DEXAMETHASONE instructions for use (injections in ampoules, eye drops, tablets). DEXAMETHASONE is a powerful synthetic glucocorticoid (containing adrenal cortex hormones and their synthetic analogues) drug designed to regulate protein, carbohydrate and mineral metabolism.
Dexamethasone instructions for use, reviews, analogs and forms of release (tablets 0.5 mg, injections in ampoules (solution for injection), eye drops oftan) drugs for the treatment of inflammation in adults, children and pregnancy.
Oral administration of Dexamethasone in the form of tablets involves the appointment of 10-15 mg of the drug per day at the initial stage of treatment, followed by a decrease in the daily dose to 2-4.5 mg with maintenance therapy. The instruction recommends dividing the daily dose of the drug Dexamethasone into 2-3 doses (after or during meals).
Maintenance small doses should be taken once a day, preferably in the morning. Dexamethasone in ampoules is intended for intravenous (drip or jet), intramuscular, periarticular and intraarticular administration. The recommended daily dose of Dexamethasone for these routes of administration is 4-20 mg. Dexamethasone in ampoules is usually used 3-4 times a day for 3-4 days, followed by switching to tablets.
Dexamethasone drops are used in ophthalmology: in acute conditions, 1-2 drops of the drug are instilled into the conjunctival sac every 1-2 hours, when the condition improves, every 4-6 hours. Chronic processes involve the use of Dexamethasone drops 2 times a day.
The duration of treatment depends on clinical course diseases, so Dexamethasone drops can be used from several days to four weeks.
Diseases requiring the introduction of a fast-acting GCS, as well as cases where oral administration of the drug is not possible:
For short-term use for health reasons, the only contraindication is hypersensitivity to dexamethasone or the components of the drug.
In children during the period of growth, corticosteroids should be used only according to absolute indications and under the most careful supervision of the attending physician.
Carefully the drug should be prescribed for the following diseases and conditions:
The therapeutic and toxic effects of Dexamethasone are reduced by barbiturates, phenytoin, rifabutin, carbamazepine, ephedrine and aminoglutethimide, rifampicin (accelerate metabolism); somatotropin; antacids (reduce absorption), enhance - 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 is increased by 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. Dexamethasone instructions for use.
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 production).
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.
It is intended for intravenous, intramuscular, 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 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 with acute and emergency conditions administered in / in slowly, stream or drip, or / m at a dose of 4-20 mg 3-4 times a day. Maximum single dose-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. Children - in / m at a dose of 0.02776-0.16665 mg / kg every 12-24 hours.
The drug is prescribed repeatedly with an interval of 3 days to 3 weeks as needed; maximum dose for adults - 80 mg per day. 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 o'clock.
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. In case of insufficiency of the adrenal cortex (children) in / m at 0.0233 mg / kg (0.67 / mg / m2) per day in 3 injections every third 24 hours, or daily at 0.00776-0.01165 mg / kg ( 0.233-0.335 mg/m2) per day.
With an acute allergic reaction or exacerbation of a chronic allergic disease, dexamethasone should be administered according to the following schedule, taking into account the combination of parenteral and oral administration: dexamethasone instructions for use injection 4 mg / ml: 1 day, 1 or 2 ml (4 or 8 mg) intramuscularly; dexamethasone tablets 0.75 mg: the second and third days, 4 pieces in 2 doses per day, the fourth - 2 pieces in 2 doses, the fifth and sixth days - 1 pc. daily, on the seventh - without treatment, day 8 - observation.
Dexamethasone is usually well tolerated. It has low mineralocorticoid activity, i.e. its impact on water-electrolyte exchange small. As a rule, low and medium doses of Dexamethasone do not cause sodium and water retention in the body, increased potassium excretion.
The following side effects have been described:
allergic reactions: skin rash, itching, anaphylactic shock, local allergic reactions.
Local for parenteral administration: burning, numbness, pain, tingling and infection at the injection site, rarely - necrosis of surrounding tissues, scarring; atrophy of the skin and subcutaneous tissue with intramuscular injection (it is especially dangerous to inject into the deltoid muscle).
Other: development or exacerbation of infections (the appearance of this side effect is facilitated by jointly used immunosuppressants and vaccination), leukocyturia, "flushing" of blood to the face, "withdrawal" syndrome.
