TEMPALGIN® TRIO (Tempalgin® trio)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsppills
Composition:

Composition per one tablet:

Active substances: paracetamol, 96%, substance-mixture-260.4 mg [active substance of the substance-mixture: paracetamol -250.0 mg, excipient substance-mixture: povidone K-30- 10.4 mg], propiphenazone - 150.0 mg , caffeine 50.0 mg.

Excipients: microcrystalline cellulose (type 101) - 90.0 mg, microcrystalline cellulose (type 102) -46.5 mg, povidone K-90 - 11.1 mg, croscarmellose sodium 15.0 mg, glyceryl distearate (Type 1) - 13.0 mg, silicon dioxide (Dental type) - 8.0 mg, talc 2.0 mg, magnesium stearate 4.0 mg.

Description:Round, flat-cylindrical tablets of white or almost white color with a facet and a risk on one side.
Pharmacotherapeutic group:An analgesic agent combined (non-steroidal anti-inflammatory drug + analgesic non-narcotic agent + psychostimulating agent)
ATX: & nbsp
  • Paracetamol in combination with psycholeptics
    • Pharmacodynamics:

    Tempalgin® Trio is a combined preparation that includes analgesics - paracetamol and propifenazone, as well as a psychostimulant caffeine. Paracetamol has analgesic and antipyretic effect, propiphenazone has analgesic, antipyretic action and anti-inflammatory action. Paracetamol non-narcotic analgesic.It blocks cyclooxygenase (COX) only in the central nervous system (CNS), affecting the centers of pain and thermoregulation (in inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on COX), which explains the lack of anti-inflammatory effect. The absence of influence on the synthesis of prostaglandins (PG) in peripheral tissues determines the absence of a negative influence on the water-salt metabolism (sodium and water retention) and the mucosa of the gastrointestinal tract.

    Propyphenazone is a derivative of pyrazolone. Mechanism of action by inhibition of COX involved in the formation of prostaglandins from arachidonic acid.

    Caffeine increases the excitability of spinal cord reflex, excites the respiratory and vasomotor centers, dilates blood vessels in skeletal muscle, brain, heart, kidneys, reducing platelet aggregation; reduces drowsiness, fatigue. In this combination caffeine in a small dose practically does not have a stimulating effect on the central nervous system, but it contributes to the regulation of the tone of the vessels of the brain, reduces drowsiness, intensifies the analgesic effect of other components of the drug.Tempalgin Trio has a pronounced and rapidly advancing analgesic and antipyretic effect. The analgesic effect of the drug begins 30 minutes after application and lasts for several hours.

    Pharmacokinetics:

    Paracetamol

    Absorption is high, the connection with plasma proteins is 15%, the time to reach the maximum concentration in the blood plasma (tmax) - 20-30 minutes. Penetrates through the blood-brain barrier (BBB). Less than 1% of the accepted dose of breastfeeding mothers penetrates into breast milk. The therapeutic effective concentration of paracetamol in plasma is achieved when it is administered at a dose of 10-15 mg / kg.

    Metabolized in the liver: 80% enters the glucuronucleation and sulfation with formation of inactive metabolites; 17% is hydroxylated to form inactive metabolites, which are further conjugated to glutathione. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis.

    The half-life is 2-3 hours. In elderly patients paracetamol clearance decreases and the half-life increases. It is excreted by the kidneys in an unchanged form of 3%.

    Propyphenazone

    The maximum concentration of propiphenazone in plasma is reached after 30 minutes. Metabolised in the liver. The half-life is 1-1.5 hours. The combination with paracetamol increases the time of its elimination by 40%, which plays a significant role, since allows you to reduce the number of medications a day. It is excreted by the kidneys.

    Caffeine

    Time to reach the maximum concentration - 1 hour; half-life - 3.5 hours; 65-80% of caffeine is excreted by the kidneys mainly in the form of 1-methylxanthine, 1-methyl uric acid and acetylated derivatives of uracil, a small amount turns into theophylline and theobromine.

    Indications:

    It is used for cupping pain syndrome of mild and moderate intensity of various genesis: headache, migraine, toothache, arthralgia, myalgia, algodismenorea.

    In complex therapy as an antipyretic agent in feverish conditions against the background of infectious and inflammatory diseases (acute respiratory viral infection, influenza, etc.).
    Contraindications:

    Hypersensitivity to the components of the drug, severe renal and / or liver failure, deficiency of the enzyme glucose-6-phosphate dehydrogenase, oppression of bone marrow hematopoiesis (leukopenia, anemia, incl.hemolytic), acute gematoporfiriya, full or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to nonsteroidal anti-inflammatory drugs (including history), states accompanied by respiratory depression, intracranial hypertension, acute myocardial infarction, coronary heart disease, arrhythmias, hypertension, peptic ulcer and duodenal ulcer in the acute stage, alcohol intoxication, glaucoma, insomnia, pregnancy, varnish ation of women, children up to 12 years.

