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Dexamethasone 4 mg / ml 25’s solution for injection in ampoules




The instruction for medical use of medicine Dexamethasone the Trade name Dexamethasone the International unlicensed name Dexamethasone Dosage Form Solution for injections, 4 mg/ml Structure One ampoule contains active agent – dexamethasone of sodium of phosphate of 4.37 mg (it is equivalent to dexamethasone of phosphate of 4.00 mg), excipients: glycerin, dinatrium edetat, sodium hydrophosphate a dihydrate, water for injections. The description Transparent, from colourless till light yellow color solution Pharmacotherapeutic group Corticosteroids for system use. Glucocorticosteroids. Dexamethasone. The ATX H02AB02 code the Pharmacological Pharmacokinetics Later properties of intravenous administration drug begins to work quickly, and after intramuscular introduction the clinical effect is reached in 8 hours. Effect of drug prolonged also continues from 17 to 28 days after intramuscular introduction and from 3 days to 3 weeks after local use (to the area of defeat). The dose of dexamethasone of 0.75 mg is equivalent to a dose of 4 mg of Methylprednisolonum and Triamcinolonum, 5 mg of Prednisonum and Prednisolonum, 20 mg of a hydrocortisone and 25 mg of a cortisone. In blood plasma about 77% of dexamethasone contact blood plasma proteins, and in the majority will be transformed to albumine. Only the minimum quantity of dexamethasone contacts not albumin proteins. Dexamethasone is fat-soluble connection. Drug is originally metabolized in a liver. Small amounts of dexamethasone it is metabolized in kidneys and other bodies. The prevailing removal happens through urine. Elimination half-life (T12) makes about 190 min. The pharmacodynamics Dexamethasone is synthetic adrenal hormone (corticosteroid) with glucocorticoid action. Drug renders expressed the anti-inflammatory, antiallergic and desensibilizing action, has immunosuppressive activity. Enough data on the mechanism of action of glucocorticoids are so far saved up to provide as they act on cellular level. There are two accurately certain systems of receptors found in cytoplasm of cells. By means of glucocorticoid receptors, corticosteroids render anti-inflammatory and immunosuppressive effects and regulate a glucose homeostasis, by means of mineralokortikoidny receptors they regulate metabolism of sodium and potassium and also water and electrolytic balance. Indications Dexamethasone is entered intravenously or intramusculary in sharp cases or at impossibility of performing oral therapy: replacement therapy of primary and secondary (hypophysial) adrenal insufficiency congenital adrenal hyperplasia a subacute thyroiditis and severe forms of a postbeam thyroiditis rheumatic fever an acute rheumatic carditis a bladderwort, psoriasis, dermatitis (contact dermatitis with defeat of a big surface of skin, atopic, exfoliative, violent herpetiform, seborrheal, etc.), eczema a toxidermia, a toxic epidermal necrolysis (Lyell’s disease) a malignant exudative erythema (Stephens-Johnson’s syndrome) allergic reactions to HP and foodstuff a serum disease, a medicinal dieback urticaria, a Quincke’s disease allergic rhinitis, the disease pollinosis menacing with loss of sight (acute central chorioretinitis, inflammation of an optic nerve) allergic states (conjunctivitis, a uveitis, a sclerite, a keratitis, iriit) general immune diseases (a sarcoidosis, temporal arteritis) proliferative change in an orbit (an endocrine ophthalmopathy, pseudoneoplasms) a sympathetic ophthalmia immunosuppressive therapy at transplantation of a cornea Drug is used systemically or locally (in the form of subconjunctival, retrobulbar or parabulbar injections): ulcer colitis Crohn’s disease local enteritis sarcoidosis (symptomatic) acute toxic bronchiolitis chronic bronchitis and asthma (aggravations) agranulocytosis, panmyelopathia, anemia (including. autoimmune hemolytic, inborn hypoplastic, an eritroblastopeniya) an idiopathic Werlhof’s disease secondary thrombocytopenia at adults, a lymphoma (hodzhkinsky, nekhodzhkinsky) leukemia, a lymphoid leukosis (sharp, chronic) diseases of kidneys of autoimmune genesis (including an acute