Active substanceSumatriptanSumatriptan
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  • Dosage form: & nbsp
    Film-coated tablets.

    Composition:
    Composition (1 tablet)
    active substance: sumatriptan succinate in an amount equivalent to 50 mg or 100 mg sumatriptan;
    auxiliary substances: cellulose microcrystalline 18 mg or 36 mg, lactose monohydrate 62.1 mg or 124.2 mg, povidone (Kollidon 25 or Kollidon 30, or Plasdon K-29/32, or Plasdon K-25) 3.3 mg or 6.6 mg, carboxymethyl-sodium starch (sodium starch glycolate, primogel) 5 mg or 10 mg, magnesium stearate 1.6 mg or 3.2 mg; Shell: opedrai II (series 85) white 6 mg or 12 mg, containing in its composition polyvinyl alcohol, partially hydrolysed 2,814 mg or 5,628 mg, talc 1,044 mg or 2,088 mg, macrogol 3350 (polyethylene glycol 3350) 1.416 mg or 2.832 mg, staining pigment: titanium dioxide 0.726 mg or 1.452 mg.

    Description:The tablets covered with a film cover, white or almost white color, round, biconcave form. On a cross-section the nucleus of tablets of both dosages has a white or almost white color.
    Pharmacotherapeutic group:Anti-migraine means.
    ATX: & nbsp

    N.02.C   Anti-migraine drugs

    Pharmacodynamics:Sumatriptan - a specific selective agonist of 5-HT1-serotonin receptors, localized predominantly in the blood vessels of the brain and their stimulation leads to narrowing of these vessels. Does not affect other subtypes of 5-HT-serotonin receptors (5-HT2-7). It activates the sensitivity of trigeminal nerve receptors.The therapeutic effect usually occurs 30 minutes after admission.
    Pharmacokinetics:
    After oral administration, it is rapidly absorbed. 70% of the maximum plasma concentration is reached after 45 minutes. The maximum concentration in the blood plasma is 54 ng / ml. Bioavailability - 14% (due to presystemic metabolism and incomplete absorption). The connection with plasma proteins is 14-21%.
    Metabolized by oxidation with the participation of monoamine oxidase (preferably isoenzyme A) to form metabolites, the main ones being the indoleacetic analogue of sumatriptan, which does not have pharmacological activity against 5-HT1-serotonin receptors, and its glucuronide. It is excreted by the kidneys, mainly in the form of metabolites
    Indications:A migraine attack with or without an aura.
    Contraindications:Hypersensitivity to any of the components of the drug.
    Hemiplegic, basilar or ophthalmoplegic forms of migraine.
    Ischemic heart disease or the presence of symptoms suggesting its presence.
    Myocardial infarction in the anamnesis.
    Pharmacologically uncontrolled arterial hypertension.
    Occlusal diseases of peripheral vessels.
    Stroke or transient impairment of cerebral circulation (including in the anamnesis). Expressed violations of the liver and kidneys.
    Simultaneous reception with ergotamine or its derivatives and within 24 hours after their administration.
    Use against the background of monoamine oxidase inhibitors or earlier than 2 weeks after the withdrawal of these drugs.
    Age to 18 and over 65 years of age (efficacy and safety not established).
    Pregnancy and breastfeeding (breastfeeding is possible not earlier than 24 hours after taking the drug).
    Congenital galactosemia, glucose malabsorption / galactose syndrome, congenital insufficiency of lactose.
    Carefully:
    Epilepsy (including any condition with a reduced epileptic threshold). Pharmacologically controlled arterial hypertension.
    Violations of the function of the liver or kidneys, which can affect the metabolism of sumatriptan.
    Hypersensitivity to sulfonamides (administration of sumatriptan may cause allergic reactions, the severity of which varies from skin manifestations to anaphylaxis).
    Dosing and Administration:
    Inside, the tablet should be swallowed whole, washed down with water.Begin the treatment should be-as soon as possible in the event of a migraine attack.
    The recommended dose is 50 mg, if necessary 100 mg.
    If migraine symptoms do not disappear and do not decrease after taking the first dose, then the drug is not used again to stop the same attack.
    To stop subsequent attacks (with a decrease or disappearance of symptoms, and then resume), you can take a second dose within the next 24 hours, provided that the interval between admission is at least 2 hours.
    The maximum daily dose is 300 mg.
    Side effects:

    The incidence of adverse reactions listed below was determined as follows:

    very often - more than 1/10

    often from more than 1/100 to less than 1/10

    sometimes from more than 1/1000 to less than 1/100,

    rarely from more than 1/10000 to less than 1/1000,

    very rarely - from less than 1/10000, including individual cases.