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Should be given credit modern pharmacology, which was able to achieve unprecedented success in the field of application hormonal drugs for the treatment of both acute and chronic ailments. The basis of such drugs are synthesized analogues of the body's own hormones. Inflammatory diseases are treated by the use of hormonal drugs, which are more analogous to the secretion of the adrenal cortex. Such drugs allow you to quickly and effectively remove inflammatory processes, which is important to take into account in the development of allergic reactions and in diseases of the joints.
One such drug is a drug called Dexamethasone. This drug refers to glucocorticosteroids, and has a number of beneficial effects. Why Dexamethasone is so useful, let's find out in more detail.
Dexamethasone is a synthetic type of glucocorticosteroid (hormonal) substances, which is a derivative of fluoroprednisolone. The drug has anti-allergic, anti-inflammatory, immunosuppressive effects, and also allows you to increase the sensitivity of adrenergic receptors. Presented as a solution for injection in ampoules of 1 and 2 ml. The package contains 25 ampoules, and the cost of the drug is about 200 rubles. The solution for injection is a clear or yellowish liquid, depending on the release series. One 1 ml ampoule contains the following components:
The effectiveness of the drug is determined by the mechanism of its action. This mechanism is associated with several fundamental effects, which are:
Through all of the above factors, it can be noted that the drug Dexamethasone has the following properties:
It's important to know! Dexamethasone has an immediate effect on intravenous administration, and with intramuscular injection after 8 hours.
Like any other medicine, the drug Dexamethasone has negative properties, through which an adverse effect is exerted on the human body.
Dexamethasone has a number of negative factors, which include:
Such negative reactions medicinal product allow you to understand what side effects can be. You can avoid the development of side effects by using the drug in the lowest possible doses, which will reduce the negative impact on the body.
Dexamethasone is popular in many areas of medicine. The drug is used to treat diseases of the joints, as well as to relieve allergic manifestations. Indications for the use of Dexamethasone are the following diseases and pathologies:
Solution for injection Dexamethasone is used in the development of acute and urgent conditions, when a person's life depends on the speed of exposure to the drug. The drug is intended primarily for short-term use in connection with vital indications.
Dexamethasone is indicated for use not only for adults, but also for children from the first year of life. Instructions for use of the drug Dexamethasone in the form of injections informs that the drug can be used not only for intramuscular injection, but also intravenously by jet or drip. The dosage of the drug depends on such factors as the severity and form of the disease, the age of the patient and the presence of negative reactions. For intravenous administration by drip infusion, a solution must first be prepared. For preparation, it is necessary to dilute the drug with saline or glucose solution. Let us consider in more detail the features of the use of Dexamethasone for adults and children.
For adults, Dexamethasone is used both intramuscularly and intravenously in an amount of 4 to 20 mg. The maximum dosage per day should not exceed 80 ml, so the drug can be administered 3-4 times a day. If there are acute dangerous cases in which a fatal outcome may occur, then on an individual basis, as directed by a doctor, the daily dose may be increased. The duration of parenteral use of the drug is no more than 3-4 days. If it is necessary to continue treatment, then the oral form of the drug in the form of tablets is used. In the event of a positive effect, the dosage is reduced until a maintenance dose is identified. The decision to stop taking the drug is made by the attending physician.
It is unacceptable to use Dexamethasone in the form of intravenous administration in large doses. fast way. This can lead to the development of cardiac complications, so the drug should be administered slowly. Intramuscularly, the drug should also be administered slowly. With the development of cerebral edema, the initial dosage of the drug should not exceed 16 mg. The subsequent dosage is 5 mg intravenously or intramuscularly every 6 hours until a positive result is achieved. If surgical interventions were performed in the brain area, then such dosages may be required for several more days. Continuous use of the drug can significantly affect the reduction of increased intracranial pressure, which occurs due to the presence of a tumor in the brain.
For children, Dexamethasone injections are prescribed in the form of intramuscular injection. Children's dosage depends on the weight of the child and is 0.2-0.4 mg / kg of body weight per day. Treatment should not be prolonged, and dosages for children should be kept to a minimum, depending on the nature of the disease.
Treatment of joint diseases with Dexamethasone is a necessary measure when non-steroidal types of drugs are not able to provide the necessary healing effect. The main indications for the use of Dexamethasone in articular diseases are:
In such diseases, Dexamethasone is supposed to be used for both local and general treatment.
