Index of drugs

Emergency treatment of migraine attacks with or without aura.

1 tabl contains 50 mg or 100 mg Sumatriptan in the form of succinate. The drug contains lactose.

The selective agonist of the vascular 5HT receptor₁, does not work on other types of 5HT receptor. The drug causes vasoconstrictor vessels to contract, which supply blood to extrasolar and intracranial tissues, including meninges. It is believed that the dilation of these vessels causes a migraine attack. In addition, sumatriptan inhibits trigeminal nerve activity. Both of these mechanisms make up the anti-migraine effect of the preparation. Clinical response occurs approximately 30 minutes after oral administration of a 100 mg dose. After oral administration, the drug is rapidly absorbed and reaches 70% of the maximum plasma concentration after approx. 45 min. The mean absolute bioavailability is about 14%. At 14-21%, the drug is bound to plasma proteins. The main route of elimination is metabolism; the main metabolite - an indole acetic acid analogue - is mainly excreted in the urine as a free acid and in a glucuronide-conjugated form. T_0,5 in the elimination phase, it is about 2 hours.

Hypersensitivity to sumatriptan or other components of the preparation. Myocardial infarction or known ischemic heart disease, Prinzmetal angina, peripheral vascular disease or signs or symptoms of ischemic heart disease. History of cerebrovascular disease or transient ischemic attack in the brain. Severe liver dysfunction. Moderate to severe hypertension or low, uncontrolled hypertension. Simultaneous use of ergotamine or ergotamine derivatives (including metyzergide). Concomitant use of reversible MAO inhibitors (e.g., moclobemide) or irreversible MAO inhibitors (e.g. selegiline); sumatriptan must not be used for 2 weeks after discontinuation of an irreversible MAO inhibitor.

The preparation is not indicated for use in hemiplegic, basal or ophthalmoplegic migraine. Only use the medicine in cases where migraine has been clearly identified. Patients with newly diagnosed migraine or with atypical symptoms of migraine should be excluded from other severe neurological disorders before treatment. Sumatriptan should not be used in people with risk factors for ischemic heart disease until a diagnosis that excludes heart disease is performed. This group of patients includes chronic tobacco smokers, patients using nicotine replacement therapy, especially postmenopausal women and men over 40 years of age. Caution should be exercised in patients with epilepsy or other risk factors that may lower the seizure threshold and in patients with balanced hypertension. In addition, caution should be used in patients with diseases that may interfere with the absorption, metabolism or excretion of the drug, eg with impaired liver or kidney function and in patients with known hypersensitivity to sulfonamides. Use with caution in combination with SSRIs, SNRIs (risk of serotonergic syndrome) and St. John's Worts (the frequency of side effects may be higher). After administration of Sumatriptan, transient symptoms may occur, especially pain or tightness in the chest that may be intense and radiate to the neck; if you suspect that these symptoms are indicative of ischemic heart disease, sumatriptan should be discontinued and appropriate tests performed. It is not recommended for use in children and adolescents under 18 years of age. Use in patients over 65 years is not recommended (limited experience, insufficient pharmacokinetic studies). The drug contains lactose and should not be used in patients with rare hereditary problems of galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

It can only be used during pregnancy if the potential benefit to the mother outweighs the risk to the fetus. Sumatriptan is excreted in breast milk - do not breastfeed for 12 hours after taking the medicine.

Common: dizziness, drowsiness, sensory disturbances (including paraesthesia and hypoaesthesia), transient increase in blood pressure shortly after administration of the drug, redness of the face, shortness of breath, nausea and vomiting (may result from a migraine attack), feeling of heaviness (symptoms may be strong and occur in various parts of the body, including the chest and throat), these symptoms are usually transient), muscle pain, pain, feeling hot or cold, pressure or tension (symptoms can be strong and occur in various parts of the body, including in the chest and throat), feeling of weakness, fatigue (symptoms of mild to moderate severity). Very rare: abnormal liver function tests. Not known: hypersensitivity reactions (from skin reactions to anaphylactic reactions), anxiety, convulsive seizures, sometimes occur in patients with a history of convulsive seizures or with concomitant conditions predisposing to convulsions, nystagmus, sclerosis in the field of vision, tremor, dystonia, flickering of light, double vision, visual field limitation, loss of vision, also permanent (symptoms may be due to a migraine attack), bradycardia, tachycardia, palpitations, arrhythmias, transient ischemic changes in ECG, coronary artery spasm, angina pectoris, myocardial infarction, hypotension , Raynaud's symptom, ischemic colitis, diarrhea, stiff neck, arthralgia, hyperhidrosis.

Orally. Adults aged 18-65: a single dose of 50 mg, some patients may require a dose of 100 mg. The drug should be taken as soon as possible after the onset of migraine symptoms (if it is given later during a migraine attack it is also effective). If the pain subsided after the first dose and reappeared, 1 or 2 additional doses may be given during the Next 24 h provided that at least a 2 h dosing interval is maintained and no more than 300 mg of the drug is used during this time. If the patient does not respond to the first dose - do not administer the next dose during the same seizure of migraine, but the preparation may be used to treat further seizures. In patients with mild or moderate hepatic impairment, lower doses (25-50 mg) should be considered. Swallow the tablets whole with water.