Sumatriptan-Teva (Sumatriptan-Teva)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceSumatriptanSumatriptan
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    • Dosage form: & nbsp
    Film-coated tablets.

    Composition:

    In one tablet 50 mg contains: active substance sumatriptan (sumatriptan succinate) 50.00 mg (70.00 mg); Excipients: lactose monohydrate 70.00 mg, croscarmellose sodium 1.50 mg, cellulose microcrystalline 6.75 mg, silicon dioxide colloid 0.25 mg, magnesium stearate 1.50 mg; sheath Opadrai II 33G23092 peach (hypromellose (E 464) 2.0000 mg, titanium dioxide (E 171) 1.1725 mg, lactose monohydrate 1.1000 mg, macrogol-3000 0.4000 mg, triacetin 0.3000 mg, iron dye red oxide (E 172) 0.0180 mg, ferric iron oxide yellow (E 172) 0.0090 mg, ferric oxide black oxide (E 172) 0.0005 mg).

    In one tablet 100 mg contains: active substance: sumatriptan (sumatriptan succinate) 100.00 mg (140.00 mg); Excipients: lactose monohydrate 140.00 mg, croscarmellose sodium 3.00 mg, cellulose microcrystalline 13.50 mg, silicon dioxide colloid 0.50 mg, magnesium stearate 3.00 mg; sheath Opadrai II 33G28707 white (hypromellose (E 464) 4.0000 mg, titanium dioxide (E 171) 2.4000 mg, lactose monohydrate 2.2000 mg, macrogol-3000 0.8000 mg, triacetin 0.6000 mg).

    Description:

    Tablets 50 mg: tablets, covered with a film shell from pink with a yellowish tinge to pink, oval with a dividing risk on both sides. On one side - engraving "5" and "0". On the cross-section - the core is white or almost white.

    Tablets 100 mg: tablets covered with a film shell of white or almost white color, oval in shape.On one side is the engraving "100". On the cross-section - the core is white or almost white.

    Pharmacotherapeutic group:Anti-migraine means.
    ATX: & nbsp

    N.02.C   Anti-migraine drugs

    Pharmacodynamics:

    Sumatriptan is a specific selective 5HT agonistID-serotonin receptors (5-hydroxytryptamine-1-like), located predominantly in the blood vessels of the brain. Stimulation of 5HTID-serotonin receptors leads to narrowing of the vessels. The drug does not affect other subtypes of 5HT-serotonin receptors (5HT2-5NT7).

    In experimental studies it was shown that sumatriptan causes a selective narrowing of the carotid arteries, which supply extracranial and intracranial tissues to the blood, incl. the meninges (the expansion of these vessels and / or their edema is the main mechanism for the development of migraine in humans) without significantly affecting cerebral blood flow.

    It has also been experimentally established that sumatriptan suppresses the activity of the receptors of the endings of the afferent fibers of the trigeminal nerve.

    Eliminates the associated nausea and photophobia associated with migraine attacks.

    Pharmacokinetics:

    Suction. After oral administration sumatriptan quickly absorbed, after 45 minutes its concentration in the blood plasma reaches 70% of the maximum value. After taking sumatriptan in a dose of 100 mg, the maximum concentration in the blood plasma is reached after 2-2,5 hours and averages 54 ng / ml. Absolute bioavailability with oral administration is an average of 14% due to presystemic metabolism and incomplete absorption.

    Distribution. Binding to plasma proteins is 14-21%, the total volume of distribution is on average 170 liters (2.4 l / kg).

    Metabolism. Sumatriptan metabolized by oxidation with the participation of monoamine oxidase (MAO) (preferably isoenzyme A) to form metabolites, the main one being the indoleacetic analogue of sumatriptan, not having pharmacological activity against 5HT1- and 5HT2-serotonin receptors, and its glucuronide.

    Excretion. The half-life is 2-2.5 hours. On average, the plasma clearance is 1160 ml / min, the renal clearance is 260 ml / min. The extrarenal clearance is 40% after oral administration. It is excreted by the kidneys, mainly in the form of metabolites (97% after ingestion) of free acid or glucuronide, the rest is excreted by the intestine.

