Dexamethasone (When ATH H02AB02)

When ATH:
H02AB02

Characteristic.

Hormonal agents (glucocorticoid for systemic and topical). Ftorirovannyi homologous gidrokortizona.

Dexamethasone - white or almost white crystalline odorless powder. Solubility in water (25 °C): 10 mg / 100ml; soluble in acetone, ethanol, xloroforme. Molecular weight 392,47.

Dexamethasone sodium phosphate - a white or slightly yellow crystalline powder. The easily soluble in water and is highly hygroscopic. Molecular weight 516,41.

Pharmacological action.
Glucocorticoid, anti-inflammatory, antiallergic, protivoshokovoe, immunosuppressive.

Application.

For systemic use (parenterally and inwardly)

Shock (ambustial, anaphylactic, posttraumatic, postoperative, toxic, cardiogenic, transfusion and others.); cephaledema (incl. in tumors, traumatic brain injury, neurosurgery, a brain haemorrhage, éncefalite, meninges, radiation injury); bronchial asthma, asthmatic status; systemic connective tissue disease (incl. systemic lupus erythematosus, rheumatoid arthritis, scleroderma, periarteritis nodosa, dermatomyositis); thyrotoxic crisis; pechenochnaya coma; poisoning cauterizing liquids (to reduce inflammation and prevent scarring restrictions); acute and chronic inflammatory diseases of the joints, incl. podagricheskiy and psoriaticheskiy arthritis, osteoarthritis (incl. posttraumatic), polyarthritis, frozen shoulder, ankylosing spondylitis (ankylosing spondylitis), yuvenilynыy arthritis, Still's syndrome in adults, ʙursit, nonspecific tenosynovitis, synovitis, epicondylitis; rheumatic fever, Acute rheumatic heart disease; acute and chronic allergic diseases: allergies to drugs and food, serum sickness, hives, nasal allergy, pollen disease, angioedema, drug rash; skin diseases: pemphigus, psoriasis, dermatitis (contact dermatitis with lesions of the large surface of the skin, atopic, exfoliative, bullosa herpetiformis, seborrheic and others.), eczema, drug reaction, toxic epidermal necrolysis (Lyell's syndrome), malignant exudative erythema (Stevens-Johnson syndrome); ocular allergy: allergic corneal ulcers, allergic conjunctivitis form; inflammatory diseases of the eye: transferred ophtalmia, heavy sluggish front and posterior uveitis, optic neuritis; primary or secondary adrenal insufficiency (incl. condition after the removal of the adrenal glands); congenital adrenal hyperplasia; kidney disease of autoimmune origin (incl. acute glomerulonephritis), nephrotic syndrome; subacute thyroiditis; diseases of the blood: agranulocytosis, panmyelopathy, anemia (incl. autoimmune hemolytic, congenital hypoplastic, erythroblastopenia), idiopaticheskaya trombotsitopenicheskaya purpura, secondary thrombocytopenia in adults, lymphoma (Hodgkins, non-Hodgkin's), leukemia, Lymphocytic Leukemia (sharp, chronic); lung diseases: Acute alveolitis, fibrosis lyegkikh, sarcoidosis II-III st.; tuberculous meningitis, pulmonary tuberculosis, inhalation pneumonia (only in conjunction with specific therapy); berylliosis, Loffler's syndrome (resistant to other therapies); lung cancer (in combination with cytostatics); multiple sclerosis; gastrointestinal diseases (to remove the patient from the critical state): yazvennыy colitis, Crohn's disease, Local enteritis; hepatitis; prevention of graft rejection; tumor hypercalcemia, nausea and vomiting during cytostatic therapy; multiple myeloma; conduct tests in the differential diagnosis of hyperplasia (hyperfunction) and tumors of the adrenal cortex.

For topical application,

Vnutrisustavno, peryartykulyarno. Rheumatoid arthritis, psoriaticheskiy arthritis, ankylosing spondylitis, Reiter's disease, osteoarthritis (when there are significant signs of joint inflammation, synovitis).

Konъyunktyvalno. Conjunctivitis (purulent and allergic), keratit, keratokonъyunktyvyt (without damage to the epithelium), Irit, iridocyclitis, .Aloe, blefarokonъyunktyvyt, episcleritis, scleritis, uveitis of various origins, retinitis, optic neuritis, optic neuritis, corneal superficial injuries of different etiologies (after complete epithelialization of the cornea), inflammation after eye injuries and eye operations, transferred ophtalmia.

The external auditory meatus. Allergic and inflammatory diseases of the ear, incl. otitis.

Contraindications.

Hypersensitivity (for short-term use of the system for health is the only contraindication).

For systemic use (parenterally and inwardly). Systemic fungal infections, parasitic and infectious diseases of viral or bacterial origin (currently without appropriate chemotherapy or recently transferred, including the recent contact with a patient), incl. herpes simplex, herpes zoster (viremicheskaya phase), enable vetryanaya, kor, ameʙiaz, strongiloidoz (or suspected), active form of tuberculosis; immunodeficiency states (incl. AIDS or HIV infection), before and after preventive vaccinations (especially antiviral); systemic osteoporosis, myastenia gravis; gastrointestinal diseases (incl. gastric ulcer and duodenal ulcer, esophagitis, gastritis, acute or latent peptic ulcer, recently established intestinal anastomosis, ulcerative colitis with the threat of perforation or abscess, diverticulitis); diseases of the cardiovascular system, incl. recent myocardial infarction, congestive heart failure, arterial hypertension; diabetes, acute renal and / or hepatic insufficiency, psychosis.

