Dexamethasone-Darnitsa solution for injection 4 mg/ml ampoule 1 ml No. 5

Instructions Dexamethasone-Darnitsa solution for injection 4 mg/ml ampoule 1 ml No. 5

Composition

active ingredient: dexamethasone;

1 ml of solution contains dexamethasone sodium phosphate 4 mg;

excipients: sodium hydrogen phosphate dodecahydrate, potassium dihydrogen phosphate, glycerin, benzyl alcohol, disodium edetate (Trilon B), water for injection.

Dosage form

Solution for injection.

Main physicochemical properties: clear colorless liquid.

Pharmacotherapeutic group

Corticosteroids for systemic use. Glucocorticoids. Dexamethasone. ATC code H02A B02.

Pharmacological properties

Pharmacodynamics.

Dexamethasone-Darnitsa is a synthetic adrenal cortex hormone (corticosteroid) that has a glucocorticoid effect. It has anti-inflammatory and immunosuppressive effects, and also affects energy metabolism, glucose metabolism, and (through negative feedback) the secretion of hypothalamic-activating factor and adenohypophyseal trophic hormone.

The mechanism of action of glucocorticosteroids is still not fully understood. There is now sufficient data on the mechanism of action of glucocorticosteroids to confirm that they act at the cellular level. There are two well-studied receptor systems in the cytoplasm of cells. By binding to glucocorticoid receptors, glucocorticosteroids have anti-inflammatory and immunosuppressive effects and regulate glucose metabolism, and by binding to mineralocorticoid receptors, they regulate sodium, potassium metabolism and water-electrolyte balance.

Glucocorticosteroids are lipid-soluble and readily penetrate target cells through the cell membrane. Binding of the hormone to the receptor results in a conformational change in the receptor, which increases its affinity for DNA. The hormone/receptor complex enters the cell nucleus and binds to a regulatory site on the DNA molecule, also called the glucocorticoid response element (GRE). The activated receptor, bound to the GRE or to specific genes, regulates mRNA transcription, which can be increased or decreased. The newly formed mRNA is transported to the ribosome, after which new proteins are formed. Depending on the target cells and the processes occurring in the cells, protein synthesis can be increased (for example, the formation of tyrosine transaminase in liver cells) or decreased (for example, the formation of IL-2 in lymphocytes). Since glucocorticosteroid receptors are present in all types of tissues, it can be assumed that glucocorticosteroids act on most cells of the body.

Clinical efficacy and safety - COVID-19

Clinical efficacy

RECOVERY (Randomised Evaluation of Covid-19 Therapy)1 is an individually randomised, controlled, open-label, adaptive platform trial initiated by the investigator to assess the effects of potential treatments in patients hospitalised with COVID-19.

The trial was conducted in 176 hospitals in the UK. 6425 patients were randomised to receive dexamethasone (2104 patients) or usual care (4321 patients). 89% of patients had laboratory-confirmed SARS-CoV-2 infection.

At randomization, 16% of patients received invasive mechanical ventilation (VMV) or extracorporeal membrane oxygenation, 60% received oxygen alone (with or without noninvasive ventilation), and 24% received neither.

The mean age of the patients was 66.1 ± 15.7 years. 36% of the patients were female. 24% of the patients had a history of diabetes, 27% had heart disease, and 21% had chronic lung disease.

Primary endpoint

Mortality at day 28 was significantly lower in the dexamethasone group than in the usual care group, where mortality was reported in 482 of 2104 patients (22.9%) and 1110 of 4321 patients (25.7%), respectively (rate ratio, 0.83; 95% confidence interval (CI), 0.75-0.93; P < .001).

In the dexamethasone group, the incidence of fatal outcomes was lower among patients in the usual care group receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51-0.81) and among those receiving supplemental oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72-0.94).

There was no clear effect of dexamethasone among patients who were not receiving any respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.91-1.55).

Secondary endpoint

Patients in the dexamethasone group had a shorter length of hospital stay than those in the usual care group (median, 12 days vs. 13 days) and were more likely to be discharged from the hospital within 28 days (rate ratio, 1.10; 95% CI, 1.03-1.17).

According to the primary endpoint, the greatest effect in reducing the length of hospital stay to 28 days was observed among patients receiving invasive mechanical ventilation at randomization (rate ratio, 1.48; 95% CI, 1.16, 1.90), followed by patients receiving oxygen alone (rate ratio, 1.15; 95% CI, 1.06-1.24), and no beneficial effect in patients not receiving oxygen (rate ratio, 0.96; 95% CI, 0.85-1.08).