    Carefully:Moderate dysfunction of the liver or kidney (see section "Special instructions"); elderly age; alcoholism; epilepsy and a tendency to convulsive seizures; peptic ulcer of stomach and duodenum in anamnesis; benign hyperbilirubinemia (including in the syndrome of Gilbert, Dubin-Johnson, Rotor).
    Pregnancy and lactation:

    Pregnancy

    The drug is not recommended for use during pregnancy.

    Breast-feeding

    Due to the fact that active ingredients of the drug are excreted in breast milk, its use during breast-feeding is not recommended.

    Dosing and Administration:

    Tablets are taken orally, 1-2 hours after eating, with plenty of liquid.

    Dosage

    Adults: 1-2 tablets 1-3 times a day. The maximum single dose is 2 tablets. The maximum daily dose is 6 tablets.

    In patients with moderate renal impairment (creatinine clearance below 10 ml / min) the interval between 2 doses of the drug should be at least 8 hours.

    Adolescents from 12 to 18 years: 1/2 1/2 tablets 1-3 times a day.

    The drug should not be used for more than 3 days as an antipyretic agent and not more than 5 days as an anesthetic.

    Do not exceed the recommended dose. If you have taken a dose exceeding the recommended dose, seek medical help, even if you are feeling well. Overdose of paracetamol can cause hepatic insufficiency.

    Side effects:

    Undesirable reactions are classified according to the system-organ class and frequency as follows: very often (≥1 / 10), often (≥1 / 100 to <1/10), infrequently (≥1 / 1,000 to <1/100), rarely (≥1 / 10,000 to <1/1 000), very rarely (<1/10 000), with an unknown frequency (based on existing data, it is impossible to make an estimate).

    From the central nervous system

    Rarely - dizziness, sleep disturbance.

    With unknown frequency - Insomnia, anxiety, headache.

    From the gastrointestinal tract

    Rarely - nausea, vomiting, heaviness and discomfort in the stomach.

    From the hepatobiliary system

    Rarely - a violation of the liver.

    From the respiratory system

    Rarely - bronchospasm.

    From the hematopoietic system

    Rarely - Lakopenia, thrombocytopenia, agranulocytosis, hemolytic anemia, methemoglobinemia, pancytopenia.

    From the immune system

    Rarely - skin rash, itching, hives, Quincke's edema, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

    Overdose:

    Symptoms (due to paracetamol) during the first 24 hours after an overdose of the drug - nausea, vomiting, abdominal pain, pale skin, decreased appetite. Signs of liver damage (tenderness in the liver, increased activity of microsomal liver enzymes) can appear through 12-48 h after an overdose. It is possible to develop a violation of carbohydrate metabolism and metabolic acidosis.In adult patients, liver damage develops after taking 10 g of paracetamol. In the presence of factors that affect the toxicity of paracetamol for the liver, liver damage is possible after taking 5 or more grams of paracetamol. In severe cases of overdose, as a result of hepatic insufficiency, encephalopathy and coma may develop, acute renal failure with tubular necrosis (including in the absence of severe liver damage) arrhythmia, pancreatitis.

    Treatment: within 1 hour after an overdose it is recommended to wash the stomach, the appointment of activated charcoal, symptomatic therapy.

    The introduction of acetylcysteine ​​is most effective during the first 8 hours after an overdose, over time, effectiveness is given, if necessary, intravenous donators SH-groups and precursors of the synthesis of glutathione-methionine within the next 24 hours after an overdose, treatment of such patients is carried out under conditions of specialized separation of liver diseases.

    High doses of caffeine cause the following symptoms: headache, tremor, irritability, gastralgia, agitation, motor anxiety, confusion, tachycardia, arrhythmia, hyperthermia, dehydration, increased tactile and pain sensitivity, frequent urination, headache, nausea, vomiting (sometimes with blood), ringing in the ears, convulsions (with acute overdose of tonic-clonic).

    Treatment: gastric lavage, intake of activated carbon, laxatives; with hemorrhagic gastritis - the introduction of antacids, washing the stomach with an ice 0.9% solution of sodium chloride; maintenance of ventilation and oxygenation; with convulsions - intravenous diazepam, phenobarbital, maintenance of water-electrolyte balance.

    It should be borne in mind that the appearance of clinically significant symptoms of caffeine overdose when taking this drug is always associated with severe liver damage caused by an overdose of paracetamol.