glomerulonephritis) a nephrotic syndrome palliative therapy of leukemia and a lymphoma at adults acute leukemia at children a hypercalcemia at malignant new growths brain hypostasis owing to primary tumors or metastases in a brain, owing to craniotomy or injuries of the head. Shock of various genesis the shock which is not responding to standard therapy shock at patients with nadpochechkovy insufficiency an acute anaphylaxis (intravenously, after administration of adrenaline) Other indications of the Indication for intra articulate administration of dexamethasone or introduction to soft tissues: a pseudorheumatism (heavy inflammation in a separate joint) an ankylosing spondylitis (when the inflamed joints do not otechat on standard therapy) psoriasis arthritis (oligoartikulyarny defeat and tendosinoviita) monoarthritis (after removal of intra articulate liquid) osteoarthrites (only in the presence of exudate and the sinoviit) extraarticular rheumatism (epicondylitis, tendosinoviita, a bursitis) Local introduction (injections in the defeat center): the hypertrophic, inflamed and infiltrirovanny centers depriving keloids, psoriasis, a ring-shaped granuloma, a sclerosing folliculitis, a diskoidny lupus and a skin sarcoidosis the localized alopecia the Route of administration and doses of the Dose are established individually for each patient depending on the nature of a disease expected duration of treatment, shipping of corticosteroids and reaction of the patient to the carried-out therapy. Parenteral use Solution for injections is entered intravenously or intramusculary and also in the form of intravenous injections (with glucose or normal saline solution). The recommended average initial daily dose at intravenous or intramuscular administration varies from 0.5 mg to 9 mg and if it is necessary, more. The initial dose of dexamethasone needs to be applied until the clinical effect is reached, then the dose gradually decreases to minimum effective. During the day it is possible to enter from 4 to 20 mg of Dexamethasone 3-4 times. Duration of parenteral administration usually is 3-4 days, then pass to maintenance therapy with an oral form of drug. The Recommended single dose of dexamethasone for intra articulate introduction makes local introduction from 0.4 mg to 4 mg. Intra articulate introduction can be repeated in 3-4 months. The injection in the same joint can carry out only 3-4 times to lives, and it is impossible to make injections more than in two joints at the same time. More frequent administration of dexamethasone can lead to injury of an intra articulate cartilage and necrosis of a bone. The dose depends on the size of the affected joint. The usual dose of dexamethasone makes from 2 mg to 4 mg for large joints and from 0.8 mg to 1 mg for small joints. The usual dose of dexamethasone for introduction in an articulate bag makes from 2 mg to 3 mg, for introduction to a sinew vagina – from 0.4 mg do1 mg, and for sinews – from 1 mg to 2 mg. At introduction to the limited centers of defeats the same doses of dexamethasone, as for intra articulate introduction are used. The drug can be administered at the same time, at most, in two centers. The recommended dexamethasone dose at inflammation of soft tissues (periartikulyarny introduction) makes from 2 mg to 6 mg. Dosing at children At intramuscular introduction the dose for replacement therapy makes 0.02 mg/kg of body weight or 0.67 mg/sq.m of surface area of a body which divide into 3 injections at an interval of the 2nd day, or from 0.008 mg to 0.01 mg/kg of body weight or from 0.2 mg to 0.3mg/sq.m body surface areas daily. For other indications the recommended dose makes from 0.02 mg to 0.1 mg/kg of body weight or from 0.8 mg to 5 mg/sq.m of surface area of a body, each 12-24 hours. Side effects decrease in tolerance to glucose, ‘steroid’ diabetes or a demonstration of latent diabetes an Icenco-Cushing syndrome, increase in body weight a hiccups, nausea, vomiting, increase or a loss of appetite, a meteorism, increase in activity of ‘hepatic’ transaminases and alkaline phosphatase, pancreatitis ‘steroid’ ulcer of stomach and duodenum, erosive zofagit, bleedings and perforation of digestive tract of