*Ratios were adjusted for age for 28-day mortality and hospital discharge outcomes. Hazard ratios were adjusted for age for invasive mechanical ventilation or death and its components;

† This category excludes patients who received invasive mechanical ventilation at randomization.

Safety

During the study, 4 serious adverse events related to the study treatment were recorded, namely: 2 cases of hyperglycemia, 1 case of steroid-induced psychosis, and 1 case of upper gastrointestinal bleeding. All cases resolved.

Subgroup analysis

Effects of dexamethasone administration on 28-day mortality, depending on age and method of respiratory support, obtained by randomization2

Effects of dexamethasone administration on 28-day mortality, by respiratory support method, obtained at randomization, and by the presence of any chronic disease3

1 www.recoverytrial.net

2, 3 (source: Horby P. et al., 2020; https://www.medrxiv.org/content/10.1101/2020.06.22.20137273v1;

doi: https://doi.org/10.1101/2020.06.22.20137273).

Pharmacokinetics.

Absorption.

Dexamethasone is rapidly absorbed from the injection site. Peak plasma concentrations are achieved within the first 5 minutes after intravenous administration and within 1 hour after intramuscular administration.

After local administration into the joint or soft tissues (inflammation site), absorption occurs more slowly than in the case of injection.

With intravenous administration, the onset of action is immediate; with intramuscular administration, it takes 8 hours.

The drug belongs to long-acting glucocorticosteroids. The effect lasts 17–28 days after intramuscular administration and from 3 days to 3 weeks after topical administration.

In blood plasma, approximately 77% of dexamethasone is bound to plasma proteins, mainly albumin. Only a small amount of dexamethasone is bound to other proteins. Dexamethasone is fat-soluble, so it freely penetrates into cells and the intercellular space. In the central nervous system (hypothalamus, pituitary gland) it binds and acts through membrane receptors. In peripheral tissues it binds and acts through cytoplasmic receptors.

Biotransformation.

Dexamethasone is metabolized at the site of action, i.e. within the cell itself. Dexamethasone is primarily metabolized in the liver, but may also be metabolized in the kidneys and other tissues.

Breeding.

The biological half-life of dexamethasone is 24–72 hours. Approximately 80% of administered dexamethasone is eliminated by the kidneys as the glucuronide within 24 hours.

Indication

Dexamethasone should be administered intravenously or intramuscularly in emergency cases and when oral administration is not possible.

Diseases of the endocrine system:

- replacement therapy for primary or secondary (pituitary) adrenal insufficiency (except for acute adrenal insufficiency, in which hydrocortisone or cortisone are more suitable, given their more pronounced hormonal effect);

- acute adrenal insufficiency (hydrocortisone or cortisone are the drugs of choice; concomitant use with mineralocorticoids may be necessary, especially when using synthetic analogues);

- before operations and in cases of serious injuries or illnesses in patients with established adrenal insufficiency or with uncertain adrenocortical reserve;

- shock resistant to conventional therapy, with existing or suspected adrenal insufficiency;

- congenital adrenal hyperplasia;

- non-purulent inflammation of the thyroid gland and severe forms of radiation thyroiditis.

Rheumatological diseases (as adjunctive therapy during the period when basic therapy has not worked, i.e. in patients in whom the analgesic and anti-inflammatory effect of non-steroidal anti-inflammatory drugs was unsatisfactory):

- rheumatoid arthritis, including juvenile rheumatoid arthritis and extra-articular manifestations of rheumatoid arthritis (rheumatic lung, changes in the heart, eyes, cutaneous vasculitis);

- synovitis in osteoarthritis; post-traumatic osteoarthritis; epicondylitis; acute nonspecific tendosynovitis; acute gouty arthritis; psoriatic arthritis; ankylosing spondylitis; systemic connective tissue diseases; vasculitis.

Skin diseases:

- pemphigus; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; bullous dermatitis herpetiformis; severe forms of exudative erythema; erythema nodosum; severe forms of seborrheic dermatitis; severe forms of psoriasis; urticaria that does not respond to standard treatment; mycosis fungoides; dermatomyositis.

