Dexazon
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
Dexazone - synthetic GCS (glucocorticosteroid); has immunosuppressive, anti-inflammatory, antitoxic, desensitizing and anti-shock effects.
Release form and composition
Dexazon is available in the following forms:
- tablets of 0.5 mg: flat, round, almost white or white, with a line only on one side [50 tablets each in polypropylene bottles with polyethylene stoppers, 1 bottle each with instructions for use in a cardboard box; 5 blisters (10 tablets in a blister) together with instructions for use in a carton box];
- solution for intramuscular or intravenous administration: transparent, colorless (in 1 ml glass ampoules).
1 tablet contains:
- active substance: dexamethasone - 0.5 mg;
- excipients: magnesium stearate, lactose, glucose, starch.
The composition of 1 ml of solution includes:
- active substance: sodium phosphate dexamethasone - 4 mg;
- excipients: sodium edetate, glycerol, phosphoric acid, sodium hydroxide, propyl hydroxide benzoate, methyl hydroxide benzoate, water for injection.
Indications for use
For both dosage forms of Dexazone:
- primary and secondary adrenal insufficiency (in combination with mineralocorticoids);
- diagnostic study of adrenal hyperfunction;
- connective tissue diseases (scleroderma, systemic lupus erythematosus);
- severe bronchospasm (exacerbation of chronic obstructive bronchitis or bronchial asthma), asthmatic status.
For tablets additionally:
- adrenogenital syndrome;
- subacute thyroiditis;
- hypercalcemia in malignant neoplasms;
- skin diseases (eczema, pemphigus, dermatitis, fungal mycosis, psoriasis, acute erythroderma);
- rheumatoid arthritis in the acute phase;
- nonspecific ulcerative colitis;
- hemoblastosis (acute / chronic leukemia);
- thrombocytopenia, autoimmune hemolytic anemia, agranulocytosis, aplasia and hypoplasia of hematopoiesis.
For the solution additionally (the drug is prescribed for diseases in which the introduction of a fast-acting glucocorticosteroid is necessary, including when oral administration of the medication is not possible):
- severe allergic reactions;
- endocrine diseases: congenital hyperplasia of the adrenal cortex, acute insufficiency of the adrenal cortex, subacute thyroiditis;
- shock resistant to standard therapy, anaphylactic shock;
- edema of the brain (with traumatic brain injury, brain tumor, neurosurgical intervention, cerebral hemorrhage, radiation injury, encephalitis, meningitis);
- acute severe dermatoses;
- rheumatic diseases;
- malignant diseases: palliative treatment of lymphoma and leukemia in adults, acute leukemia in children, hypercalcemia in patients with malignant tumors, in the absence of the possibility of oral treatment;
- blood diseases: acute hemolytic anemia, agranulocytosis, idiopathic thrombocytopenic purpura in adults;
- severe infectious diseases (in combination with antibiotics);
- in ophthalmic practice (retrobulbar, subconjunctival or parabulbar treatment): keratoconjunctivitis without damage to the epithelium, iritis, allergic conjunctivitis, keratitis, iridocyclitis, blepharitis, blepharoconjunctivitis, scleritis, ocular episclanitis, ocular inflammation, and ophthalmic surgery cornea;
- intra-articular and intra-synovial administration: arthritis of various etiologies, osteoarthritis, acute and subacute bursitis, acute tendovaginitis, epicondylitis, synovitis;
- local application (in the field of pathological education): annular granuloma, keloids.
Contraindications
For both dosage forms of Dexazone:
- hypersensitivity to drug components;
- osteoporosis;
- systemic mycoses;
- lymphadenitis (including after BCG vaccination).
For tablets additionally:
- peptic ulcer of the stomach and duodenum;
- severe arterial hypertension;
- renal failure;
- obesity of III-IV degree;
- active form of tuberculosis;
- acute viral infections;
- acute psychoses;
- period 2 months before and within 2 weeks after prophylactic immunization.
For mortar additionally:
- severe myopathies (with the exception of myasthenia gravis);
- viral infections, poliomyelitis (not including bulbar-encephalic form);
- idiopathic thrombocytopenic purpura;
- infectious lesions of periarticular tissues and joints.
Method of administration and dosage
Dexazone in the form of tablets is taken with or after meals one time in the morning (small dose) or in 2-3 doses (large dose). For adults, the average daily dose is 2 to 6 mg. The maximum daily dose is 10-15 mg. After obtaining a general therapeutic effect, the dose is systematically reduced (usually by 0.5 mg every 3 days) to a maintenance dose of 2–4.5 mg / day or more. The minimum effective dose is 0.5–1 mg / day.
Children are prescribed 0.0833-0.3333 mg / kg or 0.0025-0.01 mg / m 2 per day in 3-4 doses, choosing the dose individually depending on age.
The duration of taking Dexazone depends on the form of the pathological process and the productivity of the treatment and ranges from several days to several months or more. Treatment is stopped gradually.
When using Dexazon for intravenous and intramuscular administration, the drug is injected slowly drip or jet (in case of urgent and acute conditions); intra-synovial, intra-articular and local administration is also possible. The daily dose is from 4 to 20 mg of Dexazone 3-4 times. The period of parenteral administration usually lasts 3-4 days, then a transition to maintenance therapy with the oral form is possible.