    Indications:Migraine (for arresting seizures, with or without an aura).
    Contraindications:Hypersensitivity to sumatriptan or other components of the drug; hemiplegic, basilar and ophthalmoplegic forms of migraine; ischemic heart disease (IHD) (including myocardial infarction, postinfarction cardiosclerosis, Prinzmetal angina); Patients with risk factors for IHD; stroke or transient impairment of cerebral circulation (including in anamnesis); Occlusal diseases of peripheral vessels; uncontrolled arterial hypertension; severe hepatic and / or renal insufficiency; simultaneous application with ergot alkaloids and their derivatives (including methezegid) or other tryptans / agonists of 5HT1-serotonin receptors (see section "Interaction with other drugs"); simultaneous administration of MAO inhibitors and a period of up to 14 days after their withdrawal (see section "Interaction with other drugs"); age to 18 years, patients older than 65 years; lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
    Carefully:Epilepsy (incl.any conditions accompanied by a decrease in the threshold of convulsive readiness in the anamnesis), organic brain damage, controlled arterial hypertension, impaired renal function and / or malfunction of the liver of mild and moderate severity, pregnancy.
    Pregnancy and lactation:Although the safety data obtained with sumatriptan in 1000 women in the first trimester of pregnancy do not contain sufficient information, there is no reason to draw definitive conclusions about the risk of congenital malformation in the fetus. The experience of using sumatriptan in the II and III trimester of pregnancy is limited. The use of sumatriptan in pregnancy is possible only if the perceived benefit to the mother exceeds the potential risk to the fetus. Stop breastfeeding during sumatriptan and for 24 hours after the end of its use.
    Dosing and Administration:
    Inside (the tablet is swallowed whole, washed down with water).
    The initial single dose of 50 mg, if necessary, the dose can be increased to 100 mg. If migraine symptoms do not disappear and do not decrease after taking the first dose, then taking a second dose to stop the ongoing attack is not prescribed.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 meals is at least 2 hours. The maximum daily dose for ingestion is 300 mg.
    Side effects:

    The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01% (including isolated cases).

    From the cardiovascular system: very rarely - bradycardia, tachycardia, arrhythmia, transient increase in blood pressure (immediately after the start of treatment), transient signs of myocardial ischemia on the electrocardiogram, spasm of the coronary vessels, myocardial infarction, Raynaud's syndrome, lowering blood pressure, "tides" of blood to the face.

    From the respiratory system: often - shortness of breath, transient irritation of the mucosa or burning sensation in the nasal cavity or throat.

    From the digestive system: often - nausea, vomiting; a slight increase in the activity of "liver" enzymes; very rarely - ischemic colitis, diarrhea, a feeling of discomfort in the abdomen.

    From the nervous system: often - dizziness, drowsiness, impaired sensitivity, including paresthesia, hypesthesia; very rarely - convulsions (usually in the presence of seizures in the anamnesis); unknown frequency - tremor, dystonia, anxiety. From the side of the organ of vision: infrequently - diplopia, flashing of "flies" before the eyes, nystagmus, scotoma, reduced visual acuity; very rarely - a partial transient loss of vision (it should be borne in mind that visual impairment can be associated with the very attack of migraine).

    From the musculoskeletal system: often - myalgia; unknown frequency - the severity of the occipital muscles, arthralgia.

    Allergic reactions: very rarely - skin rash, hives, itching, erythema, anaphylaxis.

    Other: pain, tingling, fever, weakness and / or fatigue, nosebleeds, a feeling of constriction or severity (these symptoms are usually transient, but can be intense and occur in any part of the body, including the chest and neck); unknown frequency - increased sweating.

    Overdose:
    With a single subcutaneous injection at a dose of 12 mg sumatriptan did not cause any side effects. When administered subcutaneously in a dose of more than 16 mg or when ingested more than 400 mg sumatriptan Do not cause any unforeseen side effects other than those listed above.
    Treatment: gastric lavage, taking activated charcoal, monitoring the patients for at least 10 hours, if necessary, symptomatic therapy. There is no data on the effect of hemodialysis and peritoneal dialysis on the concentration of sumatriptan in plasma.
    Interaction:

    Sumatriptan does not interact with propranolol, flunarisin, pisotifen and ethyl alcohol.

