Dexamethasone 4mg 1ml injection instructions. Dexamethasone: instructions for use in adults and children

inflammatory processes in modern medicine are treated with hormonal drugs, which are analogues of the hormone of the adrenal cortex. These drugs include injections of Dexamethasone injections, which allows them to be used to treat joint diseases and relieve allergic reactions.

Properties of the drug and its use

The substance Dexamethasone is a synthetic analogue of the secretion of the adrenal cortex, which is normally produced in humans, and has the following effects on the body:

1. It reacts with the receptor protein, which allows the substance to penetrate directly into the nuclei of membrane cells.
2. Activates a number of metabolic processes by inhibiting the enzyme phospholipase.
3. Blocks mediators of inflammatory processes in the immune system.
4. It inhibits the production of enzymes that affect protein breakdown, thereby improving the metabolism of bone and cartilage tissue.
5. Reduces the production of leukocytes.
6. Reduces vascular permeability, thereby preventing the spread of inflammatory processes.

As a result of these properties, the substance Dexamethasone has a powerful anti-allergic, anti-inflammatory, anti-shock, immunosuppressive effect.

Important! A distinctive positive property of the drug is that when intravenous administration it has an almost instantaneous effect (with intramuscular injection - after 8 hours).

Dexamethasone in ampoules is used for systemic treatment of pathologies, in cases where local therapy and internal medication have not yielded any results, or their use is impossible.

Dexamethasone injections can be purchased for 35-60 rubles, or replaced with analogues, including Oftan Dexamethasone, Maxidex, Metazon, Dexazon

Most often, Dexamethasone injections are used to relieve allergic reactions, as well as to treat joint diseases. The description of the drug indicates the following conditions and diseases in which Dexamethasone is used:

• Development of acute insufficiency of the adrenal cortex;
• Rheumatic pathologies;
• Intestinal diseases of an unexplained nature;
• shock conditions;
• Acute forms of thrombocytopenia, hemolytic, severe types of diseases of an infectious nature;
• Skin pathologies:, psoriasis, dermatitis;
• , scapulohumeral periarthritis, osteoarthrosis, ;
• Laryngotracheitis in children of acute form;
• Scattered ;
• Puffiness of the brain in traumatic brain injuries, tumors, hemorrhages, radiation injuries, neurosurgical interventions,.

Note! Dexamethasone injections have a powerful anti-inflammatory and anti-allergic effect, which is 35 times more effective than cortisone.

Dexamethasone in injections is used in the development of acute and urgent conditions, when the effectiveness and speed of action of the drug depends human life. The drug is usually used for a short course, taking into account vital indications.

How to use Dexamethasone injections

Instruction Dexamethasone indicates that injections can be used already from the first year of life, not only intramuscularly, but also intravenously. Determination of the dose depends on the form and severity of the disease, the presence and manifestations side effects, age of the patient.

Dexamethasone injections intramuscularly for adults

Adults Dexamethasone can be administered in an amount of 4 mg to 20 mg, while the maximum daily dose should not exceed 80 ml, i.e. the introduction of the drug is carried out three to four times a day. In the event of acute, dangerous situations, the daily dosage may be increased with the consent and under the supervision of a physician.

In the form of injections, Dexamethasone is usually used for no more than 3-4 days, and if it is necessary to continue therapy, they switch to taking the drug in the form of tablets.

When the expected effect occurs, the dosage of the drug begins to gradually decrease to a maintenance dose, and the withdrawal of the drug is prescribed by the attending physician.

Important! With intravenous and intramuscular use, rapid administration of Dexamethasone in a large dose should not be allowed, because. this can lead to heart complications.

With cerebral edema, the dosage of the drug in the initial stage of treatment should be no more than 16 mg. After that, every 6 hours, 5 mg of the drug is administered intramuscularly or intravenously until a positive effect occurs.

Dexamethasone injections intramuscularly for children

Dexamethasone is administered to children by intramuscular route. The dosage is determined in accordance with the weight of the child - 0.2-0.4 mg per day per kilogram of weight. In the treatment of children, treatment with the drug should not be prolonged, and the dosage is minimized depending on the nature and severity of the disease.

Dexamethasone injections during pregnancy

Dexamethasone during pregnancy should be used with extreme caution, because. active forms of the drug are able to penetrate through any barriers. The medicine can have a negative effect on the fetus and cause complications, both in the fetus and in the child who was born later. Therefore, is it possible to use the drug during pregnancy, the doctor decides, because. it is advisable only when there is a threat to the life of the mother.

Treatment of joint diseases

When therapy for joint diseases using non-steroidal drugs does not bring the expected effect, doctors are forced to use Dexamethasone injections.

The use of Dexamethasone in the treatment of articular diseases is permissible under the following conditions:

• Scleroderma with joint damage;
• Still's disease;
• Articular syndrome with.

Note! To eliminate inflammatory processes in the joints of the arms and legs, Dexamethasone injections can in some cases be injected directly into the joint bag. However, long-term use inside the joints is unacceptable, because. can cause tendon rupture.

In the area of ​​\u200b\u200bthe joints, the medicine can be administered no more than once per course. The drug can be re-introduced in this way only after 3-4 months, i.e. per year, the use of Dexamethasone intraarticularly should not exceed three to four times. Exceeding this rate can cause the destruction of cartilage tissue.

Intra-articular dosage may vary from 0.4 to 4 mg, depending on the age of the patient, his weight, size shoulder joint or knee joint and the severity of the pathology.