It's important to know! The drug is injected into the joint area only in an amount of not more than 1 time. Re-injection of Dexamethasone into the joint area is allowed after 3-4 months. In a year, the number of injections for the joint should not exceed 3-4 times. If the norm is exceeded, then this threatens the development of damage to cartilage tissues.
The dosage for intra-articular use is from 0.4 to 4 mg. The dose is influenced by such features as the age of the patient, the size of the shoulder joint, as well as weight. The dosage should be prescribed by the attending physician after a preliminary examination of the patient. Below is a table that shows the approximate doses for the treatment of articular diseases.
Type of introduction | Dosage |
---|---|
Intra-articular (general) | 0.4-4 mg |
Introduction to Large Joints | 2-4 mg |
Introduction to small joints | 0.8-1 mg |
Introduction to the bursa | 2-3 mg |
Insertion into the tendon sheath | 0.4-1 mg |
Introduction to the tendon | 1-2 mg |
Local administration (into the affected area) | 0.4-4 mg |
Introduction to Soft Tissues | 2-6 mg |
The data in the table are indicative, so it is very important not to prescribe dosages yourself.
It's important to know! Prolonged intra-articular administration of the drug is unacceptable, as this can lead to tendon ruptures.
allergic reactions various forms treated with antihistamines. If the inflammatory processes are very strong, then antihistamines do not cope with the task. Dexamethasone comes to the rescue, which is a derivative of prednisone. Active substances act on mast cells, reducing allergic symptoms, resulting in the disappearance of symptoms.
Dexamethasone is used to eliminate allergic manifestations. It is effective for the following allergic abnormalities:
With the development of allergic reactions, you should immediately contact an allergist who will select the necessary dosage of the drug and will be able to provide timely and correct assistance to the patient.
The period of pregnancy and lactation in the life of every woman is a very important stage. During pregnancy, a woman's body is more susceptible to negative factors, due to a decrease in the immune system.
The main feature of Dexamethasone is the fact that its active and metabolic forms of the drug have the ability to penetrate through any barriers. It follows from this that during pregnancy it is necessary to use the drug with extreme caution. When carrying a child, the need to use Dexamethasone is taken by the doctor in each individual case.
An international organization has assigned Class C status to Dexamethasone. This means that the drug can have a negative effect on the fetus, but if there is a risk to the health of the mother, then its use is possible.
Mothers who feed their babies with natural milk should know that it is forbidden to use the medicine in any form during this period. If it is impossible to do without the use of Dexamethasone to cure the disease, then the child should be transferred to artificial feeding. When using Dexamethasone during pregnancy and breastfeeding, the following complications may develop in the fetus and already born child:
When prescribing Dexamethasone during pregnancy and breastfeeding the physician takes responsibility.
With the development of serious severe complications, such as angioedema or anaphylactic shock, the main contraindication to the use of the drug is the presence of signs of individual intolerance. In all other cases, Dexamethasone will save a life by resuscitating the patient.
If the drug is prescribed as a prophylaxis for chronic ailments, then it is important to take into account some types of contraindications. In the presence of such contraindications, the use of the drug can be harmful, so it is very important to take this seriously. The main types of contraindications are:
The main contraindication is intolerance to any component of the drug. All these contraindications should be considered in each individual case. If you use the drug in the presence of contraindications, then this will lead to a deterioration in the condition and the development of side effects. What are the side effects, find out further.
With improper use of Dexamethasone, the following may occur: adverse reactions:
The development of nosebleeds, as well as increased pain in the joints. The development of side effects in patients who, after undergoing a course of therapy, abruptly completed treatment, is not excluded. These side effects include the following ailments: adrenal insufficiency, arterial hypotension, and death.
It's important to know! With the development of side symptoms, as well as with complications and ailments, you must immediately inform your doctor about this. The course of treatment should be stopped immediately if the patient's condition worsens.
Dexamethasone is available from several manufacturers. In addition, it should be noted that the drug has analogues:
What are the advantages and disadvantages of Dexamethasone? Having received an answer to this question, we can conclude that the use of the drug is appropriate. But when it comes to life, the doctor does not think about the presence of contraindications and side effects, and prescribes the medicine urgently. Another thing is when systemic long-term treatment is planned, then in this case it is important to weigh all the pros and cons.
