Metindol ретард

Metindol ретард – non-steroidal anti-inflammatory drug (NPVP) with anesthetic and febrifugal action.

Form of release and structure

Dosage form – tablets of the prolonged action: white color (the yellowish shade), with a flat surface and the cut-off edge (on 25 pieces in blisters, 1 or 2 blisters in a pack cardboard is possible).

Active ingredient: indometacin, its contents in 1 tablet makes 75 mg.

Excipients: potato starch, magnesium stearate, copolymer of methacrylic acid, cellulose microcrystallic.

Indications to use

Metindol ретард – drug for symptomatic therapy of the diseases which are followed by an inflammation and a pain syndrome:

• Bekhterev's disease (ankylosing spondylitis) and other inflammatory and rheumatic diseases of a backbone;
• Pain syndrome at backbone diseases;
• Rheumatic diseases of soft tissues;
• Pseudorheumatism;
• Gouty arthritis;
• Inflammation and pain syndrome after injuries or operative measures (including dental and gynecologic).

Contraindications

Absolute:

• Exacerbation of inflammatory diseases of intestines (nonspecific ulcer colitis, disease Krone);
• Active gastrointestinal bleeding, erosive cankers mucous stomach and/or 12-perstny gut;
• The confirmed hyperpotassemia;
• Disturbances of coagulability of blood (including hemophilia, tendency to bleedings, lengthening of a bleeding time);
• The progressing diseases of kidneys, the expressed renal failure (the clearance of creatinine is less than 30 ml/minute);
• Active disease of a liver, the expressed liver failure;
• Instructions in the anamnesis on the bronchospasm, rhinitis or urticaria caused by reception of acetylsalicylic acid or other NPVP (full or incomplete intolerance of acetylsalicylic acid – polyps mucous a nose, a small tortoiseshell, rinosinusit, asthma);
• Inborn heart diseases (atresia of a pulmonary artery, heavy coarctation of an aorta, heavy tetrad of Fallo);
• The period after aortocoronary shunting;
• Period of pregnancy and lactation;
• Age up to 18 years;
• Hypersensitivity to drug components.

Relative:

• The accompanying therapy by the following drugs: antiagregant, peroral glucocorticosteroids, anticoagulants, selective serotonin reuptake inhibitors;
• Prolonged use of NPVP;
• Frequent alcohol intake;
• Smoking;
• Advanced age;
• Mental disorders;
• The postoperative period after surgical intervention;
• Existence of an infection of Helicobacter pylori;
• Anamnestic data on development of a canker of digestive tract;
• Clearance of creatinine less than 60 ml/minute;
• Cirrhosis with portal hypertensia;
• Heavy somatopathies;
• Arterial hypertension;
• Parkinsonism;
• Дислипидемия / lipidemia;
• Diabetes mellitus;
• Cerebrovascular diseases;
• Epilepsy;
• Coronary heart disease;
• Congestive heart failure;
• Hemopoiesis disturbances (leukopenia and anemia);
• Diseases of peripheral arteries;
• Thrombocytopenia;
• Depression.

Route of administration and dosage

The metindol ретард should be accepted inside, swallowing of tablets entirely, in time or at once after food, washing down with enough liquid (water or milk).

To adult patients appoint 1-2 tablets a day.

The highest admissible daily dose of indometacin makes 150 mg (2 tablets).

Side effects

• Alimentary system: The NPVP-gastropathy, heartburn, diarrhea, an abdominal pain, a loss of appetite, nausea, vomiting, an ulceration of a mucous membrane of digestive tract (including with perforation and/or bleeding), an abnormal liver function (a hyperbilirubinemia, increase in activity of hepatic transaminases);
• Nervous system: irritability, excessive fatigue, excitement, drowsiness, sleeplessness, depression, вертиго, headache, peripheral neuropathy;
• Urinary system: hamaturia, proteinuria, intersticial nephrite, necrosis of nipples, nephrotic syndrome, renal failure;
• Cardiovascular system: a tachyarrhythmia, increase in arterial pressure, an edematous syndrome, development or aggravation of the available chronic heart failure;
• Bodies of a hemopoiesis and system of a hemostasis: anemia (including hemolitic and aplastic), agranulocytosis, eosinophilia, thrombocytopenia, Werlhof's disease, leukopenia, bleeding (gingival, gastrointestinal, hemorrhoidal, uterine);
• Sense bodys: a sonitus, decrease in hearing, doubling in eyes, taste disturbance, conjunctivitis, opacification of a cornea of eyes, an illegibility of visual perception;
• Allergic reactions: skin itch, skin rash, small tortoiseshell, bronchospasm, Quincke's disease; in isolated cases – an acute anaphylaxis, a photosensitization, a knotty erythema, a toxic epidermal necrolysis;
• Laboratory indicators: hyperglycemia, thrombocytopenia, glucosuria, leukopenia, hyperpotassemia, agranulocytosis;
• Others: sweating strengthening, autoimmune hemolitic and aplastic anemia, aseptic meningitis (is more often at patients with autoimmune diseases).

Special instructions

It is necessary to apply minimum effective dose during shorter period to decrease in risk of development of undesirable reactions.

For the prevention or decrease in the dispepsichesky phenomena it is possible to accept antiacid drugs.

During treatment it is necessary to control a pattern of peripheral blood, a functional condition of kidneys and a liver.

In need of carrying out a research for the purpose of definition of 17 ketosteroids it is necessary to cancel the Metindol ретард in 48 hours prior to the fixed time.

During use of drug it is necessary to be careful when driving and performing the tasks demanding the high speed of reactions and the increased concentration of attention.

Medicinal interaction

In need of simultaneous use of the following medicines it is important to consider that indometacin:

• Increases concentration in a blood plasma of a methotrexate, drugs of lithium and digoxin owing to what strengthening of their toxicity is possible;
• Strengthens hypoglycemic effect of insulin and peroral hypoglycemic drugs;
• Reduces efficiency uricosuric and antihypertensives (including beta adrenoblockers);
• Strengthens action of indirect antiagregant, anticoagulants, trombolitik (Streptokinasa, an alteplaza, an urokinase) owing to what there is a risk of development of bleedings;
• Strengthens side effects of acetylsalicylic acid, other NPVP, glucocorticosteroids, estrogen;
• Reduces effect of diuretics; at use in a combination with kaliysberegayushchy diuretics – increases risk of development of a hyperpotassemia;
• Increases toxicity of a zidovudine;
• Increases risk of development of toxic effects of aminoglycosides in newborns (since reduces their renal clearance and increases concentration in blood).

At use of the Metindol ретард the risk of development of side effects increases in a combination with the following medicines:

• Glucocorticosteroids, colchicine, corticotropin, inhibitors of the return serotonin reuptake, ethanol: the risk of development of gastrointestinal bleedings increases;
• Cyclosporine, paracetamol, gold drugs: nephrotoxicity of indometacin increases;
• Antacids and Colestyraminum: indometacin absorption decreases;
• Myelotoxic means: manifestations of a gematotoksichnost of indometacin amplify;
• Valproic acid, цефоперазон, пликамицин, цефамандол, цефотетан: frequency of development of prothrombinopenias increases, the risk of development of bleedings increases.

Terms and storage conditions

To store in protected from light, the place, dry, unavailable to children. To observe temperature condition of 15-25 °C.

Period of validity – 5 years.