Description
release form
tablet form462629 zrrdds tablets heel
packing
2 pcs
Pharmacological action
Sumatriptan is an anti-migraine agent.
A specific and selective agonist of 5-HT1-serotonin receptors, localized mainly in the blood vessels of the brain, and does not affect other subtypes of 5-HT-serotonin receptors (5-HT 2-7).
Causes narrowing of the vessels of the carotid arterial bed, which supply extracranial and intracranial tissues with blood (dilation of the vessels of the meninges and / or their edema is the main mechanism for the development of migraine in humans), without significantly affecting the cerebral blood flow.
Suppresses activity of terminal receptors of afferent trigeminal fibers in the dura mater (as a result, the secretion of sensory neuropeptides is reduced). Eliminates nausea and photophobia associated with a migraine attack.
In 50-70% of cases, it quickly eliminates an attack when taken orally at a dose of 25-100 mg. Within 24 hours, in 1/3 of cases, relapse may develop, requiring repeated use. The beginning of the action is 30 minutes. After oral administration at a dose of 100 mg.
Indications
Stopping migraine attacks with or without aura.
Contraindications
– Hypersensitivity.
– Hemiplegic, basilar or ophthalmoplegic forms of migraine.
– Coronary heart disease (CHD) and suspicion of it.
– Angina pectoris (including Prinzmetal angina).
– Myocardial infarction (including history).
– Arterial hypertension (uncontrolled).
– Occlusive peripheral artery disease
– Stroke or transient cerebrovascular accident (including a history of).
Caution should be used:
– Epilepsy (including any condition with a reduced epileptic threshold).
– Arterial hypertension (controlled).
Pregnancy and lactation.
– Children and teens under 18 years of age.
– Elderly over 65 years old.
– Concurrent administration of drugs containing ergotamine and its derivatives, as well as MAO inhibitors AND for up to 14 days after their withdrawal.
Special instructions
Not intended for the prevention of migraine (administration during a migraine aura before other symptoms occur may not prevent the development of a headache). If there is no effect on the first dose, the diagnosis should be clarified.
It must be borne in mind that patients suffering from migraine have a risk of developing a stroke or transient cerebrovascular accident. When prescribed during lactation, it is not recommended to breast-feed a baby within 24 hours after taking sumatriptan. In patients with hypersensitivity to sulfonamides with the introduction of sumatriptan, there is an increased risk of allergic reactions (from skin manifestations to anaphylactic shock).
Patients at risk from the cardiovascular system do not start therapy without preliminary examination (women in the postmenopausal period, men over the age of 40, people with risk factors for CHD).
Before prescribing sumatriptan to patients with newly diagnosed or atypically occurring migraines, other potentially dangerous neurological diseases should be excluded.
Experience with the use of sumatriptan in patients over 65 years of age is limited (there is no significant difference in pharmacokinetics compared with younger patients).
Application when driving vehicles: during the treatment period, care must be taken when driving vehicles and engaging in other potential activities that require an increased concentration of attention and speed of psychomotor reactions.
Composition of
In 1 film-coated tablet contains: sumatriptan succinate 140 (70) mg, in terms of sumatriptan 100 (50) mg.
Excipients:
hyprolysis (hydroxypropyl cellulose Klucel LF),
calcium hydrogen phosphate dihydrate,
mannitol (mannitol),
magnesium stearate,
croscarmellose sodium (primrose), microcrystalline microcrystallose.
Composition of the film coat:
selecout AQ-02003 (hypromellose (hydroxypropyl methylcellulose),
macrogol (polyethylene glycol 6000), titanium dioxide).
Dosage and Administration
– Hypersensitivity.
– Hemiplegic, basilar or ophthalmoplegic forms of migraine.
– Coronary heart disease (CHD) and suspicion of it.
– Angina pectoris (including Prinzmetal angina).
– Myocardial infarction (including history).
– Arterial hypertension (uncontrolled).
– Occlusive peripheral artery disease.
– Stroke or transient cerebrovascular accident (including a medical history).
– Hepatic or renal failure.
Caution should be used:
– Epilepsy (including any condition with a reduced epileptic threshold).
– Arterial hypertension (controlled).
Pregnancy and lactation.
– Children and teens under 18 years of age.
– Elderly over 65 years old.
– Concurrent administration of drugs containing ergotamine and its derivatives, as well as MAO inhibitors AND the period up to 14 days after their cancellation.
Side effects of the
From the cardiovascular system: lowering blood pressure, transient increase in blood pressure (observed shortly after administration), bradycardia, palpitations, tachycardia (incl. ventricular) in some cases – severe heart rhythm disturbances (up to ventricular fibrillation), transient changes in the ECG of ischemic type, myocardial infarction in isolated cases – Raynaud’s syndrome.
From the digestive system: nausea and vomiting in some cases – a slight increase in the activity of hepatic transaminases, discomfort in the abdomen, dysphagia, ischemic colitis.
On the part of the nervous system: dizziness, weakness (usually mild or moderate and transient) rarely – drowsiness, fatigue (more often when taken orally) in some cases – epileptic seizures (usually with a history of epilepsy).
On the part of the sensory organs: diplopia, flickering flies in front of the eyes, nystagmus, scotoma, decreased visual acuity (can be associated with migraine attacks themselves).
Allergic reactions: skin rash (including urticaria and erythematous rashes), pruritus, anaphylactic reactions.
Other: myalgia, flushing.
Drug interaction
When administered simultaneously with ergotamine and ergotamine-containing drugs, a prolonged vasospasm may occur (the interval between their intake should be at least 24 hours).
Interaction between sumatriptan and MAO inhibitors is possible (decrease in the intensity of sumatriptan metabolism, increase in its concentration).
With the simultaneous use of sumatriptan and drugs from the group of selective serotonin reuptake inhibitors, weakness, hyperreflexion, and impaired coordination of movements may develop.
overdose
Symptoms:
does not show any side effects other than those listed above when taken orally up to 400 mg.
Treatment:
monitoring the patient for 10 hours, symptomatic therapy.
Storage conditions
Store in a dry, dark place at a temperature not exceeding 25 ° C.
Expiration date
2 years
Deystvuyushtee substance
Sumatriptan
Conditions of release from drugstores
Prescription
Dosage form
tablets
Possible product names
Sumatriptan tablets are coated. 50 mg 2 pcs.
Vertex, Russia