The main advantages of Dexamethasone are:
It is also important to take into account the disadvantages of the drug, which are not so few:
Catad_pgroup Systemic corticosteroids
Catad_pgroup Preparations for ophthalmology
INSTRUCTIONS for medical use drug
Excipients:
glycerol (distilled glycerin) - 22.5 mg
disodium edetate (trilon B) - 0.1 mg
sodium hydrogen phosphate dodecahydrate (sodium phosphate disubstituted 12-water) - 0.8 mg
water for injection - up to 1 ml
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, incl. lipocortin mediating cellular effects. Lipocortin inhibits phospholipase A2, inhibits the release of arachidonic acid and inhibits the biosynthesis of endoperoxides, prostaglandins, leukotrienes, which promote inflammation, allergies, and others.
Protein metabolism: reduces the amount of protein in plasma (due to globulins) with an increase in the albumin / globulin ratio, increases the synthesis of albumins in the liver and kidneys; enhances protein catabolism in muscle tissue.
Lipid metabolism: increases the synthesis of higher fatty acids and triglycerides, redistributes fat (accumulation of fat mainly in the shoulder girdle, face, abdomen), leads to the development of hypercholesterolemia.
Carbohydrate metabolism: increases the absorption of carbohydrates from the gastrointestinal tract; increases the activity of glucose-6-phosphatase, which leads to an increase in the flow of glucose from the liver into the blood; increases the activity of phosphoenolpyruvate carboxylase and the synthesis of aminotransferases, leading to the activation of gluconeogenesis.
Antagonistic action in relation to vitamin D: "washing out" of calcium from the bones and increasing its renal excretion.
The anti-inflammatory effect is associated with inhibition of the release of inflammatory mediators by eosinophils; inducing the formation of lipocortins and reducing the number of mast cells that produce hyaluronic acid; with a decrease in capillary permeability; stabilization of cell membranes and organelle membranes (especially lysosomal ones).
The antiallergic effect is due to a decrease in the number of circulating eosinophils, which leads to a decrease in the release of immediate allergy mediators; reduces the effect of allergy mediators on effector cells.
The immunosuppressive effect is due to inhibition of the release of cytokines (interleukin1 and interleukin2, interferon gamma) from lymphocytes and macrophages.
Suppresses the synthesis and secretion of adrenocorticotropic hormone and secondarily - the synthesis of endogenous glucocorticosteroids. The peculiarity of the action is a significant inhibition of the function of the pituitary gland and the almost complete absence of mineralocorticosteroid activity.
Doses of 1-1.5 mg / day inhibit the function of the adrenal cortex; the biological half-life is 32-72 hours (the duration of the inhibition of the hypothalamus-pituitary-adrenal cortex system).
According to the strength of glucocorticosteroid activity, 0.5 mg of dexamethasone corresponds to approximately 3.5 mg of prednisone (or prednisolone), 15 mg of hydrocortisone, or 17.5 mg of cortisone.
Pharmacokinetics
In the blood, it binds (60-70%) to a specific protein - the carrier - transcortin. Easily passes through histohematic barriers (including through the blood-brain barrier and placental). A small amount is excreted in breast milk. Metabolized in the liver (mainly by conjugation with glucuronic and sulfuric acids) to inactive metabolites. Excreted by the kidneys.
Endocrine diseases (acute insufficiency of the adrenal cortex, primary or secondary insufficiency of the adrenal cortex, congenital hyperplasia of the adrenal cortex, subacute thyroiditis);
- shock resistant to standard therapy; anaphylactic shock;
- cerebral edema (with a brain tumor, traumatic brain injury, neurosurgical intervention, cerebral hemorrhage, encephalitis, meningitis, radiation injury);
- status asthmaticus; severe bronchospasm (exacerbation of bronchial asthma, chronic obstructive bronchitis);
- severe allergic reactions;
- rheumatic diseases;
- systemic connective tissue diseases;
- acute severe dermatoses;
- malignant diseases(palliative treatment of leukemia and lymphoma in adult patients; acute leukemia in children; hypercalcemia in patients suffering from malignant tumors when oral treatment is not possible);
- diagnostic study of hyperfunction of the adrenal glands;
- blood diseases (acute hemolytic anemia, agranulocytosis, idiopathic thrombocytopenic purpura in adults);
- severe infectious diseases (in combination with antibiotics);
- intra-articular and intra-synovial administration: arthritis various etiologies, osteoarthritis, acute and subacute bursitis, acute tendovaginitis, epicondylitis, synovitis;
- local application (in the area of pathological formation): keloids, discoid lupus erythematosus, granuloma annulare.
