Dexamed

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Instructions for use:

1. Release form and composition
2. Indications for use
3. Contraindications
4. Method of application and dosage
5. Side effects
6. Special instructions
7. Drug interactions
8. Analogs
9. Terms and conditions of storage
10. Terms of dispensing from pharmacies

Dexamed is a synthetic glucocorticoid, a methylated derivative of fluoroprednisolone with antiallergic, desensitizing, anti-shock, anti-inflammatory, immunosuppressive and antitoxic action.

Release form and composition

solution for injection (d / i): a transparent slightly yellowish or colorless liquid (1, 2 or 5 ml in dark glass ampoules, 5 ampoules in blisters, in a cardboard box 2 or 20 packs);
tablets: round, flat, Ø - 7 mm, scored; pink with engraving MS (dose 0.5 mg) or white (dose 1.5 mg) (10 pcs. in blisters, 10 blisters in a cardboard box).

1 ml of solution contains:

active substance: dexamethasone phosphate (in the form of sodium salt) - 4 mg;
auxiliary ingredients: disodium edetate, sodium metabisulfite, sodium citrate dihydrate, sodium phosphate disubstituted dodecahydrate, sodium chloride, propyl 4-hydroxybenzoate, methyl 4-hydroxybenzoate, water d / i.

1 tablet contains:

active substance: dexamethasone - 0.5 or 1.5 mg;
auxiliary ingredients: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, magnesium stearate, anhydrous colloidal silicon dioxide, quinoline yellow aluminum varnish (E 104), erythrosine varnish (E 127).

Indications for use

Solution d / i

Dexamed in the form of a solution is recommended for the treatment of the following diseases / conditions in which it is necessary to administer a fast-acting glucocorticosteroid (GCS) or oral administration of dexamethasone is impossible:

endocrine pathologies: primary, secondary or acute adrenal insufficiency, subacute thyroiditis, VHKN (congenital adrenal hyperplasia);
shock: traumatic, toxic, burns, operational - with the ineffectiveness of plasma-substituting, vasoconstrictor drugs, other symptomatic treatment;
cerebral edema: consequences of a tumor, traumatic brain injury, neurosurgical intervention, cerebral hemorrhage, encephalitis, meningitis, radiation injury;
bronchopulmonary pathologies: severe bronchospasm as a result of exacerbation of bronchial asthma and COPD (chronic obstructive pulmonary disease), asthmatic status;
severe hypersensitivity reactions, anaphylactic shock;
diffuse connective tissue diseases;
rheumatic diseases;
acute severe dermatoses: Stevens-Johnson syndrome, exudative erythema multiforme, Lyell's syndrome (toxic epidermal necrolysis);
malignant neoplasms: leukemia and lymphoma in adult patients (palliative therapy), acute leukemia in children, hypercalcemia in patients with impossibility of oral administration of dexamethasone;
blood diseases: agranulocytosis, acute hemolytic anemias, Werlhof's disease (idiopathic thrombocytopenic purpura) in adults;
severe infections (in combination with antibiotics);
ophthalmic diseases / conditions (for retrobulbar, parabulbar or subconjunctival administration): keratitis, iritis, iridocyclitis, keratoconjunctivitis without the integrity of the corneal epithelium, allergic conjunctivitis, blepharitis, blepharoconjunctivitis, ocular inflammation and ocular inflammation and surgery, episcleritis, sympathetic ophthalmia;
local application (application to the area of pathological formations): discoid lupus erythematosus, keloid scars, annular granuloma.

Pills

Itsenko-Cushing's syndrome - for differential diagnosis of hyperfunction of the adrenal cortex;
primary and secondary pituitary insufficiency - as replacement therapy;
anaphylaxis, angioedema, serum sickness;
polymyositis;
rheumatoid arthritis, polymyalgia rheumatica, polyarteritis nodosa;
sarcoidosis;
leukemia, hemolytic anemia, multiple myeloma;
Crohn's disease, NUC (ulcerative colitis);
Dressler's syndrome (postinfarction syndrome);
severe infectious diseases, miliary tuberculosis - as part of complex treatment;
cerebral edema as a result of head trauma, craniotomy, primary tumor, brain metastases;
lupus jade;
aspiration pneumonitis, bronchial asthma;
optic neuritis, uveitis (anterior and posterior);
pemphigus vulgaris.