Treatment of allergic diseases

If the allergy is accompanied by strong inflammatory processes, then conventional drugs will not be able to remove this condition. In these cases, Dexamethasone is used, which is a derivative of prednisolone, which reduces the manifestation of allergic symptoms.

When to use Dexamethasone injections:

• , and other skin allergic manifestations;
• Inflammatory allergic reactions on the nasal mucosa;
• Angioedema and.

The description of the use of Dexamethasone injection injections indicates that it is advisable to use injections in conjunction with oral medications for allergies. Usually, injections are made only on the first day of therapy - intravenously 4-8 mg. Next, tablets are prescribed for 7-8 days.

Side effects and contraindications

If there are serious complications and the risk of developing severe conditions, the main contraindication to the use of Dexamethasone is the presence of the patient's individual intolerance to the components of the drug.

At chronic pathologies and the use of the medicinal product as a prophylaxis, are taken into account the following contraindications to use:

Development of immunodeficiency (acquired and congenital);

• Severe form;
• Joint fractures;
• Infectious diseases of viral, fungal and bacterial nature in the active phase;
• internal bleeding;
• Mental disorders.

The expediency of using Dexamethasone in the presence of contraindications should be considered in each individual case separately. In some cases, the use of the drug with any contraindication can lead to the development of side effects.

The use of Dexamethasone during pregnancy is allowed if the expected effect of therapy exceeds potential risk for the fetus. Stop during treatment breast-feeding. Infants born to mothers who received significant doses of corticosteroids during pregnancy should be carefully monitored for signs of adrenal hypofunction.

Dexamethasone has a certain effect on the body, which can cause side effects:

1. It has a depressing effect on the immune system, which increases the risk of tumors and the development of severe infectious diseases;
2. hinders healthy formation bone tissue, because inhibits absorption;
3. Redistributes deposits of fat cells, due to which fatty tissues are deposited on the body;
4. Delays sodium ions and water in the kidneys, due to which the removal of adrenocorticotropic hormone from the body is disturbed.

Such properties of Dexamethasone can cause negative side reactions:

• arterial hypertension;
• Decrease in the level of monocytes and lymphocytes;
• Insomnia, mental disorders, hallucinations, depression;
• nausea, vomiting, internal bleeding, hiccups,
• Swelling of the visual disc;
• weight gain, menstrual irregularities, growth problems in children;
• , muscle weakness, damage to articular cartilage, tendon rupture;
• , increased intraocular, cataract, exacerbations of infectious processes in the eyes.

At the injection site, pain and local symptoms may be felt - scarring, atrophy of the skin.

Note! You can reduce the negative impact of the drug by reducing the dosage, but in some cases only the abolition of the drug helps. In any case, if you feel unwell, you should immediately inform your doctor about it.

Negative consequences can occur with a sharp end to the course of therapy without medical consent. In such cases, the development arterial hypertension, adrenal insufficiency, and sometimes death.

Dexamethasone is a hormonal medicinal product, which in modern medicine is considered as one of the vital pharmaceuticals belonging to the group of synthetic glucocorticosteroids. Dexamethasone is able to penetrate the tissues of all organs and systems, including the brain and nervous system, and affect the entire body. At severe conditions- shock, acute systemic allergy, severe inflammation, abnormal immune reactions, the drug can save a life.

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

This substance is a synthetic analogue of the natural steroid hormone, which is produced in the body by the adrenal glands.

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 active substance(5 or 25 units per pack). It is used for injection into a muscle, vein (stream or drip), inside the joint, in 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 - tube 2.5 g.

All forms of the drug as auxiliary components contain substances that are necessary for stabilizing, shaping and transporting dexamethasone to the painful focus, as well as preservatives and additives that facilitate the absorption of the drug.

Each medicinal form has its own purposefulness in use, certain indications and contraindications, so you should not engage in treatment yourself - only a specialist is able to develop the desired treatment regimen, calculate doses and frequency of use.

The medicine is dispensed by prescription, where the name of the drug in Latin is denoted as Dexamethasoni.

Pharmacological properties and pharmacokinetics

Medicinal properties

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

This allows the active substance to work in the brain and nervous tissues, relieve swelling of the brain, lungs in case of hemorrhage, poisoning, injuries, tumors, taking the patient out of life threatening state of shock, slow down the course of cancerous processes, eliminate the manifestations of acute allergies.

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

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

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

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

Absorption and elimination from the body

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

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

The largest number active substance in the blood, providing maximum healing effect observed in the range of 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 amounts (about 10%) is excreted by the intestines. A small amount of dexamethasone passes into women's milk, which should be taken into account when prescribing the drug to a nursing mother.

