Dexazone - instructions for use, dose, side effects, contraindications

Dexazone is a synthetic glucocorticosteroid, the molecule of which includes a fluorine atom. Has a pronounced anti-inflammatory, antiallergic and desensitizing effect, has immunosuppressive activity. Slightly retards sodium and water in the body. The main effect on the metabolism is associated with protein catabolism, increased gluconeogenesis in the liver and a decrease in the utilization of glucose by peripheral tissues.

Dexazone suppresses vitamin activity D, which leads to a decrease in calcium absorption and an increase in its excretion. Dexazone inhibits the synthesis and secretion of ACTH and, again, the synthesis of endogenous glucocorticosteroids.

A special feature of the drug is a significant inhibition of pituitary function and a complete absence of mineralocorticoid activity.

The activity of 0.5 mg dexamethasone corresponds to approximately 3.5 mg prednisone (or prednisolone), 15 mg hydrocortisone or 17.5 mg cortisone.

Pharmacokinetics:

After the introduction of the inside quickly and completely absorbed. Blood is bound (60-70%) with a specific transporter protein - transcortin. Easily passes through the histohematological barriers. Biotransformiruetsya in the liver (mainly by conjugation with glucuronic and sulfuric acids) to inactive metabolites. It is excreted in urine (a small part with lactating glands). The half-life is 36-54 hours.

Indications:

- Primary adrenal insufficiency (usually - in combination with mineralocorticoids);

- secondary adrenal insufficiency;

- adrenogenital syndrome;

- subacute thyroiditis;

- hypercalcemia in malignant neoplasms;

- bronchial asthma;

- Rheumatoid arthritis in the phase of exacerbation;

- connective tissue diseases (systemic lupus erythematosus, scleroderma, etc.);

- skin diseases (psoriasis, eczema, dermatitis, pemphigus, fungal mycosis, acute erythroderma, etc.);

- nonspecific ulcerative colitis;

- hemoblastoses (acute and chronic leukemia, lymphosarcoma, etc.);

- autoimmune hemolytic anemia, thrombocytopenia, aplasia and hypoplasia of hematopoiesis, agranulocytosis;

- Conducting a test in the differential diagnosis of hyperplasia (hyperfunction) and adrenal cortex tumors.

Contraindications:

- Hypersensitivity to dexamethasone;

- osteoporosis;

- peptic ulcer of the stomach and duodenum;

- severe arterial hypertension;

- kidney failure;

- obesity III-IV degree;

- active form of tuberculosis;

- systemic fungal infections;

- acute viral infections;

- lymphadenitis;

- acute psychosis;

- the period 8 weeks before and within 2 weeks after preventive immunization.

Carefully:

With caution, Dexazone should be used in patients with diabetes mellitus, mental illness, glaucoma, ulcerative colitis, with diverticulitis, newly created intestinal anastomosis, myasthenia gravis, arterial hypotension.

Pregnancy and lactation:

Dexazone during pregnancy, especially in the first trimester, can only be used for life indications. With prolonged therapy during pregnancy, the possibility of impaired fetal growth is not ruled out. In case of taking the drug at the end of pregnancy, there is a risk of atrophy of the adrenal cortex in the fetus, which may require replacement therapy with glucocorticoids in the newborn.

During the reception of Dexazone, breast-feeding should be discontinued.

Dosing and Administration:

Dexazone is prescribed inside during or after a meal, once in the morning (a small dose) or in 2-3 doses (a large dose). The average daily intake for adults ranges from 2-3 mg to 6 mg. The maximum daily dose is 10-15 mg. After reaching the therapeutic effect, the dose is gradually reduced (usually by 0.5 mg in 3 days) to the maintenance dose - 2-4.5 and more mg / day. The minimum effective dose is 0.5-1 mg / day.

Children prescribe 0,0833-0,3333 mg / kg or 0,0025-0,0001 mg / m² per day in 3-4 hours depending on the age.

The duration of the use of Dexazone depends on the nature of the pathological process and the effectiveness of the treatment and ranges from several days to several months or more. Treatment is stopped gradually.

