reached).
With long-term use of high doses inside, the drug is recommended to be taken with meals, and in the intervals between meals, you need to take antacids. 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. Treatment is stopped gradually (at the end, several injections of corticotropin are prescribed).
- with bronchial asthma, rheumatoid arthritis, ulcerative colitis - 1.5-3 mg / day;
- with systemic lupus erythematosus - 2-4.5 mg / day;
- with oncohematological diseases - 7.5-10 mg.
For the treatment of acute allergic diseases, it is advisable to combine parenteral and oral administration: 1 day - 4-8 mg parenterally; Day 2 - by mouth, 4 mg 3 times a day; 3, 4 days - by mouth, 4 mg 2 times a day; 5, 6 days - 4 mg / day, inside; Day 7 - drug withdrawal.
Dosing in children
Children (depending on age) are prescribed 2.5-10 mg / m2 of body surface area / day, dividing the daily dose into 3-4 doses.

Short 1 mg dexamethasone test: 1 mg dexamethasone by mouth at 11:00; blood sampling for determination of serum cortisol at 8.00 the next day.
Special 2-day test with 2 mg dexamethasone: 2 mg dexamethasone by mouth every 6 hours for 2 days; 24-hour urine is collected to determine the concentration of 17-hydroxycorticosteroids.

Overdose

A single use of a large number of tablets does not lead to clinically significant intoxication.
Symptoms: Possible increased dose-related side effects. In this case, the dose of the drug should be reduced.
Treatment: supportive and symptomatic.
There is no specific antidote.
Hemodialysis is ineffective.

Side effect

Classification of the incidence of side effects (WHO): very often> 1/10, often from> 1/100 to 1/1000 to 1/10000 to From the immune system: infrequently - hypersensitivity reactions, a decrease in the immune response and an increase in susceptibility to infections ...
From the endocrine system: often - transient adrenal insufficiency, growth retardation in children and adolescents, adrenal insufficiency and atrophy (decreased response to stress), Itsenko-Cushing syndrome, menstrual irregularities, hirsutism, the transition of latent diabetes mellitus to clinically manifest, increased the 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.
Metabolic and nutritional disorders: often - decreased tolerance to carbohydrates, increased appetite and weight gain, obesity; infrequently - hypertriglyceridemia.
From the nervous system: often - mental disorders; infrequently - edema of the papillae of the optic nerve and increased intracranial pressure (pseudotumor of the brain) after discontinuation of therapy, dizziness, headache; very rarely - convulsions, euphoria, insomnia, irritability, hyperkinesia, depression; rarely - psychosis.
From the digestive system: infrequently - peptic ulcers, acute pancreatitis, nausea, hiccups, stomach or 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).
From the senses: infrequently - posterior subcapsular cataract, increased intraocular pressure, a tendency to develop secondary bacterial, fungal or viral eye infections, trophic changes in the cornea, exophthalmos.
From the side of the cardiovascular system: infrequently - arterial hypertension, hypertensive encephalopathy; very rarely - polyfocal ventricular extrasystoles, transient bradycardia, heart failure, myocardial rupture after a recent acute heart attack.
On the part of the skin: often - erythema, thinning and fragility of the skin, delayed healing of wounds, striae, petechiae and ecchymosis, excessive sweating, steroid acne, suppression of skin reactions during allergological tests; very rarely - angioedema, allergic dermatitis, urticaria.
On the part of the musculoskeletal system: often - muscle atrophy, osteoporosis, muscle weakness, steroid myopathy (muscle weakness due to muscle tissue catabolism); infrequently - aseptic bone necrosis; very rarely - compression fractures of the vertebrae, tendon ruptures (especially when some quinolones are used together), damage to articular cartilage and bone necrosis (associated with frequent intra-articular injections).
From the hematopoietic system: rarely - thromboembolic complications, a decrease in the number of monocytes and / or lymphocytes, leukocytosis, eosinophilia (as in other glucocorticosteroids), thrombocytopenia and non-thrombocytopenic purpura.
Allergic reactions: rarely - skin rash, itching, angioedema, bronchospasm, anaphylactic shock.
From the genitourinary system: rarely - impotence.

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 is being treated. With the development of severe adverse events, treatment with Dexamethasone should be discontinued.

Compound

1 tab. dexamethasone 0.5 mg

Interaction with other drugs

The simultaneous use of dexamethasone and non-steroidal anti-inflammatory drugs (NSAIDs) increases the risk of developing and forming ulcers of the gastrointestinal tract.
The effect of dexamethasone is reduced with the simultaneous use of inducers of the isoenzyme CYP3A4 (for example, phenytoin, phenobarbitone, carbamazepine, primidone, rifabutin, rifampicin) or drugs that increase the metabolic clearance of glucocorticoids (ephedrine and aminoglutethimide); in such cases, it is necessary to increase the dose of dexamethasone.
Interaction between dexamethasone and the above drugs can distort the results of dexamethasone suppression tests. If tests with dexamethasone are to be performed during therapy with one of the listed drugs, this interaction should be considered when interpreting the test results.
The simultaneous use of dexamethasone and inhibitors of the isoenzyme CYP3A4 (eg, ketoconazole, macrolide antibiotics) may lead to an increase in the concentration of dexamethasone in the blood.
The simultaneous use of drugs that are metabolized by CYP3A4 (for example, indinavir, erythromycin) may increase their clearance, which may be accompanied by a decrease in their serum concentrations.
Dexamethasone reduces the effectiveness of hypoglycemic drugs, antihypertensive drugs, praziquantel and natriuretics (it is necessary to increase the dose of these drugs); increases the activity of heparin, albendazole and potassium-sparing diuretics (if necessary, reduce the dose of these drugs).
Dexamethasone can alter the action of coumarin anticoagulants, therefore, more frequent monitoring of prothrombin time is recommended during therapy. Antacids reduce the absorption of dexamethasone in the stomach. Smoking does not affect the pharmacokinetics of dexamethasone.
With the simultaneous use of oral contraceptives, the T1 / 2 of glucocorticosteroids may increase, with a corresponding increase in their biological effects and an increase in the incidence of adverse side effects.
The simultaneous use of ritodrin and dexamethasone during labor is contraindicated, since this can lead to the death of the mother due to pulmonary edema. The combined use of dexamethasone and thalidomide can cause toxic epidermal necrolysis.
Potential, therapeutically beneficial interactions: Concomitant use of dexamethasone and metoclopramide, diphenhydramine, prochlorperazine, or 5-HT3 receptor antagonists (serotonin or 5-hydroxytryptamine receptors type 3) such as ondansetron or granisetron ( cyclophosphamide, methotrexate, fluorouracil).