For intra-articular administration: previous arthroplasty, pathological bleeding (endogenous or caused by the use of anticoagulants), intra-articular bone fracture, infectious (septic) inflammatory process in the joint and periarticular infections (including history), as well as general infection, pronounced periarticular osteoporosis, no signs of inflammation in the joint (the so-called "dry" joint, for example, in osteoarthritis without synovitis), severe bone destruction and joint deformity (sharp narrowing of the joint space, ankylosis), joint instability as an outcome of arthritis, aseptic necrosis of the joints forming epiphyses of bones.
Post-vaccination period (period lasting 8 weeks before and 2 weeks after vaccination), lymphadenitis after BCG vaccinations. Immunodeficiency states (including AIDS or HIV infection).
Diseases of the gastrointestinal tract (gastric ulcer and 12 duodenal ulcer, esophagitis, gastritis, acute or latent peptic ulcer, recently created intestinal anastomosis, ulcerative colitis with the threat of perforation or abscess formation, diverticulitis).
Diseases of the cardiovascular system, incl. recent myocardial infarction (in patients with acute and subacute myocardial infarction, the focus of necrosis may spread, slowing down the formation of scar tissue and, as a result, rupture of the heart muscle), decompensated chronic heart failure, arterial hypertension, hyperlipidemia.
Endocrine diseases - diabetes mellitus (including impaired carbohydrate tolerance), thyrotoxicosis, hypothyroidism, Itsenko-Cushing's disease.
Severe chronic renal and / or liver failure, nephrourolithiasis. Hypoalbuminemia and conditions predisposing to its occurrence.
Systemic osteoporosis, myasthenia gravis, acute psychosis, obesity (III-IV stage), poliomyelitis (except for the form of bulbar encephalitis), open-angle and angle-closure glaucoma, pregnancy, lactation.
For intra-articular administration: the general serious condition of the patient, the ineffectiveness (or short duration) of the action of 2 previous injections (taking into account the individual properties of the glucocorticosteroids used).
Intramuscularly or intravenously - 0.5-9 mg / day.
For the treatment of cerebral edema - 10 mg in the first injection, then 4 mg intramuscularly every 6 hours until the symptoms disappear. The dose can be reduced after 2-4 days with a gradual withdrawal in the period of 5-7 days after the elimination of cerebral edema. Maintenance dose - 2 mg 3 times / day.
For the treatment of shock, 20 mg intravenously at the first injection, then 3 mg/kg for 24 hours as an intravenous infusion or intravenous bolus - from 2 to 6 mg/kg as a single injection or 40 mg as a single injection given every 2- 6 h; possible intravenous administration of 1 mg / kg once. Shock therapy should be canceled as soon as the patient's condition stabilizes, the usual duration is no more than 2-3 days.
Allergic diseases - intramuscularly in the first injection of 4-8 mg. Further treatment is carried out with oral dosage forms.
With nausea and vomiting, during chemotherapy - intravenously 8-20 mg 5-15 minutes before a chemotherapy session. Further chemotherapy should be carried out using oral dosage forms.
For the treatment of respiratory distress syndrome in newborns - intramuscularly 4 injections of 5 mg every 12 hours for two days.
The maximum daily dose is 80 mg.
For children: for the treatment of adrenal insufficiency - intramuscularly at 23 mcg / kg (0.67 mg / sq. M) every 3 days, or 7.8-12 mcg / kg (0.23-0.34 mg / sq. m.). m / day), or 28-170 mcg / kg (0.83-5 mg / sq. m) every 12-24 hours.
From the side of metabolism: sodium and water retention in the body; hypokalemia; hypokalemic alkalosis; negative nitrogen balance caused by increased protein catabolism, increased appetite, weight gain.
From the side of the cardiovascular system: higher risk of thrombosis (especially in immobilized patients), arrhythmias, increased blood pressure, development or aggravation of chronic heart failure, myocardial dystrophy, steroid vasculitis.
From the musculoskeletal system: muscle weakness, steroid myopathy, decreased muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of the femoral head and humerus, pathological fractures of long bones.
From the digestive system: nausea, vomiting, erosive and ulcerative lesions of the gastrointestinal tract (which can cause perforations and bleeding), hepatomegaly, pancreatitis, ulcerative esophagitis.
Dermatological reactions: thinning and vulnerability of the skin, petechiae and subcutaneous hemorrhages, ecchymosis, striae, steroid acne, delayed wound healing, increased sweating.