Allergic diseases (that do not respond to traditional treatment):

- bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; chronic or seasonal allergic rhinitis; drug allergy; urticaria after blood transfusion.

Diseases of the organs of vision:

- inflammatory eye diseases (acute central choroiditis, optic neuritis); allergic diseases (conjunctivitis, uveitis, scleritis, keratitis, iritis); systemic immune diseases (sarcoidosis, temporal arteritis); proliferative changes in the eye socket (endocrine ophthalmopathy, pseudotumor); immunosuppressive therapy during corneal transplantation. The solution can be administered systemically or locally (subconjunctival injection and retrobulbar or parabulbar injection).

Gastrointestinal diseases:

- to remove the patient from the critical period in: ulcerative colitis (severe development), Crohn's disease (severe development); chronic autoimmune hepatitis; rejection reaction during liver transplantation.

Respiratory tract diseases:

- symptomatic sarcoidosis (symptomatically); acute toxic bronchiolitis; chronic bronchitis and asthma (during exacerbation); focal or disseminated pulmonary tuberculosis (along with appropriate anti-tuberculosis therapy); berylliosis (granulomatous inflammation); radiation or aspiration pneumonitis.

Hematological diseases:

- acquired or congenital chronic aplastic anemia; autoimmune hemolytic anemia;

- secondary thrombocytopenia in adults; erythroblastopenia; acute lymphoblastic leukemia (induction therapy); idiopathic thrombocytopenic purpura in adults (intravenous administration only - intramuscular administration is contraindicated).

Kidney diseases:

- immunosuppressive therapy in kidney transplantation; stimulation of diuresis or reduction of proteinuria in idiopathic nephrotic syndrome (without uremia) and renal dysfunction in systemic lupus erythematosus.

Malignant oncological diseases:

- palliative treatment of leukemia and lymphoma in adults; acute leukemia in children; hypercalcemia in malignant diseases.

Brain swelling:

- cerebral edema due to primary or metastatic brain tumor, craniotomy, and traumatic brain injury.

- shock that is not amenable to classical treatment; shock in patients with adrenal insufficiency; anaphylactic shock (intravenously after administration of adrenaline); before surgery to prevent shock in suspected or established adrenal insufficiency.

Coronavirus disease 2019 (COVID-19):

- treatment of coronavirus disease 2019 (COVID-19) in adults and adolescent patients (aged 12 years and over with a body weight of at least 40 kg) who require supplemental oxygen therapy.

Other indications:

- tuberculous meningitis with subarachnoid blockade (along with appropriate anti-tuberculosis therapy); trichinellosis with neurological symptoms or myocardial trichinellosis; cystic tumor of the aponeurosis or tendon (ganglion);

Indications for intra-articular or soft tissue administration

- rheumatoid arthritis (severe inflammation of a single joint); ankylosing spondylitis (when inflamed joints do not respond to traditional treatment); psoriatic arthritis (oligoarticular form and tendovaginitis); monoarthritis (after evacuation of synovial fluid); osteoarthritis of the joints (only in the case of synovitis and exudation); extra-articular rheumatism (epicondylitis, tendovaginitis, bursitis); acute and gouty arthritis.

Local administration (administration to the lesion site):

- keloid lesions; hypertrophic, inflammatory and infiltrated lesions in lichen, psoriasis, granuloma annulare, sclerosing folliculitis, discoid lupus and cutaneous sarcoidosis; discoid lupus erythematosus; Urbach-Oppenheim disease; localized alopecia.

Contraindication

– Hypersensitivity to the active substance or to other components of the medicinal product.

– Acute viral, bacterial or systemic fungal infections (if appropriate therapy is not used).

– Vaccination with a live vaccine.

– Itsenko-Cushing syndrome.

– Intramuscular administration is contraindicated in patients with severe blood clotting disorders.

– In case of topical application – bacteremia, systemic fungal infections, infections at the application site, including septic arthritis due to gonorrhea or tuberculosis, use in patients with unstable joints.

