Active substanceSumatriptanSumatriptan
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  • Dosage form: & nbspFilm-coated tablets.
    Composition:

    Tablets 50 mg:

    Round biconvex tablets, coated with a white coating, with a stamping "RDY" on one side, and on the other - "292".

    Tablets 100 mg:

    Capsule-shaped tablets, coated with a white shell, embossed "RDY" on one side, and on the other - "293".


    Description:Round biconvex tablets coated with a white coating, embossed "RDY" on one side, and on the other: tablets 50 mg - "292", tablets 100 mg - "293".
    Pharmacotherapeutic group:Anti-migraine means.
    ATX: & nbsp

    N.02.C   Anti-migraine drugs

    Pharmacodynamics:

    Sumitran is a specific and selective agonist of vascular 5-dihydroxytryptamine-1 receptors (5HTID), does not affect other subtypes of 5HT-serotonin receptors (5HT2 - 5HT7). 5HT ReceptorsID are located, mainly, in the blood vessels of the brain, and their stimulation leads to narrowing of these vessels. Reduces the sensitivity of the trigeminal nerve. Both of these effects can underlie the anti-migraine effect of sumatriptan. The clinical effect is usually observed after 30 minutes after oral administration of the drug.

    Pharmacokinetics:
    After oral administration sumatriptan quickly absorbed, 70% of the maximum plasma concentration is achieved after 45 minutes. After taking 100 mg, the maximum concentration in the blood plasma is, on average, 54 ng / ml.Bioavailability is 14% due to intensive pre-systemic metabolism and incomplete absorption. The connection with plasma proteins is 14-21%. Sumatriptan is metabolized by the action of monoamine oxidase A. The main metabolite, indoleacetic analogue of sumatriptan, is excreted predominantly in urine, in the form of free acid and glucuronide conjugate. This metabolite has no activity with respect to 5HT1 and 5HT2-serotonin receptors. Migraine attacks do not seem to have a significant effect on the pharmacokinetics of sumatriptan taken internally.
    Indications:Coping migraine attacks with or without an aura.
    Contraindications:

    - Hemiplegic, basilar and ophthalmoplegic forms of migraine.

    - Hypersensitivity to any component of the drug

    - Ischemic heart disease (IHD) (including myocardial infarction, postinfarction cardiosclerosis, Prinzmetal angina), as well as the presence of symptoms suggesting the presence of IHD.

    - Occlusion diseases of peripheral vessels

    - Stroke or transient ischemic attack (including anamnesis)

    - Uncontrolled hypertension.

    - Admission simultaneously with ergotamine or its derivatives (including metisergid).

    - Use on the background of taking monoamine oxidase inhibitors or earlier than 2 weeks after the withdrawal of these drugs.

    - Severe dysfunction of the liver and / or kidney.

    - Age under 18 and over 65 years of age (safety and efficacy not established).

    - Pregnancy and lactation

    Carefully:

    - Controlled arterial hypertension.

    - Diseases in which can changeto become absorbed, metabolized or eliminated (eg, impaired renal or hepatic function).

    - Epilepsy (including any condition with a decrease in the threshold of convulsive alertness).

    - In patients with hypersensitivity to sulfanilamides (administration of sumatriptan can cause allergic reactions, the severity of which varies from skin manifestations to anaphylaxis.) Data on cross-sensitivity are limited, but caution should be exercised when assigning sumatriptan to such patients).

    Dosing and Administration:
    Inside, swallowing the tablet whole and squeezed water.
    The recommended adult dose is 50 mg, if necessary 100 mg.If migraine symptoms do not disappear and do not decrease after the first dose, then to stop the same attack, do not take the drug again. However, the drug can be used to stop subsequent migraine attacks.
    If the patient feels better after the first dose and then the symptoms resume, you can take a second dose within the next 24 hours. The maximum dose of sumatriptan should not exceed 300 mg during the 24-hour period.
    Side effects:

    Co cardiovascular system

    Reduced blood pressure, bradycardia, tachycardia, a transient increase in blood pressure (observed soon after taking sumatriptan). Rarely - violations of the heart rate, transient ECG changes in the ischemic type, myocardial infarction, spasm of the coronary arteries. Sometimes Raynaud's syndrome develops.

