Active substanceParacetamolParacetamol
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  • Dosage form: & nbsppills
    Composition:

    Each tablet contains:

    Active substance: paracetamol 200 mg or 500 mg.

    Auxiliary substances: potato starch, stearic acid, starch syrup, gelatin - to obtain tablets weighing 220 mg or 550 mg.

    Description:Tablets from white to white with a creamy shade of color, flat-cylindrical with a facet and a risk.
    Pharmacotherapeutic group:analgesic non-narcotic remedy
    ATX: & nbsp

    N.02.B.E   Anilides

    N.02.B.E.01   Paracetamol

    Pharmacodynamics:

    Paracetamol has an analgesic and antipyretic effect. The drug blocks cyclooxygenase I and II mainly in the central nervous system, affecting the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase,which explains the almost complete absence of anti-inflammatory effect. The drug has no adverse effect on water-salt metabolism (sodium and water retention) and gastrointestinal mucosa due to the lack of influence on the synthesis of prostaglandins in peripheral tissues.

    The possibility of methaemoglobin formation is unlikely.
    Indications:

    Moderately or mildly expressed pain syndrome (headache, dental, migraine pain, neuralgia, myalgia).

    Elevated body temperature for colds and other infectious and inflammatory diseases.

    Contraindications:

    - Hypersensitivity to paracetamol.

    - Children up to 8 years.

    Carefully:renal and hepatic insufficiency, benign hyperbilirubinemia (including Gilbert's syndrome, viral hepatitis, alcoholic liver damage), alcoholism, pregnancy, lactation, elderly age, deficiency of glucose-6-phosphate dehydrogenase
    Dosing and Administration:

    Apply inside with a large amount of liquid for 0.5 g-1 g 2-3 times a day at intervals of not less than 4 hours. The maximum single dose for adults and children over 15 years is 1 g, daily - 4 g.

    In patients with impaired hepatic or renal function, with Gilbert's syndrome and in elderly patients, the interval between doses should be at least 8 hours and the daily dose should be reduced.

    Children are prescribed 10-15 mg / kg body weight 3-4 times a day (no more than 3 days). Duration of admission is no more than 5 days with the appointment as an anesthetic and 3 days as an antipyretic.

    Side effects:

    - Nausea, vomiting, epigastric pain, allergic reactions (skin rash, itching, hives, Quincke's edema).

    - Rarely, anemia, leukopenia, thrombocytopenia, agranulocytosis.

    - With prolonged use in large doses - hepatotoxic action, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia.

    - Nephrotoxicity (renal colic, pyuria, interstitial nephritis, papillary necrosis).

    Overdose:

    Symptoms: pallor of the skin, anorexia, nausea, vomiting: hepatonecrosis (the severity of necrosis directly depends on the degree of overdose). The toxic effect of the drug in adults is possible after taking more than 10-15 g of paracetamol: an increase in the activity of "liver" transaminases, an increase in prothrombin time, an extensive clinical picture of liver damage manifests itself after 1-6 days.Rarely, liver function abnormalities develop with lightning speed and can be complicated by renal failure (tubular necrosis).

    Treatment: stop taking the drug, do a lavage, take Activated carbon. Further therapeutic measures should be carried out in the setting of a medical institution: the introduction of donators SH-groups and precursors of the synthesis of glutathione-methionine after 8-9 hours after an overdose and N - Acetylcysteine ​​- after 12 h. The need for additional therapeutic measures (further introduction of methionine, iv administration N - acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

    Interaction:

    Stimulants of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, which allows the development of severe intoxication with small overdoses. Ethanol promotes the development of acute pancreatitis. Inhibitors of microsomal oxidation (incl. cimetidine) reduce the risk of hepatotoxic effects.

    Reduces the effectiveness of uricosuric drugs.

    Special instructions:

    With caution and under the supervision of a doctor, the drug should be administered to patients with impaired liver or kidney function, along with other

    anti-inflammatory and analgesic agents, as well as with anticoagulants and drugs affecting the central nervous system. When taking metoclopramide, domperidone or cholestyramine is also necessary consult a doctor.

    Distorts the indicators of laboratory studies in the quantitative determination of sodaneighing uric acid in the plasma. To avoid toxic damage to the liver paracetamol should not be combined with the reception of alcoholic beverages, but also to people prone to chronic alcohol consumption.

    The risk of liver damage increases in patients with alcoholic hepatosis.

    When the drug is used for a long time, it is necessary to monitor the pattern of peripheral blood and the functional state of the liver.

    Form release / dosage:Tablets, 200 and 500 mg.
    Packaging:For 10 tablets in a contour mesh package made of a polyvinylchloride film and aluminum foil or a non-jellied package ofpaper with a polymer coating or a material combined on a paper or cardboard basis. 1200 or 1000 contiguous cell packs with a dosage of 200 mg or 500 mg, respectively, or 900 or 600 contiguous cell-free packages with a dosage of 200 mg or 500 mg respectively, with instructions for use placed in carton boxes.
    Storage conditions:

    In the dark place at a temperature of 10 ° C to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years. Do not use the drug after the expiration of the period indicated on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-009047/08
    Date of registration:18.11.2008
    The owner of the registration certificate:IRBITSK HFZ, OJSC IRBITSK HFZ, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp07.10.2015
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