Active substanceMetamizol sodiumMetamizol sodium
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  • Dosage form: & nbsp

    solution for intravenous and intramuscular introduction of

    Composition:Active substance: metamizole sodium - 500 mg
    Excipient: 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. Metamizol sodium by the mechanism of action does not differ from other NSAIDs (selectively blocks cycloxeginase and reduces the formation of prostaglandins from arachidonic acid).Prevents painful extra- and proprioceptive pulses along the Gaull and Burdach beams, raises the threshold of excitability of thalamic pain centers 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 (retention of sodium and water ions) and the mucous membrane of the gastrointestinal tract. Possesses anesthetizing, antipyretic and some spasmolytic action (for the smooth muscles of the urinary and biliary tracts).
    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 mild to moderate severity of various origin (headache, migraine, toothache, neuralgia, myalgia, dysmenorrhea).

    Pain of visceral origin - in combination with antispasmodic agents for renal, intestinal and biliary colic.

    To reduce pain after surgical and diagnostic interventions, injuries, burns, decompression sickness.

    Feverish conditions with infectious and inflammatory diseases, insect bites, posttransfusion complications. The expediency of using the drug is decided in each case, depending on the severity, nature and tolerability of the fever.

    Contraindications:
    Hypersensitivity to pyrazolone derivatives, inhibition of bleeding (agranulocytosis, neutropenia), hepatic and / or renal failure, hereditary hemolytic anemia associated with deficiency of glucose-6-phosphate dehydrogenase and other anemia, complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and peroneous sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in anamnesis), leukopenia, pregnancy, lactation, children in the first three months of life or with a body weight less than 5 kg. It is inadmissible to use to relieve acute pain in the abdomen (until the cause is clarified).
    Carefully:

    Kidney disease (pyelonephritis, glomerulonephritis, including, in the anamnesis); alcoholism. Intravenous administration to patients with systolic blood pressure below 100 mm. gt; Art. or with circulatory instability, for example, against a background of myocardial infarction, multiple trauma, and shock.

    Pregnancy and lactation:Application during pregnancy is contraindicated. If you need to use the drug during lactation at the time of treatment should stop breastfeeding.
    Dosing and Administration:

    The drug is administered intramuscularly or intravenously (with severe pain) for 1-2 ml of 500 mg / ml solution 2-3 times a day, but not more than 2 grams per day. The maximum single dose is 1 g, the daily dose is 2 g.

    Children are prescribed at the rate of 5-10 mg / kg 2-3 times a day.

    Children up to 1 year, but older than 3 months or with a body weight of more than 5 kg, the drug is administered only intramuscularly, the course is not more than 3 days.

    The injected solution must have a body temperature. Doses over 1 g should be administered intravenously, it is necessary to have conditions for antishock therapy.

    The most common cause of a sharp drop in blood pressure is an excessive injection rate,therefore, intravenous administration should be slow (at a rate of not more than 1 ml / min), in the position of the patient lying down, under the control of blood pressure, heart rate and respiration.

    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.

    Allergic reactions, agranulocytosis, leukopenia, thrombocytopenia, urticaria, Quincke's edema, anaphylactic shock, lowering blood pressure, transient renal impairment: oliguria, anuria, proteinuria, interstitial nephritis, urticaria, conjunctivitis; Stevens-Johnson syndrome, Lyell syndrome, bronchospastic syndrome.

    With intramuscular injection, 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, paralysis of the respiratory musculature.

    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:
    The simultaneous use of metamizole sodium with other non-narcotic analgesics, as well as with allopurinol can lead to a mutual enhancement of toxic effects. Tricyclic antidepressants and contraceptives for oral administration disrupt the metabolism of metamizole sodium in the liver and increase its toxicity. Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the action of metamizole sodium. Simultaneous use of metamizole sodium with cyclosporine reduces the concentration of the latter in the blood. Sedatives and tranquilizers increase pain medication action of metamizole sodium. The effect is enhanced by simultaneous use with codeine, H blockers2- histamine receptors and propranolone. Enhances the effects of ethanol.

    Radiopaque preparations, colloidal blood substitutes and penicillin should not be used during treatment with metamizole sodium.Myelotoxic agents increase the manifestation of hematotoxicity of the drug, thiamazole and cytostatics, but increase the risk of developing leukopenia. Metamizol sodium, displacing from the connection with plasma proteins, oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin, increases their activity.

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

    Special instructions:

    When treating children under 5 years of age and patients receiving cytotoxic drugs, metamizole sodium should be taken only under medical supervision.

    Intolerance is very rare, but the threat of anaphylactic shock after IV injection 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,and also with 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.

    For the / m introduction, a long needle should be used.

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

    Effect on the ability to drive transp. cf. and fur:

    The adverse effect of the drug on the ability to drive a car and other activities that require concentration and speed of psychomotor reactions have not been reported.

    Form release / dosage:

    Solution for intravenous and intramuscular injection 500 mg / ml.

    Packaging:

    1 ml or 2 ml into neutral glass ampoules.

    For 10 ampoules with instruction for use and a knife for opening ampoules or a scarifier ampullum is placed in a box of cardboard.

    5 or 10 ampoules are placed in a contoured cell pack of a polyvinylchloride film or polyethylene terephthalate tape and aluminum foil or paper with a polyethylene coating or without a foil, or without paper.

    For 1 or 2 contour packs with instructions for use and a knife for opening ampoules or a scarifier ampullum is placed in a pack of cardboard.

    When you pack the ampoules with a break ring or break point, the ampoule opener or ampoule scapper is not put in.

    Storage conditions:

    In the dark place at a temperature of 15 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

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

    Terms of leave from pharmacies:On prescription
    Registration number:P N000597 / 01
    Date of registration:29.02.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:NOVOSIBHIMFARM, OJSC NOVOSIBHIMFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp26.08.2017
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