    From the gastrointestinal tract

    Nausea, vomiting, ischemic colitis (the association of these side effects with sumatriptan is not established); dysphagia, a feeling of discomfort in the abdomen.

    From the side of the central nervous system and sensory organs

    Dizziness, rarely convulsive attacks (in a number of cases they were observed in patients with a history of seizures orconditions predisposing to the occurrence of seizures; in some patients predisposing factors were not identified). Sometimes after taking sumatriptan, there is diplopia, flickering of the "flies" before the eyes, nystagmus, scotoma, visual acuity reduction. Very rarely develops a partial transient loss of vision. However, it should be borne in mind that visual impairment may be associated with the very seizure of the migraine itself.

    Hypersensitivity reactions

    Varies from skin manifestations (rash, hives, itching, erythema) to rare cases of anaphylaxis.


    From the laboratory indicators

    Minor changes in the activity of "liver" transaminases.

    Other

    Myalgia, the "flushes" of blood to the face, dizziness, a sense of weakness, a feeling of fatigue, drowsiness is usually weak or moderate and is of a transient nature.

    Overdose:
    Symptoms: increased severity of side effects.
    Treatment: gastric lavage, reception of activated charcoal, symptomatic therapy, dynamic observation of the patient for at least 10 hours. There is no data on the effect of hemodialysis or peritoneal dialysis on the concentration of sumatriptan in plasma.
    Interaction:
    No interaction of sumatriptan with propranolol, flunarizine, pizotifen and ethyl alcohol has been observed.
    With simultaneous administration with ergotamine, a prolonged vasospasm was noted. Sumatriptan can be prescribed no earlier than 24 hours after taking medications containing ergotamine; and vice versa, preparations containing ergotamine can be prescribed no earlier than 6 hours after taking sumatriptan.
    Possible interaction between sumatriptan and MAO inhibitors, as well as sumatriptan and drugs from the group of selective serotonin reuptake inhibitors (SSRIs). There are separate reports on the development of weakness, hyperreflexia and coordination disorders in patients after taking sumatriptan and drugs from the SSRI group. In the case of simultaneous administration of sumatriptan and SSRIs, the patient's condition should be carefully monitored.
    Special instructions:
    Sumatriptan should be prescribed only if the diagnosis of migraine is undoubted, and it should be used as soon as possible after the onset of a migraine attack, although it is equally effective when used at any stage of an attack. Can not be used for preventive purposes.
    As with the use of other antimigraine drugs, when prescribing sumatriptan in patients with a previously unidentified migraine or in patients with atypical migraine, other potentially serious neurologic conditions should be excluded. It should be noted that in patients with migraine, the risk of developing cerebrovascular complications (stroke or transient cerebral circulation disorders) is increased. Sumatriptan Do not prescribe to patients with presumed heart disease without a preliminary examination to exclude cardiovascular disease. Such patients include women in the postmenopausal period, men over the age of 40 and patients with risk factors for coronary heart disease. Although the examination does not always allow the identification of heart disease in some patients, in very rare cases they develop side effects from the cardiovascular system. After taking sumatriptan, transient intense pains and chest tightness that can spread to the neck area may occur.
    If there is reason to believe that these symptoms are a manifestation of coronary heart disease,it is necessary to conduct an appropriate diagnostic examination. Do not exceed the recommended dose of sumatriptan.
    Effect on the ability to drive transp. cf. and fur:In patients with migraine, there may be drowsiness associated with both the disease itself and with the use of sumatriptan, so they should be especially careful when driving and working with moving mechanisms.
    Form release / dosage:Tablets, film-coated, 50 mg and 100 mg.
    Packaging:

    Tablets 50 mg. For 2, 4 or 10 tablets in a blister of PVC / PVDC / aluminum foil, laminated paper with the outside. For 1 blister in pack of cardboard with instructions on application.

    Tablets of 100 mg. By 2, 4 or 10 tablets in a blister of PVC / PVDH / aluminum foil, laminated paper with an external side. By 1 blister in a pack cardboard with instructions for use.

    Storage conditions:
    List B. In a dry, 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:On prescription
    Registration number:LSR-007096/08
    Date of registration:05.09.2008
    The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspDR REDDY'S LABORATORIS LTD. DR REDDY'S LABORATORIS LTD. India
    Information update date: & nbsp06.09.2015
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