Flukomp Extract (Flucomp Extratab)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCaffeine + Paracetamol + PropyphenazoneCaffeine + Paracetamol + Propyphenazone
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  • Flukomp Extract
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    OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC     Russia
    • Dosage form: & nbspPills
    Composition:

    Composition per one tablet:

    Acetaminophen (paracetamol) - 250 mg

    Propyphenazone - 210 mg

    Caffeine anhydrous - 50 mg

    Auxiliary substances:

    [potato starch - 35.0 mg,

    microcrystalline cellulose - 117.5 mg,

    hypromellose (hydroxypropylmethylcellulose) - 20.0 mg ,

    Copovidone - 3.0 mg ,

    sodium lauryl sulfate - 4.0 mg,

    crospovidone - 30.0 mg ,

    sodium croscarmellose (BP or USP / NF) - 22.5 mg

    magnesium stearate - 8.0 mg ]

    Average weight of a tablet - 750 mg

    Description:

    Tablets white or white with a creamy shade of color, biconvex, oblong with rounded ends, with a risk.

    Pharmacotherapeutic group:Analgesic agent (analgesic non-narcotic remedy + psychostimulating agent)
    ATX: & nbsp

    N.02.B.E   Anilides

    Pharmacodynamics:

    Flukomp Extratab is a combined preparation, the action of which is determined by the components that make up its composition.The combination of the three components of the drug leads to a mutual enhancement of their pharmacological action.
    Paracetamol and propifenazone have an analgesic and antipyretic effect. Paracetamol non-narcotic analgesic. It blocks cyclooxygenase (COX) only in the central nervous system (CNS), affecting the centers of pain and thermoregulation (in cellular tissues, cellular peroxidases neutralize the effect of paracetamol on COX), which explains the almost complete absence of anti-inflammatory effect. The absence of influence on the synthesis of prostaglandins (PG) in peripheral tissues determines the absence of negative influence on it, on water-salt metabolism (sodium and water retention) and gastrointestinal tract mucosa (GIT). The possibility of methaemoglobin formation is unlikely.

    Propyphenazone is a derivative of pyrazolone. The mechanism of action is carried out by inhibiting the COX involved in the formation of prostaglandins from arachidonic acid.

    Caffeine increases the reflex excitability of the spinal cord, excites the respiratory and vessel of the motor, centers, expands-the blood vessels of skeletal muscles brain, heart, kidneys, reduces 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.

    Pharmacokinetics:

    Paracetamol.

    Absorption is high, the connection with plasma proteins is -15,%, the time to reach the maximum concentration in the blood plasma (TSmax) - 20-30 min. Penetrates through blood-brain barrier (BBB). Less than 1% of the dose of paracetamol taken by the lactating mother penetrates into breast milk. The therapeutically effective concentration of paracetamol in plasma is achieved when it is administered at a dose of 10-15 mg / kg. Metabolised in the liver: 80% reacts with glucuronic acid and sulfuric acid to form inactive metabolites; 17th % is hydroxylated to form active metabolites that are conjugated to glutathione and form inactive metabolites. With a lack of glutathione these metabolites can block enzyme systems of hepatocytes and cause their necrosis. The half-life (T1 / 2) is 2-3 hours.
    In elderly patients paracetamol clearance decreases and T1 / 2 increases. It is excreted by the kidneys in an unchanged form of 3%.

    Propyphenazone.

    The antipyrazole in plasma is reached in 30 minutes.Metabolised in the liver. T1 / 2 is 1-1.5 hours. The combination with paracetamol increases the time it is taken to 40% that plays significant role, because allows you to reduce the number of medications a day. It is excreted by the kidneys.

    Caffeine.

    TSmax caffeine -1h; T1 / 2 - 3.5 hours; 65-80 % caffeine is excreted by the kidneys mainly in the form of 1-methylxatine, 1-methyl uric acid and acetylated derivatives of uracil; a small amount turns into theophylline and theobromine.
    Indications:

    In complex therapy to eliminate the symptoms of infectious and inflammatory diseases (ARVI, including influenza), accompanied by fever, chills, headache and muscle pain;

    relief of the pain syndrome of moderate severity of various genesis: headache, migraine, toothache, neuralgia, muscular and rheumatic pain, algodismenorea.
    Contraindications:Hypersensitivity to the drug components, severe renal and / or hepatic impairment, insufficiency, children's age (under 12 years), pregnancy, lactation, glucose-6-phosphate dehydrogenase deficiency, gastric and duodenal ulcer in the acute stage, oppression of bone marrow hematopoiesis , anemia, incl.hemolytic), acute hematoporphyria, bronchial asthma, conditions accompanied by respiratory depression, intracranial hypertension, acute myocardial infarction, arrhythmias, arterial hypertension, alcohol intoxication, alcoholism, glaucoma.
    Carefully:

    With caution apply the drug in the following conditions and diseases:

    benign hyperbilirubinemia (including Gilbert's syndrome), advanced age, glaucoma, alcoholism, epilepsy and a tendency to convulsive seizures.