Why is the drug prescribed

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

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

• life threatening shock states all forms, including pain shock, toxic, cardiogenic, allergic, postoperative, blood transfusion (after blood transfusions);
• swelling of brain tissues (with hemorrhage, meningitis, tumors, encephalitis, trauma, surgery);
• an attack of bronchial asthma or long-term asthmatic status;
• lung pathology: berylliosis, tuberculosis, alveolitis, pneumonia, Leffler's syndrome (resistant to other medicines);
• allergic reactions: urticaria, Quincke's edema, hay fever, allergy to drugs and products, serum sickness;
• endocrine disorders - adrenal insufficiency, diseases thyroid gland, thyrotoxic crisis, thyroiditis, adrenogenital syndrome;
• autoimmune diseases - rheumatic heart disease, multiple sclerosis, systemic lupus erythematosus, pemphigus, scleroderma, systemic vasculitis;
• inflammation pain reproductive organs including prostatitis; various types of myositis;
• intractable skin diseases- eczema, various types of dermatitis, 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;
• inflammation of the joints of various courses: arthritis of various forms, osteoarthritis, polyarthritis, ankylosing spondylitis, bursitis, tendosynovitis and others;
• hematopoietic disorders: Addison's disease, lymphoma, agranulocytosis, anemia different origin, thrombocytopenia;
• critical conditions in case of injury 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 poisoning with alkalis, acids to suppress inflammation and prevent cicatricial narrowing;
• sharp renal pathologies- glomerulonephritis, nephrotic syndrome;
• malignant processes in the lungs, leukemia, lymphocytic leukemia, multiple myeloma;
• nausea and vomiting while taking cytostatics.

Application instruction of Dexamethasone

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

Pills

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 the patient's response.

The usual minimum effective dose for adults per day is 0.5-9 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, the drug is combined with food. In this case, between meals, it is desirable to use means 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 a withdrawal syndrome,

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

Dosing for children

Juvenile 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 children'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 do inside the muscle, or are administered intravenously, which is preferable in life-threatening situations, when the risk to the life of the patient is high. The solution immediately enters the bloodstream, providing a rapid therapeutic effect.

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

Adults in acute and emergency conditions per day can enter 3-4 times 4-20 mg. AT acute phase pathology, as well as at the beginning of therapy, use higher doses of corticosteroid. highest dose- 80 mg, but in critical cases - higher.

Children's doses for intramuscular injection are calculated according to 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 injection with a gradual decrease in dose usually does not exceed 3-4 days, after which the patient is transferred to taking tablets at a maintenance dose.

Drops eye and ear

At acute inflammation Patients over 12 years of age for 48 hours 4-5 times a day drip an ophthalmic solution over the lower eyelid, 1-2 drops. 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 remedy 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 they gradually reduce the frequency of instillation to 2 times a day and stop treatment 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 the operation to eliminate cataracts, retinal detachment, strabismus up to 4 times a day for 2 to 4 weeks.

With inflammation of the ear (otitis media) of a non-viral nature, it is instilled into sore ear in the form of heat 3 - 4 drops (children 1 - 2) three times a day.

The lenses are removed before instillation. 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 of age. 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 not more than 20 days.

Use during pregnancy and lactation

In a study on small mammals, it was found that Dexamethasone, like many other hormonal agents, penetrates through the placenta into the tissues of the embryo and can lead to the death of the embryo at an early stage and fetal deformities. The class of action of the drug on the fetus is C (according to the FDA).

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

If the pregnant woman received Dexamethasone, after childbirth, monitoring of the baby's health is necessary - since the child may be diagnosed with adrenal dysfunction, which requires immediate intensive treatment.

Since the drug passes into women's milk, breastfeeding mothers need to switch to artificial feeding or stop the drug.

With long-term use of ointment or drops, partial absorption of the drug into the blood occurs. 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 is acceptable for no longer than 7 to 10 days.

Can I drink alcohol while taking the drug

Treatment with Dexamethasone is incompatible with the use of alcohol, otherwise the consequences of parallel 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 pain at the injection site;
• redness of the skin on the chest, urticaria, acne rash on the face;
• ulceration of the mucous membrane of the digestive organs;
• internal bleeding.

If the patient has a serious alcohol dependence and is not able to give up alcohol for the duration of therapy, other drugs are required.

Drug interactions with other drugs

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

The action of the corticosteroid is reduced with concomitant use:

• antacids that reduce the absorption of the treating substance in the stomach;
• growth hormone;
• drugs from a series of inducers of the CYP3A4 isoenzyme (for example, phenobarbital, phenobarbital, rifabutin, rifampicin, carbamazepine);
• aminoglutethimide and ephedrine.

With parallel use, Dexamethasone is capable of:

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

Antifungals based on ketoconazole, birth control pills, macrolide antibiotics can prolong the urinary excretion of dexamethasone and increase the frequency and severity 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 facial hair, chest, edema, acne.

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

Contraindications, side effects and overdose

Contraindications

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

For any severe infections, it is permissible to prescribe Dexamethasone injections and tablets only with the simultaneous specific treatment of these diseases.

Contraindications for intra-articular injections:

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

Contraindications for local forms (ointment, drops):

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

Important! Ointment and drops Dexamethasone 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 identifying the infection, the drug should be used with appropriate antimicrobial treatment.

Side effects

A 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, swelling on the face, respiratory disorders, bronchospasm, anaphylactic shock;
• restlessness, disorientation, depressive, paranoid states or euphoria;
• double vision, visual disturbances, headache due to magnification intracranial pressure, characteristic of a rapid decrease in dose;
• insomnia, dizziness;
• persistent increase in blood pressure;
• weakening of the myocardium, arrhythmias;
• potassium deficiency and cardiac disorders associated with hypokalemia;
• decrease in adrenal function, development of diabetes mellitus, Itsenko-Cushing's syndrome, excessive hair growth, disorder monthly cycle, developmental delay in children;
• a sharp increase in blood viscosity and thrombosis;
• nausea, bouts of vomiting, ulceration of the digestive organs, gastritis, pancreatitis, colitis;
• frequent infections against the background of immunosuppression;
• osteoporosis, abnormal fractures, joint and muscle pain, femoral head necrosis, tendon rupture;
• acne, sweating, dry skin, slow healing of lesions;
• 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 mucosa and skin (ointment and drops), with treatment longer than 20 days, allergies, glaucoma and cataracts may develop, and visual function may decrease.