For intraarticular administration. Unstable joints, previous arthroplasty, abnormal bleeding (endogenous or caused by the use of anticoagulants), chressustavnoy fracture, infected lesions of the joints, periarticular soft tissue intervertebral spaces, marked periarticular osteoporosis.

Ocular form. Viral, tuberculosis and fungal eye damage, incl. keratit, caused Herpes simplex, viral conjunctivitis, acute purulent eye infection (in the absence of antibiotic therapy), violation of the integrity of the corneal epithelium, trachoma, glaucoma.

Ear shapes. The perforation of the eardrum.

Restrictions apply.

For systemic use (parenterally and inwardly): pituitary basophilia, Obesity grade III-IV, convulsive status, hypoalbuminemia and condition, predisposing to its occurrence; otkrыtougolynaya glaucoma.

For intraarticular administration: general grave condition of the patient, inefficiency or short duration of the two previous administrations (taking into account the individual properties used glucocorticoids).

Pregnancy and breast-feeding.

The use of corticosteroids during pregnancy is possible, if the effect of therapy outweighs the potential risk to the fetus (adequate and well-controlled studies of the safety of not performed). Women of childbearing age should be warned about the potential risk to the fetus (Corticosteroids cross the placenta). It should be carefully monitored for newborns, whose mothers during pregnancy were treated with corticosteroids (adrenal insufficiency may develop in the fetus and newborn).

Dexamethasone shown to be teratogenic in mice and rabbits following topical ophthalmic applications of multiple therapeutic doses.

In the mouse, corticosteroids produce fetal resorption and specific violation - the development of cleft palate in the offspring. In rabbits, corticosteroids produce fetal resorption and multiple violations, incl. malformations of the head, ear, limbs, sky, etc..

Category actions result in FDA - C. (The study of reproduction in animals has revealed adverse effects on the fetus, and adequate and well-controlled studies in pregnant women have not held, However, the potential benefits, associated with drugs in pregnant, may justify its use, in spite of the possible risk.)

Nursing women should stop any breastfeeding, or use of drugs, especially in high doses (corticosteroids penetrate into breast milk and could suppress growth, production of endogenous corticosteroids and cause undesirable effects in the newborn).

It will be appreciated, that the local application of glucocorticoids systemic absorption occurs.

Side effects.

The frequency and severity of side effects depend on the duration of use, the value of the dosage used and the possibility of compliance circadian rhythm of destination PM.

Systemic effects

From the nervous system and sensory organs: delirium (confusion, excitation, anxiety), disorientation, euphoria, hallucinations, manic / depressive episode, depression or paranoia, increased intracranial pressure syndrome stagnant nipples optic nerve (pseudotumor of the brain — more often in children, usually after too rapid dose reduction, the symptoms — headache, deterioration of visual acuity or double vision); sleep disturbance, dizziness, vertigo, headache; sudden loss of vision (by parenteral administration in the head, Neck, turbinates, Scalp), posterior subcapsular cataract formation, increased intraocular pressure with possible damage to the optic nerve, glaucoma, steroid exophthalmos, the development of secondary fungal or viral eye infections.

Cardio-vascular system and blood (hematopoiesis, hemostasis): arterial hypertension, the development of chronic heart failure (in predisposed patients), miokardiodistrofija, hypercoagulation, thrombosis, ECG changes, typical of hypokalemia; when administered parenterally: flushing.

From the digestive tract: nausea, vomiting, erosive and ulcerative lesions of the gastrointestinal tract, pancreatitis, erosive esophagitis, Ikotech, increase / decrease of appetite.

Metabolism: delay Na⁺ and water (peripheral edema), kaliopenia, hypocalcemia, negative nitrogen balance due to protein catabolism, weight gain.

On the part of the endocrine system: inhibition of the function of the adrenal cortex, reduced glucose tolerance, steroid diabetes or a manifestation of latent diabetes mellitus, Cushing's syndrome, girsutizm, violation of the regularity of menstruation, growth retardation in children.

On the part of the musculoskeletal system: muscular weakness, steroidnaya myopathy, reduced muscle mass, osteoporosis (incl. spontaneous bone fractures, quiet hip disease), tendon rupture; pain in the muscles or joints, back; With intraarticular injection: strengthening joint pain.

For the skin: steroid acne, striae, thinning of the skin, petechiae and ecchymosis, delayed wound healing, increased perspiration.

Allergic reactions: skin rash, hives, swelling of the face, wheezing or shortness of breath, anaphylactic shock.

Other: decreased immunity and activation of infectious diseases, withdrawal (anorexia, nausea, lethargy, abdominal pain, general weakness, and others.).