Release form

Tablets
1 tab. dexamethasone 0.5 mg
Other ingredients: lactose monohydrate, corn starch, povidone, magnesium stearate, talc, anhydrous colloidal silicon dioxide.
10 pieces. - contour cell packaging (1) - cardboard packs.
10 pieces. - dark glass bottles (1) - cardboard packs.

Release form, composition and packaging

10 pieces. - contour cell packaging (1) - cardboard packs.
10 pieces. - dark glass bottles (1) - cardboard packs.

Clinical and pharmacological group

GCS for oral administration

pharmachologic effect

Glucocorticosteroid (GCS) - a methylated derivative of fluoroprednisolone, inhibits the release of interleukin-1 and interleukin-2, interferon gamma from lymphocytes and macrophages. It has anti-inflammatory, anti-allergic, desensitizing, anti-shock, anti-toxic and immunosuppressive effects.

Suppresses the release of adrenocorticotropic hormone (ACTH) and beta-lipotropin by the pituitary gland, but does not reduce the content of circulating beta-endorphin. Inhibits the secretion of thyroid-stimulating hormone (TSH) and follicle-stimulating hormone (FSH).

Increases the excitability of the central nervous system (CNS), reduces the number of lymphocytes and eosinophils, increases - erythrocytes (stimulates the production of erythropoietins).

Interacts with specific cytoplasmic receptors, forms a complex that penetrates the cell nucleus, stimulates the synthesis of mRNA, which induces the formation of proteins, incl. lipocortin, which mediate cellular effects. Lipocortin inhibits phospholipase A2, inhibits the release of arachidonic acid and inhibits the synthesis of endoperoxides, Pg, leukotrienes, which promote inflammation, allergies, etc.

Protein metabolism: reduces the amount of protein in plasma (due to globulins) with an increase in the albumin / globulin ratio, increases the synthesis of albumin in the liver and kidneys; enhances protein catabolism in muscle tissue.

Lipid metabolism: increases the synthesis of higher fatty acids and triglycerides (TG), redistributes fat (accumulation of fat mainly in the shoulder girdle, face, abdomen), leads to the development of hypercholesterolemia.

Carbohydrate metabolism: increases the absorption of carbohydrates from the gastrointestinal tract (GIT); increases the activity of glucose-6-phosphatase, leading to an increase in the flow of glucose from the liver into the blood; increases activity
phosphoenolpyruvate carboxylases and the synthesis of aminotransferases leading to the activation of gluconeogenesis.

Water-electrolyte exchange: retains Na + and water in the body, stimulates the excretion of K + (MCS activity), reduces the absorption of Ca2 + from the gastrointestinal tract, "flushes" Ca2 + from the bones, and increases the excretion of Ca2 + by the kidneys.

The anti-inflammatory effect is associated with inhibition of the release of inflammatory mediators by eosinophils; inducing the formation of lipocortin and reducing the number of mast cells that produce hyaluronic acid; with a decrease in capillary permeability; stabilization of cell membranes and membranes of organelles (especially lysosomal).

The antiallergic effect develops as a result of suppression of the synthesis and secretion of allergy mediators, inhibition of the release of histamine and other biologically active substances from sensitized mast cells and basophils, a decrease in the number of circulating basophils, suppression of the development of lymphoid and connective tissue, a decrease in the number of T- and B-lymphocytes, obese cells, a decrease in the sensitivity of effector cells to allergy mediators, inhibition of antibody production, changes in the body's immune response.

In chronic obstructive pulmonary disease (COPD), the action is mainly based on inhibition of inflammatory processes, inhibition of the development or prevention of edema of the mucous membranes, inhibition of eosinophilic infiltration of the submucous layer of the bronchial epithelium, deposition of circulating immune complexes in the mucous membrane of the bronchi, as well as inhibition of erosion and desquamation ... Increases the sensitivity of small and medium-sized bronchial beta-adrenergic receptors to endogenous catecholamines and exogenous sympathomimetics, reduces the viscosity of mucus by inhibiting or reducing its production.

The anti-shock and antitoxic effect is associated with an increase in blood pressure (due to an increase in the concentration of circulating catecholamines and restoration of the sensitivity of adrenergic receptors to them, as well as vasoconstriction), a decrease in vascular wall permeability, membrane-protective properties, activation of liver enzymes involved in the metabolism of endo- and xenobiotics.

The immunosuppressive effect is due to inhibition of the release of cytokines (interleukin1, interleukin2; interferon gamma) from lymphocytes and macrophages.

Suppresses the synthesis and secretion of ACTH, and secondarily - the synthesis of endogenous GCS. It inhibits connective tissue reactions during the inflammatory process and reduces the possibility of scar tissue formation.

A feature of the action is a significant inhibition of the function of the pituitary gland and an almost complete absence of ISS activity. Doses of 1-1.5 mg / day inhibit the adrenal cortex; biological T 1/2 - 32-72 hours (duration of inhibition of the hypothalamus-pituitary-adrenal cortex).

In terms of the strength of glucocorticosteroid activity, 0.5 mg of dexamethasone corresponds to approximately 3.5 mg of prednisone (or prednisolone), 15 mg of hydrocortisone, or 17.5 mg of cortisone.

Pharmacokinetics

Dexamethasone is rapidly and almost completely absorbed after oral administration. The bioavailability of dexamethasone tablets is approximately 80%. C max in blood plasma and the maximum effect after oral administration is achieved in 1-2 hours; after taking a single dose, the effect persists for about 2.75 days.

In blood plasma, approximately 77% of dexamethasone binds to proteins, mainly albumin. A small amount of dexamethasone binds to non-albumin proteins. Dexamethasone is a fat-soluble substance that can penetrate into extra- and intracellular spaces. In the central nervous system (hypothalamus, pituitary gland), its effects are due to binding to membrane receptors. In peripheral tissues, it binds to cytoplasmic receptors. Its disintegration takes place in the place of its action, i.e. in a cage. It is metabolized mainly in the liver to the formation of inactive metabolites. It is excreted by the kidneys.

Indications for the use of the drug

replacement therapy of primary and secondary (pituitary) adrenal insufficiency, congenital adrenal hyperplasia, subacute thyroiditis and severe forms of postradiation thyroiditis. Rheumatic diseases: rheumatoid arthritis (including juvenile chronic arthritis) and extra-articular lesions in rheumatoid arthritis (lungs, heart, eyes, cutaneous vasculitis).

