Active substanceIndomethacinIndomethacin
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  • Dosage form: & nbsprectal suppositories
    Composition:

    1 suppository (50 mg / 100 mg) contains:

    of the active substance: indomethacin 0.05 g / 0.10 g;

    Excipients: fat solid Estaram 8770 N15 (Witepsol H15) - 1.30 g / 1.30 g, solid fat Estaram 8780 W35 (Witepsol W35) - 0.65 g / 0.60 g.

    Description:

    Suppositories torpedo shaped with a smooth surface from white to light yellow color, odorless. The surface of the cut must be smooth and uniform.

    Pharmacotherapeutic group:NSAIDs
    ATX: & nbsp

    C.01.E.B.03   Indomethacin

    S.01.B.C.01   Indomethacin

    M.02.A.A.23   Indomethacin

    Pharmacodynamics:

    Indomethacin has anti-inflammatory, analgesic, antipyretic and antiplatelet effect. Suppresses the activity of proinflammatory factors, reduces platelet aggregation. By depressing cyclooxygenase I and II, it breaks the metabolism of arachidonic acid, reduces the amount of prostaglandins both in the inflammation focus and in healthy tissues, suppresses the exudative and proliferative phases of inflammation. Eliminates or reduces pain syndrome of rheumatic and non-rheumatic nature (including pain in joints at rest and during movement, reduces morning stiffness and swelling of the joints,promotes an increase in the volume of movements; in inflammatory processes that occur after surgery and trauma, quickly alleviates both spontaneous pain and pain during movement, reduces inflammatory edema at the wound site).

    Pharmacokinetics:

    Absorption is fast. Bioavailability in the rectal route of administration is 80-90%. The connection with plasma proteins is 90%, the half-life is 4.5 hours. It is metabolized mainly in the liver, 70% is excreted by the kidneys (30% unchanged), 30% through the gastrointestinal tract (GIT). It is not removed during dialysis. Penetrates into breast milk.

    Indications:

    - Acute and chronic pain in inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid arthritis, juvenile chronic arthritis, ankylosing chronic spondylitis (Bechterew's disease), gouty arthritis, psoriatic arthritis, Reiter's disease;

    - rheumatic affections of soft tissues: tendinitis, bursitis, tendo bursitis, tendovaginitis;

    - discopathy, neuritis, plexitis, radiculoneuritis;

    - dysmenorrhea.

    The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

    Contraindications:

    - Hypersensitivity to indomethacin or any of the excipients of the drug;

    - complete or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (including history), rhinitis or urticaria.;

    - Stomach ulcer and 12-perstnoy ulcer, inflammatory bowel disease (ulcerative colitis, Crohn's disease), bleeding (including intracranial, from the gastrointestinal tract (GIT);

    - Congenital heart defects (severe coarctation of the aorta, pulmonary atresia, heavy tetralogy of Fallot), period after coronary artery bypass grafting;

    - severe heart failure;

    - renal failure (creatinine clearance (CK) less than 30 ml / min);

    - hepatic insufficiency, active liver disease;

    - disorders of blood clotting (including hemophilia, prolonged bleeding time, a tendency to bleed);

    - violation of hematopoiesis (leukopenia and anemia);

    - confirmed hyperkalemia;

    - pregnancy and breastfeeding;

    - children's age (up to 15 years).

    Carefully:

    Ischemic heart disease, cerebrovascular disease, chronic heart failure, dyslipidaemia, hyperlipidemia, diabetes, thrombocytopenia, peripheral artery disease, hypertension, smoking, chronic Spot metering failure (creatinine clearance of 30-60 ml / min), cirrhosis with portal hypertension, hyperbilirubinemia, gastroesophageal ulcer in history, infection Helicobacter pylori, Long-term use of NSAIDs, frequent alcohol consumption, severe somatic diseases, concomitant therapy with the following drugs: anticoagulants (including warfarin), antiaggregants (incl. acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (incl. prednisolone), selective inhibitors of serotonin reuptake (including citalopa, fluoxetine, paroxetine, sertraline); mental disorders, epilepsy, parkinsonism, depression, elderly age.

    Pregnancy and lactation:

    Pregnancy

    Indomethacin is not used during pregnancy.

    Breast-feeding

    Indomethacin excreted in breast milk. If it is necessary to treat the drug, breastfeeding should be discontinued.

    Dosing and Administration:

    Rectally.

    Adults and children over 15 years of age: suppositories at 50 mg twice a day or 100 mg once a day. The maximum daily dose is 200 mg.

    A dose higher than 150-200 mg increases the risk of side effects.

    Duration of treatment: not more than 7 days.

    Side effects can be reduced by using the minimum effective dose for as short a period of time as possible.