Contraindications

Solution d / i

The only absolute contraindication for the short-term use of Dexamed solution for health reasons is hypersensitivity to dexamethasone or other components of the drug.

Children during the period of growth are prescribed GCS only for absolute indications under the close supervision of the attending physician.

The following diseases / conditions are relative contraindications for using the drug in the form of a solution:

diseases of the gastrointestinal tract (gastrointestinal tract): diverticulitis, gastritis, gastric ulcer and 12 duodenal ulcer, esophagitis, acute / latent peptic ulcer, recently created intestinal anastomosis, UC with the threat of abscess formation or perforation;
infections and invasions of a fungal, viral, bacterial nature (current or recently transferred, including recent contact with a patient): herpes zoster in the viremic phase, chickenpox, herpes simplex, measles, strongyloidosis, amebiasis, systemic mycosis, latent / active tuberculosis - using dexamethasone against a background of severe infections is permissible only in combination with specific therapy;
immune disorders: the period of pre- and post-vaccination (within 8 weeks before and 2 weeks after immunization), lymphadenitis as a result of anti-tuberculosis vaccination with BCG, immunodeficiency states, including AIDS (acquired immunodeficiency syndrome) or HIV (human immunodeficiency virus);
cardiovascular pathologies: recent myocardial infarction (in patients with acute and subacute myocardial infarction, it is possible to expand the focus of necrosis, inhibition of the formation of scar tissue and, as a result, rupture of the heart muscle), arterial hypertension, severe CHF (chronic heart failure), hyperlipidemia;
endocrine diseases: diabetes mellitus (including impaired carbohydrate tolerance), hypothyroidism, thyrotoxicosis, Itsenko-Cushing's disease, III – IV degree of obesity;
severe renal / liver dysfunction, nephrourolithiasis, hypoalbuminemia and conditions conducive to its occurrence (nephrotic syndrome, liver cirrhosis);
systemic osteoporosis, myasthenia gravis, acute psychosis, poliomyelitis (except bulbar encephalitis), open-angle / closed-angle glaucoma.

During pregnancy, especially in its first trimester, the drug is used only for vital indications, when the expected effect of therapy outweighs the potential risks to the fetus. If it is necessary to use Dexamed during lactation, breastfeeding should be interrupted.

Pills

osteoporosis;
peptic ulcer and 12 duodenal ulcer;
systemic fungal, acute viral and bacterial infections in the absence of adequate treatment;
Cushing's syndrome;
severe form of arterial hypertension;
severe renal dysfunction;
chronic hepatitis or cirrhosis of the liver;
obesity of III-IV degree;
active tuberculosis;
acute psychoses;
the period of pregnancy and breastfeeding;
children and adolescents up to 18 years old;
increased individual sensitivity to dexamethasone and any other auxiliary components of the tablets.

Method of administration and dosage

The dosage regimen of Dexamed and the dosage form of the drug are determined in each case individually, depending on the diagnosis, the patient's condition and his response to dexamethasone therapy.

Solution d / i

Dexamed solution is injected intravenously (intravenously) slowly drip or jet (for the treatment of acute and urgent conditions), intramuscularly (intramuscularly) or locally (into the body of a pathological formation). The drug for intravenous drip infusion is prepared using 5% dextrose solution or isotonic NaCl solution.

For the treatment of various diseases in the acute phase and at the beginning of the course of therapy, higher doses of the drug are used - from 4 to 20 mg 3-4 times a day.

Recommended dosage for children (i / m):

holding replacement therapy in adrenal insufficiency: I scheme - 0.67 mg / m ² body surface area, or 0.0233 mg / kg body weight of the child, divided into 3 doses administered every 3rd day; II scheme - 0.233-0.335 mg / m ² of body surface area or 0.00776-0.01165 mg / kg of the child's weight, administered daily;
other indications: 0.833-5 mg / m ² body surface area or 0.02776-0.16665 mg / kg of the child's weight every 12-24 hours. Upon reaching the desired effect, the dose is reduced to a maintenance dose or the treatment is gradually discontinued.