Systemic connective tissue diseases, vasculitis and amyloidosis (as part of combination therapy): systemic lupus erythematosus (treatment of polyserositis and lesions of internal organs), Sjogren's syndrome (treatment of lesions of the lungs, kidneys and brain), systemic sclerosis (treatment of myositis, pericarditis and alveolitis), polymyositis, dermatomyositis, systemic vasculitis, amyloidosis (replacement therapy for adrenal insufficiency ), scleroderma.

Skin diseases: pemphigoid, bullous dermatitis, herpetiformis dermatitis, exfoliative dermatitis, exudative erythema (severe forms), erythema nodosum, seborrheic dermatitis (severe forms), psoriasis (severe forms), lichen, fungoid mycoses, asthma edema, atrial bronchitis , serum sickness, allergic rhinitis, drug disease (hypersensitivity to drugs), urticaria after blood transfusion, systemic immune diseases (sarcoidosis, temporal arteritis).

Eye diseases: proliferative changes in the orbit (endocrine ophthalmopathy, pseudotumors), sympathetic ophthalmia, immunosuppressive therapy in corneal transplantation.

ulcerative colitis (severe exacerbations), Crohn's disease (severe exacerbations), chronic autoimmune hepatitis, rejection reaction after liver transplantation.

Blood diseases: congenital or acquired acute pure aplastic anemia, autoimmune hemolytic anemia, secondary thrombocytopenia in adults, erythroblastopenia, acute lymphoblastic leukemia (induction therapy), myelodysplastic syndrome, angioimmunoblastic malignant T-cell lymphoma (in combination with cytostatics) (in combination with cytotoxic drugs) , anemia after myelofibrosis with myeloid metaplasia or lymphoplasmacytoid immunocytoma, systemic histiocytosis (systemic process).

Kidney disease: primary and secondary glomerulonephritis (Goodpasture's syndrome), kidney damage in systemic connective tissue diseases (systemic lupus erythematosus, Sjogren's syndrome), systemic vasculitis (usually in combination with cyclophosphamide), glomerulonephritis in polyarteritis nodosa, Churg-Strauss syndrome, Wegener's granulomatosis Genocha, mixed cryoglobulinemia, kidney damage in Takayasu's arteritis, interstitial nephritis, immunosuppressive therapy after kidney transplantation, induction of diuresis or reduction of proteinemia in idiopathic nephrotic syndrome (without uremia) and kidney damage associated with systemic lupus erythematosus.

Malignant diseases: palliative therapy of leukemia and lymphoma in adults, acute leukemia in children, hypercalcemia in malignant neoplasms.

Other indications: tuberculous meningitis with subarachnoid blockade (in combination with adequate anti-tuberculosis therapy), trichinosis with neurological or myocardial manifestations.

Dosage regimen

Doses are set individually for each patient, depending on the nature of the disease, the expected duration of treatment, drug tolerance and the patient's response to the therapy.

Regular supportive dose - from 0.5 mg to 3 mg / day.

Minimally effective the daily dose is 0.5-1 mg.

Maximum daily the dose is 10-15 mg.

The daily dose can be divided into 2-4 doses.

After reaching a therapeutic effect, the dose is gradually reduced (usually by 0.5 mg every 3 days until a maintenance dose is reached).

With long-term use of high doses inside, the drug is recommended to be taken with meals, and in the intervals between meals, it is necessary to take antacids. 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. Treatment is stopped gradually (at the end, several injections of corticotropin are prescribed).

- at bronchial asthma, rheumatoid arthritis, ulcerative colitis - 1.5-3 mg / day;

- at systemic lupus erythematosus- 2-4.5 mg / day;

- at oncohematological diseases- 7.5-10 mg.

For the treatment of acute allergic diseases, it is advisable to combine parenteral and oral administration: 1 day - 4-8 mg parenterally; Day 2 - by mouth, 4 mg 3 times a day; 3, 4 days - by mouth, 4 mg 2 times a day; 5, 6 days - 4 mg / day, by mouth; Day 7 - drug withdrawal.

Dosing in children

Children (depending on age) are prescribed 2.5-10 mg / m 2 body surface area / day, dividing the daily dose into 3-4 doses.

Diagnostic tests for hyperfunction of the adrenal cortex

Short 1mg Dexamethasone Test: 1 mg dexamethasone orally at 11.00; blood sampling for determination of serum cortisol at 8.00 the next day.

Special 2-day test with 2 mg dexamethasone: 2 mg dexamethasone by mouth every 6 hours for 2 days; 24-hour urine is collected to determine the concentration of 17-hydroxycorticosteroids.

Side effect

Classification of the incidence of side effects (WHO): very often> 1/10, often from> 1/100 to 1/1000 to 1/10000 to

From the immune system: infrequently - hypersensitivity reactions, decreased immune response and increased susceptibility to infections.

From the endocrine system: often - transient adrenal insufficiency, growth retardation in children and adolescents, adrenal insufficiency and atrophy (decreased response to stress), Itsenko-Cushing syndrome, menstrual irregularities, hirsutism, 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.

Metabolic and nutritional disorders: often - decreased tolerance to carbohydrates, increased appetite and weight gain, obesity; infrequently - hypertriglyceridemia.

From the nervous system: often - mental disorders; infrequently - edema of the papillae of the optic nerve and increased intracranial pressure (pseudotumor of the brain) after discontinuation of therapy, dizziness, headache; very rarely - convulsions, euphoria, insomnia, irritability, hyperkinesia, depression; rarely - psychosis.

From the digestive system: infrequently - peptic ulcers, acute pancreatitis, nausea, hiccups, stomach or 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).

From the senses: infrequently - posterior subcapsular cataract, increased intraocular pressure, a tendency to develop secondary bacterial, fungal or viral eye infections, trophic changes in the cornea, exophthalmos.

On the part of the cardiovascular system: infrequently - arterial hypertension, hypertensive encephalopathy; very rarely - polyfocal ventricular extrasystoles, transient bradycardia, heart failure, myocardial rupture after a recent acute heart attack.

From the side of the skin: often - erythema, thinning and fragility of the skin, delayed wound healing, striae, petechiae and ecchymosis, increased sweating, steroid acne, suppression of skin reactions during allergological tests; very rarely - angioedema, allergic dermatitis, urticaria.