Drivers of transport and workers who require increased concentration should be careful when treating with Dexamethasone, as concentration is disturbed when it is taken.

Overdose

Excessive doses of 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.

With long-term therapy, constant monitoring of the development of children is required, periodic examination of the organs of vision, control of intraocular, intracranial pressure, sugar and blood coagulability, 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 - Dexamethasone Long, Maxidex, Oftan Dexamethasone, Ozurdex.

Analogues with a similar action, but a different composition:

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

APPROVED

By order of the chairman

Medical and
pharmaceutical activities

Ministry of Health

Republic of Kazakhstan

From "____" _______ 201__

№____________

Instructions for medical use

medicinal product

DEXAMETHASONE

Tradename

Dexamethasone

International non-proprietary name

Dexamethasone

Dosage form

Solution for injection 4 mg/ml

Compound

One ampoule contains

The active substance is dexamethasone sodium phosphate 4.37 mg (equivalent to dexamethasone phosphate 4.00 mg),

Excipients: glycerin, disodium edetate, sodium hydrogen phosphate dihydrate, water for injection.

Description

Clear, colorless or slightly yellowish solution.

Pharmacotherapeutic group

Corticosteroid agent for systemic use, glucocorticosteroids.

ATC code H02AB02

Pharmacological properties

Pharmacokinetics

After intravenous administration, the drug begins to act quickly, and after intramuscular administration clinical effect reached after 8 hours. The action of the drug is prolonged and lasts from 17 to 28 days after intramuscular injection and from 3 days to 3 weeks after local application(to the affected area). A dose of 0.75 mg dexamethasone is equivalent to a dose of 4 mg methylprednisolone and triamcinolone, 5 mg prednisone and prednisolone, 20 mg hydrocortisone, and 25 mg cortisone. In plasma, about 77% of dexamethasone binds to plasma proteins, and the majority is converted to albumin. Only a minimal amount of dexamethasone binds to non-albumin proteins. Dexamethasone is a fat soluble compound. The drug is initially metabolized in the liver. Small amounts of dexamethasone are metabolized in the kidneys and other organs. The predominant excretion occurs through the urine. The half-life (T1 \ 2) is about 190 minutes.

Pharmacodynamics

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

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

Indications for use

Dexamethasone is administered intravenously or intramuscularly in acute cases or when oral therapy is not possible.

Replacement therapy of primary and secondary (pituitary)

Adrenal insufficiency

congenital adrenal hyperplasia,

Subacute thyroiditis and severe forms of postradiation thyroiditis.

rheumatic fever

Acute rheumatic heart disease

Pemphigus, psoriasis, dermatitis ( contact dermatitis with defeat

Large skin surface, atopic, exfoliative, bullous

Herpetiform, seborrheic, etc.), eczema

Toxidermia, toxic epidermal necrolysis (Lyell's syndrome)

Malignant exudative erythema(Stevens-Johnson syndrome)

Allergic reactions to drugs and food products

Serum sickness, drug exanthema

Urticaria, angioedema

Allergic rhinitis, hay fever

Diseases that threaten the loss of vision (acute central

Chorioretinitis, inflammation of the optic nerve)

Allergic conditions (conjunctivitis, uveitis, scleritis, keratitis, iritis)

Systemic immune diseases (sarcoidosis, temporal arteritis)

Proliferative changes in the orbit (endocrine ophthalmopathy,

pseudotumors)

Sympathetic ophthalmia

Immunosuppressive therapy in corneal transplantation.

The drug is applied systemically or locally (in the form of subconjunctival, retrobulbar or parabulbar injections)

Ulcerative colitis

Crohn's disease

Local enteritis

Sarcoidosis (symptomatic)

Acute toxic bronchiolitis

Chronical bronchitis and asthma (exacerbations)

Agranulocytosis, panmyelopathy, anemia (including autoimmune

Hemolytic, congenital hypoplastic, erythroblastopenia)

Idiopathic thrombocytopenic purpura

Secondary thrombocytopenia in adults, lymphoma (Hodgkin's,

Non-Hodgkin's)

Leukemia, lymphocytic leukemia (acute, chronic)

Kidney diseases of autoimmune origin (including acute glomerulo-

Lonephritis)

nephrotic syndrome

Palliative care for leukemia and lymphoma in adults

Acute leukemia in children

Hypercalcemia with malignant neoplasms

Cerebral edema due to primary tumors or metastases

In the brain, due to craniotomy or head trauma.

Shock various genesis

Shock not responding to standard therapy

Shock in patients with adrenal insufficiency

Anaphylactic shock (intravenously, after the administration of adrenaline)

Other indications

Indications for intra-articular administration of dexamethasone or injection into soft tissues:

Rheumatoid arthritis (severe inflammation in a single joint)

Ankylosing spondylitis (when inflamed joints do not swell to

standard therapy)

Psoriatic arthritis (oligoarticular lesion and tendosynovitis)

Monoarthritis (after removal of intra-articular fluid)

Osteoarthritis (only in the presence of exudate and synovitis)

Extra-articular rheumatism (epicondylitis, tendosynovitis, bursitis).