From the side of the central nervous system: fatigue, dizziness, headache, mental disorders, convulsions and false symptoms of a brain tumor (increased intracranial pressure with congestive optic disc).
From the endocrine system: decreased glucose tolerance, "steroidal" diabetes mellitus or manifestation of latent diabetes mellitus, suppression of adrenal function, Itsenko-Cushing's syndrome (moon face, pituitary-type obesity, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia gravis, striae), delayed sexual development in children.
From the side of the organs of vision: posterior subcapsular cataract, increased intraocular pressure, exophthalmos.
Side effects associated with immunosuppressive action: more frequent occurrence of infections and aggravation of the severity of their course.
Others: allergic reactions.
Local reactions (at the injection site): hyperpigmentation and leukoderma, atrophy of subcutaneous tissue and skin, aseptic abscess, hyperemia at the injection site, arthropathy.
Simultaneous use with diuretics (especially "loop") can lead to increased excretion of potassium from the body.
With simultaneous appointment with cardiac glycosides, the possibility of cardiac arrhythmias increases.
Dexamethasone weakens (rarely enhances) the effect of coumarin derivatives, which requires dose adjustment.
Dexamethasone enhances the side effects of non-steroidal anti-inflammatory drugs, especially their effect on the gastrointestinal tract (increased risk of erosive and ulcerative lesions and bleeding from the gastrointestinal tract). In addition, it reduces the concentration of non-steroidal anti-inflammatory drugs in the blood serum and thereby their effectiveness.
Carbonic anhydrase inhibitors: increase the risk of hypernatremia, edema, hypokalemia, osteoporosis.
Reduces the effectiveness of insulin and oral hypoglycemic drugs, antihypertensive drugs.
Antacids weaken the effect of dexamethasone.
In combination with paracetamol leads to an increased risk of hepatotoxicity, due to the induction of liver enzymes and the formation of a toxic metabolite of paracetamol.
The simultaneous use of androgens, steroid anabolics contributes to the appearance of edema, hirsutism and acne; estrogen, oral contraceptives - leads to a decrease in clearance, an increase in the toxic effects of dexamethasone.
The risk of developing cataracts increases with the use of antipsychotics (neuroleptics) and azathioprine in combination with dexamethasone.
Simultaneous administration with M-anticholinergics (including antihistamines, tricyclic antidepressants) and nitrates contributes to the development of glaucoma.
When used simultaneously with live antiviral vaccines and against the background of other types of immunizations, it increases the risk of virus activation and the development of infections.
Amphotericin B increases the risk of developing heart failure.
In combination with anticoagulants and thrombolytics, the risk of developing gastrointestinal ulcers and bleeding increases.
Reduces the plasma concentration of salicylates (increases the excretion of salicylates).
Increases the metabolism of mexiletine, reducing its plasma concentration.
If it is necessary to carry out drug treatment during breastfeeding then breastfeeding should be discontinued.
Solution for injections 4 mg/ml.
1 ml in neutral glass ampoules.
10 ampoules, together with instructions for use and a knife for opening ampoules or an ampoule scarifier, are placed in a cardboard box.
5 ampoules in a blister pack made of polyvinyl chloride film.
1 or 2 blister packs, together with instructions for use and a knife for opening ampoules or an ampoule scarifier, are placed in a pack of cardboard.
When using ampoules with notches, rings and break points, an ampoule scarifier or a knife for opening ampoules may not be inserted.
INN: Dexamethasone
Manufacturer: Krka, d.d., Novo Mesto
Anatomical-therapeutic-chemical classification: Dexamethasone
Registration number in the Republic of Kazakhstan: No. RK-LS-5 No. 003394
Registration period: 05.08.2016 - 05.08.2021
Dexamethasone
Dexamethasone
Dosage form
Solution for injection, 4 mg/ml
One ampoule contains
active substance- dexamethasone sodium phosphate 4.37 mg (equivalent to dexamethasone phosphate 4.00 mg),
inexcipients: glycerin, disodium edetate, sodium hydrogen phosphate dihydrate, water for injection.
Description
Clear, colorless to light yellow solution
Corticosteroids for systemic use. Glucocorticosteroids. Dexamethasone.
ATX code H02AB02
Pharmacokinetics
After intravenous administration, the drug begins to act quickly, and after intramuscular administration, the clinical effect is achieved 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 (in 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 a synthetic adrenal hormone (corticosteroid) with glucocorticoid action. The drug has a pronounced anti-inflammatory, anti-allergic and desensitizing effect, has immunosuppressive activity.
