Tempalgin® (Tempalgin®)

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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  • Tempalgin®
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    Sopharma, AO     Bulgaria
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    Balkanfarma - Dupnitsa AD     Bulgaria
    • Dosage form: & nbspTfilm-covered abeys.
    Composition:

    1 tablet contains:

    active substances: metamizole sodium monohydrate - 500.0 mg; triacetonamino-4-toluenesulfonate 20.0 mg;

    Excipients: wheat starch (95.0 mg), microcrystalline cellulose (75.0 mg), povidone K 25 (45.0 mg), talc (15.0 mg), magnesium stearate (10.0 mg);

    film coating:

    Opapray II green 85F21526 (23.0 mg):

    - Polyvinyl alcohol partially hydrolyzed - 9.2 mg;

    - Macrogol 3350 - 4,646 mg;

    - Titanium dioxide (E 171) - 4.37 mg;

    - Talc - 3.404 mg;

    - Quinoline yellow (E 104) aluminum varnish - 1,035 mg;

    - Brilliant blue (E 133) FCF aluminum varnish - 0.345 mg.

    Description:Round, biconvex tablets, covered with a film coat, green in a transverse section of almost white color.
    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:Metamizole sodium as an analgesic agent has a strong analgesic and anti-inflammatory effect.It inhibits the synthesis of prostaglandins, suppressing cyclooxygenase, has some membrane-stabilizing action, inhibits the formation of endogenous pyrogens. Triazetonamine-4-toluenesulfonate has a moderate anxiolytic activity and relieves anxiety, fear and tension. It reduces motor excitation, has a central n-anticholinergic action, intensifies and prolongs the analgesic effect of metamizole sodium, suppressing the emotional component of pain. The combination of metamizole sodium and triacetonamine-4-toluenesulfonate enhances the analgesic effect of metamizole sodium and increases the duration of its action.
    Pharmacokinetics:

    After oral administration metamizol sodium hydrolyzed in the gastrointestinal tract. Active metabolites are 4-methylaminoantipyrine (MAA) and 4-aminoantipyrine (AA). MAA is characterized by rapid and complete absorption. The maximum concentration in the blood plasma is reached within 1-2 hours. The bioavailability of MAA is about 90%.

    Food does not affect the pharmacokinetics of metamizole sodium.

    Triazetonamine-4-toluenesulfonate is absorbed in the upper gastrointestinal tract.Therapeutic plasma concentrations are established 30 minutes after admission.

    The maximum plasma concentration of 0.8 μg / ml is reached within 60 min.

    Metamizole sodium partially binds to plasma proteins.

    Metamizole sodium is subject to intensive metabolism in the liver. Its main metabolites MAA, AA are pharmacologically active.

    It is excreted in the urine in the form of metabolites, with only 3% of the allocated amount of metamizole sodium being unchanged. Metabolites of metamizole sodium are excreted in breast milk. Triazetonamine-4-toluenesulfonate is excreted unchanged in urine, in an amount of 2/3 of the applied dose.

    Patients with hepatic impairment: The half-life of the active metabolite MAA in patients with impaired liver function is approximately 3-fold longer. Such patients are recommended treatment with lower doses of metamizole sodium.

    Patients with impaired renal function: In patients with impaired renal function, a decrease in the excretion rate of some metabolites is observed. These patients are recommended treatment with lower doses of metamizole sodium.

    Indications:

    For a brief symptomatic treatment of mild to moderate pain in the following conditions: headache, toothache and dental procedures, myalgia, neuralgia, joint pain (arthralgia).

    Contraindications:

    - Hypersensitivity to metamizole sodium, triacetonamine-4-toluenesulfonate or any of the excipients;

    - hypersensitivity to other pyrazolone preparations;

    - impaired metabolism of porphyrin and bilirubin (acute hepatic porphyria);

    - Anemia due to insufficiency of glucose-6-phosphate dehydrogenase (threat of hemolysis);

    severe liver or kidney disease;

    - impaired bone marrow function (eg after treatment with cytostatics) or diseases of the hematopoietic system (aplastic anemia, agranulocytosis, violation of white blood cells (leukopenia);

    - hypotension with blood pressure values ​​below 100 mm Hg;

    - pregnancy and the period of breastfeeding;

    - Children under 15 years of age.

    Carefully:

    Kidney disease (tubulointerstitial nephritis (pyelonephritis), glomerulonephritis, including in history), moderate renal and / or hepatic insufficiency,with a complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (including history), predisposition to low blood pressure, alcoholism.

    Pregnancy and lactation:

    Pregnancy

    Controlled clinical trials in pregnant women have not been conducted and there are no data on the use of the drug in this group. Although metamizol sodium is a weak inhibitor of the synthesis of prostaglandins, there is a possibility of premature closure of the Botallus duct and perinatal complications as a result of reduced platelet aggregation in the fetus and the mother, so the use of the drug is contraindicated in pregnancy.

    Breast-feeding

    Metabolites of metamizole sodium are excreted in breast milk. If treatment with Tempalgin® is required, breastfeeding should be discontinued.

    Dosing and Administration:

    Inside. Tablets are taken after meals, washed down with water.

    Dosage

    The dose depends on the severity of the pain, and on the individual sensitivity to the drug.

    Adults

    Usual dose - 1 tablet 1-3 times a day. The maximum single dose should not exceed 1 tablet. The maximum daily dose is 4 tablets.

    With dental procedures: 1 tablet 30 minutes before the intervention.

    Children over 15 years of age

    1 tablet a day. The maximum daily dose is 2 tablets.

    Patients over 65 years of age

    Usually, dose reduction is not required. In patients with age-related renal and hepatic impairment, treatment with Tempalgin® should be short-lived. The maximum daily dose of 2 tablets.