    Side effects:

    From the digestive system: NSAIDs-gastropathy, nausea, heartburn, decreased appetite, abdominal pain, hemorrhages and ulcers, vomiting (including bloody), diarrhea, constipation, melena, ulcerative stomatitis, increased activity of "liver transaminases" (ALAT, ACAT) , transient increase in bilirubin; rarely - toxic hepatitis with or without jaundice; very rarely - fulminant hepatitis. With prolonged use in large doses - ulceration of the mucous membrane of the gastrointestinal tract.

    From the nervous system: headache, dizziness, insomnia, agitation, irritability, excessive fatigue, drowsiness, depression, peripheral neuropathy.

    From the sense organs: diplopia, blurred vision, hearing loss, tinnitus, impaired taste, corneal opacity, conjunctivitis.

    From the cardiovascular system: tachyarrhythmia, edematous syndrome, increased arterial pressure, the development (aggravation) of chronic heart failure.

    From the urinary system: renal dysfunction, nephrotic syndrome, proteinuria, hematuria, interstitial nephritis, papillary necrosis.

    On the part of the organs of hematopoiesis and the system of hemostasis: bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), leukopenia, thrombocytopenia, agranulocytosis, anemia (including hemolytic and aplastic), eosinophilia, thrombocytopenic purpura.

    Allergic reactions: usually itchy skin, skin rash; rarely - urticaria, bronchospasm, asthmatic attacks, angioedema; very rarely - bullous eruptions, skin redness, eczema, exfoliative dermatitis, allergic-type purpura, Stevens-Johnson syndrome; in isolated cases - photosensitivity, toxic epidermal necrolysis (Lyell's syndrome), erythema nodosum, anaphylactic shock.

    Laboratory indicators: agranulocytosis, leukopenia, thrombocytopenia, hyperglycemia, glucosuria, hyperkalemia.

    Local reactions: irritation, heaviness in the anorectal area, exacerbation of hemorrhoids.

    Other: aseptic meningitis (more often in patients with autoimmune diseases), increased sweating, aplastic anemia, autoimmune hemolytic anemia.

    Overdose:

    Symptoms: nausea, vomiting, severe headache, dizziness, memory impairment, disorientation. In severe cases - paresthesia, numbness of limbs, convulsions.

    Treatment: rapid removal of the drug from the body, symptomatic therapy. Hemodialysis is ineffective.

    Interaction:

    Increases plasma concentrations of digoxin, methotrexate and drugs Li+, which can lead to an increase in their toxicity.

    Sharing with paracetamol increases the risk of developing nephrotoxic effects.

    Ethanol, colchicine, glucocorticosteroids and corticotropin increase the risk. development of bleeding in the gastrointestinal tract.

    Strengthens hypoglycemic action of insulin and oral. hypoglycemic drugs; strengthens the effect of indirect anticoagulants, antiaggregants, thrombolytics (alteplase, streptokinase and urokinase) - there is a risk of bleeding.

    Reduces the effect of diuretics, against the background of the use of potassium-sparing diuretics increases the risk of hyperkalemia; reduces the effectiveness of uricosuric and antihypertensive drugs (incl.beta-blockers); increases the side effects of methotrexate, acetylsalicylic acid, glucocorticosteroids, other NSAIDs.

    Cyclosporine and gold preparations increase nephrotoxicity (apparently due to suppression of prostaglandin synthesis in the kidneys).

    Cefamandol, cefapperazone, cefotetan, valproic acid, plikamycin increase the frequency of hypoprotothrombinemia and the risk of bleeding.

    Antacids and colestramine reduce the absorption of indomethacin.

    Increases the toxicity of zidovudine (due to inhibition of metabolism).

    In newborns, it increases the risk of toxic effects of aminoglycosides (because it reduces renal clearance and increases the concentration in the blood).

    Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

    Special instructions:

    During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys.

    If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.

    To prevent and reduce the dyspeptic phenomena should use antacid medicines.

    Do not use the drug simultaneously with other NSAIDs.

    The drug can change the properties of platelets, but does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases.

    The use of the drug may adversely affect female fertility and is not recommended for women planning pregnancy.

    Effect on the ability to drive transp. cf. and fur:During the treatment with indomethacin, it is necessary to refrain from managing motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:

    Suppositories rectal, 50 mg and 100 mg.

    Packaging:

    6 suppositories per contour cell box made of white, opaque PVC / PE film.

    1 circuit cell pack together with the instruction for use is placed in a cardboard box.

    Storage conditions:

    In dry, dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.
    Shelf life:

    3 of the year.

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

    Terms of leave from pharmacies:On prescription
    Registration number:P N008968
    Date of registration:10.06.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:Sopharma, AOSopharma, AO Bulgaria
    Manufacturer: & nbsp
    Representation: & nbspSOFARMA SA SOFARMA SA Bulgaria
    Information update date: & nbsp31.10.2017
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