To date, enough information has been accumulated on the mechanism of action of glucocorticoids to 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 into acute cases or if oral therapy is not possible:
replacement therapy for 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 affecting a large surface of the skin, 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
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 used 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 disease of autoimmune origin (including acute glomerulonephritis)
nephrotic syndrome
palliative care for leukemia and lymphoma in adults
acute leukemia in children
hypercalcemia in malignant neoplasms
cerebral edema due to primary tumors or metastases to the brain, due to craniotomy or head trauma.
Shock of various origins
shock not responding to standard therapy
shock in patients with adrenal insufficiency
anaphylactic shock (intravenously, after the introduction 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 respond 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):
hypertrophic, inflamed, and infiltrated lesions of lichen, psoriasis, granuloma annulare, sclerosing folliculitis, discoid lupus, and cutaneous sarcoidosis
localized alopecia
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 body or 0.2 mg to 0.3 mg/m2 of body surface area daily. For other indications, the recommended dose is 0.02 mg to 0.1 mg/kg body weight, or 0.8 mg to 5 mg/m2 body surface area, every 12 to 24 hours.
decreased glucose tolerance, "steroidal" diabetes mellitus, or manifestation of latent diabetes mellitus
Itsenko-Cushing's syndrome, weight gain
hiccups, nausea, vomiting, increased or decreased appetite, flatulence, increased activity of "liver" transaminases and alkaline phosphatase, pancreatitis
"steroid" ulcer of the stomach and duodenum, erosive zophagitis, bleeding and perforation of the gastrointestinal tract
arrhythmias, bradycardia (up to cardiac arrest), development (in predisposed patients) or increased severity of chronic heart failure, increased blood pressure
hypercoagulation, 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 of vision (with parenteral administration, crystals of the drug may be deposited in the vessels of the eye), posterior subcapsular cataract, increased intraocular pressure with possible damage to the optic nerve, trophic changes in the cornea, exophthalmos, development of secondary bacterial, fungal or viral eye infections
negative nitrogen balance (increased protein breakdown), hyperlipoproteinemia
increased sweating
fluid and sodium retention (peripheral edema), hyperkalemia syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue)
growth retardation and ossification processes in children (premature closure of the epiphyseal growth zones)
increased excretion of calcium, osteoporosis, pathological bone fractures, aseptic necrosis of the head of the humerus and femur, tendon rupture
"steroid" myopathy, muscle atrophy
delayed wound healing, a tendency to develop pyoderma and candidiasis
petechiae, ecchymosis, thinning of the skin, hyper- or hypopigmentation,
steroid acne, striae
generalized and local allergic reactions
decreased immunity, development or exacerbation of infections
leukocyturia
violation of the secretion of sex hormones (menstrual irregularities, hirsutism, impotence, delayed sexual development in children
withdrawal syndrome
burning, numbness, pain, paresthesias and infections, necrosis of surrounding tissues, scarring at the injection site, atrophy of the skin and subcutaneous tissue when administered intramuscularly (injection into the deltoid muscle is especially dangerous), arrhythmias, flushing of blood to the face, convulsions (with intravenous introduction), collapse (with the rapid introduction of large doses)
Contraindications
hypersensitivity to the active substance or auxiliary components of the drug
peptic ulcer of the 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 injection is contraindicated in patients with severe disorders of hemostasis (idiopathic thrombocytopenic
for use in ophthalmic practice: viral and fungal diseases eye
acute form purulent eye infection in the absence of a specific
therapy, corneal diseases associated with epithelial defects, trachoma, glaucoma
active tuberculosis
The effectiveness of dexamethasone is reduced when taken concomitantly rifampicin, carbamazepine, phenobarbitone, phenytoin (diphenylhydantoin), primidone, ephedrine, or aminoglutethimide. Dexamethasone reduces therapeutic effect hypoglycemic drugs, antihypertensive drugs, praziquantel and natriuretics; dexamethasone increases activity heparin, albendazole and kaliuretics. Dexamethasone may change the action coumarin anticoagulants.
Simultaneous use of dexamethasone and high doses glucocorticoids or agonists 2-receptor increases the risk of developing 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 during labor is contraindicated, since 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 .
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, heart and kidney failure, nonspecific 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 stressful situations arise during this period, temporarily glucocorticoids are prescribed, 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.
