Active substanceMetamizol sodiumMetamizol sodium
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  • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:

    Active substance: metamizole sodium (analgin) - 250 mg or 500 mg.

    Excipients: water for injection - up to 1 ml.

    Description:

    Transparent lightly 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 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 insignificant 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. Has analgesic, antipyretic and some spasmolytic (with respect to the smooth muscles of the urinary and bile ducts) action.

    Pharmacokinetics:

    After intravenous administration, the elimination half-life is 14 minutes. About 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 concentrations penetrates into breast milk.

    Indications:

    Feverish conditions with infectious and inflammatory diseases.

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

    Contraindications:

    Hypersensitivity, oppression hemopoiesis (agranulocytosis, cytostatic or infectious neutropenia),hepatic and / or renal failure, hereditary hemolytic anemia associated with a deficiency of glucose-6-phosphate dehydrogenase; complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in history); anemia, and leukopenia.

    Carefully:

    Children in the first three months of life or with a body weight of less than 5 kg, kidney disease (pyelonephritis, glomerulonephritis - including in the history), alcoholism.

    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:

    In the I and III trimester of pregnancy, the use of the drug is contraindicated.

    Use in the II trimester of pregnancy is possible only in cases where the intended benefit to the mother exceeds the potential risk to the fetus.

    During the treatment, the drug should stop breastfeeding.

    Dosing and Administration:

    The drug is administered intramuscularly or intravenously (with severe pain).

    Adults: Intramuscularly or intravenously - 250-500 mg 3 times a day. Maximum single dose - 1 g, daily - 2 grams.

    Children prescribe at the rate of 5-10 mg / kg 2-3 times a day. Children under 1 year, but older than 3 months or with a body weight of more than 5 kg drug is administered only intramuscularly. The duration of the drug is no more than 3 days.

    The injectable solution must have a body temperature. Doses greater than 1 g should be administered intravenously. It is necessary to have conditions for antishock therapy. The most frequent reason for a sharp drop in blood pressure is too high a rate of injection, and therefore 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, the number of heartbeats and the number breathing.
    Side effects:

    In therapeutic doses, the drug is usually well tolerated.

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

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

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

    Other: lowering blood pressure.

    Local Reactions: with intramuscular injection, infiltrates are possible at the injection site.

    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 use of cyclosporine, the concentration of the latter in the blood decreases.

    Metamizole sodium, displacing from the connection with plasma proteins, 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 use 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 of age and patients receiving cytotoxic drugs, metamizole sodium intake should only be performed under the supervision of a physician. Intolerance is very rare, but the threat of anaphylactic shock after intravenous injection is relatively high. 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, therefore, if an unmotivated rise in temperature, chills, sore throats, difficulty swallowing, stomatitis, as well as the development of the phenomena of vaginitis or proctitis, immediate withdrawal of the drug is necessary. 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.

    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.

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

    Given the side effect of the drug, during the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

    Form release / dosage:

    Solution for intravenous and intramuscular injection 250 mg / ml, 500 mg / ml.

    Packaging:

    1 ml, 2 ml or 10 ml into neutral glass ampoules. For 10 ampoules, together with an instruction for use and a knife for opening ampoules or a scarifier, an ampoule is placed in a box of cardboard.

    For 5 ampoules (for 1 ml, 2 ml) in a contour mesh package made of a polyvinyl chloride film. 2 contoured cell packs together with instructions for use and a knife for opening ampoules or a scarifier ampullum are placed in a pack of cardboard.

    When using ampoules with break points or rings, the ampoule opener or ampoule scaper is allowed not to be inserted.

    Storage conditions:

    In the dark place at a temperature of 5 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

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

    Terms of leave from pharmacies:On prescription
    Registration number:P N001051 / 02-2002
    Date of registration:23.05.2008 / 29.12.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:DALHIMFARM, OJSC DALHIMFARM, OJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspDALHIMFARM, OJSCDALHIMFARM, OJSC
    Information update date: & nbsp26.08.2017
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