Local administration (injections into the lesion):

Keloids

Hypertrophic, inflamed and infiltrated foci of lichen,

Psoriasis, granuloma annulare, sclerosing folliculitis,

Discoid lupus and cutaneous sarcoidosis

Localized alopecia

Dosage and administration

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

Parenteral application

The solution for injection is administered intravenously or intramuscularly, as well as in the form of intravenous infusions (with glucose or saline).

The recommended average initial daily dose for intravenous or intramuscular administration varies from 0.5 mg to 9 mg and, if necessary, more. The initial dose of dexamethasone should be used until the clinical effect is achieved; then the dose is gradually reduced to the minimum effective. During the day, you can enter from 4 to 20 mg of Dexamethasone 3-4 times. The duration of parenteral administration is usually 3-4 days, then they switch to maintenance therapy with the oral form of the drug.

Local administration

The recommended single dose of dexamethasone for intra-articular administration is from 0.4 mg to 4 mg. Intra-articular injection can be repeated after 3-4 months. Injections into the same joint can only be done 3-4 times in a lifetime, and injections into more than two joints at the same time should not be made. More frequent administration of dexamethasone can lead to damage to intra-articular cartilage and bone necrosis. The dose depends on the size of the affected joint. The usual dose of dexamethasone is 2 mg to 4 mg for large joints and 0.8 mg to 1 mg for small joints.

The usual dose of dexamethasone for intraarticular capsule administration is 2 mg to 3 mg, for administration into the tendon sheath, 0.4 mg to 1 mg, and for tendons, 1 mg to 2 mg.

When administered to limited lesions, the same doses of dexamethasone are used as for intra-articular administration. The drug can be administered simultaneously, at most, in two foci.

Dosing in children

When administered intramuscularly, the dose for replacement therapy is 0.02 mg / kg of body weight or 0.67 mg / m2 of body surface area, which is divided into 3 injections with an interval of 2 days, or from 0.008 mg to 0.01 mg / kg of body weight or from 0.2 mg up to 0.3 mg/m2 body surface area daily.

Side effects

Decreased glucose tolerance, "steroidal" diabetes mellitus, or

Manifestation of latent diabetes mellitus

Itsenko-Cushing syndrome, weight gain

Hiccups, nausea, vomiting, increased or decreased appetite, flatulence,

Increased activity of "liver" transaminases and alkaline

Phosphatases, pancreatitis

- "steroid" gastric ulcer and duodenum, erosive

Esophagitis, bleeding and perforation gastrointestinal tract

Arrhythmias, bradycardia (up to cardiac arrest), development

(in predisposed patients) or increased severity

Chronic heart failure, increased blood pressure

Pressure

Hypercoagulability, thrombosis

Delirium, disorientation, euphoria, hallucinations, manic

depressive psychosis depression, paranoia

Increased intracranial pressure, nervousness, anxiety,

Insomnia, headache, dizziness, convulsions, vertigo

Pseudotumor of the cerebellum

sudden loss vision (with parenteral administration, it is possible

Deposition of crystals of the drug in the vessels of the eye), posterior subcapsular

Cataract, increase intraocular pressure with a possible

Damage to the optic nerve, trophic changes in the cornea,

Exophthalmos, the development of secondary bacterial, fungal or

Viral eye infections

Negative nitrogen balance (increased protein breakdown),

Hyperlipoproteinemia

Increased sweating

Fluid and sodium retention (peripheral edema), hyperkilemic

Cue syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm,

Unusual weakness and fatigue)

Slow growth and ossification processes in children (premature

Closure of epiphyseal growth zones)

Increased calcium excretion, osteoporosis, pathological fractures

bones, aseptic necrosis humeral heads and femur, gap

Tendons

- "steroid" myopathy, muscle atrophy

Delayed wound healing, tendency to develop pyoderma and

candidiasis

Petechiae, ecchymosis, thinning of the skin, hyper- or hypopigmentation,

Steroid acne, striae

Generalized and local allergic reactions

Reduced immunity, development or exacerbation of infections

Leukocyturia

Violation of the secretion of sex hormones (menstrual disorders)

Cycle, hirsutism, impotence, delayed sexual development in children

Syndrome "cancellation"

Burning, numbness, pain, paresthesia and infection, necrosis of surrounding

tissue, scarring at the injection site, skin atrophy and

Subcutaneous tissue when administered intramuscularly (especially dangerous

Introduction to the deltoid muscle), arrhythmias, flushes of blood to the face,

Convulsions (with intravenous administration), collapse (with rapid administration

large doses)

Contraindications

Hypersensitivity to the active substance or excipients

Components of the drug

peptic ulcer stomach and duodenum

Osteoporosis

Acute viral, bacterial and systemic fungal infections

(when appropriate therapy is not used)

Cushing's syndrome

Pregnancy and lactation

kidney failure

Cirrhosis of the liver or chronic hepatitis

Acute psychoses

Intramuscular administration contraindicated in patients with severe

Hemostatic disorders (idiopathic thrombocytopenic

Purpura)

For use in ophthalmic practice: viral and fungal

Eye diseases

Acute form of purulent eye infection in the absence of a specific

Therapies, diseases of the cornea, combined with defects in the epithelium,

Trachoma, glaucoma

active form tuberculosis

Drug Interactions

The effectiveness of dexamethasone decreases with simultaneous reception rifampicin, carbamazepine, phenobarbitone, phenytoin (diphenylhydantoin), primidone, ephedrine, or aminoglutethimide. Dexamethasone reduces the therapeutic effect of hypoglycemic drugs, antihypertensive drugs, praziquantel and natriuretics; dexamethasone increases the activity of heparin, albendazole and kaliuretics. Dexamethasone may alter the effect of coumarin anticoagulants.