If treatment with Dexamethasone is carried out for 8 weeks before and 2 weeks after active immunization (vaccination), then in this case the effect of immunization will be reduced or completely neutralized.
Patients with severe traumatic brain injury and ischemic cerebrovascular accident should be prescribed glucocorticoids with caution.
Features of influenceon the ability to manage vehicle or potentially dangerous mechanisms
Because Dexamethasone can cause dizziness and headache, when driving vehicles or working with other mechanisms, it is recommended to refrain from driving a car and operating other potentially dangerous mechanisms.
Symptoms: possible aggravation of side effects.
Treatment: should be canceled and symptomatic therapy prescribed. There is no specific antidote.
After the disappearance of symptoms of an overdose, the drug is resumed.
Release formand packaging
1 ml in dark glass ampoules with a white dot and a green ring for opening the ampoules. A self-adhesive label is attached to the ampoule.
"Dexamethasone" refers to drugs that can save lives in some cases. Such a hormonal remedy effectively copes with an anaphylactic reaction, bronchospasm, toxic shock and many other dangerous conditions. Not everyone knows when it is prescribed to children, in what form it is used, what adverse reactions it can cause in childhood and what are the consequences of exceeding its dosage.
"Dexamethasone" is produced in such forms.
They are small, round flat shape and often white. One package contains 10 , 20 pieces or more.
They are presented in plastic bottles 5 ,10 ml colorless transparent solution.
One ampoule of this medicine contains 1-2 ml clear solution, which is often colorless, but may be slightly yellowish. One box include 5 or 10 ampoules.
Main component any form of the drug is represented by dexamethasone in the form of sodium phosphate. This compound is contained in 1 ml of injection solution at a dose of 4 mg, and in one tablet - in the amount of 500 mcg (0.5 mg). The concentration of such a substance in eye drops is 0.1%, which corresponds to 1 mg per 1 ml of solution.
In addition to the active compound, the injection solution contains sterile water, sodium hydrogen phosphate, disodium edetate and glycerol. The eye drops include additional ingredients such as benzalkonium chloride, disodium edetate, water, sodium tetraborate decahydrate, and boric acid. Auxiliary additives in tablet form are lactose, corn starch, colloidal silicon dioxide, povidone, talc and magnesium stearate.
Dexamethasone injections intramuscularly or intravenously are prescribed in acute cases or in situations where oral administration is not possible. In other cases, a tablet form is used.
The drug is effective:
The injectable form can also be used topically, for example, injected into a soft tissue lesion, into a joint, or into the tissues of the eyes. For an emergency decrease in body temperature, a lytic mixture with "Dexamethasone", whose components are "Analgin" And "Dimedrol".
Eye drops are used for keratitis, conjunctivitis, iritis, uveitis and other diseases of the organ of vision. Inhalations with "Dexamethasone" are prescribed by doctors for obstructive bronchitis, barking cough, false croup (stenosis of the larynx). The drug is poured into the nebulizer along with saline and the procedure is carried out for 5-10 minutes.
If there are serious indications for the use of Dexamethasone, such a medication can be prescribed at any age, even for a 10-month-old or one-year-old child. At the same time, treatment with such a hormonal agent should only be under medical supervision (both children under one year old and an older child). It is unacceptable to give the drug to children without a doctor's prescription.
Any form of "Dexamethasone" is not used for hypersensitivity to substances in its composition. The drug is contraindicated in acute viral, fungal or bacterial infection. Eye drops should not be used if the integrity of the cornea is damaged.
Injections and tablets are not prescribed for vaccination (when using live vaccines) and for Itsenko-Cushing's syndrome. Injections are prohibited in case of serious problems with hemostasis, and tablets due to the lactose content are not prescribed for violations of carbohydrate metabolism.
Caution in prescribing the drug is required by patients with arterial hypertension, tuberculosis, kidney failure, epilepsy, peptic ulcer, hypothyroidism, liver failure and some other pathologies. If a child has any chronic illness, the question of the appointment of "Dexamethasone" should be decided by a specialist on an individual basis.
Dexamethasone treatment can provoke:
In addition, a local reaction to the medicine may occur - for example, a burning sensation during an injection or redness of the skin after an injection. If you cancel the drug abruptly, this will lead to the development of a withdrawal syndrome, manifested by a decrease in blood pressure, nausea, headache and other negative symptoms.