arrhythmia, bradycardia (up to cardiac arrest), development (at predisposed patients) or strengthening of severity of chronic heart failure, increase in arterial blood pressure hypercoagulation, thrombosis a delirium, a disorientation, euphoria, hallucinations, maniacal depressive psychosis, a depression, paranoia increase in intracranial pressure, nervousness, concern, insomnia, a headache, dizziness, spasms, vertigo a cerebellum pseudoneoplasm sudden loss of sight (at parenteral administration the adjournment of crystals of drug in eye vessels), a back subkapsulyarny cataract, increase in intraocular pressure with potential damage of an optic nerve is possible, trophic changes of a cornea, an exophthalmos, development of consecutive bacterial, fungal or viral infections of eyes negative nitrogenous balance (the increased disintegration of proteins), a giperlipoproteinemiya the increased sweating a delay of liquid and sodium (peripheral swell), a giperkiliyemichesky syndrome (hypopotassemia, arrhythmia, myalgia or a spasm of muscles, unusual weakness and fatigue) delay of growth and processes of ossification at children (premature closing of epiphyseal regions of growth) the increased calcium removal, osteoporosis, pathological bone fractures, aseptic necrosis of a head humeral and a femur, a rupture of sinews a ‘steroid’ myopathy, an atrophy of muscles the slowed-down healing of wounds, tendency to development of a pyoderma and candidiases of a petechia, ecchymomas, thinning of skin, hyper – or hypopigmentation, steroid eels, striya generalized and local allergic reactions decrease in immunity, development or exacerbation of infections a leukocyturia disturbance of secretion of sex hormones (disturbance of a menstrual cycle, a hirsutism, impotence, a delay of sexual development at children a syndrome of ‘cancellation’ burning, numbness, pain, paresthesias and infections, necrosis of surrounding fabrics, formation of hems in the place of an injection, an atrophy of skin and hypodermic cellulose at intramuscular introduction (introduction to a deltoid muscle is especially dangerous), of arrhythmia, ‘inflows’ of blood to the person, spasms (at intravenous administration), collapse (at fast introduction of high doses) Contraindications hypersensitivity to active agent or auxiliary components of drug a peptic ulcer of a stomach and duodenum osteoporosis acute viral, bacterial and system fungal infections (when the corresponding therapy is not performed) Cushing’s syndrome pregnancy and the period of a lactation a renal failure cirrhosis or chronic hepatitis acute psychoses intramuscular introduction is contraindicated to patients with heavy disturbances of a hemostasis (idiopathic Werlhof’s disease) for use in ophthalmologic practice: viral and fungus diseases of eyes acute form of a purulent eye infection in the absence of specific therapy, the cornea diseases which are combined with defects of an epithelium, trachoma, glaucoma the active form of tuberculosis Medicinal interactions Efficiency of dexamethasone decreases at a concomitant use of rifampicin, carbamazepine, Phenobarbitonum, Phenytoinum (diphenylhydantoin), Primidonum, ephedrine or aminoglutethimide. Dexamethasone reduces therapeutic effect of gipoglikemiziruyushchy drugs, antihypertensives, a prazikvantel and natriuretics, dexamethasone increases activity of heparin, an albendazol and kaliyuretik. Dexamethasone can change effect of anticoagulative drugs of a coumarinic row. Simultaneous use of dexamethasone and high doses of glucocorticoids or 2 receptors agonists increases risk of development of a hypopotassemia. Higher aritmogennost and toxicity of cardiac glycosides is noted at the patients suffering from a hypopotassemia. At simultaneous use of oral contraceptives the elimination half-life of glucocorticoids can increase that leads to strengthening of their action and increase in amount of side effects. Contraindicated simultaneous use of Ritodrinum and dexamethasone during patrimonial activity as it can lead to death of mother because of a fluid lungs. Co-administration of dexamethasone and Metoclopramidum, a difengidramin, prochlorperazine or antagonists of 5-HT3 receptors (serotoninovy or 5th hydroksitriptaminovy