The simultaneous use of dexamethasone and large doses of glucocorticoids or β2-receptor agonists increases the risk of hypokalemia. Higher arrhythmogenicity and toxicity of cardiac glycosides is noted in patients suffering from hypokalemia.

With the simultaneous use of oral contraceptives, the half-life of glucocorticoids may increase, which leads to an increase in their action and an increase in the number of side effects.

The simultaneous use of ritodrine and dexamethasone is contraindicated in the period labor activity, as this can lead to the death of the mother due to pulmonary edema.

Co-administration of dexamethasone and metoclopramide, diphenhydramine, prochlorperazine, or 5-HT3 receptor antagonists (serotonin or 5-hydroxytryptamine type 3 receptors), such as ondansetron or granisetron, is effective in preventing nausea and vomiting caused by chemotherapy with cisplatin, cyclophosphamide, methotrexate, fluorouracil .

special instructions

Application in pediatrics

In children during long-term treatment, it is necessary to carefully monitor the dynamics of growth and development. In children during the period of growth, glucocorticosteroids should be used only for health reasons and under the most careful supervision of a physician. To prevent disruption of growth processes during long-term treatment of children under the age of 14 years, it is advisable to take a 4-day break in treatment every 3 days.

Children who are in contact with patients with measles, chickenpox during treatment are prescribed specific immunoglobulins.

With diabetes mellitus, tuberculosis, bacterial and amoebic dysentery, arterial hypertension, thromboembolism, cardiac and kidney failure, ulcerative colitis, diverticulitis, recently formed intestinal anastomosis, Dexamethasone should be used very carefully and subject to the possibility of adequate treatment of the underlying disease. If the patient had a history of psychosis, then treatment with glucocorticosteroids is carried out only for health reasons.

With the sudden withdrawal of the drug, especially in the case of high doses, there is a withdrawal syndrome of glucocorticosteroids: anorexia, nausea, lethargy, generalized musculoskeletal pain, general weakness. After discontinuation of the drug for several months, relative insufficiency of the adrenal cortex may persist. If during this period there are stressful situations, appoint temporarily glucocorticoids, and if necessary - mineralocorticoids.

Before starting the use of the drug, it is desirable to examine the patient for the presence of ulcerative pathology of the gastrointestinal tract. Patients with a predisposition to the development of this pathology should be prescribed antacids for prophylactic purposes.

During treatment with the drug, the patient should follow a diet rich in potassium, protein, vitamins, with a reduced content of fats, carbohydrates and sodium.

If the patient has intercurrent infections, a septic condition, treatment with Dexamethasone should be combined with antibiotic therapy.

Dexamethasone is an anti-allergic, anti-inflammatory, immunosuppressive drug. It has well-pronounced antifibroblastogenic, anti-exudative properties. In pharmacies, it is dispensed by prescription.

Diseases for which dexamethasone is used

• Addison's disease.
• Adrenal insufficiency.
• Thyroiditis.
• Hypothyroidism.
• adrenogenital syndrome.
• Tumor hypercalcemia.
• Spicy rheumatoid arthritis.
• collagenoses.
• Diseases of the joints of an inflammatory and degenerative nature.
• Bronchial asthma of an infectious-allergic nature.
• Cerebral edema.
• Asthmatic status.
• Myositis.
• Hepatitis.
• Nonspecific ulcerative colitis.
• heavy respiratory diseases.
• Hepatitis.
• Anemia.
• Lymphoma.
• Leukemia.
• Agranulocytosis.
• Lymphocytic leukemia.
• Plasmacytoma.
• Infectious diseases in a severe form.
• Inflammatory and allergic processes in the eyes.
• Inflammation of the posterior segment and anterior segment of the eye.
• Chemical damage to the eyes.
• Eye burns.
• Sympathetic uveitis.
• Recovery period after eye surgery.
• Bronchial asthma.

Instructions for use of dexamethasone

Inside, instillation into the eyes, intramuscularly, intravenously, retrobulbar, periarticularly, intraarticularly. Stop taking the drug should be gradual, otherwise the manifestation of the "withdrawal syndrome" is possible.

Varieties of dexamethasone

Tablets, eye drops, injection solution.

Dosage of dexamethasone

For adults

Injections

• Acute and emergency conditions: 3-4 times a day, a single dose is 4-20 mg, intramuscularly or intravenously. In case of complications, a single dose can be increased to 80 mg. For maintenance treatment, 0.2-9 mg of the drug is administered per day. After 3-4 days, the injections are replaced with tablets.
• Intra-articular, periarticular (introduction into soft tissues): 0.2-6 mg. Between injections should pass at least 3 days.
• State of shock: a single injection of 20 mg intravenously. For maintenance treatment, 3 mg per 1 kg of body weight. The drug is administered continuously for 24 hours.
• Cerebral edema: a single dose of 10 mg intravenously. Until the symptoms are completely eliminated, 4 mg is administered intramuscularly with an interval of 6 hours. After 2-4 days after the start of treatment, the dose is gradually reduced.

