Migraine (Migrenium)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCaffeine + ParacetamolCaffeine + Paracetamol
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    • Dosage form: & nbsp

    film-coated tablets

    Composition:

    Active substances: paracetamol - 0.500 g; caffeine - 0.065 g;

    Excipients: potato starch, microcrystalline cellulose, croscarmellose sodium, giprolose (hydroxypropylcellulose), silicon colloidal dioxide (grade A-300), magnesium stearate;

    shell composition: giprolose (hydroxypropyl cellulose), copovidone, talc, titanium dioxide, silicone emulsion (50% solution).

    Description:

    The tablets are oval, biconcave, covered with a film coat of white or almost white color with a risk on one side. Two layers are visible on the cross-section. The color of the core is white or almost white in color.

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

    N.02.B.E.71   Paracetamol in combination with psycholeptics

    Pharmacodynamics:

    Migraine is a combined drug, the action of which is determined by the components that make up its composition.

    Caffeine exerts a psychostimulant (stimulates the psychomotor centers of the brain), an analeptic effect, enhances the effect of analgesics, eliminates drowsiness and fatigue, increases physical and mental performance.

    Paracetamol - antipyretic and analgesic effect (due to inhibition of cyclooxygenase (COX) and inhibition of prostaglandin synthesis (Pg) affects the center of thermoregulation in the hypothalamus and pain impulses in the central nervous system (CNS)).

    The drug blocks COX 1 and 2 mainly in the central nervous system, affecting the centers of pain and thermoregulation. In inflamed tissues cellular peroxidase neutralize the effect of paracetamol on the cyclo-oxygenase, which explains the almost complete absence of his anti-inflammatory effect. The drug does not adversely affect the water-salt metabolism (sodium and water retention) and the mucous membrane of the gastrointestinal tract (GIT) due to the lack of influence on the synthesis of prostaglandins in peripheral tissues: The possibility of forming methhemoglobin -unlikely.
    Pharmacokinetics:

    Caffeine is well absorbed in the intestine (including the large intestine). The time to reach the maximum concentration AT plasma (TCam) - 50-75 minutes after ingestion, the maximum concentration (Cmax) is 1.58-1.76 mg / l. Quickly rasredelyaetsya in all organs and tissues of the body; easily penetrates the blood-brain barrier and the placenta. Communication with blood proteins (albumins) is 25-36%. The half-life of the drug (T1/2) is about 5 hours, in some individuals - up to 10 hours. The main part is demethylated and oxidized. About 10% is excreted by the kidneys unchanged.

    Paracetamol is rapidly and almost completely absorbed from the digestive tract. The concentration in the plasma reaches a maximum after 30-60 minutes. Cmax - 5-20 mcg / ml. Connection with plasma proteins - 15%. T1/2 plasma - 1-4 hours Metabolised in the liver. Excreted in the urine, the main in the form of esters with glucuronic and sulfuric acids; less than -5% - is output inchanged form.

    Indications:

    Pain syndrome (mild and moderate): headache, migraine, ossalgia, myalgia, neuralgia, arthralgia, algodismenorea, toothache; febrile syndrome, including those with "colds", ARVI and influenza.

    Contraindications:

    Hypersensitivity, severe hepatic and / or renal failure, epilepsy, deficiency of glucose-6-phosphate dehydrogenase, old age, children's age (up to 12 years).

    Carefully:

    Pregnancy, lactation, congenital hyperbilirubinemia (syndromes Gilbert, Dubin-Johnson and Rotor).

    Pregnancy and lactation:Carefully.
    Dosing and Administration:

    Inside, adults and children from 12 years - 1-2 tablets 4 times a day with an interval of at least 4 h. The maximum daily dose is 8 tablets.

    Duration of application - no more than 3 days (as an antipyretic) and no more than 5 days (as analgesic).

    Side effects:

    Allergic reactions (skin rash, angioedema, urticaria), dyspeptic disorders (including nausea, epigastric pain).

    In rare cases - hemolytic anemia, thrombocytopenia, methemoglobinemia.

    With prolonged use in large doses - hepatotoxicity, pancytopenia, nephrotoxicity (renal colic, pyuria, interstitial nephritis, papillary necrosis).

    Overdose:

    Symptoms:

    For paracetamol - pallor of the skin, decreased appetite, nausea, vomiting,sometimes with blood; hepatonecrosis (the severity of necrosis due to intoxication directly depends on the degree of overdose), gastralgia, agitation, anxiety, agitation, motor anxiety, confusion, delirium, dehydration, tachycardia, arrhythmia, hyperthermia, frequent urination, headache, increased tactile or pain sensitivity, tremor or muscle twitching; ringing in the ears, epileptic seizures (with acute overdose - tonic-clonic), increased activity of "liver" transaminases, an increase in prothrombin time; a detailed clinical picture of liver damage manifests itself after 1-6 days.