From the side of the musculoskeletal system: often - muscle atrophy, osteoporosis, muscle weakness, steroid myopathy (muscle weakness due to muscle tissue catabolism); infrequently - aseptic bone necrosis; very rarely - compression fractures of the vertebrae, tendon ruptures (especially when some quinolones are used together), damage to articular cartilage and bone necrosis (associated with frequent intra-articular injections).

From the hematopoietic system: rarely - thromboembolic complications, a decrease in the number of monocytes and / or lymphocytes, leukocytosis, eosinophilia (as in other glucocorticosteroids), thrombocytopenia and non-thrombocytopenic purpura.

Allergic reactions: rarely - skin rash, itching, angioedema, bronchospasm, anaphylactic shock.

From the genitourinary system: rarely - impotence.

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 is being treated. With the development of severe adverse events, drug treatment Dexamethasone should be terminated.

Contraindications to the use of the drug

For short-term use for "vital" indications, the only contraindication is hypersensitivity to the active substance or auxiliary components of the drug.

A drug Dexamethasone contraindicated in patients with galactosemia, lactase deficiency and glucose-galactose malabsorption syndrome, due to the fact that the drug contains lactose.

Diseases of the gastrointestinal tract: peptic ulcer and 12 duodenal ulcer, esophagitis, gastritis, acute or latent peptic ulcer, newly 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-angle and closed-angle glaucoma, lactation period.

Use of the drug during pregnancy and lactation

During pregnancy (especially in the first trimester), the drug Dexamethasone can be used only when the expected therapeutic effect outweighs the potential risk to the fetus. With prolonged therapy with dexamethasone during pregnancy, the possibility of impaired fetal growth is not excluded. In case of using the drug Dexamethasone in the last 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 a woman received glucocorticosteroids during pregnancy, additional use of glucocorticosteroids is recommended during childbirth. If labor is delayed or a cesarean section is planned, during the peripartum period, it is recommended to inject 100 mg of hydrocortisone intravenously every 8 hours. Dexamethasone breastfeeding should be discontinued.

special instructions

In patients requiring long-term dexamethasone therapy, after stopping therapy, a "withdrawal" syndrome (also without clear signs of adrenal insufficiency) may develop: 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 gradually reducing the dose. Rapid withdrawal of the drug 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 the use of dexamethasone, due to the fact that induced adrenal insufficiency can persist for several months after discontinuation of the drug.

Dexamethasone therapy may 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.

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 need special attention and close medical supervision. Carefully the drug is prescribed in the first weeks after acute myocardial infarction, to patients with thromboembolism, myasthenia gravis, glaucoma, hypothyroidism, psychosis or psychoneuroses, as well as to patients over 65 years of age.

During therapy with dexamethasone, diabetes mellitus decompensation or the transition of latent diabetes 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 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 is used in children and adolescents only under 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 includes 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 does not affect the ability to drive vehicles and work with technical devices that require concentration of attention and speed of psychomotor reactions.

Overdose

A single use of a large number of tablets does not lead to clinically significant intoxication.

Symptoms: possible increase in dose-dependent side effects. In this case, the dose of the drug should be reduced.

Treatment: supportive and symptomatic.

There is no specific antidote.

Hemodialysis is ineffective.

Drug interactions

The simultaneous use of dexamethasone and non-steroidal anti-inflammatory drugs (NSAIDs) increases the risk of developing and forming ulcers of the gastrointestinal tract.

The effect of dexamethasone is reduced with the simultaneous use of inducers of the isoenzyme CYP3A4 (for example, phenytoin, phenobarbitone, carbamazepine, primidone, rifabutin, rifampicin) or drugs that increase the metabolic clearance of glucocorticoids (ephedrine and aminoglutethimide); in such cases, it is necessary to increase the dose of dexamethasone.

Interaction between dexamethasone and the above drugs can distort the results of dexamethasone suppression tests. If tests with dexamethasone are to be performed during therapy with one of the listed drugs, this interaction should be considered when interpreting the test results.

The simultaneous use of dexamethasone and inhibitors of the isoenzyme CYP3A4 (eg, ketoconazole, macrolide antibiotics) may lead to an increase in the concentration of dexamethasone in the blood.

The simultaneous use of drugs that are metabolized by CYP3A4 (for example, indinavir, erythromycin) may increase their clearance, which may be accompanied by a decrease in their serum concentrations.

Dexamethasone reduces the effectiveness of hypoglycemic drugs, antihypertensive drugs, praziquantel and natriuretics (it is necessary to increase the dose of these drugs); increases the activity of heparin, albendazole and potassium-sparing diuretics (if necessary, reduce the dose of these drugs).

Dexamethasone can alter the action of coumarin anticoagulants, therefore, more frequent monitoring of prothrombin time is recommended during therapy. Antacids reduce the absorption of dexamethasone in the stomach. Smoking does not affect the pharmacokinetics of dexamethasone.

With the simultaneous use of oral contraceptives, T 1/2 of glucocorticosteroids may increase, with a corresponding increase in their biological effects and an increase in the frequency of adverse side effects.

The simultaneous use of ritodrin and dexamethasone during labor is contraindicated, since this can lead to the death of the mother due to pulmonary edema. The combined use of dexamethasone and thalidomide can cause toxic epidermal necrolysis.

Potential, therapeutically beneficial interactions: the simultaneous use of dexamethasone and metoclopramide, diphenhydramine, prochlorperazine, or 5-HT 3 receptor antagonists (serotonin or 5-hydroxytryptamine receptors type 3), such as ondansetron or granisetron, is effective in the prevention of nausea and vomiting caused by chemotherapy, cyclophosphamide, cyclophocyte ).

Conditions of dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

Store the drug at a temperature not exceeding 25 ° C, in its original packaging. Keep out of the reach of children.

Best before date - 5 years. Do not use the drug after the expiration date.