Eye drops

• Acute inflammation: 4-5 times a day, 1-2 drops at a time. Repeat 2 days. When the therapeutic effect begins to appear, instill the drug 3-4 times a day.
• Chronic inflammation: 2 times a day, instill 1-2 drops. Take the drug for no longer than 4 weeks.
• Care after injuries and operations: 2-4 times a day, instill 1-2 drops.

inside

The usual daily dose of the drug is 2-3 mg. In severe cases, if there is an urgent need, you can increase the dose to 4-6 mg. For maintenance therapy, 0.5-1 mg per day is administered. The daily dose is divided into 2-3 doses.

For kids

Injections

• Acute and emergency conditions: 0.02776-0.16665 mg per 1 kg of body weight. 12-24 hours should elapse between doses. Intramuscularly.
• Insufficiency of the adrenal cortex: the daily dose is 0.233-0.335 mg per m2 of body area.

Eye drops (ages 6-12)

Inflammatory, allergic processes: 2-3 times a day, 1 drop. The course lasts 7-10 days, if necessary, it can be continued.

inside

Depending on the age and nature of the disease, the daily dose is 0.25-2 mg. Distributed into 3-4 doses.

Side effects of dexamethasone

• Using eye drops: short-term tearing and burning, possible violation of intraocular pressure. At long-term use- perforation of the cornea, posterior capsular cataract.
• Ulcerative erosive lesions of the gastrointestinal tract.
• Loss of potassium, calcium.
• Nausea, vomiting.
• Weakness in the muscles.
• Water retention, sodium.
• Atony of the gastrointestinal tract.
• Hemorrhagic pancreatitis.
• Osteoporosis.
• Myopathy.
• Bradycardia.
• Arrhythmia.
• Osteoporosis.
• Myopathy.
• Myocardial infarction.
• Syndrome Itsenko-Cushing.
• myocardial dystrophy.
• Hyperlipoproteinemia.
• Hyperglycemia.
• Headaches.
• Dizziness.
• Increased intracranial pressure.
• Seizures.
• Skin thinning, pigmentation change.
• Mood changes.
• "Withdrawal syndrome" with a sharp cessation of the drug.
• Allergic reaction.
• Thromboembolism, thrombosis.
• Kidney disorders.
• Violation of the secretion of sex hormones.
• Pancreatitis.
• Delayed wound healing.
• Obesity.

Dexamethasone contraindications

• Hypersensitivity.
• For eye drops: fungal, viral, acute purulent diseases, glaucoma, trachoma, damaged corneal epithelium.
• Infection in the joints and soft tissues adjacent to the joints.
• Tuberculosis in active form.
• amoebic infection.
• Systemic mycosis.
• Preventive vaccinations.

Dexamethasone during pregnancy

During pregnancy, the drug should be taken only when absolutely necessary, when its use is more important than potential danger for the fetus. During lactation, taking the drug, it is recommended to stop breastfeeding.

Description

Clear, colorless or yellowish solution.

Compound

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

Pharmacotherapeutic group

Corticosteroids for systemic use. Glucocorticoids.
ATS code: H02AB02.

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pharmachologic effect

Dexamethasone is a synthetic fluorinated glucocorticosteroid that has anti-inflammatory, anti-allergic, immunosuppressive effects, has anti-exudative and anti-fibroblastogenic properties, and has practically no mineralocorticosteroid effect. Interacts with specific cytoplasmic receptors and forms a complex that penetrates the cell nucleus and stimulates mRNA synthesis; the latter induces the formation of proteins that mediate cellular effects, including lipocortin, which inhibits phospholipase A2, inhibits the liberation of arachidonic acid and inhibits the biosynthesis of endoperoxides, prostaglandins, leukotrienes, which contribute to inflammation, allergies, etc. Dexamethasone inhibits the expression of protein genes involved in the development inflammatory reactions. Prevents the release of inflammatory mediators from eosinophils and mast cells. Inhibits the activity of hyaluronidase, collagenase and proteases. Suppresses the activity of fibroblasts and the formation of collagen. Reduces capillary permeability, stabilizes cell membranes, including lysosomal ones, inhibits the release of cytokines from lymphocytes and macrophages.