    Simultaneous application of sumatriptan with ergot alkaloids and their derivatives (including methegergid) or other tryptans / agonists 5HT1-serotonin receptors is accompanied by an increased risk of developing a prolonged vasospasm and ischemia. Sumatriptan can be used no earlier than 24 hours after ingestion of ergot alkaloids and their derivatives or other tryptans / agonists 5HT1-serotonin receptors, in turn, preparations containing ergot alkaloids can be taken no earlier than 6 hours after taking sumatriptan, other triptans / agonists 5HT1-serotonin receptors can be taken no earlier than 24 hours after taking sumatriptan.

    Possible interaction between sumatriptan and MAO inhibitors, their simultaneous use is contraindicated.

    There are very rare reports from post-marketing surveillance of the development of serotonin syndrome (including psychiatric disorders, vegetative lability and neuromuscular disorders) with simultaneous application of sumatriptan with selective serotonin reuptake inhibitors (SSRIs). Also, the development of serotonin syndrome was reported with the simultaneous use of tryptanes with selective serotonin and noradrenaline reuptake inhibitors (SSRIs).

    Single reports have been obtained on a more pronounced manifestation of adverse reactions from sumatriptan when used simultaneously with herbal preparations containing St. John's wort perforated
    Special instructions:Sumatriptan is not intended to prevent migraine.
    Sumatriptan should be taken only if the diagnosis of migraine is undoubted.
    Sumatriptan should be used as soon as possible after the onset of a migraine attack, but the drug is equally effective at any stage of the attack.In the absence of the effect of the first dose, the diagnosis should be clarified. When applying sumatriptan for the relief of headache in patients with a previously unidentified migraine or migraine with atypical symptoms, other potentially neurological diseases should be excluded. It should be borne in mind that in patients with migraine there is a risk of developing cerebrovascular complications (including stroke or transient disorders of cerebral circulation).
    It should be taken with caution sumatriptan with epilepsy and any other conditions, accompanied by a decrease in the threshold of convulsive readiness. In the case of simultaneous use with SSRIs / SSRIs, the patient's condition should be carefully monitored (see section "Interaction with other medicinal products").
    Before applying sumatriptan, patients should be excluded from the presence of cardiovascular disease, especially in patients at risk. Such patients include women in the postmenopausal period, men over the age of 40 and patients with risk factors for developing coronary artery disease.
    The examination does not always allow to identify cardiovascular disease in some patients. In very rare cases, after taking sumatriptan, there may be transient side effects such as pain and a feeling of tightness in the chest. The pain can be intense and radiate into the neck (pharynx). If there is reason to believe that these symptoms may be a manifestation of IHD, it is necessary to stop taking the drug and perform a diagnostic examination. Caution should be exercised with sumatriptan in patients with controlled hypertension, since in some cases there may be an increase in blood pressure and peripheral vascular resistance. Sumatriptan Care should be exercised in patients with diseases in which a significant change in absorption, metabolism or excretion of sumatriptan is possible, for example, in disorders of kidney or liver function. In patients with hypersensitivity to sulfanilamides with the use of sumatriptan, it is possible to develop allergic reactions that range from skin manifestations to anaphylactic shock.Data on cross-sensitivity are limited, but care should be taken when applying sumatriptan to such patients.
    Abuse of medicines intended to stop migraine attacks is associated with increased headaches in sensitive patients (headache associated with drug abuse). In this case, the possibility of drug cancellation should be considered.

    Effect on the ability to drive transp. cf. and fur:
    With migraine, and also against the background of therapy with su-mattamane, the development of drowsiness is possible.
    Therefore, during the period of application of sumatriptan, care must be taken when driving vehicles and engaging in other potentially dangerous activities requiring an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:
    Tablets, film-coated 50 mg, 100 mg.
    Packaging:
    By 2, 6,12, 30 tablets in a blister made of polyvinyl chloride and aluminum foil.
    For 1 blister, along with instructions for use in a cardboard bundle.
    Storage conditions:
    Store at a temperature not higher than 25 ° C. Keep out of the reach of children!
    Shelf life:
    3 years.Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-001107
    Date of registration:03.11.2011
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp04.09.2015
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