Dispensing the drug

On prescription

Manufacturer's country of origin

Slovenia

Basic shelf life (in months)

Method of drug administration

Oral

Nosological classification ICD-10 (name)

Tuberculous meningitis; Trichinosis; Peripheral and cutaneous T-cell lymphomas; Fungal mycosis; Acute lymphoblastic leukemia; Myelodysplastic syndromes; Acquired hemolytic anemia; Acquired pure red cell aplasia (erythroblastopenia); Secondary rubbing cells of other thrombocytocytocytopenia; X); Thyroiditis; Adrenogenital disorders; Primary adrenal insufficiency; Other and unspecified adrenal insufficiency; Amyloidosis; Other endophthalmitis (sympathetic uveitis); Allergic rhinitis caused by pollen; Other allergic rhinitis (perennial allergic rhinitis); regional enteritis]; Ulcerative colitis; Chronic hepatitis, not elsewhere classified; Pemphigus [pemphigus]; Ophthalmic pemphigoid L12 .-; Dermatitis herpetiformis; Other atopic dermatitis; Seborrheic dermatitis; Seborrhea of ​​the head; Allergic contact with simple contact dermatitis dermatitis; Exfoliative dermatitis; Lichen simplex; Psoriasis; Seropositive rheumatoid arthritis; Juvenile [juvenile] arthritis; Polyarteritis nodosa and related conditions; Other necrotizing vasculopathies; Systemic lupus erythematosus; Dermatopolymyositis; Systemic sclerosis; Dry syndrome; Nephritis syndrome; (acute glomerulonephritis); Chronic nephritic syndrome (chronic glomerulonephritis); Angioedema (angioedema); Other serum reactions; Pathological reaction to a drug or medication, unspecified; Palliative care; The presence of transplanted organs and tissues

Glucocorticosteroid Symptoms

No questions yet

In this article, you can read the instructions for the use of the medicinal product. Dexamethasone... Reviews of website visitors - consumers of this medication, as well as opinions of doctors of specialists on the use of Dexamethasone in their practice are presented. A big request to more actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, which may not have been declared by the manufacturer in the annotation. Dexamethasone analogs if structural analogs are available. Use for the treatment of inflammatory and systemic diseases, including the eyes, in adults, children, as well as during pregnancy and lactation.

Dexamethasone- a synthetic glucocorticosteroid (GCS), a methylated derivative of fluoroprednisolone. It has anti-inflammatory, anti-allergic, immunosuppressive effects, increases the sensitivity of beta-adrenergic receptors to endogenous catecholamines.

Interacts with specific cytoplasmic receptors (receptors for GCS are present in all tissues, especially in the liver) to form a complex that induces the formation of proteins (including enzymes that regulate vital processes in cells.)

Protein metabolism: reduces the amount of globulins in the plasma, increases the synthesis of albumin in the liver and kidneys (with an increase in the albumin / globulin ratio), reduces the synthesis and enhances the catabolism of protein in muscle tissue.

Lipid metabolism: increases the synthesis of higher fatty acids and triglycerides, redistributes fat (fat accumulation occurs mainly in the shoulder girdle, face, abdomen), leads to the development of hypercholesterolemia.

Carbohydrate metabolism: increases the absorption of carbohydrates from the gastrointestinal tract; increases the activity of glucose-6-phosphatase (increasing the flow of glucose from the liver into the blood); increases the activity of phosphoenolpyruvate carboxylase and the synthesis of aminotransferases (activation of gluconeogenesis); promotes the development of hyperglycemia.

Water-electrolyte metabolism: retains Na + and water in the body, stimulates the excretion of K + (mineralocorticoid activity), reduces the absorption of Ca + from the gastrointestinal tract, and reduces bone mineralization.

The anti-inflammatory effect is associated with inhibition of the release of inflammatory mediators by eosinophils and mast cells; inducing the formation of lipocortins and reducing the number of mast cells that produce hyaluronic acid; with a decrease in capillary permeability; stabilization of cell membranes (especially lysosomal) and organelle membranes. Acts at all stages of the inflammatory process: inhibits the synthesis of prostaglandins (Pg) at the level of arachidonic acid (lipocortin inhibits phospholipase A2, inhibits the liberation of arachidonic acid and inhibits the biosynthesis of endoperoxides, leukotrienes that promote inflammation, allergies, etc.), the synthesis of "pro-inflammatory" cytokines ( interleukin 1, tumor necrosis factor alpha, etc.); increases the resistance of the cell membrane to the action of various damaging factors.

The immunosuppressive effect is caused by the involution of lymphoid tissue caused by the inhibition of the proliferation of lymphocytes (especially T-lymphocytes), suppression of the migration of B-cells and the interaction of T- and B-lymphocytes, inhibition of the release of cytokines (interleukin-1, 2; gamma-interferon) from lymphocytes and macrophages and a decrease in the formation of antibodies.

The antiallergic effect develops as a result of a decrease in the synthesis and secretion of allergy mediators, inhibition of the release of histamine and other biologically active substances from sensitized mast cells and basophils, a decrease in the number of circulating basophils, T- and B-lymphocytes, and mast cells; suppressing the development of lymphoid and connective tissue, reducing the sensitivity of effector cells to allergy mediators, suppressing antibody production, changing the body's immune response.

In obstructive diseases of the respiratory tract, the action is mainly due to the inhibition of inflammatory processes, the prevention or reduction of the severity of edema of the mucous membranes, a decrease in eosinophilic infiltration of the submucous layer of the bronchial epithelium and the deposition of circulating immune complexes in the bronchial mucosa, as well as inhibition of erosion and desquamation of the mucosa. Increases the sensitivity of the beta-adrenergic receptors of the bronchi of small and medium caliber to endogenous catecholamines and exogenous sympathomimetics, reduces the viscosity of mucus by reducing its production.

Suppresses the synthesis and secretion of ACTH and, secondarily, the synthesis of endogenous GCS.

It inhibits connective tissue reactions during the inflammatory process and reduces the possibility of scar tissue formation.

A feature of the action is a significant inhibition of the function of the pituitary gland and an almost complete absence of mineralocorticosteroid activity.

Doses of 1-1.5 mg per day inhibit the function of the adrenal cortex; biological half-life - 32-72 hours (duration of inhibition of the hypothalamus-pituitary-adrenal cortex).

In terms of the strength of glucocorticoid activity, 0.5 mg of dexamethasone corresponds to approximately 3.5 mg of prednisone (or prednisolone), 15 mg of hydrocortisone, or 17.5 mg of cortisone.

Pharmacokinetics

Easily passes through the histohematogenous barriers (including through the blood-brain and placental barriers). It is metabolized in the liver (mainly by conjugation with glucuronic and sulfuric acids) to inactive metabolites. It is excreted by the kidneys (a small part by the lactating glands).