    Interaction:

    Simultaneous use of paracetamol with drugs, inducers of microsomal liver enzymes, such as some hypnotic drugs (barbiturates), antiepileptic drugs (phenobarbital, phenytoin, carbamazepine), rifampicin, ethanol, may increase the risk of toxic damage to the liver, even with therapeutic doses.

    Under the influence of paracetamol, the period half-life of chloramphenicol increases 5-fold.

    Simultaneous use with metoclopramide or domperidone accelerates the absorption of paracetamol.

    Simultaneous use of paracetamol in high doses increases the effect of anticoagulants, which increases the risk of bleeding.

    Myelotoxic means reinforce manifestations of hematotoxicity paracetamol.

    Simultaneous use with acetylsalicylic acid and other non-steroidal anti-inflammatory drugs increases the risk of kidney damage.

    Cholestyramine and antacid drugs reduce the absorption of paracetamol.

    The effectiveness of paracetamol may decrease with simultaneous use with cholestyramine, anticholinergics, antidepressants, alkaline substances.

    The use of paracetamol together with zidovudine increases the risk of developing neutropenia.

    The use of paracetamol can affect the results of analyzes of uric acid and blood glucose levels.

    Caffeine accelerates the absorption of ergotamine; reduces absorption of calcium preparations; reduces the effect of narcotic and hypnotics, increases the excretion of lithium preparations; accelerates absorption and enhances the action of cardiac glycosides, increases their toxicity. Simultaneous use of caffeine with beta-blockers can lead to mutual suppression of therapeutic effects, with beta-adrenomimetics to additional stimulation of the central nervous system and other toxic effects. Caffeine reduces the effect of many sedatives, such as barbiturates, antihistamines; strengthens tachycardia, provoked by sympathomimetics, thyroxine.

    Oral contraceptives, cimetidine and disulfiram slow the metabolism of caffeine, barbiturates and tobacco speed it up.

    Simultaneous use with inhibitors of DNA gyrase (eg, ciprofloxacin) may slow the elimination of caffeine and its metabolite paraxanthin.

    Caffeine leads to a slower release of theophylline when they are used simultaneously. Inhibitors of monoamine oxidase, furazolidone, procarbazine, selegiline and large doses of caffeine can cause the development of dangerous cardiac arrhythmias or a marked increase in blood pressure.

    Mexiletine reduces the excretion of caffeine by 50%. Caffeine is an adenosine antagonist.

    Caffeine can interact with ephedrine, causing clinically significant cardiovascular effects, so their simultaneous use should be avoided.

    Propifenazone can increase the effect of oral hypoglycemic agents, sulfonamide drugs, anticoagulants, ulcerogenic effect of glucocorticosteroids, and decrease the effectiveness of potassium-sparing diuretics.

    Special instructions:

    With prolonged use of the drug (more than 5 days), control of the picture of peripheral blood and the functional state of the liver is necessary. During treatment, you should stop using alcohol-containing beverages (increased risk of gastrointestinal bleeding).

    In the presence of violations of the function of the lobes, the drug should be administered under the supervision of a physician while monitoring the clearance of creatinine.

    When using Tempalgina® Trio, it is not recommended to take other medications containing paracetamol and / or pyrazolone derivatives, including metamizol sodium. Excessive consumption of caffeine-containing foods during treatment may cause symptoms of caffeine overdose.

    Taking the drug may make it difficult to establish a diagnosis for acute abdominal pain syndrome.

    Deficiency of glutathione due to eating disorders, dietary fibrosis, HIV infection, starvation, exhaustion causes the possibility of developing severe liver damage with small overdoses of paracetamol (5 g or more). It is necessary to inform the attending physician, when performing tests for the determination of urinary acid and blood glucose level that you are taking this medication. Can change the results of doping control tests in athletes.

    The use of the drug as a means to relieve the headache, longer than the recommended time, can lead to chronic headaches.

    Effect on the ability to drive transp. cf. and fur:During the period of taking the drug, care should be taken when driving vehicles and engaging in other activities that require an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:

    Tablets 50 mg + 250 mg + 150 mg.

    Packaging:

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

    For 2 blisters together with instructions for use, put in a pack of cardboard.

    Storage conditions:

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

    Keep out of the reach of children!

    Shelf life:

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

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-004433
    Date of registration:28.08.2017
    Expiration Date:28.08.2022
    The owner of the registration certificate:Sopharma, AOSopharma, AO Bulgaria
    Manufacturer: & nbsp
    Representation: & nbspSOFARMA SA SOFARMA SA Bulgaria
    Information update date: & nbsp29.09.2017
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