Active substanceMetamizol sodiumMetamizol sodium
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  • Dosage form: & nbsp

    solution for intravenous and intramuscular administration

    Composition:

    Active component: metamizole sodium (analgin) - 500 mg, auxiliary component: water for injection - up to 1 ml.

    Description:

    Transparent colorless or slightly colored liquid.

    Pharmacotherapeutic group:Analgesic non-narcotic remedy
    ATX: & nbsp
  • Metamizol sodium
  • Pharmacodynamics:

    An analgesic non-narcotic agent, a derivative of pyrazolone, nonselectively blocks cyclooxygenase and reduces the formation of prostaglandins (Pg) from arachidonic acid.

    Prevents painful extra- and proprioceptive pulses along Gaull's bundles andBurdaha, raises the threshold of excitability of thalamic centers of pain sensitivity, increases heat transfer.

    A distinctive feature is the slight severity of the anti-inflammatory effect. Has analgesic, antipyretic and some spasmolytic (with respect to the smooth muscles of the urinary and biliary tract) action.

    The action develops in 20-40 minutes and reaches a maximum after 2 hours.

    Pharmacokinetics:

    After intravenous administration, the elimination half-life is 14 minutes.

    Approximately 96% is excreted in the urine in the form of metabolites. The association of the active metabolite with plasma proteins is 50-60 %. Metabolized in the liver, excreted by the kidneys. In therapeutic doses penetrates into breast milk.

    Indications:

    Pain syndrome of various origins of mild to moderate degree (headache, migraine, toothache, neuralgia, myalgia, dysmenorrhea, postoperative pain, in combination with the appointment of antispasmodics in renal, biliary and intestinal colic). Feverish conditions with infectious and inflammatory diseases.

    Contraindications:

    Hypersensitivity, oppression of hematopoiesis (agranulocytosis,cytostatic or infectious neutropenia), hepatic and / or renal failure, hereditary hemolytic anemia associated with glucose-6-phosphate dehydrogenase deficiency, asthma induced by acetylsalicylic acid (ASA), salicylates or other non-steroidal anti-inflammatory drugs, anemia, leukopenia, pregnancy I and III trimesters, lactation period.

    Carefully:

    Pregnancy II trimester, infant age up to 3 months, kidney disease (pyelonephritis, glomerulonephritis - including in the history), long-term abuse of ethanol. Intravenous administration to patients with systolic blood pressure below 100 mm Hg. or in case of instability of blood circulation (for example, against a background of myocardial infarction, multiple trauma, beginning shock).

    Pregnancy and lactation:Contraindicated.
    Dosing and Administration:

    The drug is administered intramuscularly (in / m) or intravenously (iv) (with severe pain).

    Adults 1-2 ml of solution 2-3 times a day, maximum single dose -1 g, daily - 2 g. Children Enter from the calculation of 0.1-0.2 ml of the solution for every 10 kg of the child's body weight 2-3 times a day.Children under 1 year of drug administered only intramuscularly, the course is not more than 3 days. The injectable solution must have a body temperature. Doses greater than 1 g should be given IV. It is necessary to have conditions for antishock therapy. The most frequent cause of a sharp decrease in blood pressure is too high a rate injections, in connection with which the IV administration should be carried out slowly (at a rate of not more than 1 ml / min), in the patient's position "lying", under the control of blood pressure, heart rate and the number of breaths.

    With prolonged (more than a week) application of the drug, control of the picture of peripheral blood and the functional state of the liver is necessary.

    Side effects:

    In therapeutic doses, the drug is usually well tolerated. When using the drug in some patients, there may be adverse reactions:

    Allergic reactions: skin rash, Quincke's edema, urticaria (conjunctiva and mucous membranes of the nasopharynx), angioedema, in rare cases - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), bronchospastic syndrome, anaphylactic shock.

    With prolonged use can occur granulocytopenia, thrombocytopenia, arterial hypotension, interstitial nephritis. With propensity to bronchospasm may provoke an attack.