Interaction with other medicinal products and other types of interactions

When using the drug simultaneously with other drugs, the following interactions are possible:

with drugs that inhibit the CYP 3A4 enzyme (e.g. ketoconazole, macrolide antibiotics) - increased plasma concentrations of dexamethasone; ketoconazole may inhibit adrenal synthesis of glucocorticosteroids, thus, adrenal insufficiency may develop due to a decrease in dexamethasone concentrations;

with aminoglutethimide, ephedrine, inhibitors of adrenal cortex function (e.g. mitotane), carbamazepine, primidone, rifampicin, rifabutin, phenobarbital, phenytoin - reduced effectiveness of dexamethasone; with simultaneous use of these drugs, the dose of dexamethasone should be increased;

with azathioprine, antipsychotics, other glucocorticosteroids, carbutamide - increased risk of cataract development;

with albendazole, heparin, kaliuretics, cyclosporine - increased effectiveness of the latter; with simultaneous use of cyclosporine and glucocorticosteroids, seizures may occur;

with amphotericin B, β2-adrenomimetics, drugs that remove potassium from the body (for example, diuretics) - increased risk of hypokalemia, which can lead to heart failure; with simultaneous use of amphotericin B and glucocorticosteroids, the risk of osteoporosis also increases;

with antihypertensive agents, natriuretics, praziquantel, hypoglycemic agents, salicylates, somatotropin (in high doses) - reduced effectiveness of the latter; with simultaneous use of dexamethasone and salicylates, the dose of dexamethasone should be carefully reduced, since an increase in the concentration of salicylates in the blood plasma and intoxication may occur;

with antihistamines, m-cholinoblockers, nitrates, tricyclic antidepressants - the risk of increased intraocular pressure; with simultaneous use of tricyclic antidepressants and glucocorticosteroids, the risk of depression also increases;

with anticholinesterase agents – increased risk of developing severe weakness in patients with myasthenia gravis;

with vitamin D – weakening the latter's effect on calcium absorption from the intestines;

with thyroid hormones – increased clearance of glucocorticosteroids;

with isoniazid, mexiletine – a decrease in the concentration of the latter in blood plasma due to increased metabolism;

with immunosuppressants - increased risk of developing infections, lymphoma or other lymphoproliferative disorders associated with the Epstein-Barr virus;

with carbonic anhydrase inhibitors – increased risk of osteoporosis;

with indomethacin – increased toxic effects of dexamethasone (due to its displacement from albumin binding);

with live antiviral vaccines and against the background of other types of immunization - increased risk of virus activation and development of infections;

with muscle relaxants – increased severity and duration of muscle blockade against the background of hypokalemia caused by glucocorticosteroids;

with nonsteroidal anti-inflammatory drugs, ethanol - increased risk of gastrointestinal bleeding and ulceration;

with paracetamol – increased risk of developing hepatotoxic effects of paracetamol due to induction of “liver” enzymes and formation of its toxic metabolite;

with drugs metabolized by CYP 3A4 (indinavir, erythromycin) - a decrease in the concentration of the latter due to an increase in their clearance;

with ritordine - possible development of pulmonary edema; fatal outcome for a woman in labor due to the development of this condition has been reported; simultaneous use of ritordine and dexamethasone is contraindicated during labor;

with cardiac glycosides – risk of heart rhythm disturbances in patients with hypokalemia and increased toxic effects of glucocorticosteroids;

with steroid hormonal drugs (e.g., androgens, anabolic steroids, estrogens, oral contraceptives) – the appearance of acne and hirsutism; estrogens, oral contraceptives enhance the therapeutic and toxic effects of glucocorticosteroids, reducing the clearance of glucocorticosteroids;

with thalidomide – increased risk of toxic epidermal necrolysis.

Ergocalciferol and parathormone prevent the development of osteopathy caused by glucocorticosteroids.

Types of interactions that have therapeutic benefits: simultaneous administration of dexamethasone and metoclopramide, diphenhydramide, prochlorperazine or 5-HT3 receptor antagonists (serotonin or 5-hydroxytryptamine receptors, type 3, such as ondansetron or granisetron) is effective for the prevention of nausea and vomiting caused by chemotherapy with cisplatin, cyclophosphamide, methotrexate, fluorouracil.

Interaction with dexamethasone and all of the above-mentioned drugs may distort the dexamethasone suppression test. This should be taken into account when interpreting the test results.

Antacids reduce the absorption of dexamethasone in the stomach. The effect of dexamethasone when taken with food and alcohol has not been studied, but simultaneous use of the drug and food with a high sodium content is not recommended.

Smoking does not affect the pharmacokinetics of dexamethasone.

Application features

Before starting and during therapy with glucocorticosteroids, it is necessary to perform a complete blood count, monitor the level of glycemia and the content of electrolytes in the blood plasma.