The standard course of parenteral administration is 3-4 days, after which they switch to taking dexamethasone inside in the form of tablets. Long-term use of the drug in high doses should be completed, reducing them gradually, in order to avoid the development of acute adrenal insufficiency.

Pills

Dexamed tablets are taken orally. With long-term therapy with high doses, the drug is recommended to be taken with meals, and in the intervals between them, additionally, antacids are used.

Recommended daily doses:

initial - 0.5-9 mg; for the treatment of severe diseases, an increase in the initial dose of ≥ 9 mg is allowed;
minimally effective - 0.5-1 mg;
maximum - 10-15 mg.

The drug is used in the initial dose until a therapeutic effect is achieved, after which it is gradually reduced (0.5 mg every 3 days) to a maintenance dose of 2–4.5 mg per day and above. The course of therapy varies from 5-7 days to 2-3 months.

Taking high doses for several days requires a gradual subsequent dose reduction over several days or more.

In the dosage regimen, it is recommended to take into account the daily circadian fluctuations in the endogenous secretion of glucocorticoids and take most or all of the daily dose of dexamethasone in the interval 6-8 am.

In case of a severe acute allergic reaction proceeding without treatment, or in the case of an exacerbation of a chronic hypersensitivity reaction, a combined regimen of parenteral and oral therapy is used.

It is required to monitor changes in the patient's clinical status after trauma, surgery, or during an exacerbation of the infection. Under stress, it is allowed to temporarily increase the dose.

Side effects

Usually, Dexamed is well tolerated due to its low mineralocorticoid activity (insignificant effect on water and electrolyte balance). Low and medium doses of Dexamed, as a rule, do not cause sodium and water retention in the body and do not increase potassium excretion.

The following side effects from systems and organs are possible:

endocrine system: decreased glucose tolerance, steroidal diabetes mellitus / manifestation of latent diabetes mellitus, delayed sexual development in children, hypocorticism and hypercorticism (Itsenko-Cushing syndrome), including symptoms such as moon face, hirsutism, pituitary obesity, dysmenorrhea, amenorrhea increased blood pressure (blood pressure), myasthenia gravis, striae;
digestive system: nausea / vomiting, indigestion, erosive esophagitis, steroid stomach and duodenal ulcer, pancreatitis, bleeding and gastrointestinal perforation, increased or decreased appetite, hiccups, flatulence; in rare cases - increased activity of liver enzymes;
cardiovascular system: bradycardia (up to sudden cardiac arrest), arrhythmias, development (in patients with a predisposition) or increased severity of blood pressure, hypercoagulation, thrombosis; in acute and subacute myocardial infarction - expansion of the focus of necrosis, slowing down the formation of scar tissue and, as a consequence, a possible rupture of the heart muscle;
nervous system: disorientation, euphoria, delirium, hallucinations, depression, manic-depressive psychosis, paranoia, increased intracranial pressure, nervousness / anxiety, dizziness, vertigo, insomnia, headache, cerebellar pseudotumor, convulsions;
sensory organs: increased intraocular pressure with possible damage to the optic nerve, posterior subcapsular cataract, tendency to develop secondary eye infections (viral, bacterial, fungal), corneal degeneration, exophthalmos, sudden loss of vision (due to parenteral administration in the head, neck, nasal sinuses) possible deposition of dexamethasone crystals in the vessels of the eyes);
metabolism: hypocalcemia, increased excretion of calcium, weight gain, increased protein breakdown (negative nitrogen balance), hyperhidrosis; due to mineralocorticoid activity - hypernatremia, sodium and fluid retention in the body (peripheral edema), hypokalemic syndrome (arrhythmia, hypokalemia, myalgia or muscle spasms, unusual fatigue / weakness);
musculoskeletal system: in children - growth retardation and ossification processes due to premature closure of the epiphyseal growth zones; osteoporosis, steroid myopathy, muscle tendon rupture, muscle atrophy; very rarely - aseptic necrosis of the femoral head and humerus, pathological bone fractures;
hypersensitivity reactions: generalized (pruritus, rash, anaphylactic shock) and local allergic reactions;
mucous membranes, skin: slow healing of wounds, ecchymosis, petechiae, thinning of the skin, acne, striae, hyper- or hypopigmentation, a tendency to develop candidiasis and pyoderma;
reactions at the injection site: numbness, burning, pain, hyperemia, tingling, infection; rarely - necrosis of adjacent tissues, scarring at the injection site; with i / m administration, atrophy of the skin and subcutaneous tissue, especially in the region of the deltoid muscle;
other reactions: development / exacerbation of infections (especially when combined with immunosuppressants and during vaccination), leukocyturia, withdrawal syndrome; due to intravenous administration - flushing of the face, arrhythmias, convulsions.