Indications

Diseases requiring the introduction of fast-acting corticosteroids, as well as cases when oral administration of the drug is not possible:

• 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 (burn, traumatic, operational, toxic) - with the ineffectiveness of vasoconstrictors, plasma-substituting drugs and other symptomatic therapy;
• 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, anaphylactic shock;
• 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 suffering from malignant tumors, when oral treatment is impossible;
• blood diseases: acute hemolytic anemia, agranulocytosis, idiopathic thrombocytopenic purpura in adults;
• severe infectious diseases (in combination with antibiotics);
• in ophthalmic practice (subconjunctival, retrobulbar or parabulbar treatment): allergic conjunctivitis, keratitis, keratoconjunctivitis without damage to the epithelium, iritis, iridocyclitis, blepharitis, blepharoconjunctivitis, scleritis, inflammatory process of the eyes, episclanic surgery cornea;
• local application (in the field of pathological education): keloids, discoid lupus erythematosus, annular granuloma.

Forms of issue

Tablets 0.5 mg.

Solution in ampoules for intravenous and intramuscular administration (injections for injections) 4 mg / ml.

Eye drops Oftan 0.1%.

Ophthalmic suspension 0.1%.

Instructions for use and dosage

The dosage regimen is individual and depends on the indications, the patient's condition and his response to therapy. The drug is injected intravenously slowly in a stream or drip (in acute and urgent conditions); intramuscularly; local (in pathological education) introduction is also possible. In order to prepare a solution for intravenous drip infusion (dropper), isotonic sodium chloride solution or 5% dextrose solution should be used.

In the acute period for various diseases and at the beginning of therapy, Dexamethasone is used in higher doses. During the day, you can enter from 4 to 20 mg of Dexamethasone 3-4 times.

Doses of the drug for children (intramuscularly):

The dose of the drug during replacement therapy (in case of adrenal cortex insufficiency) is 0.0233 mg / kg body weight or 0.67 mg / m2 body surface area, divided into 3 doses, every 3rd day or 0.00776 - 0.01165 mg / kg body weight or 0.233 - 0.335 mg / m2 body surface area daily. For other indications, the recommended dose is from 0.02776 to 0.16665 mg / kg body weight or 0.833 to 5 mg / m2 body surface area every 12-24 hours.

When the effect is achieved, the dose is reduced to a maintenance one or until treatment is discontinued. The duration of parenteral administration is usually 3-4 days, then they switch to maintenance therapy with dexamethasone tablets.

Long-term use of high doses of the drug requires a gradual dose reduction in order to prevent the development of acute adrenal cortex insufficiency.

Drops

Conjunctivally, adults and children over 12 years of age in acute inflammatory conditions: 1-2 drops 4-5 times a day for 2 days, then 3-4 times a day for 4-6 days.

Chronic conditions: 1-2 drops 2 times a day for a maximum of 4 weeks (no more).

In postoperative and post-traumatic cases: starting from the 8th day after surgery for strabismus, retinal detachment, cataract extraction and from the moment of the onset of injury - 1-2 drops 2-4 times a day for 2-4 weeks; with antiglaucoma filtering surgery - on the day of surgery or the next day after it.

Children from 6 to 12 years old with allergic inflammatory conditions: 1 drop 2-3 times a day for 7-10 days, if necessary, treatment is continued after monitoring the state of the cornea on the 10th day.

Side effect

Dexamethasone is usually well tolerated. It has low mineralocorticoid activity, i.e. its effect on water-electrolyte metabolism is insignificant. As a rule, low and medium doses of Dexamethasone do not cause sodium and water retention in the body, increased potassium excretion. The following side effects have been described:

• decreased glucose tolerance;
• steroidal diabetes mellitus or latent diabetes mellitus manifestation;
• suppression of adrenal function;
• Itsenko-Cushing's syndrome (moon face, pituitary obesity, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, muscle weakness, striae);
• delayed sexual development in children;
• nausea, vomiting;
• pancreatitis;
• steroid ulcer of the stomach and duodenum;
• erosive esophagitis;
• gastrointestinal bleeding and perforation of the wall of the gastrointestinal tract;
• increased or decreased appetite;
• indigestion;
• flatulence;
• arrhythmias;
• bradycardia (up to cardiac arrest);
• increased blood pressure;
• hypercoagulation;
• thrombosis;
• euphoria;
• hallucinations;
• affective insanity;
• depression;
• paranoia;
• increased intracranial pressure;
• nervousness or anxiety;
• insomnia;
• dizziness;
• headache;
• convulsions;
• increased intraocular pressure with possible damage to the optic nerve;
• tendency to develop secondary bacterial, fungal or viral eye infections;
• trophic changes in the cornea;
• exophthalmos;
• sudden loss of vision (with parenteral administration in the head, neck, nasal concha, scalp, crystals of the drug may be deposited in the vessels of the eye);
• hypocalcemia;
• increased body weight;
• negative nitrogen balance (increased protein breakdown);
• excessive sweating;
• fluid and sodium retention (peripheral edema);
• growth retardation and ossification processes in children (premature closure of the epiphyseal growth zones);
• osteoporosis (very rarely - pathological bone fractures, aseptic necrosis of the head of the humerus and femur);
• muscle tendon rupture;
• delayed wound healing;
• steroid acne;
• striae;
• tendency to develop pyoderma and candidiasis;
• skin rash;
• anaphylactic shock;
• local allergic reactions.

Local for parenteral administration: burning, numbness, pain, tingling at the injection site, infection at the injection site, rarely - necrosis of surrounding tissues, scarring at the injection site; atrophy of the skin and subcutaneous tissue with intramuscular injection (injection into the deltoid muscle is especially dangerous).

Contraindications

For short-term use for health reasons, the only contraindication 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.

With caution, the drug should be prescribed for the following diseases and conditions:

Application during pregnancy and lactation

During pregnancy (especially in the 1st trimester), the drug can be used only when the expected therapeutic effect outweighs the potential risk to the fetus. With prolonged therapy during pregnancy, the possibility of impaired fetal growth 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.

If it is necessary to carry out drug treatment during breastfeeding, then breastfeeding should be discontinued.

special instructions

During treatment with Dexamethasone (especially long-term), it is necessary to observe an ophthalmologist, control blood pressure and the state of water-electrolyte balance, as well as a picture of peripheral blood and blood glucose levels.

In order to reduce side effects, antacids can be prescribed, and the intake of K + into the body (diet, potassium preparations) should also be increased. Food should be rich in proteins, vitamins, with limited content of fats, carbohydrates and table salt.

The effect of the drug is enhanced in patients with hypothyroidism and liver cirrhosis. The drug can exacerbate existing emotional instability or psychotic disturbances. If a history of psychosis is indicated, Dexamethasone in high doses is prescribed under the strict supervision of a physician.

