Indometatsin-Zdorovye, the tab. on 25 mg No. 30

General characteristics. Structure:

International and chemical names: indometacin; [1-(4 chlorbenzoyl) - 5-metoksi-2-skatole-3-silt] acetic acid; main physical and chemical properties: tablets coated from a yellow oranzhe-vogo till orange color, a biconvex surface. On a surface of tablets the mramornost and impregnations is allowed. On cross section two layers are visible; structure: 1 tablet contains indometacin 25 mg;
excipients: the tselaktoza, potato starch, коповидон, calcium stearate, oydragit L 100 or yellow "Sunset" E 110 oydragit L 100-55, titanium dioxide, talc, a macrogoal 6000, dye.

Pharmacological properties:

Pharmacodynamics. Non-steroidal anti-inflammatory drug. Has the antiinflammatory, febrifugal, anesthetizing effect. 
The mechanism of action is caused by cyclooxygenase inhibition that leads to decrease in synthesis of prostaglandins causing development of pain, temperature increase and increase in fabric permeability in the inflammation center. Drug promotes weakening of a pain syndrome, especially joint pains at rest and at the movement, to reduction of morning constraint and a swelling of joints, increase in volume of movements. Inhibits aggregation of thrombocytes.
The antiinflammatory effect develops by the end of the first week of treatment.

Pharmacokinetics. At intake it is quickly soaked up from a digestive tract. The maximum concentration in blood is reached in 2 hours. Bioavailability makes about 98%. Intensively contacts proteins of plasma. An elimination half-life – 2–11 h (on average – about 6 h). It is metabolized generally in a liver; is exposed to enterohepatic recirculation. It is brought (to 20% in an invariable look) preferential by kidneys – 70%, and also with a stake – 30%.
Gets through hematoencephalic and placental barriers. Gets into a cavity of joints slowly. 
At some patients, especially at elderly and with disorder of function of kidneys and a liver, drug cumulation is possible.

Indications to use:

Acute arthritises of various genesis (including at gout), except for infectious; chronic arthritises, in particular at rheumatic diseases; ankylosing spondylitis (Bekhterev's disease) and other spondylarthrites; arthrosis and spondylarthrosis; extraarticular rheumatic diseases of soft tissues (bursitis, miositis); painful hypostases and inflammations after injuries and operative measures (all-surgical, gynecologic, dental). As a part of complex therapy: infectious and inflammatory diseases of ENT organs, adnexitis, prostatitis, cystitis.

Route of administration and doses:

Appoint inside in time or after food, without chewing, washing down with milk.
The adult appoint in an initial dose 25 mg (1 tablet) 2 – 3 times a day, at insufficient expressiveness of effect the dose is raised to 50 mg (2 tablets) by 3 times a day. The dose is increased gradually, estimating effect within 10 – 14 days. At achievement of effect treatment is continued within 4 weeks in the same or in the reduced dose. The maximum daily dose – 200 mg (8 tablets), at prolonged use a daily dose should not exceed 75 mg (3 tablets).
To children, 14 years are more senior, appoint in a dose 2 mg/kg of body weight a day in 3 – 4 receptions.
Drug is usually appointed it is long. The premature termination of reception can lead to resuming of displays of a disease. Duration of a course of treatment depends on disease severity and is defined individually.

Features of use:

With care appoint drug to patients of advanced age, and also at diseases of a liver, kidneys, a digestive tract in the anamnesis, at dispeptic symptoms at the time of purpose of drug, arterial hypertension (are possible a liquid delay in an organism and decrease in efficiency of anti-hypertensive drugs), of heart failure, right after serious surgical interventions, at parkinsonism, epilepsy, alcoholism, a diabetes mellitus. 
Carefully and only at direct medical control it is possible to apply indometacin at patients with bronchial asthma, allergic ("hay") cold, polyps mucous a nose, and also at chronic obstructive respiratory diseases and persistent infections of respiratory tracts in connection with danger of emergence of an attack of bronchial asthma, a Quincke's edema or urtikariya.
At the elderly and weakened patients the risk of formation of stomach ulcers and a duodenum, bleedings and perforation is increased.
During treatment systematic control of function of a liver and kidneys, a picture of peripheral blood (especially at patients with a renal failure of easy and moderate degree is necessary, and also at combined use with cyclosporine).
In case of carrying out the analysis on 17 ketosteroids drug should be cancelled the 48th hour prior to a research.
Use during pregnancy and feeding by a breast. Drug is contraindicated during pregnancy. For the period of treatment it is necessary to stop feeding by a breast since indometacin in small amounts is emitted with breast milk.
Influence on an opportunity to manage vehicles and mechanisms. During treatment it is necessary to abstain from control of motor transport and performance of potentially dangerous types of activity which demand concentration of attention and the increased speed of psychomotor reactions, because of possibility of such by-effects as 