During treatment with dexamethasone (especially long-term treatment), ophthalmological supervision, monitoring of blood pressure and water-electrolyte balance, in particular serum potassium levels, as well as peripheral blood picture and glycemia levels are necessary.

During parenteral treatment with corticosteroids, hypersensitivity reactions may occur in isolated cases, therefore, appropriate measures should be taken before starting treatment with dexamethasone, taking into account the possibility of allergic reactions (especially in patients with a history of allergic reactions to any other drugs).

When discontinuing the drug in the case of long-term treatment, withdrawal syndrome may develop (without visible signs of adrenal insufficiency) with the following symptoms: fever, runny nose, conjunctival redness, headache, dizziness, drowsiness or irritability, lethargy, muscle and joint pain, nausea, vomiting, weight loss, general weakness, convulsions. In this regard, the dose of dexamethasone should be reduced gradually. Abrupt discontinuation can be fatal.

If the patient is under severe stress (due to trauma, surgery, or serious illness) during or after dexamethasone therapy, the dose should be increased or hydrocortisone or cortisone should be used.

Patients who have been taking dexamethasone for a long time and experience severe stress after stopping therapy should resume taking dexamethasone, as the resulting adrenal insufficiency may persist for several months after stopping treatment.

Treatment with dexamethasone or natural glucocorticosteroids may mask the symptoms of an existing or new infection, as well as symptoms of intestinal perforation. During treatment, contact with people with colds or other infections should be avoided.

Dexamethasone may cause exacerbation of systemic fungal infections, latent amebiasis, and pulmonary tuberculosis.

Patients with active pulmonary tuberculosis should receive dexamethasone (along with anti-tuberculosis drugs) only for transient or disseminated pulmonary tuberculosis. Patients with inactive pulmonary tuberculosis treated with dexamethasone or patients who respond to tuberculin should receive chemical prophylactics.

The drug should be prescribed with caution to infectious patients, especially with chickenpox and measles, since these diseases are more severe when using dexamethasone. Therefore, people who have not had these diseases should be careful to exclude infection as much as possible. In case of contact with patients, it is necessary to immediately consult a doctor. Prophylactic treatment with immunoglobulin is recommended.

Glucocorticosteroids should be prescribed with caution to patients with herpes simplex, as their use may lead to corneal perforation.

Caution and medical supervision are recommended for patients with osteoporosis, arterial hypertension, heart failure, tuberculosis, glaucoma, hepatic or renal failure, diabetes mellitus, gastritis, esophagitis, diverticulitis, active peptic ulcer, with recent intestinal anastomosis, patients with colitis and epilepsy, thyrotoxicosis, obesity (III-IV degree), nephrourolithiasis, hyperlipidemia, poliomyelitis (except for the form of bulbar encephalitis), hypoalbuminemia and patients with conditions leading to its occurrence, patients with immunodeficiency states (including AIDS or HIV infection), lymphadenitis after BCG vaccination.

Special care is required for patients during the first weeks after myocardial infarction, patients with thromboembolism, severe myasthenia gravis, hypothyroidism, psychosis or psychoneurosis, as well as elderly patients.

During treatment with dexamethasone, exacerbation of diabetes mellitus or transition from the latent phase to clinical manifestations may occur.

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

Patients with impaired water and electrolyte balance should be careful when taking dexamethasone, because medium and high doses of glucocorticosteroids can cause salt and fluid retention in the body, as well as increased potassium excretion. In these cases, salt restriction and additional potassium intake are indicated. All corticosteroids enhance the process of calcium excretion, as a result of which mineralocorticoid secretion may be impaired. Therefore, additional salt and/or mineralocorticoid administration is indicated.

Long-term use of glucocorticosteroids can lead to the development of posterior subcapsular cataracts, glaucoma, with damage to the optic nerve, and also increases the risk of secondary viral or fungal eye infections.

Caution is advised in patients recovering from surgery or bone fractures, as dexamethasone may slow wound healing and bone formation.

Systemic corticosteroids should not be discontinued in patients who are already taking systemic (oral) corticosteroids for other reasons (e.g., patients with chronic obstructive pulmonary disease) and do not require supplemental oxygen.