    For caffeine - gastralgia, agitation, anxiety, agitation, motor anxiety, confusion, delirium, dehydration, tachycardia, arrhythmia, hyperthermia, frequent urination, headache, increased tactile or pain sensitivity, tremor or muscle twitching; nausea and vomiting, sometimes with blood; ringing in the ears, epileptic seizures (with acute overdose - tonic-clonic). Caffeine in doses more than 300 mg / day (incl.against the background of the abuse of coffee - more than 4 cups of natural coffee at 150 ml) can cause anxiety, tremor, headache, confusion, extrasystole.

    Treatment:

    For paracetamol: introduction of donators SH-groups and precursors of the synthesis of glutathione-methionine for 8-9 hours after overdose and acetylcysteine-for 12 hours. To prevent late-onset toxicity, gastric lavage is performed.

    For caffeine: gastric lavage if caffeine was taken in the last 4 hours at a dose of more than 15 mg / kg and there was no vomiting caused by caffeine; reception of activated carbon, laxative drugs; with hemorrhagic gastritis - the introduction of antacid drugs and washing the stomach with an ice-cold 0.9% solution of sodium chloride; maintenance of ventilation and oxygenation; with epileptic seizures - intravenously injected diazepam, phenobarbital or phenytoin; maintaining the balance of liquid and salts.

    Interaction:

    Caffeine enhances the action of monoamine oxidase inhibitors (MAO).

    Caffeine accelerates the absorption of ergotamine.

    Mexiletine - reduces caffeine withdrawal to 50%; nicotine - Increases the speed of caffeine removal.

    Caffeine reduces absorption of calcium preparations in the digestive tract, reduces the effect of narcotic and hypnotic drugs, increases the excretion of lithium drugs with urine; accelerates absorption and enhances the action of cardiac glycosides, increases their toxicity.

    Joint use of caffeine with beta-blockers can lead to mutual suppression of therapeutic effects; with adrenergic bronchodilating drugs - to additional stimulation of the CNS, and other additive toxic effects.

    Caffeine can reduce the clearance of theophylline and, possibly, other xanthines, increasing the possibility of additive pharmacodynamic and toxic effects.

    With the joint use of caffeine and barbiturates, primidone, anticonvulsant drugs (hydantoin derivatives, especially phenytoin) it is possible to increase metabolism and increase caffeine clearance; cimetidine, oral contraceptive drugs, disulfiram, ciprofloxacin, norfloxacin - a decrease in the metabolism of caffeine in the liver (slowing its elimination and increasing blood concentrations).

    Paracetamol reduces the effectiveness of uricosuric medicines (LS).

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

    With long-term admission paracetamol can enhance the effect of anticoagulants (derivatives of dicumarin).

    Simultaneous reception of paracetamol and ethanol increases the risk of hepatotoxic effects and acute pancreatitis. Barbiturates, phenytoin, ethanol, rifampicin, phenylbutazone, tricyclic antidepressants and other stimulators of microsomal oxidation, increase the production of hydroxylated active metabolites, causing the possibility of the development of severe intoxication with small overdoses. Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic effects. Metoclopramide and domperidone increase, and colestramine reduces absorption.

    Long-term combined use of paracetamol increases the risk of developing "analgesic" nephropathy and renal papillary necrosis, the onset of the terminal stage of renal failure.

    Simultaneous long-term administration of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer.

    Special instructions:

    Excessive consumption of caffeinated products (coffee, tea) on the background of treatment can cause symptoms of an overdose.

    With prolonged (more than 1 week) treatment, monitoring of the peripheral blood picture and the functional state of the liver is necessary. Without consulting a doctor take no more than 3 days in the treatment of febrile syndrome and no more than 5 days - with pain.

    Can change the results of tests of doping control athletes:

    It is difficult to establish a diagnosis with an "acute abdomen".

    In patients with atopic bronchial asthma, pollinosis, there is an increased risk of allergic reactions.

    During treatment should be abandoned the use of ethanol (increased risk of hepatotoxicity).

    Form release / dosage:

    Tablets, film-coated 65 mg + 500 mg.

    Packaging:For 10 tablets in a planar cell package, 10 tablets per jar type BTS, or in a can of polymer. Each jar or 1, 2 contour squeeze packs is placed in a cardboard pack together with instructions for use.
    Storage conditions:

    In a dry, protected from light place at a temperature of no higher than 25 ° C.

    In a place inaccessible to children.

    Shelf life:

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

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-008564/10
    Date of registration:23.08.2010 / 28.04.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:Promomed Rus, Open CompanyPromomed Rus, Open Company Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.04.2018
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