It should be used with caution in acute and subacute myocardial infarction - it is possible to spread the focus of necrosis, slow down the formation of scar tissue and rupture of the heart muscle.

In stressful situations during supportive treatment (for example, surgery, trauma or infectious diseases), the dose of the drug should be adjusted due to the increased need for glucocorticosteroids. Patients should be carefully monitored for a year after the end of long-term therapy with Dexamethasone due to the possible development of relative adrenal insufficiency in stressful situations.

With a sudden cancellation, especially in the case of previous use of high doses, it is possible to develop a withdrawal syndrome (anorexia, nausea, lethargy, generalized musculoskeletal pain, general weakness), as well as an exacerbation of the disease for which Dexamethasone was prescribed.

During treatment with Dexamethasone, vaccination should not be carried out due to a decrease in its effectiveness (immune response).

Prescribing Dexamethasone for intercurrent infections, septic conditions and tuberculosis, it is necessary to simultaneously treat with antibiotics with bactericidal action.

In children, during long-term treatment with Dexamethasone, 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.

Due to the weak mineralocorticoid effect for replacement therapy for adrenal insufficiency, Dexamethasone is used in combination with mineralocorticoids.

In patients with diabetes mellitus, blood glucose should be monitored and, if necessary, therapy should be corrected.

X-ray control of the osteoarticular system is shown (images of the spine, hand).

In patients with latent infectious diseases of the kidneys and urinary tract, Dexamethasone can cause leukocyturia, which may be of diagnostic value.

Drug interactions

Possible pharmaceutical incompatibility of dexamethasone with other intravenous injected drugs - it is recommended to administer it separately from other drugs (intravenous bolus, or through another dropper, as a second solution). When mixing a solution of dexamethasone with heparin, a precipitate is formed.

Simultaneous administration of dexamethasone with:

• inducers of hepatic microsomal enzymes (phenobarbital, rifampicin, phenytoin, theophylline, ephedrine) leads to a decrease in its concentration;
• diuretics (especially thiazide and carbonic anhydrase inhibitors) and amphotericin B - can lead to increased excretion of K + from the body and an increased risk of heart failure;
• with sodium-containing drugs - to the development of edema and increased blood pressure;
• cardiac glycosides - their tolerance worsens and the likelihood of developing ventricular extrasitolia increases (due to hypokalemia caused);
• indirect anticoagupants - weakens (less often enhances) their effect (dose adjustment is required);
• anticoagulants and thrombolytics - the risk of bleeding from ulcers in the gastrointestinal tract increases;
• ethanol (alcohol) and non-steroidal anti-inflammatory drugs - the risk of erosive and ulcerative lesions in the gastrointestinal tract and the development of bleeding increases (in combination with NSAIDs in the treatment of arthritis, it is possible to reduce the dose of glucocorticosteroids due to the summation of the therapeutic effect);
• paracetamol - the risk of developing hepatotoxicity increases (induction of liver enzymes and the formation of a toxic metabolite of paracetamol);
• acetylsalicylic acid - accelerates its excretion and reduces the concentration in the blood (when dexamethasone is canceled, the level of salicylates in the blood increases and the risk of side effects increases);
• insulin and oral hypoglycemic drugs, antihypertensive drugs - their effectiveness decreases;
• vitamin D - its effect on the absorption of Ca2 + in the intestine decreases;
• growth hormone - reduces the effectiveness of the latter, and with praziquantel - its concentration;
• M-anticholinergics (including antihistamines and tricyclic antidepressants) and nitrates - increases intraocular pressure;
• isoniazid and mexiletine - increases their metabolism (especially in "slow" acetylators), which leads to a decrease in their plasma concentrations.

Carbonic anhydrase inhibitors and loop diuretics may increase the risk of osteoporosis.

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

ACTH enhances the effect of dexamethasone.

Ergocalciferol and parathyroid hormone prevent the development of osteopathy caused by dexamethasone.

Cyclosporine and ketoconazole, slowing down the metabolism of dexamethasone, can in some cases increase its toxicity.

The simultaneous administration of androgens and steroid anabolic drugs with dexamethasone contributes to the development of peripheral edema and hirsutism, the appearance of acne.

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

When used simultaneously with live antiviral vaccines and against the background of other types of immunization, it increases the risk of virus activation and the development of infections.

Antipsychotics (neuroleptics) and azathioprine increase the risk of developing cataracts when dexamethasone is given.

With simultaneous use with antithyroid drugs, it decreases, and with thyroid hormones, the clearance of dexamethasone increases.

Analogues of the drug Dexamethasone

Structural analogues for the active substance:

• Decadron;
• Dexaven;
• Dexazon;
• Dexamed;
• Dexamethasone bufus;
• Dexamethasone Nycomed;
• Dexamethasone-Betalek;
• Dexamethasone Vial;
• Dexamethasone-LENS;
• Dexamethasone-Ferein;
• Dexamethasone sodium phosphate;
• Dexamethasone phosphate;
• Dexamethasonlong;
• Dexapos;
• Dexafar;
• Dexon;
• Maxidex;
• Oftan Dexamethasone;
• Fortecortin.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and see the available analogues for the therapeutic effect.

Instructions for use Dexamethasone
Buy Dexamethasone TB 0.5mg

Dosage forms
tablets 0.5mg
Manufacturers
Krka dd, Novo mesto (Slovenia)