Side effects:

The arising side effects depend on individual sensitivity, size of the applied dose and duration of treatment.
From the alimentary system: nausea, vomiting, anorexia, pains in epigastriums, a lock or diarrhea, erosive cankers, bleeding and perforation of a digestive tract; seldom – intestines strictures, stomatitis, gastritis, a meteorism, bleeding from a sigmoid gut or from a diverticulum, hepatitis. From the central and peripheral nervous systems: headache, dizziness, depression; seldom – alarm, a syncope, drowsiness, spasms, peripheral neuropathy, muscular weakness, the involuntary muscular movements, mental disorders (depersonalization, psychotic episodes), paresthesias, parkinsonism. From cardiovascular system: increase in arterial pressure, tachycardia, arrhythmia. From system of a hemopoiesis: seldom – a leukopenia, a marrow hypoplasia, aplastic anemia, autoimmune hemolitic anemia, an agranulocytosis, thrombocytopenia, dysfunction of thrombocytes. Allergic reactions: seldom – a skin itch, a small tortoiseshell, a knotty erythema, skin rash, exfoliative dermatitis, Stephens-Johnson's syndrome, a multiformny erythema, a hair loss, an acute anaphylaxis, a bronchospasm, a vasculitis, a fluid lungs. From sense bodys: seldom – disturbance of clearness of visual perception, a diplopia, a hearing disorder. From an urinary system: seldom – a proteinuria, a nephrotic syndrome, intersticial nephrite, a renal failure. From a metabolism: seldom - a hyperglycemia, a glucosuria, a hyperpotassemia. Another: seldom – vaginal bleeding, the raised potovydeleniye, nasal bleeding, increase and tension of mammary glands, a gynecomastia.
Use of drug at treatment of elderly patients is followed by the increased risk of side effect: severe damages of a digestive tract and psychotic reactions; in some cases peripheral neuropathy with paresthesias and muscular weakness can be observed.
In case of the expressed side effects drug needs to be cancelled and passed to use of less toxic means urgently.

Interaction with other medicines:

Reduces diuretic effect of kaliysberigayushchy, thiazide and loopback diuretics, and also hypotensive effect 
 adrenoblockers. Strengthens effects of indirect anticoagulants. Increases (mutually) risk of development of side effects (first of all, damages of a digestive tract) other non-steroidal anti-inflammatory drugs, glucocorticoids and colchicine. At simultaneous use with diflunizaly there is a risk of developing of severe bleeding from a digestive tract; with probenetsidy – increases in concentration of indometacin in blood; with digoxin, Phenytoinum – increases in their concentration in blood; with cyclosporine – increases in nefrotoksichny action of the last, with acetylsalicylic acid and/or other salicylates - increases in risk of development of by-effects, with hypoglycemic means – development hypo - or a hyperglycemia. Strengthens toxic action of a methotrexate (as reduces its canalicular secretion). Detains in plasma of lities and reduces its clearance at patients with mental diseases. At the use of alcoholic drinks the risk of development of side effects from a digestive tract increases.

Contraindications:

The increased individual sensitivity to drug components, conjunctivitis or a bronchospasm against the background of reception of non-steroidal anti-inflammatory drugs, erosive cankers of a digestive tract, bleeding (especially intracranial or from a digestive tract), thrombocytopenia, hypocoagulation, suspicion on a necrotic coloenteritis, the expressed renal failures and/or a liver, inborn heart diseases (Fallo's tetrad, an atresia of a pulmonary artery), severe forms of chronic heart failure, arterial hypertension, disturbances of color sight, decrease in hearing, pathology of a vestibular mechanism, pancreatitis, epilepsy, parkinsonism, mental diseases, pregnancy, feeding of a breast, children's age up to 14 years.

Overdose:

Symptoms: nausea, vomiting, severe headache, dizziness, memory disturbances, disorientation. In more hard cases paresthesias, numbness of extremities and a spasm are observed. Treatment: drug withdrawal, gastric lavage and purpose of 20-30 mg of absorbent carbon. Further carry out a symptomatic treatment with observation within several days of a condition of the patient for timely diagnosis of possible ulcerogenic action and gastrointestinal bleeding. Is not removed at a hemodialysis. The specific antidote does not exist.

Storage conditions:

To store in the dry, protected from light place at a temperature from 8 °C to 25 °C. To store in the place, unavailable to children.
Period of validity – 3 years.

Issue conditions:

According to the recipe

Packaging:

Tablets, coated, kishechnorastvorimy, on 25 mg, No. 10, No. 10х3, No. 30 in a blister strip packaging in a pack; No. 10 in a blister strip packaging.