Shock states (post-traumatic, postoperative, cardiogenic, anaphylactic shock). Swelling of the larynx and vocal cords. acute allergic reactions. Severe bronchial spastic states (asthmatic condition, bronchial asthma in the course of infection, chronic bronchitis). After strumectomy (prophylactic, treatment of complications). Breakthroughs in Addison's disease. Due to the serious complications and side effects of chronic extramarital corticotherapy, the decision to undertake such treatment should always be considered taking into account both the possible benefits for the patient and the potential risks.
Composition:
1 ml contains 4 mg Dexamethasone phosphate in the form of a sodium salt. The product contains sodium sulfite.
Action:
Synthetic glucocorticosteroid with very strong and long-lasting anti-inflammatory, antiallergic and immunosuppressive activity, practically does not show mineralocorticoid activity. By inhibiting the phospholipase A2 activity, it prevents the release of arachidonic acid, which slows the synthesis of leukotrienes and prostaglandins. It reduces the number of lymphocytes, monocytes and eosinophils. It blocks the secretion of histamine-dependent IgE. It inhibits the synthesis and release of cytokines: Interferon g, TNF-α and GMF-CSF, IL-1, -2, -3, -6 interleukin. It blocks the secretion of ACTH by the pituitary gland, which leads to the development of adrenocortical insufficiency. Dexamethasone inhibits the action of hyaluronidase, reduces capillary permeability and reduces swelling; increases blood glucose; it accelerates the breakdown and inhibits protein synthesis and weakens the body's resistance to infection. It intensifies Calcium resorption from the bones, causes the development of osteoporosis. It reduces the absorption of calcium ions from the gastrointestinal tract while increasing the excretion of calcium in the urine; inhibits growth in children. After intravenous administration, the maximum concentration in blood reaches after 10-30 minutes, after intramuscular administration - within 60 minutes. The maximum concentration in the cerebrospinal fluid, corresponding to 1/6 of the serum concentration, is achieved in 4 h after intravenous administration. T0,5 in the serum is 2.2-3.8 h. In blood, dexamethasone combines with specific proteins that condition the transport of adrenocortical hormones. It is metabolised mainly in the liver and excreted in the majority with bile. It is excreted in 2.6% of the kidneys in an unchanged form. Dekasamethasone passes through the placenta and is excreted in human milk.
Contraindications:
In ACUTE, life-threatening conditions, there are no contraindications, especially if the preparation is intended for a short time (24-36 h). In other cases, contraindications are hypersensitivity to the active substance, other corticosteroids or to any of the excipients, systemic mycoses. Intramuscular injection should not be used in patients with ITP.
Precautions:
During the period of glucocorticoid administration, no vaccination should be carried out because immune responses are weakened and the production of antibodies may be impaired. Particular caution and frequent clinical control of the health condition is required in patients with: purulent infection, active or latent peptic ulcer, osteoporosis (especially in postmenopausal women), hypertension, congestive heart failure, diabetes, ongoing or severe manic depressive psychosis ( especially with post-traumatic psychosis), tuberculosis, glaucoma (also if the disease is in the family), liver damage or cirrhosis, kidney failure, epilepsy, gastrointestinal ulceration, fresh intestinal anastomosis, predisposition to thrombophlebitis, ulcerative colitis , diverticulitis, myasthenia gravis, herpes of the eye threatening corneal perforation, hypothyroidism. The product contains sodium sulfite, which can rarely cause severe hypersensitivity reactions and bronchospasm.
Pregnancy and lactation:
The preparation can be used during pregnancy only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.Newborns born to mothers who during pregnancy received significant doses of dexamethasone should be observed due to the risk of adrenal insufficiency. For breastfeeding mothers at high doses of Dexamethasone, it is recommended to stop breast-feeding during treatment.
Side effects:
The following may occur: sterile osteonecrosis of the femoral and humerus head, muscle weakness, posteroidal myopathy, loss of muscle mass, osteoporosis, spontaneous fractures including compression spinal fractures and pathological fractures of the long bones; vomiting, nausea, loss of appetite that can cause weight loss, increased appetite that can lead to weight gain, diarrhea, constipation, abdominal distension, stomach irritation and oesophagitis with ulcers, gastric ulcer with the possibility of perforation and bleeding, intestinal perforation thin and thick, especially in inflammatory bowel diseases; impaired wound healing, thinning of the skin, which becomes sensitive and susceptible to damage, ecchymosis and haemorrhages, erythema on the face, dermatoses, hirsutism, acne-like eruptions, decreased reactivity in skin tests, hypersensitivity reactions such as allergic dermatitis, urticaria, angioneurotic edema, parenteral administration causes hypo- and hyperpigmentation, scarring, hardening within the skin, reduced pain sensation, disappearance of the skin or subcutaneous tissue and abscesses at the injection site; convulsive seizures, neuritis, paresthesia, after discontinuation, there may be an increase in intraocular pressure with the congestive disc (the alleged brain tumor); menstrual disorders, symptoms of Cushing's syndrome, inhibition of growth in children, secondary suppression of pituitary-adrenal axis function, reduction of carbohydrate tolerance, latent diabetes mellitus and increased insulin requirements or oral antidiabetic agents in diabetic patients; increased intraocular pressure, secondary glaucoma, exophthalmos, optic nerve damage, subcapsular cataract of the posterior part of the lens; negative nitrogen balance due to increased catabolism of proteins, sodium retention, fluid retention, potassium loss, hypokalemic alkalosis, hypocalcaemia; pain and dizziness, hallucinations, psychosis, euphoria, mood changes, symptoms of an alleged brain tumor caused by increased intracranial pressure and the occurrence of congestive disc; thrombus with emboli, fat embolism, hypercholesterolemia, accelerated atherosclerosis, thrombophlebitis; arrhythmias or ECG changes associated with potassium deficiency, fainting, increased hypertension, heart failure as a consequence of a recent myocardial infarction, reports of sudden cardiac arrest, hypotension; leukocytosis, thrombocytopenia, lymphopenia; severity or masking of symptoms of infection, insomnia, anaphylactic reactions, burning and tingling that may occur after intravenous administration of the drug. The withdrawal syndrome occurs after a rapid discontinuation after prolonged use. It is caused by acute adrenal insufficiency and may be life-threatening. The withdrawal syndrome may also include fever, muscle pain, arthralgia, rhinitis, conjunctivitis, painful skin nodules and weight loss.
Dosage:
Dosage should be individualized depending on the indications, the patient's condition and its response to treatment. Apply 4-16 mg / day, exceptionally up to 32 mg / day. Usually, a single dose is 4-8 mg. The dose can be repeated if necessary at appropriate intervals, several times a day. Usually, the starting doses are higher and, after obtaining the desired therapeutic effect, they are reduced until the lowest dose is set, which allows maintaining a beneficial therapeutic effect, or until the preparation is discontinued. Stressful situations of the patient may result in the need to increase the dosage. After prolonged use, the preparation should be withdrawn slowly. Elderly use does not require special dosing; however, when choosing a dose, account should be taken of the greater susceptibility of this group of patients to the occurrence of side effects. The preparation may be administered by intravenous or intramuscular injection or by drip infusion. Strict adherence to the aseptic administration technique is mandatory. The intramuscular administration should be deep, to a large muscle mass.Immediately prior to administration, the content of the ampoule is diluted with an isotonic sodium chloride solution or a 5% Glucose solution.