Group
Drugs with glucocorticosteroid activity
Compound
The international name is dexamethasone.
International non-proprietary name
Dexamethasone
Synonyms
Vero-Dexamethasone, Decadron, Dexa-Allvoran, Dexazone, Dexacort, Dexamed, Dexamethasone bufus, Dexamethasone phosphate, Dexamethasone-Betalek, Dexamethasone-Vial, Dexamethasone-Lance, Dexamethasone, Dexftazone, Dexamethasone, Dexamethasone, Dexftazone, Dexamethasone , Sondex
pharmachologic effect
Pharmacological action - anti-inflammatory, anti-allergic, desensitizing, anti-shock, immunosuppressive. Inhibits phospholipase A2, reduces the synthesis of PG and LT, prevents the release of inflammatory mediators. It stabilizes cell membranes, reduces capillary permeability, has an anti-exudative effect due to the stabilization of lysosomal membranes. Decreases absorption and increases calcium excretion; delays sodium (and water), the secretion of ACTH. After oral administration, it is rapidly and completely absorbed. In the blood, it binds (60-70%) to a specific carrier protein - transcortin. Easily passes through histohematological barriers, including the BBB and placental. Biotransformed in the liver (mainly by conjugation with glucuronic and sulfuric acids) to inactive metabolites. T1 / 2 - 36-54 hours. It is excreted in the urine (a small part - by the lactating glands). When applied to the skin, absorption is determined by many factors: the dosage form (excipients), the integrity of the skin, the presence of an occlusive dressing, etc.
Indications for use
Addison's disease, congenital adrenal hypoplasia, adrenal insufficiency (usually in combination with mineralocorticoids), adrenogenital syndrome, thyroiditis (acute, subacute), hypothyroidism, tumor hypercalcemia, shock (anaphylactic, post-traumatic, postoperative, postoperative rheumatoid) arthritis in the acute phase, acute rheumatic heart disease, collagenosis (rheumatic diseases; disseminated lupus erythematosus, etc.), inflammatory and degenerative diseases of the joints (arthritis, tendovaginitis, bursitis, epicondylitis, styloiditis, osteochondrosis, osteoarthritis, ankylosing spondylitis, etc.) infectious-allergic bronchial asthma, status asthma (i / v, i / m), allergic and anaphylactoid reactions, incl. drug-induced dermatitis (contact, atopic, exfoliative, vesicular, herpetiform, seborrheic, etc.), psoriasis, eczema, exudative erythema multiforme, pemphigus, fungal mycosis, erythroderma and other skin diseases, cerebral edema (with tumors, cranial - brain injury, neurosurgical intervention, cerebral hemorrhage, encephalitis, meningitis, radiation damage to the lungs (IV, IM), ulcerative colitis, hepatitis, sarcoidosis, beryllium, disseminated tuberculosis (only in combination with anti-tuberculosis drugs) Leffler and other severe respiratory diseases, anemias (autoimmune, hemolytic, congenital, hypoplastic, idiopathic, erythroblastopenia), idiopathic thrombocytopenic purpura (in adults), secondary thrombocytopenia, lymphoma (Hodgkin's, non-Hodgkin's, ostrichous leukemia), leukemia agranulocytosis, plasmacytoma and other blood diseases, nephrotic syndrome, severe fecal diseases (with a mandatory combination with antibiotics), multiple sclerosis, non-purulent and allergic eye diseases (conjunctivitis, keratitis, iritis, iridocyclitis, blepharitis, blepharoconjunctivitis, episcleritis, scleritis), inflammatory processes after eye trauma and surgery, sympathetic ophthalmology , pituitary short stature (in children), affective disorders, incl. with depression.
Contraindications
Hypersensitivity, systemic mycoses, amoebic infections, active forms of tuberculosis, infectious lesions of the joints and periarticular soft tissues, the period before and after prophylactic vaccinations (especially antiviral), obesity III-IV degree (inside); eye drops - viral, including lichen simplex, chickenpox, fungal and tuberculous lesions of the eyes, acute purulent eye infection (in the absence of antibiotic therapy), diseases of the cornea with epithelial defects, trachoma, glaucoma. Restrictions on use: Peptic ulcers of the gastrointestinal tract, peptic ulcer of the stomach and duodenum, esophagitis, gastritis, intestinal anastomosis (in the closest history), congestive heart failure, arterial hypertension, thrombosis, diabetes mellitus, osteoporosis, Itsenko's disease according to Cushing's and / or liver failure, psychosis, convulsive conditions, myasthenia gravis, open-angle glaucoma (oral, parenteral), AIDS, pregnancy, breastfeeding.
Side effect
Retention of sodium and water, loss of potassium and calcium, edema, erosive and ulcerative lesions of the gastrointestinal tract (with exacerbation of peptic ulcer up to perforation, bleeding), hemorrhagic pancreatitis, gastrointestinal atony, increased appetite, nausea and vomiting, hepatomegaly, muscle weakness, myopathy, osteoporosis , pathological fractures, tendon ruptures, arrhythmia, bradycardia, increased blood pressure, congestive heart failure, myocardial infarction and dystrophy, Itsenko-Cushing's syndrome, hyperglycemia, hyperlipoproteinemia, negative nitrogen balance, dysmenorrhea, growth retardation in children, hirsutism, decreased immunity and reparative processes, dizziness, headaches, mood disorders, psychosis, increased intracranial pressure, convulsions, thinning and fragility of the skin, petechiae, ecchymosis, striae, erythema and changes in facial pigmentation, increased sweating, increased intraocular pressure, exophthalmos, thrombosis and thromboembolism, withdrawal syndrome (malaise, pain: headaches, in vota, joints and muscles), depression, secondary adrenal insufficiency; rarely - allergic reactions (rash, itching).
Interaction
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 severe hypokalemia, heart failure and osteoporosis - amphotericin B and carbonic anhydrase inhibitors, the risk of erosive and ulcerative lesions and bleeding from the gastrointestinal tract - NSAIDs. 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. Weakens the hypoglycemic activity of insulin and oral antidiabetic agents, anticoagulant - coumarins, 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.
Method of administration and dosage
The dose is set individually, depending on the disease and the patient's condition. Inside (during or after meals) once, in the morning (small dose) or in 2-3 doses (large dose): 2-3 mg to 4-6 mg (10-15 mg) per day, after achieving the effect, the dose is gradually reduced up to supporting - 0.5-1 mg, (2-4.5 mg and more) per day; treatment is stopped gradually (at the end, several injections of corticotropin are prescribed. Children - 0.25-25 mg, or 0.0833-0.3333 mg / kg or 0.0025-0.0001 mg / m2 per day in 3-4 doses depending on age.
Overdose
Treatment: with the development of undesirable phenomena - symptomatic, Itsenko-Cushing's syndrome - the appointment of aminoglutethimide.
special instructions
Use with caution in ulcerative colitis, intestinal diverticulitis, hypoalbuminemia. The appointment in the case of intercurrent infections, tuberculosis, septic conditions requires preliminary and subsequent simultaneous antibiotic therapy. It is necessary to take into account the enhancement of the action in hypothyroidism and cirrhosis of the liver, aggravation of psychotic symptoms and emotional lability at their high baseline level, masking of some symptoms of infections, the likelihood of persisting for several months (up to a year) relative adrenal insufficiency after discontinuation of dexamethasone (especially in the case of long-term use) ... Breastfeeding is stopped for the period of treatment. 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 children, in order to avoid overdose, the dose is calculated based on the surface area of ​​the body. In case of contact with patients with measles, chickenpox and other infections, appropriate preventive therapy is prescribed.
Storage conditions
List B. In the dark place at room temperature.