    From the nervous system: often - dizziness, drowsiness, sensitivity disorders, including paresthesia and decreased sensitivity.

    From the side of the cardiovascular system: often - a transient increase in blood pressure (observed soon after taking the drug), "hot flashes".

    From the respiratory system and chest organs: often - dyspnea; light, transient irritation of the mucosa or burning sensation in the nasal cavity or throat, nosebleeds.

    From the gastrointestinal tract: often - nausea, vomiting.

    From the side of the musculoskeletal system and connective tissue: often a feeling of heaviness (usually transient, can be intense and occur in any part of the body, including the chest and throat).

    General and local reactions: often - painful sensations, a feeling of cold or heat, feeling. pressure or contraction (usually transient, can be intense and occur in any part of the body, including the thoracic, cage and throat). Often - weakness, fatigue (usually mild or moderately expressed, transient).

    Laboratory indicators: very rarely minor deviations in liver function tests.

    Postmarketing surveillance

    From the immune system: very rarely - hypersensitivity reactions, including skin manifestations, as well as anaphylaxis.

    From the nervous system: very rarely convulsive seizures (in a number of cases, observed in patients with seizures in the anamnesis or with concomitant conditions predisposing to the onset of seizures, some patients did not have risk factors), tremor, dystonia, nystagmus, scotoma.

    On the part of the organs of vision: very rarely - flickering, diplopia, decreased visual acuity, blindness (usually transient). However, vision disorders can be caused by the actual migraine attack.

    From the cardiovascular system: very rarely - bradycardia, tachycardia, flutter, arrhythmias, transient changes in the ECG, coronary vasospasm, angina pectoris, myocardial infarction. Very rarely, hypotension, Raynaud's syndrome.

    From the gastrointestinal tract: very rarely - ischemic colitis, dysphagia, - a feeling of discomfort in the abdomen.

    Overdose:
    Symptoms: when administered orally to 400 mg, no other adverse reactions are noted other than those listed above.

    Treatment: gastric lavage, observation of the patient for 10 hours, symptomatic therapy.
    Interaction:
    With the simultaneous administration of ergotamine and ergotamine-containing drugs, a prolonged vasospasm is possible.
    Possible interaction between sumatriptan and monoamine oxidase inhibitors (decrease in the intensity of metabolism of sumatriptan, increasing its concentration). With the simultaneous use of sumatriptan and drugs from the group of selectiveinhibitors of serotonin reuptake may develop weakness, hyperreflexia and impaired coordination of movements.
    No interaction of sumatriptan with propranolol, flunyrizine, pizotifen and ethanol has been observed.
    Special instructions:
    Do not use to prevent a migraine attack.
    Patients at risk of cardiovascular disease do not start therapy without a preliminary examination (women in the postmenopausal period, men over the age of 40, persons with risk factors for coronary heart disease). Before prescribing sumatriptan to patients with a newly diagnosed or atypical migraine, other potentially neurological diseases should be excluded. After taking sumatriptan, pain and a feeling of tightness in the chest may occur. The pain can be intense and radiate into the neck. If there is reason to believe that these symptoms are, a manifestation of coronary heart disease, it is necessary to conduct an appropriate examination.
    During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:
    Tablets, film-coated, 50 and 100 mg.


    Packaging:
    2 tablets per contour cell package; 1 contour pack together with the instruction for use is placed in a cardboard package.
    10 tablets per can of polymer. Each bank along with the instruction for use is placed in a cardboard pack.
    Storage conditions:In dry, 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 the product after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-000105
    Date of registration:23.12.2010
    The owner of the registration certificate:Berezovsky Pharmaceutical Plant, ZAO Berezovsky Pharmaceutical Plant, ZAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp04.09.2015
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