    From the urinary system: a violation of kidney function, oliguria, anuria, proteinuria, interstitial nephritis, urine staining in red.

    On the part of the organs of hematopoiesis: agranulocytosis, leukopenia, thrombocytopenia.

    Other: lowering of blood pressure.

    Local Reactions: when administered intramuscularly, infiltrates are possible at the site of administration.
    Overdose:

    Symptoms: nausea, vomiting, gastralgia, oliguria, hypothermia, lowering of arterial pressure, tachycardia, dyspnea, tinnitus, drowsiness, delirium, impaired consciousness, acute agranulocytosis, hemorrhagic syndrome, acute renal and / or hepatic insufficiency, convulsions, respiratory muscle paralysis.

    Treatment: gastric lavage, saline laxatives, Activated carbon; carrying out forced diuresis, hemodialysis, with the development of convulsive syndrome - intravenous diazepam and high-speed barbiturates.

    Interaction:

    Because of the high likelihood of developing pharmaceutical incompatibility, you should not mix it with other drugs in the same syringe.

    Enhances the effects of ethanol.

    Radiopaque drugs, colloidal blood substitutes and penicillin should not be used during treatment with metamizole sodium.

    With the simultaneous administration of cyclosporine, the concentration of the latter in the blood decreases. Metamizol sodium, displacing out of association with the plasma protein, oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin, increases their activity.

    Phenylbutazone, barbiturates and other inducers of microsomal liver enzymes with simultaneous administration decrease the effectiveness of metamizole sodium.

    Simultaneous administration with other non-narcotic analgesics, tricyclic antidepressants, contraceptive hormonal drugs and allopurinol can lead to increased toxicity.

    Sedative and anxiolytic drugs (tranquilizers) increase the analgesic effect of metamizole sodium.

    Thiamazole and cytostatics increase the risk of developing leukopenia.

    The effect is enhanced codeine, H2-histamine receptor blockers and propranolol (slows inactivation).

    Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

    Special instructions:

    When treating children under 5 years and patients receiving cytotoxic drugs, the use of metamizole sodium should only be carried out under the supervision of a doctor. Intolerance is very rare, but the threat of developing an anaphylactic shock after intravenous administration of the drug is relatively higher than after taking the drug inside. Patients with atopic bronchial asthma and pollinosis have an increased risk of developing allergic reactions.

    Against the background of the use of metamizole sodium, the development of agranulocytosis is possible, in connection with which, when an unmotivated rise in temperature, chills, sore throat is detected, it is difficultswallowing, stomatitis, and also in the development of the phenomena of vaginitis or proctitis, immediate withdrawal of the drug is necessary. With prolonged use, it is necessary to monitor the picture of peripheral blood.

    It is inadmissible to use to relieve acute pain in the abdomen (until the cause is clarified).

    For intramuscular injection, a long needle should be used.

    It is possible to stain urine in red by excretion of the metabolite (it has no value).

    Metamizole sodium has a weak sedative effect on the central nervous system.

    In this regard, it is not recommended driving and working with vehicles.

    Effect on the ability to drive transp. cf. and fur:It is not recommended to drive vehicles and work with machinery.
    Form release / dosage:

    Solution for intravenous and intramuscular injection 500 mg / ml.

    Packaging:
    2 ml in ampoules of neutral glass grade HC-3 or imported.

    10 ampoules are placed in a box of cardboard.

    5 ampoules in a contour mesh package made of PVC film.

    1 or 2 contour packs are placed in a pack of cardboard.

    5 or 10 ampoules are placed in a pack of cardboard with baffles or lattices, or a separator made of cardboard or paper sack.

    Each instruction pack or box is supplied with instructions for use and an ampoule or ampoule ceramic scapper.

    When you use ampoules with notches, rings and dots, the ampoule opener or the ampoule ceramic scapegrator is not inserted.

    Storage conditions:In the dark place.In a place inaccessible to 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 N001780 / 01
    Date of registration:12.05.2010 / 12.08.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Promomed Rus, Open CompanyPromomed Rus, Open Company Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.08.2017
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