Side effects:

With prolonged therapy with Dexazone, the following are possible:

- the Itenko-Cushing syndrome;

- erosive and ulcerative lesions of the stomach and duodenum;

- hepatomegaly;

- Hyperglycemia up to the development of steroid diabetes;

- hyperlipoproteinemia;

- arterial hypertension;

- increased intracranial pressure, dizziness, headache;

- convulsions;

- osteoporosis;

- atrophy of the adrenal cortex;

- increased risk of thrombosis;

- sodium retention in the body and development of edema;

- myopathy;

- insomnia, mental disorders;

- erythema of the face, thinning of the skin, striae, petechiae, ecchymosis;

- violation of the secretion of sex hormones (menstrual irregularities, hirsutism, impotence);

- growth retardation in children;

- in rare cases - aseptic necrosis of bones (head of the femoral and humerus bones);

- catabolic effect on protein metabolism (negative nitrogen balance);

- increased intraocular pressure, cataract;

- increased risk of developing pancreatitis in alcoholism;

- more frequent occurrence of infections and aggravation-severity of their course;

- slowing down the process of wound healing.

Overdose:

It is possible to enhance the described side effects. In this case, the dose of the drug should be reduced or temporarily canceled.Treatment is symptomatic.

Interaction:

With the simultaneous use of dexazone:

- With cardiac glycosides, the tolerance of the latter may be worsened due to potassium deficiency;

- with diuretics - potassium elimination may be increased;

- with antidiabetic drugs - a decrease in their hypoglycemic activity and the development of hyperglycemia are possible;

- with coumarin derivatives - weakening of anticoagulant action is possible;

- with rifampicin, phenytoin, barbiturates - possible weakening of the effect of Dexazone;

- With hormonal contraceptives - Dexazone action may be enhanced;

- with non-steroidal anti-inflammatory drugs - there may be an increased risk of erosive ulcerative lesions and bleeding from the gastrointestinal tract;

- with acetylsalicylates - the level of salicylates in the blood decreases;

- with prazikvantelom - it is possible to reduce its concentration in the blood.

Special instructions:

Applying Dexazone in intercurrent infections, septic state and tuberculosis, it is necessary to simultaneously treat with appropriate antibiotics. It should be remembered that the drug can mask some of the symptoms of infections.

With the daily use of Dexazone by the 5th month of treatment, development of atrophy of the adrenal cortex is possible.

With sudden withdrawal of the drug, especially in the case of the previous use of high doses, there is a so-called "withdrawal syndrome" (not caused by hypocorticism): anorexia, nausea, blocking, generalized musculo-skeletal pain, general weakness. After the drug is discontinued within a few months, the relative insufficiency of the adrenal cortex may remain. If stressful situations occur during this period, you should prescribe (for indications) for a time glucocorticoid, if necessary in combination with mineralocorticoids.

Children during prolonged treatment need careful monitoring of the dynamics of growth and development.

Children who were in contact with sick measles or chickenpox during the treatment period prophylactically prescribe specific immunoglobulins.

During the treatment with Dexazone (especially long) it is necessary to observe the oculist, control blood pressure and water-electrolyte balance, as well as patterns of peripheral blood and glycemia.

In order to reduce side effects, it is possible to prescribe anabolic steroids, antacids, and also increase the intake of potassium in the body (diet, potassium preparations). Food should be rich in potassium, proteins, vitamins, containing a small amount of fats, carbohydrates and salt.

Form release / dosage:

Tablets, 0.5 mg.

Packaging:

For 50 tablets in polypropylene bottles with polyethylene corks. One bottle with instructions for use is placed in a cardboard box.

10 tablets are placed in a blister. For 5 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N014411 / 01-2002

Date of registration:24.05.2010 / 18.05.2012

Expiration Date:Unlimited

The owner of the registration certificate:Galenika ad.Galenika ad. Serbia and Montenegro

Manufacturer: & nbsp

GALENIKA, a.d. Serbia and Montenegro

Representation: & nbspGALENIKA A.D.GALENIKA A.D.Russia

Information update date: & nbsp20.03.2017

Illustrated instructions

Instructions

Dexazone (Dexason)