Special attention is required when using systemic glucocorticosteroids in patients with severe affective disorders, including depressive, manic-depressive psychosis, previous steroid psychosis, including patients with a history of such disorders. Patients and/or caregivers should be warned about the possibility of developing serious psychiatric side effects. Symptoms usually appear within a few days or weeks after starting treatment. The risk of these side effects is higher when using high doses. Most reactions disappear after reducing the dose or discontinuing the drug, although sometimes specific treatment is necessary.

It is necessary to observe and timely detect changes in mental status, especially depressed mood, suicidal thoughts and intentions. With particular caution, corticosteroids should be used in patients with a history of affective disorders, especially in patients with a history of allergic reactions to any other drugs, as well as in close relatives. If such symptoms develop, you should consult a doctor. Mental disorders can also be observed when glucocorticoids are discontinued.

Glucocorticosteroids may interfere with the results of allergy skin tests.

Hypertrophic cardiomyopathy has been reported following systemic corticosteroid administration to premature infants. In most cases, this was reversible upon discontinuation of treatment. Diagnostic evaluation and monitoring of cardiac function and structure are recommended in premature infants receiving systemic dexamethasone.

Children should be treated with dexamethasone only if clearly necessary. During treatment with dexamethasone, careful monitoring of the growth and development of children is necessary.

There is evidence of long-term neurological side effects after early treatment (< 96 hours) of premature infants with chronic lung disease at initial doses of 0.25 mg/kg twice daily.

Intra-articular use of the drug may lead to local or systemic adverse reactions. Frequent use may cause cartilage damage or bone necrosis.

Frequent intra-articular injections can injure joint tissues. During treatment, patients should avoid excessive loads on the affected joints until the inflammatory process has completely disappeared, even if symptomatic improvement occurs.

The drug should be discontinued in patients who, upon intra-articular administration of glucocorticosteroids, experience significantly increased pain, accompanied by swelling and subsequent limitation of joint mobility, fever, and general malaise (these symptoms indicate the occurrence of septic arthritis). In the event of the development of septic arthritis and the confirmation of the diagnosis of sepsis, appropriate antibacterial therapy should be prescribed.

Excipients

This medicinal product contains less than 1 mmol (23 mg) sodium/dose, i.e. essentially 'sodium-free'.

Use during pregnancy or breastfeeding

Pregnancy period.

Glucocorticosteroids cross the placenta and reach high concentrations in the fetus. Harmful effects on the fetus and newborn cannot be excluded. Dexamethasone inhibits intrauterine development. According to some data, even pharmacological doses of glucocorticosteroids increase the risk of placental insufficiency, oligohydramnios, fetal growth retardation or intrauterine death, increased leukocyte count (neutrophils) in the fetus, and adrenal insufficiency. There is no data on the teratogenic effect of dexamethasone. Children born to mothers who were prescribed glucocorticosteroids during pregnancy should be carefully monitored for adrenal insufficiency.

Also, some studies have shown an increased risk of neonatal hypoglycemia after prenatal short-term use of corticosteroids in women at risk of late preterm birth.

The drug should be used in emergency cases when the expected benefit to the mother outweighs the potential risk to the fetus.

Special caution is advised in preeclampsia. According to general recommendations, when treating with glucocorticosteroids during pregnancy, the lowest effective dose to control the underlying disease should be used.

Women who have used glucocorticosteroids during pregnancy are advised to use additional doses of them during labor. In case of prolonged labor or when a cesarean section is planned, intravenous administration of 100 mg of hydrocortisone every 8 hours is recommended.

Breastfeeding period.

The drug is contraindicated during breastfeeding (except in emergency cases).

Glucocorticosteroids pass into breast milk. In the case of dexamethasone use, especially in doses exceeding physiological norms (about 1 mg), breastfeeding is not recommended, as this may lead to a slowdown in the growth of the child and a decrease in the secretion of endogenous corticosteroids.

Ability to influence reaction speed when driving vehicles or other mechanisms

There is no data, but the possibility of developing adverse reactions from the nervous system and visual organs should be taken into account.

Method of administration and doses

The medicine can be used by adults and children from birth.

Administer intravenously (as an injection or infusion), intramuscularly or locally – by intra-articular injections or injections into the lesion on the skin or into the soft tissue infiltrate. As a solvent for intravenous infusion, use 0.9% sodium chloride solution or 5% glucose solution.

When used in infants, especially premature infants, solutions intended for intravenous administration or further dilution of the drug should not contain preservatives.

When mixing medicinal