    When using the drug, control of peripheral blood and the functional state of the liver is necessary. During treatment, you should stop using alcohol containing drinks (increased risk of gastrointestinal bleeding). Excessive consumption of caffeinated products (coffee, tea) on the background of treatment can cause symptoms of an overdose. The drug can be taken complicate the establishment of a diagnosis in acute, abdominal pain syndrome. There is an increased risk of developing hypersensitivity in the complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance of nonsteroidal anti-inflammatory drugs (including in history).

    Pregnancy and lactation:

    The drug is contraindicated for use by pregnant women and women during lactation.

    Dosing and Administration:

    Inside, adults and children over 12 years of age, washed down with plenty of fluids, 1-2 hours after eating (taking immediately after a meal leads to a delay in the onset of action).

    Adults and adolescents: 1 tablet four times a day, as necessary, with an interval between taking at least 4 hours. The maximum single dose is 2 tablets. Do not take more than 6 tablets in 24 hours.

    Do not exceed the indicated dose. If you take a dose that exceeds the recommended dose, seek medical help, even if you are feeling well. Overdose of paracetamol can cause hepatic insufficiency.

    The drug is not recommended for more than five days as an anesthetic and more than three days as an antipyretic.

    Side effects:

    Possible side effects when using a medicinal product Allergic reactions (skin rash, itching, hives, Quincke's edema), multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), dizziness, nausea, epigastric pain; anemia, thrombocytopenia, agranulocytosis; insomnia.

    With long-term use in large doses of hepatotoxic effects,

    hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia, nephrotoxicity.
    Overdose:

    Symptoms: (due to paracetamol, appear after taking 10-15 g) pallor skin, decreased appetite, nausea / vomiting, pain, in the epigastric region, hepatotoxic and nephrotoxic action, in severe cases, - hepatic insufficiency, hepatonecrosis, increased activity of "hepatic" transaminases, increased prothrombin time, encephalopathy and coma.

    Treatment: gastric lavage, the appointment of activated charcoal, symptomatic therapy, the introduction of donators SH-groups and precursors of glutathione-methionine synthesis 8-9 hours after an overdose and N-acetylcysteine ​​after 12 hours.

    Interaction:

    Barbiturates, rifampicin, salicylamide, antiepileptic drugs and other inducers of microsomal liver enzymes contribute to the formation of toxic metabolites of paracetamol, affecting liver function.

    Metoclopramide accelerates the absorption of paracetamol.

    Under the influence of paracetamol, the half-life of chloramphenicol increases five-fold. At repeated reception paracetamol can enhance the effect of indirect anticoagulants (dicumarin derivatives).

    With the simultaneous administration of the drug and alcohol-containing liquids, the risk of toxic damage to the liver increases.

    Caffeine accelerates the absorption of ergotamine.

    Propifenazone increases the effect of oral antidiabetic drugs and anticoagulants, reduces the effectiveness of potassium-sparing diuretics.

    Special instructions:

    The drug is contraindicated for use in children under 12 years.

    Adults with chronic diseases:

    The drug is contraindicated for adult patients with severe renal and / or liver failure, a deficiency of glucose-6-phosphate dehydrogenase, peptic ulcer of the stomach and 12 duodenal ulcer in the stage of exacerbation.

    Effect on the ability to drive transp. cf. and fur:In therapeutic doses not exceeding the maximum daily (6 tablets), the drug does not affect the ability to drive vehicles.
    Form release / dosage:

    Tablets 250 mg + 210 mg + 50 mg.

    For 5, 6, 7, 10, 12, 15 tablets in a contour mesh box made of polyvinyl chloride film and aluminum foil printed lacquered.

    For 1, 2 or 3 contour squares, together with instructions for medical use, are placed in a pack of cardboard.

    Packaging:Pack of cardboard
    Storage conditions:

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

    Keep out of the reach of children.
    Shelf life:

    Shelf life 2 of the year.

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

    Terms of leave from pharmacies:Without recipe
    Registration number:LS-001769
    Date of registration:19.10.2011
    The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp16.10.2011
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