1 tabl contains 50 mg or 100 mg Sumatriptan in the form of succinate. The preparation contains lactose.
Action:
Antimigraine drug - a selective agonist of 5-HT serotonin receptors1D. It does not affect other receptor subtypes (5-HT2 up to 5-HT7). The drug selectively narrows the blood vessels in the area of blood circulation of the carotid artery, not affecting the cerebral flow. In addition, the results of experimental studies indicate that it inhibits trigeminal nerve activity. Both mechanisms underlie the anti-migraine effect of sumatriptan. The effect of the drug starts about 30 minutes after administration. After oral administration the drug is rapidly absorbed, 70% of the maximum plasma concentration occurs after 45 min. The average bioavailability of sumatriptan in the oral form is 14%. The degree of binding to plasma proteins is small (14-21%). It is metabolized mainly by monoamine oxidase A. The major transformation product - an indole acetic acid analogue is excreted in the urine, where it occurs in the form of free acid and glucuronides. Its action was not found on 5-HT receptors1 and 5-HT2. Non-renal excretion accounts for about 80% of total clearance. T0,5 in the blood is about 2 hours. The pharmacokinetics of sumatriptan after oral administration is not significantly impaired by migraine attacks.
Contraindications:
Hypersensitivity to the components of the preparation. Do not use in the prevention of migraine attacks. Patients under 18 years of age or over 65 years. Coronary heart disease or symptoms associated with it, coronary vasospasm (Prinzmetal's angina), previous myocardial infarction. A stroke or transient cerebral ischemic attack. Peripheral vascular disease. Moderate and severe hypertension and under-controlled hypertension. Concomitant use with MAO inhibitors and and a period of 14 days from discontinuation of their use. Simultaneous use with ergotamine or its derivatives, such as, for example, merserergide or other 5-HT receptor agonists1. Severe hepatic failure.
Precautions:
Sumatriptan is not indicated in patients with hemiplegic, basal or occiput migraine. It should not be used in patients at risk of ischemic disease, including patients who smoke or use nicotine substitutes, postmenopausal women, and men over 40 without prior cardiac assessments. After administration of Sumatriptan, transient pain and tightness in the chest and throat, sometimes severe (these symptoms may suggest ischemic heart disease) may occur - if they occur, it is recommended to discontinue the drug and perform appropriate tests. The drug should be used with particular caution in patients with hypertensive disease. In patients with migraine-like headache who have not previously been diagnosed with migraine and in patients with previously diagnosed migraine but with an atypical picture of a given headache, the neurological cause of pain should be taken into account. In patients with migraine, there is an increased risk of vascular brain damage, such as transient ischemic attack or stroke. Exercise caution in patients with hepatic or renal insufficiency (disturbances of absorption, metabolism or excretion of the drug) and in patients who have experienced seizures or factors that lower the seizure threshold. Prolonged use of any painkillers may cause headache. If such a cause of headache is suspected, the drug should be discontinued. In patients who have frequent or daily headaches despite (or because of) regular use of anti-acne medications, consideration should be given to diagnosing a headache depending on the continued use of medications. In patients with hypersensitivity to sulphonamides, hypersensitivity reactions (including anaphylactic shock) may occur after administration of sumatriptan. The product contains lactose - should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.The 50 mg tablets contain a cochineal red lake which can cause hypersensitivity reactions.
Pregnancy and lactation:
It can only be used during pregnancy if the benefit to the mother outweighs the potential risk to the fetus. Sumatriptan is excreted in milk - breastfeeding should be avoided within 12 hours of admission.
Side effects:
Common: dizziness, drowsiness, sensory disturbances (including paraesthesia and hypoaesthesia), transient increase in blood pressure soon after administration, sudden redness (especially of the face), shortness of breath, nausea and vomiting (the connection with sumatriptan is not clear), feeling heaviness, muscle pain, pain, feeling hot, cold, tension or tightness, feeling weak, tired. Very rare: slight changes in liver function values. In addition, hypersensitivity reactions (from skin lesions to rare cases of anaphylactic shock), seizures, tremor, dystonia, nystagmus, scotoma, flicker, diplopia, changes in visual field, loss of vision, including permanent visual defects, bradycardia, tachycardia have been observed. , palpitations, arrhythmias, transient ischemic changes in the ECG, coronary spasm, angina pectoris, myocardial infarction, hypotension, Raynaud's syndrome, ischemic colitis, diarrhea, stiff neck, arthralgia, anxiety, excessive sweating.
Dosage:
Orally. The preparation should be used as soon as possible after the onset of a migraine attack, however the drug administered at any stage of the attack is equally effective. Adults: the recommended dose is 50 mg, some patients may need 100 mg. If symptoms persist after a single dose, do not take another dose during the same episode of migraine. The Next tablet can be taken during the next robbery. If the use of a single dose caused the symptoms to disappear, however, the onset of migraine returned, the second dose can be taken within the next 24 hours, however, a dose of more than 300 mg per day should not be used. In patients with impaired liver function, the maximum daily dose is 50 mg. The tablets should be swallowed whole with water.