Indications for use

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

Dosage and administration

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

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Side effect

The incidence of side effects is given in the following gradation: very frequent (≥1/10); frequent (≥1/100,<1/10); нечастые (≥1/1000, <1/100); редкие (≥1/10000, <1/1000); очень редкие (<1/10000); неизвестные (по имеющимся данным определить частоту встречаемости не представляется возможным). Частота нежелательных эффектов зависит от дозы и продолжительности лечения.
Side effects associated with short-term treatment with dexamethasone include:
From the side of the immune system: infrequent - hypersensitivity reactions.
: frequent - transient adrenal insufficiency.
: frequent - decreased tolerance to carbohydrates, increased appetite and weight gain; infrequent - hypertriglyceridemia.
Psychiatric disorders: frequent - mental disorders.
: infrequent - peptic ulcers and acute pancreatitis.
Side effects associated with long-term treatment with dexamethasone include:
From the side of the immune system: infrequent - a decrease in the immune response and an increase in susceptibility to infections.
From the endocrine system: frequent - long-term adrenal insufficiency, growth retardation in children and adolescents.
Metabolic and nutritional disorders: frequent - upper type of obesity.
Violation of the organ of vision: infrequent - cataract, glaucoma.
: infrequent - arterial hypertension.
: frequent - thinning and fragility of the skin.
: frequent - muscle atrophy, osteoporosis; infrequent - aseptic necrosis of bones.
The following side effects associated with dexamethasone treatment may also occur (they are presented in decreasing order of significance).
From the lymphatic system and the hematopoietic system: rare - thromboembolic complications, a decrease in the number of monocytes and / or lymphocytes, leukocytosis, eosinophilia (as with other glucocorticoids), thrombocytopenia and non-thrombocytopenic purpura.
From the side of the immune system: rare - rash, bronchospasm, anaphylactic reactions; very rare - angioedema.
From the sidehearts: very rare - polyfocal ventricular extrasystoles, transient bradycardia, heart failure, myocardial rupture after a recent acute myocardial infarction.
From the vascular system: infrequent - hypertensive encephalopathy.
Psychiatric disorders: infrequent - changes in personality and behavior, which are most often manifested by euphoria, insomnia, irritability, hyperkinesia, depression; rarely - psychosis.
From the endocrine system: often - insufficiency and atrophy of the adrenal glands (decreased response to stress), Itsenko-Cushing's syndrome, irregular menstrual cycle, hirsutism.
Metabolic and nutritional disorders: rarely - the transition of latent diabetes mellitus to clinically manifest, an increase in 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.
From the digestive system: infrequent - nausea, hiccups, stomach or duodenal ulcers; very rarely - esophagitis, ulcer perforation 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 side of the musculoskeletal system and connective tissue: frequent - muscle weakness, steroid myopathy (muscle weakness due to catabolism of muscle tissue); very rare - compression fractures of the vertebrae, tendon ruptures (especially with the combined use of certain quinolones), necrosis of the cartilage tissue of the joint and bones (with frequent intra-articular injections).
From the skin and subcutaneous tissue: frequent - slowing wound healing, striae, petechiae and ecchymosis, excessive sweating, acne, suppression of skin reactions during allergy tests; very rarely - allergic dermatitis, urticaria.
Violation of the organ of vision: infrequent - increased intraocular pressure; very rarely - exophthalmos.
From the reproductive system and mammary glands: rarely - impotence.
General disorders and disorders at the injection site: very rare - edema, hyper- and hypopigmentation of the skin, atrophy of the skin or subcutaneous tissue, sterile abscess and redness of the skin.
Signs and symptoms of glucocorticosteroid withdrawal syndrome.
If a patient taking glucocorticosteroids for a long time is to 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 those of an exacerbation or relapse of the disease for which the patient was receiving treatment. With the development of severe adverse events, treatment should be discontinued.
In the event of the above adverse reactions or adverse reactions not listed in these instructions for medical use of the drug, you should consult a doctor.

Contraindications

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

Overdose

There are isolated reports of cases of acute overdose or death due to acute overdose. An overdose usually only becomes apparent after a few weeks of overdosing and can cause most of the unwanted effects listed in the "Adverse Reactions" section, most notably Cushing's Syndrome.
There is no known specific antidote. Treatment is supportive and symptomatic. Hemodialysis is ineffective in accelerating the elimination of dexamethasone from the body.

Precautionary measures

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

Use during pregnancy and lactation

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

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

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

Interaction with other drugs

The therapeutic and toxic effects of Dexamethasone are reduced by barbiturates, phenytoin, rifabutin, carbamazepine, ephedrine and aminoglutethimide, rifampicin (accelerate metabolism); somatotropin; antacids (reduce absorption), increase - estrogen-containing oral contraceptives. Simultaneous use with cyclosporine increases the risk of seizures in children. The risk of arrhythmias and hypokalemia is increased by cardiac glycosides and diuretics, the likelihood of edema and arterial hypertension - sodium-containing drugs and nutritional supplements, severe hypokalemia, heart failure and osteoporosis - amphotericin B and carbonic anhydrase inhibitors; the risk of erosive and ulcerative lesions and bleeding from the gastrointestinal tract - non-steroidal anti-inflammatory drugs. When used simultaneously with live antiviral vaccines and against the background of other types of immunization, it increases the risk of virus activation and infection. Simultaneous use with thiazide diuretics, furosemide, ethacrynic acid, carbonic anhydrase inhibitors, amphotericin B can lead to severe hypokalemia, which can increase the toxic effects of cardiac glycosides and non-depolarizing muscle relaxants. Weakens the hypoglycemic activity of insulin and oral antidiabetic agents; anticoagulant - coumarins; diuretic - diuretic diuretics; immunotropic - vaccination (suppresses antibody formation). It worsens the tolerance of cardiac glycosides (causes a potassium deficiency), reduces the concentration of salicylates and praziquantel in the blood. May increase the concentration of glucose in the blood, which requires dose adjustment of hypoglycemic drugs, sulfonylurea derivatives, asparaginase. GCS increase the clearance of salicylates, so after the abolition of Dexamethasone, it is necessary to reduce the dose of salicylates. When used simultaneously with indomethacin, the Dexamethasone suppression test may give false negative results.
The combined use of dexamethasone and drugs that inhibit the activity of the CYP 3A4 enzyme (ketoconazole, macrolides) may cause an increase in the concentration of dexamethasone in serum. Dexamethasone is a moderate inducer of CYP 3A4. Co-administration with drugs that are metabolized by CYP 3A4 (indinavir, erythromycin) may increase their clearance, resulting in a decrease in serum concentrations.
The simultaneous use of dexamethasone and thalidomide can cause toxic epidermal necrolysis.
The simultaneous use of ritodrine and dexamethasone is contraindicated during childbirth, as this can lead to a fatal outcome of the parturient woman due to pulmonary edema.
During the treatment period, the simultaneous use of drugs and foods high in sodium is not recommended.

Storage conditions

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