Tempanginol® (Tempanginol®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceMetamizol sodium + Triacetonamino-4-toluenesulfonateMetamizol sodium + Triacetonamino-4-toluenesulfonate
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    Balkanfarma - Dupnitsa AD     Bulgaria
    • Dosage form: & nbspTfilm-covered abeys.
    Composition:

    1 tablet, film-coated, contains:

    active substances: metamizole sodium 500 mg, triacetonamine-4-toluenesulfonate 20 mg;

    Excipients: wheat starch, microcrystalline cellulose, povidone, talc, magnesium stearate;

    shell: methacrylic acid and methyl methacrylate copolymer 1: 1 (Eudragit L 12.5% ​​as a dry substance), talc, titanium dioxide, macrogol 400, glycerol, castor oil, polysorbate 80, yellow quinoline dye 70 E 104, blue patented E 131 dye.

    Description:

    Round, biconvex tablets, covered with a film membrane of green color. AT the fracture is a white core with a fine-grained structure, surrounded by a continuous green layer of the film shell.

    Pharmacotherapeutic group:Analgesic agent combined (analgesic non-narcotic means + anxiolytic agent)
    ATX: & nbsp

    N.02.B.B.72   Metamizole sodium in combination with psycholeptics

    Pharmacodynamics:

    Combined drug, which includes a non-steroidal anti-inflammatory drug - metamizol sodium and anxiolytic drug (tranquilizer) - triacetonamine-4-toluenesulfonate, which has a mild tranquilizing effect and enhances the analgesic effect of metamizole sodium. The drug has analgesic, antipyretic, weak anti-inflammatory and sedative effect.

    Metamizole sodium suppresses the synthesis of prostaglandins, blocking cyclooxygenase and causing a peripheral analgesic effect (suppresses the synthesis of endogenous algogens).

    Triazetonamine-4-toluenesulfonate reduces motor excitation, relieves the state of tension. Possesses N-holinolytic effect, shows gangliolytic effect.

    Pharmacokinetics:

    After ingestion, the drug is well absorbed from the gastrointestinal tract. The maximum therapeutic effect develops when the maximum concentration of metamizole sodium in the blood plasma is reached. Time to reach the maximum concentration of metamizole sodium in blood plasma is observed in 30-120 minutes after taking the drug. Metamizol sodium partially binds to plasma proteins. Metabolised in the liver.It is subject to rapid hydrolysis in the body, with some of the metabolites having pharmacological activity.

    The half-life of metamizole sodium is 7 hours, and its active metabolites - 2 hours. 90% of the drug is excreted in the urine in the form of metabolites and 10% - with bile.

    Triazetonamine-4-toluenesulfonate is well absorbed in the gastrointestinal tract. The concentration of triacetonamino-4-toluenesulfonate is sufficient for the therapeutic effect achieved 30 minutes after the administration of the drug. 2/3 of the accepted dose is excreted in the urine unchanged. Half-life is up to 3 days.

    Indications:

    Pain syndrome is mild and mild (including headache, toothache, migraine, neuritis, lumbago, neuralgia, myalgia, arthralgia, algodismenorea), especially in people with emotional lability.

    Pain syndrome with renal, hepatic, intestinal colic weakly expressed (in combination with antispasmodics).

    Pain syndrome after surgical and diagnostic interventions (as part of combination therapy).

    Contraindications:

    Hypersensitivity, marked renal / hepatic insufficiency, porphyria,chronic heart failure, arterial hypotension (systolic blood pressure below 100 mmHg), hematopoietic suppression (hemolytic anemia, aplastic anemia, granulocytopenia, leukopenia, agranulocytosis, cytostatic or infectious neutropenia), congenital 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); patients with gluten enteropathy, pregnancy and lactation period, children's age (up to 14 years).

    Carefully:

    Kidney disease (pyelonephritis, glomerulonephritis, including in history), moderate renal and / or liver failure, bronchial asthma, predisposition to the development of arterial hypotension, prolonged abuse of ethanol, the presence of edema and food allergy in the anamnesis.

    Dosing and Administration:

    Inside, not liquid, with enough liquid, during or after a meal: adults and children from 14 years - 1 tablet 1-3 times a day, with insufficient effectiveness - 4 times a day.

    The maximum single dose is 2 tablets, the maximum daily dose is 6 tablets.

    Duration of reception - no more than 5 days.

    Depending on the clinical situation, an increase in the daily dose or the duration of treatment under medical supervision is possible.

    Side effects:

    From the digestive system: nausea, vomiting, stomach pain, ulceration of the gastric mucosa, bleeding in the gastrointestinal tract, burning in the epigastric region, dry mouth, cholestasis, jaundice, increased activity of "liver" transaminases, hyperbilirubinemia.

    From the nervous system: rarely - headache, dizziness; in isolated cases - hallucinations.

    From the side of the cardiovascular system: decrease or increase in blood pressure, tachycardia, cyanosis.

    On the part of the system of hematopoiesis: agranulocytosis, leukopenia, thrombocytopenia, hemolytic anemia, thrombocytopenic purpura.

    From the respiratory system: shortness of breath, asthma attack, bronchospasm - in predisposed patients.

    From the urinary system: renal dysfunction (when taking high doses) - oliguria, anuria, proteinuria, interstitial nephritis; staining the urine in red.

    Allergic reactions: urticaria (incl.on the conjunctiva and mucous membranes of the nasopharynx), skin rash, itching, angioedema, in rare cases - multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospasm, anaphylactic shock.

    From the skin: epidermolysis, necrotic processes in the oral cavity, nose, ears and genitals.

    Overdose:

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

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

    Interaction:

    Enhances the effects of ethanol.

    Simultaneous use with chlorpromazine or other phenothiazine derivatives can lead to the development of severe hyperthermia.

    Chloramphenicol and other drugs that suppress hematopoiesis increase the myelotoxic effect of metamizole sodium.

    Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

    With the simultaneous administration of metamizole sodium and cyclosporine, the concentration of the latter in the blood decreases.

    Metamizole sodium, displacing from the bond with protein oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin, increases their activity.

    Phenylbutazone, barbiturates and other inducers of microsomal liver enzymes at the same time reduce the effectiveness of metamizole sodium.

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

    Triazetonamine-4-toluenesulfonate potentiates the effect of hypnotics, general anesthetics, narcotic and non-narcotic analgesics.

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

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

    Special instructions:

    During the intake of the drug should be excluded from the use of ethanol.

    In the treatment of patients receiving cytotoxic drugs, metamizole sodium should be administered only under medical supervision.

    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 phenomena of vaginitis or proctitis, immediate withdrawal of the drug is necessary.

    With long-term use (more than 1 week), it is necessary to monitor the picture of peripheral blood and liver function parameters.

    At an arterial hypotension before the beginning of treatment it is necessary to measure arterial pressure.

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

    It is possible to stain urine red due to the release of metamizole sodium metabolite (does not matter).

    The drug should not be used in patients with gluten enteropathy in view of the presence of wheat starch in the composition.

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

    During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Tablets, film-coated, 500 mg + 20 mg.

    Packaging:

    For 10 tablets in a blister made of polyvinyl chloride film and aluminum foil.

    For 1 or 2 blisters together with instructions for use in a cardboard box.

    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    4 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N013814 / 01
    Date of registration:20.07.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:Balkanfarma - Dupnitsa ADBalkanfarma - Dupnitsa AD Bulgaria
    Manufacturer: & nbsp
    Representation: & nbspAktavis, Open Company Aktavis, Open Company
    Information update date: & nbsp29.12.2016
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