    Patients with impaired hepatic function

    In such patients, it is possible to increase the half-life of metamizole sodium metabolites. In patients with moderate or severe liver damage, a recommended dose of 1/2 is recommended for adults (maximum daily dose of 2 tablets).

    Patients with impaired renal function

    Metamizol sodium and its metabolites are excreted by the kidneys. In patients with renal disease, treatment with Tempalgin® should be performed using 1/2 the recommended dose for adults (maximum daily dose of 2 tablets).

    Duration of treatment

    Treatment with Tempalgin® should not last more than 3-5 days. Its use for a longer period of time or in higher doses is possible only after consulting a doctor.

    Side effects:

    Possible side effects with Tempalgin® are most often due to sodium metamizole:

    Violations of the blood and lymphatic system: violation of white blood cells (leukopenia), agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia.

    Immune system disorders: fixed drug exanthema, maculopapular rash, anaphylactic or anaphylactoid reactions, itching, burning, urticaria, edema (generalized or local), malignant exudative erythema (erythema multiforme, Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospasm, asthmatic attack (in patients with aspirin asthma), cardiogenic shock.

    Disorders from the metabolism and nutrition: decreased appetite.

    Disturbances from the nervous system: headache, dizziness.

    Disorders from the cardiovascular system: heart rhythm disturbance (tachycardia), cyanosis, lowering of blood pressure (sometimes with a previous increase), dyspnea.

    Disturbances from the gastrointestinal tract (GIT): nausea, vomiting, pain and discomfort in the abdomen; ulceration of the mucous membrane of the gastrointestinal tract and bleeding from the gastrointestinal tract.

    Disturbances from the liver and bile ducts: increased levels of hepatic enzymes (ACT, ALT), cholestasis, jaundice.

    Disorders from the kidneys and urinary tract : proteinuria, oliguria, anuria, polyuria, interstitial nephritis.

    Overdose:

    Because of the increased risk of agranulocytosis with prolonged use of the drug, it is necessary to monitor the blood picture, including the leukocyte formula.

    Overdose Symptoms:

    from the gastrointestinal tract - nausea, vomiting, vomiting of blood, tarry stools;

    from the central nervous system and peripheral nervous system - lesser-like syndrome, tinnitus, drowsiness, respiratory arrest, coma with lowering of arterial pressure, tonic-clonic convulsions;

    from the hematopoiesis system - agranulocytosis, aplastic anemia, hemorrhagic diathesis;

    from the side of metabolism metabolic alkalosis;

    from the urinary system - oliguria to anuria;

    toxic-allergic reactions - bullous-urticarial and petechial, sometimes korepodobnaya or typhoid rash;

    other - some of the patients may develop a toxic-allergic shock.

    Treatment: gastric lavage, saline laxatives, Activated carbon, hemodialysis or forced diuresis, symptomatic therapy, with the development of convulsive syndrome - iv injection of diazepam and fast-acting barbiturates.

    Interaction:

    The action of tricyclic antidepressants (imipramine, amitriptyline), oral contraceptives, analgesics, allopurinol and alcohol is potentiated with simultaneous use with metamizole sodium.

    Barbiturates and phenylbutazone reduce the strength and shorten the duration of pharmaco-dynamic effects of metamizole sodium due to the induction of hepatic enzymes.

    Metamizole sodium lowers the activity of coumarin anticoagulants when used as a result of induction of liver enzymes.

    Metamizole sodium lowers plasma levels of cyclosporine.

    Chloramphenicol and other hematopoietic suppressants increase myelotoxicitymetamizole sodium.

    With the simultaneous use of metamizole sodium with chlorpromazine may occur hypothermia.

    Triazetonamine-4-toluenesulfonate potentiates the sedative effect of hypnotics, agents for general anesthesia, narcotic and non-narcotic analgesics.

    Special instructions:

    Treatment with Tempalgin® (because of the sodium metamizole content) is carried out only for a short period of time when there is no other alternative treatment.

    Tempalgin® should be administered with caution to allergic patients, patients with hypersensitivity to analgesic and antirheumatic drugs (analgesic intolerance), to other medicines or food products because of the increased risk of allergic reactions with complete or incomplete combination of bronchial asthma, recurrent polyposis nose and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs reparatov (including in the anamnesis).

    Metamizole sodium can provoke hypotensive reactions.Treatment with Tempalgin® should be carried out with extreme caution in patients with reduced blood pressure, fluid deficiency in the body or dehydration, unstable blood circulation.

    With simultaneous use with alcohol, the risk of side effects increases.

    Use with caution in patients with liver or kidney damage.

    Wheat starch, which is a part of the preparation, can contain only traces of gluten and is considered safe for persons with celiac disease.

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

    In connection with the presence of an anxiolytic agent (triacetonamine-4-toluenesulfonate) during the treatment period, it is necessary to refrain from carrying out potentially dangerous activities requiring special attention and speed of reactions (driving and other vehicles, working with moving mechanisms, dispatcher work and operator, etc.)

    Form release / dosage:

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

    Packaging:

    For 10 tablets in a blister of PVC / aluminum foil.

    For 2 or 10 blisters together with instructions for use in a cardboard bundle.

    For 30 blisters in a cardboard box together with an equal number of instructions for use (for inpatient).

    Storage conditions:

    In a dry place, at a temperature not exceeding 25 FROM.

    Keep out of the reach of children.

    Shelf life:

    4 years.

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

    Terms of leave from pharmacies:Without recipe
    Registration number:P N008775
    Date of registration:30.06.2010 / 25.08.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Sopharma, AOSopharma, AO Bulgaria
    Manufacturer: & nbsp
    Representation: & nbspSOFARMA SA SOFARMA SA Bulgaria
    Information update date: & nbsp29.12.2016
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