When the result is achieved, the dose is reduced or the treatment is gradually stopped. The dosing system is selected individually and depends on the patient's condition, his indications and his response to therapy.
Side effects
For both dosage forms:
- metabolism: water and sodium retention in the body;
- cardiovascular system: high risk of thrombus formation, arterial hypertension;
- musculoskeletal system: steroid myopathy, osteoporosis, aseptic necrosis of the femoral head and humerus;
- digestive system: erosive and ulcerative lesions of the gastrointestinal tract (which can cause perforation and bleeding);
- nervous system: dizziness, headaches, mental disorders, insomnia, convulsions, increased intracranial pressure;
- endocrine system: menstrual irregularities, Cushing's syndrome, growth retardation in children, hyperglycemia up to the development of steroid diabetes mellitus, increased need for insulin or oral hypoglycemic agents in diabetic patients, adrenal insufficiency (most often during stress, trauma, surgery, concomitant diseases);
- organ of vision: posterior subcapsular cataract, increased intraocular pressure, exophthalmos;
- dermatological reactions: thinning and fragility of the skin, petechiae and subcutaneous hemorrhages, ecchymosis, striae, steroid acne, delayed wound healing, increased sweating.
For tablets additionally:
- hepatomegaly;
- hyperlipoproteinemia;
- catabolic effect on protein metabolism (negative nitrogen balance);
- more frequent occurrence of infections and aggravation of the severity of their course.
For mortar additionally:
- metabolism: hypokalemia, hypokalemic alkalosis, negative nitrogen balance caused by increased protein catabolism;
- cardiovascular system: congestive heart failure in patients with heart disease;
- musculoskeletal system: muscle weakness, decreased muscle mass, compression fractures of the vertebrae, pathological fractures of long bones;
- nervous system: false symptoms of a brain tumor;
- organ of vision: exophthalmos, posterior subcapsular cataract, increased intraocular pressure;
- allergic reactions;
- local reactions (at the injection site): atrophy of the subcutaneous tissue and skin, aseptic abscess, hyperpigmentation and leukoderma, hyperemia at the injection site, arthropathy.
special instructions
With daily use of Dexazone by the 5th month of treatment, adrenal cortex failure is possible.
With a sharp withdrawal of the medication, especially if the drug was previously used in high doses, a withdrawal syndrome may occur, accompanied by the following symptoms: nausea, weakness, anorexia, lethargy, generalized musculoskeletal pain. After discontinuation of the drug for several months, conditional adrenal insufficiency may remain. If during this time stressful situations arise, it is required to prescribe (according to the testimony of a specialist) glucocorticoids, if necessary, in combination with mineralocorticoids.
For intercurrent infections, tuberculosis and septic conditions, treatment should be carried out with the necessary antibiotics. The drug can mask some of the symptoms of the infection.
In the case of prolonged use of the drug in children, careful monitoring of their development and growth dynamics is necessary.
Children in contact with patients with chickenpox or measles are prescribed immunoglobulins for prophylaxis.
During the period of long-term treatment with Dexazone, it is necessary to carry out tests of peripheral blood and glycemic levels, as well as observation of an ophthalmologist, control of water and electrolyte balance and blood pressure (BP).
In patients with cirrhosis of the liver and hypothyroidism, an increase in the effect of the drug is noted.
Taking Dexazon during pregnancy (especially in the first trimester) is possible only for health reasons. With prolonged therapy during pregnancy, the possibility of impaired fetal growth is permissible. When taking the drug at the end of pregnancy, there is a risk of atrophy of the adrenal cortex in the fetus, which may require glucocorticoid replacement therapy in the newborn. While taking Dexazone, breastfeeding should be stopped.
Drug interactions
For both dosage forms:
- hormonal contraceptives - an increase in the effect of Dexazone is possible;
- diuretics - an increase in the excretion of potassium from the body is possible;
- rifampicin, barbiturates, phenytoin - presumably can weaken the effect of Dexazone;
- coumarin derivatives - there is a weakening of the anticoagulant effect (an adjustment of their dose is required);
- cardiac glycosides - the likelihood of cardiac arrhythmias increases (due to impaired tolerance of the latter due to potassium deficiency);
- non-steroidal anti-inflammatory drugs (NSAIDs) - Dexazone increases the side effect on the gastrointestinal tract (increased risk of bleeding and erosive and ulcerative lesions), and also reduces the concentration of NSAIDs in the blood serum and, accordingly, their effect.
Additionally for tablets: when combined with antidiabetic drugs, the development of hyperglycemia and a decrease in their hypoglycemic activity are observed; when taken simultaneously with acetylsalicylates, a decrease in the level of salicylates in the blood is possible; when combined with praziquantel, a decrease in its concentration in the blood is noted.
Analogs
Dexamethasone analogs are: Dexamed, Dexamethasone, Dexamethasone-Betalek, Dexamethasone-Vial, Dexamethasone-LENS, Dexamethasone-MEZ, Dexamethasone-Ferein, Dexamethasonlong, Dexapos, Maxidex, Megadexan, Ozurdexan Ozurdexan.
Terms and conditions of storage
Store in a dry, dark place at a temperature not exceeding 25 ° C. Keep out of reach of children.
The shelf life of the solution is 3 years.
The shelf life of the tablets is 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!