receptors 3 types), such as ondansetron or granisetron, it is effective for the prevention of nausea and vomiting caused by chemotherapy using Cisplatinum, cyclophosphamide, a methotrexate, a ftorouratsil. The special instructions Use in pediatrics At children during long-term treatment it is necessary to watch dynamics of growth and development carefully. At children during a growth period the glucocorticosteroids have to be applied only according to vital indications and under especially careful observation of the doctor. For prevention of disturbance of processes of growth at long drug treatment of children aged up to 14 years it is desirable to take every 3 day a 4-day break in treatment. To the children, during treatment who are in contact with patients with measles, chicken pox appoint specific immunoglobulins. In diabetes, tuberculosis, bacterial and amoebic dysentery, arterial hypertension, tromboemboliya, a heart and renal failure, nonspecific ulcer colitis, a diverticulitis, recently formed anastomosis of intestines it is necessary to apply Dexamethasone very carefully and on condition of a possibility of adequate treatment of a basic disease. If the patient in the anamnesis had psychoses, then treatment by glucocorticosteroids is carried out only according to vital indications. At sudden drug withdrawal, especially in case of use of high doses, arises, a withdrawal of glucocorticosteroids: anorexia, nausea, block, generalized musculoskeletal pains, general weakness. After drug withdrawal for several months the relative insufficiency of bark of adrenal glands can remain. If during this period there are stressful situations, appoint temporarily glucocorticoids, and if necessary – mineralokortikoida. Before use of drug it is desirable to perform examination of the patient on presence of ulcer pathology of digestive tract. Patients with predisposition to development of this pathology need to appoint antiacid means with the preventive purpose. During drug treatment the patient has to adhere to the diet rich with potassium, proteins, vitamins, with the reduced content of fats, carbohydrates and sodium. In the presence at the patient of intercurrent infections, a septic state the treatment by Dexamethasone needs to be combined with antibacterial therapy. If treatment by Dexamethasone is performed for 8 weeks to and 2 weeks after active immunization (vaccination), then in this case the effect of immunization will be reduced or completely neutralized. Patients with severe craniocereberal injuries and disturbance of cerebral circulation on ischemic type need to appoint glucocorticoids with care. Features of influence on ability to run the vehicle or potentially dangerous mechanisms As Dexamethasone can cause dizziness and a headache, during the driving of motor transport or work with other mechanisms it is recommended to refrain from driving of the car and control of other potentially dangerous mechanisms. Overdose Symptoms: aggravation of side effects is possible. Treatment: it is necessary to cancel and appoint symptomatic therapy. There is no specific antidote. After disappearance of symptoms of overdose the administration of drug is resumed. A form of release and packing On 1 ml in ampoules from dark glass with a white dot and a ring of green color for opening of ampoules. On an ampoule paste the self-adhesive label. On 5 ampoules place in blister strip packaging from a film of polyvinylchloride and aluminum foil. On 5 planimetric packs together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions at a temperature not above 25 °C. X
to anit out of children’s reach! Not to apply a period of storage of 5 years after an expiration date. Prescription status According to the prescription the Producer of KRK, of. The place is new, Slovenia Shmaryeshka 6, 8501 the place, Slovenia the Owner of the registration certificate of KRK, of Is new. The place is new, Slovenia the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) and responsible for post-registration observation of safety of medicine of KRKA Kazakhstan LLP, RK, 050059, Almaty, Al-Farabi Ave. 19, body 1b, the 2nd floor, the 207th office
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