Overdose may increase the side effects described above. For the treatment of the condition, the dose of the drug should be reduced and symptomatic treatment should be carried out.

special instructions

Before starting therapy, the patient needs to undergo an examination in order to identify possible contraindications, which should include studies of the stomach and duodenum, cardiovascular system, urinary system, visual organs, X-ray of the lungs, control of blood composition, plasma glucose and electrolytes. Such control cannot be carried out during therapy due to the urgency of the patient's condition.

In case of a predisposition to the development of peptic ulcer of the gastrointestinal tract, it is necessary to prescribe antacids for prevention.

During the course of treatment with dexamethasone, especially long-term, one should be observed by an ophthalmologist, monitor blood pressure, the state of water and electrolyte balance, the picture of peripheral blood and blood glucose levels.

To reduce the risk of side effects, it is required to ensure a sufficient intake of potassium K + into the patient's body (potassium preparations, special diet). The patient's diet should be rich in vitamins, proteins, but limited in carbohydrates, fats and table salt.

In patients with hypothyroidism and liver cirrhosis, the effect of dexamethasone is enhanced.

Existing emotional instability or psychotic disturbances may worsen during treatment. If there is a history of psychoses, high doses of dexamethasone are taken only under strict medical supervision.

Under stress conditions during maintenance therapy, for example, during surgery, trauma or infectious diseases, it is necessary to adjust the dose of the drug upward due to an increase in the need for GCS. Throughout the year after the completion of a long course of therapy, it is necessary to carefully monitor the patients due to the risk of developing relative adrenal insufficiency in stressful situations.

Sudden withdrawal of Dexamed, especially with the previous use of high doses, can cause the development of a withdrawal syndrome, accompanied by anorexia, nausea, lethargy, generalized musculoskeletal pain, general weakness, and also exacerbation of the condition for which Dexamed was used.

During therapy, vaccination should not be carried out due to a decrease in the immune response (effectiveness). The use of Dexamed in septic conditions, tuberculosis, intercurrent infections requires the simultaneous conduct of antimicrobial bactericidal therapy.

Children during long-term therapy with dexamethasone require careful monitoring of the dynamics of growth and development. If during the period of treatment the child was in contact with infected chickenpox or measles, specific immunoglobulins should be prescribed for prevention.

Patients with diabetes mellitus need to monitor blood glucose levels and, if necessary, adjust the dosage regimen.

It is recommended to carry out X-ray control of the osteoarticular system (X-ray of the spine, hands).

With latent infectious lesions of the kidneys and urinary tract, under the influence of Dexamed, leukocyturia may develop, affecting the results of diagnosis. Dexamethasone increases the concentration of 11- and 17-oxyketocorticosteroid metabolites.

For elderly patients, especially during long-term therapy, it is important to consider the consequences of standard adverse reactions such as diabetes, osteoporosis, hypokalemia, hypertension, thinning of the skin, susceptibility to infections. In order to timely prevent the development of life-threatening reactions, careful clinical observation and timely examination are necessary.

Taking into account such side effects of dexamethasone such as dizziness, headache, etc. from driving and performing other potentially dangerous types of work that require increased attention, it is recommended to refrain.

Drug interactions

Possible pharmaceutical incompatibility of the Dexamed solution with other drugs administered intravenously, and therefore it is recommended to administer it separately from other drugs (IV bolus, or through another dropper, as a second solution). When mixing solutions of dexamethasone and heparin, a precipitate is formed.

Due to the high pharmacological activity of dexamethasone and the significant likelihood of interaction of the drug Dexamed with other drugs / substances, recommendations for their joint use can only be given by the attending physician.

Analogs

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

Terms and conditions of storage

Store in a dry, dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Shelf life: solution - 3 years, tablets - 5 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!