Active substanceMetamizol sodiumMetamizol sodium
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  • Dosage form: & nbsp

    solution for intravenous and intramuscular administration

    Composition:

    Metamizole sodium - 500 mg.

    Water for injection up to 1 ml.

    Description:Transparent, colorless or yellowish 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.

    It prevents painful extra- and proprioceptive pulses along the Gaull and Burdach beams, 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, which causes a weak effect on water-salt metabolism (delay Na+ and water) and the mucous membrane of the gastrointestinal tract. Provides analgesic, jelaponiesand some spasmolytic (with respect to the smooth muscles of the urinary and biliary tract) action.

    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 proteins is 50-60%. Metabolised in the liver, excreted by the kidneys. In therapeutic doses penetrates into breast milk.

    Indications:Pain syndrome of various origins (headache, migraine, toothache, neuralgia, myalgia, dysmenorrhea, postoperative pain, combined 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 a deficiency of glucose-6-phosphate dehydrogenase, asthma induced by acetylsalicylic acid (ASA), salicylates or other non-steroidal anti-inflammatory drugs, anemia, leukopenia, pregnancy I and III trimesters, lactation.

    Carefully:

    Infant age to 3 months, kidney disease (pyelonephritis, glomerulonephritis - including in the anamnesis), 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:
    Intramuscularly or intravenously, adults - 250-500 mg 3 times a day. The maximum single dose - 1 g, daily - 2 g. Children prescribe at the rate of 5-10 mg / kg 2-3 times a day. Children up to 1 year of the drug is administered only intramuscularly. Injectable injection must have body temperature. Doses more 1 g should be administered intravenously. 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 of injection, in connection with which intravenous administration should be slow (at a rate not more than 1 ml / min), in the patient's "lying" position, under the control of blood pressure, heart rate and the number of breaths.
    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 (including conjunctiva and mucous membranes), angioedema, in rare cases - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospastic syndrome, anaphylactic shock.

    With prolonged use there may be granulocytopenia, arterial hypotension, interstitial nephritis. With propensity to bronchospasm may provoke an attack. With intramuscular injection, infiltrates are possible at the site of administration.

    Signs of acute poisoning: nausea, vomiting, stomach pain. If necessary, conduct symptomatic treatment

    From the urinary system: renal dysfunction, oliguria, anuria, proteinuria, interstitial nephritis, urine staining in red.

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

    Other: lowering blood pressure.

    Local Reactions: intramuscular injection possible infiltrates 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 probability of developing pharmaceutical incompatibility, one should not mix with other drugs in one syringe. Enhances the effects of ethanol. Radiocontrast 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 protein oral hypoglycemic drugs, indirect anticoagulants, GCS and indomethacin, increases their activity. Phenylbutazone, barbiturates and other hepatoinducers with simultaneous administration decrease the effectiveness of metamizole sodium. Simultaneous appointment with other non-narcotic analgesics, tricyclic antidepressants, contraceptive hormonal drugs and allopurinol may 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, metamizole sodium intake should be done only 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 taking metamizole sodium, the development of agranulocytosis is possible, in connection with which, when an unmotivated rise in temperature, chills, sore throats, difficulty swallowing, stomatitis, as well as 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 that the urine is colored red by the release of a metabolite (it does not matter).

    Form release / dosage:

    Solution for intravenous and intramuscular injection 500 mg / ml.

    Packaging: 2 ml per ampoule of neutral glass. 10 ampoules per box of cardboard. In each box, insert an ampoule opener or ampoule scarifier together with an instruction for use.
    Storage conditions:

    List B. In the dark place at temperature from 5 to 30 ° C. Keep out of the reach of children.

    Shelf life:

    3 years. Do not use at the end of the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-002942/10
    Date of registration:07.04.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:StatusPharm, LLC StatusPharm, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp26.08.2017
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