Local reactions when administered parenterally: burning, numbness, pain, paresthesia, and infection at the injection site, scarring at the injection site; Hyper- or hypopigmentation; atrophy of the skin and subcutaneous tissue (when i / m administration).

Ocular form: prolonged use (more 3 Sun) may increase intraocular pressure and / or glaucoma with damage to the optic nerve, reduced visual acuity and visual field loss, posterior subcapsular cataract formation, thinning and perforation of the cornea; possible spread of herpes and bacterial infections; in patients with hypersensitivity to dexamethasone or benzalkonium chloride may develop conjunctivitis and blepharitis.

Local reactions (in applying eye and / or ear shapes): irritation, itching and burning of the skin; dermatitis.

Cooperation.

Reduce the therapeutic and toxic effects of barbiturates, phenytoin, rifampicin (accelerate metabolism), somatotropin, antacids (reduce the absorption of), increase - estrogensoderzhaschie oral contraceptives, the risk of arrhythmias and hypokalaemia - cardiac glycosides and diuretics, the likelihood of edema and hypertension - sodium-containing medications or supplements, severe hypokalaemia, cardiac insufficiency and osteoporosis - Amphotericin B and carbonic anhydrase inhibitors, the risk of erosive and ulcerative lesions and bleeding from the gastrointestinal tract - NSAIDs.

While the use of live virus vaccines, and in comparison with other types of immunization increases the risk of activation of viruses and development of infections. Weakens hypoglycemic activity of insulin and oral antidiabetic agents, antikoagulyantnuyu - coumarin, diuretic - diuretic, immunotropic - vaccination (suppresses antibody production). Tolerance worsens cardiac glycosides (cause potassium deficiency), It reduces the concentration of salicylate in the blood and praziquantel.

Overdose.

Symptoms: increased side effects.

Treatment: the development of adverse events - symptomatic therapy, the syndrome of Cushing - appointment aminoglutethimide.

Dosing and Administration.

Inside, parenterally, locally, incl. konъyunktyvalno. The mode set individually, depending on the evidence, the patient's condition and response to therapy.

Inside, single, morning (small dose) or 2-3 hours (a large dose): from 2-3 mg to 4-6 mg (10-15 Mg) per day, after reaching effect gradually reduce the dose to maintenance - 0.5-1 mg (2-4.5 Mg or more) per day; treatment should be stopped gradually (at the end of several injections administered corticotropin). Babies (depending on the age) - 0,0833-0,3333 mg / kg or 0,0025-0,0001 mg / m² per day in 3-4 divided doses.

Parenteral: I /, slow bolus or infusion (acute and urgent conditions) or / m 4-20 mg (to 80 mg) 3-4 Times daily, Maintenance doses - 0,2-9 mg per day, Course 3-4 days, then - Ingestion. Children - / m, 0,02776-0.16665 Mg / kg every 12-24 hours.

Vnutrisustavno (intralesional) or periarticular (soft tissue): adults and teenagers - 0.2-6 mg (2-8 Mg), repeatedly with an interval of 3 days before 3 weeks as needed; the maximum dose for adults - 80 mg per day.

Locally. When otitis: 3-4 drops in the affected ear 2-3 times per day.

Konъyunktyvalno: in acute conditions - 1-2 drops every 1-2 hours, then - after 4-6 hours; in other cases - 1-2 drops 3-4 times daily; course - from 1-2 days to a few weeks (2-5 Sun) depending on the condition.

Precautions.

Appointment in the case of intercurrent infections, TB, septic conditions requires pre- and post-simultaneous antibiotic therapy.

It is necessary to take into account the strengthening of the action of corticosteroids in hypothyroidism and liver cirrhosis, aggravation of psychotic symptoms and emotional lability at their highest baseline, camouflage some of the symptoms of infections, the probability of survival for several months (up to a year) Relative adrenal insufficiency after the abolition of dexamethasone (especially in case of prolonged use).

In stressful situations during maintenance treatment (such as surgery, disease, trauma) should be to adjust the dose of the drug due to the increased need for glucocorticoids.

In the long course closely monitor the dynamics of growth and development of children, systematically carried out ophthalmological examinations, monitor the status of hypothalamic-pituitary-adrenal axis, blood glucose.

In connection with the possibility of an anaphylactic reaction occurs during parenteral therapy before drug administration should take all precautions (especially in patients with a propensity for drug allergies).

Discontinue therapy only gradually. With the sudden cancellation after prolonged treatment may develop withdrawal, manifested by fever, myalgia and arthralgia, malaise. These symptoms may appear even in the case of, When not marked adrenal insufficiency.

It is recommended to be careful when carrying out any kind of operations, Emerging Infectious Diseases, injuries, Avoid Immunization, eliminate the use of alcoholic beverages. Children, avoid overdose, calculation of the dose to make better, on the basis of body surface area. In case of contact with patients with measles, chicken pox and other infections prescribe the appropriate preventive therapy.

Before using dexamethasone ophthalmic forms necessary to remove soft contact lenses (they can be re-set no earlier than 15 m). During treatment should monitor the status of the cornea and measure the intraocular pressure.

Should not be used during the drivers of vehicles and people, skills relate to the high concentration of attention.

Cooperation