After oral administration, sumatriptan is rapidly absorbed, of the maximum plasma concentration is reached after 45 minutes. After receiving 100 mg of the maximum concentration in plasma is on average. Bioavailability is as a result oral masteron of first-pass metabolism and incomplete absorption. Relationship to plasma proteins is low . Sumatriptan is metabolized by the action of monoamine oxidase A main metabolite – indoleacetic analog output of sumatriptan, preferably in the urine in the form of free acid and glucuronide conjugate. This metabolite has no activity against -serotoninovym receptors.Migraine attacks, apparently no significant effect on the pharmacokinetics of sumatriptan ingestable.
- Hypersensitivity to any component of the formulation.
- Hemiplegic, basilar migraine and oftalmoplegicheskaya form.
- Coronary heart disease (CHD) (including myocardial infarction, myocardial infarction, angina, Prinzmetal), as well as the presence of symptoms to suggest the presence of coronary artery disease.
- Occlusive peripheral vascular disease
- Stroke or transient ischemic attack (in Vol. H. In history)
- Uncontrolled hypertension.
- Receiving simultaneously with ergotamine or derivatives thereof (including methysergide).
- The use in patients receiving monoamine oxidase inhibitors or earlier than 2 weeks after the cancellation of these drugs.
- Severe liver and / or kidneys.
- Age 18 years and older than 65 years (the safety and effectiveness of Imigran is not installed).
- Pregnancy and lactation.
- controlled hypertension.
- diseases that may change the absorption, metabolism or excretion of the drug (eg, renal or hepatic function).
- epilepsy (including any condition with a reduction in seizure threshold)
- in patients with hypersensitivity to sulfonamides (administration sumatriptan can cause allergic reactions, the severity of which varies from cutaneous manifestations of anaphylaxis. Data on the cross-sensitivity is limited, however, caution should be exercised in the appointment of sumatriptan in these patients).
DOSAGE AND ADMINISTRATION
Inside, swallowing the tablet whole and with water.
The recommended dose is one tablet of 50 mg. Some patients may need a higher dose – 100 mg. If migraine symptoms do not disappear or diminish after the first dose of Imigran. something for the relief of the same re-taking the drug should not attack. However Imigran can be used for relief of subsequent migraine attacks.
If the patient has felt improvement after the first dose, and then resumed symptoms can take a second dose for the next 24 hours. Imigran maximum dose should not exceed 300 mg over a 24-hour period.
Adverse reactions are listed below, depending on the anatomical and physiological classification and occurrence frequency.
The frequency is defined as follows: very common (> 1/10); often (> 1/100 and <1/10); sometimes (> 1/1000 and <1/100); rare (> 1/10 000 and <1/1000); very rare (<1/10000), including isolated cases.Evaluated data from clinical trials, it must be remembered that the frequency of adverse reactions in patients receiving comparator drugs are not taken into account. Also taken into account post-marketing data. Clinical Studies : From the nervous system : often – dizziness, drowsiness, sensory disturbances including paresthesia and decrease in sensitivity. Since the cardiovascular system : often – a transient increase in blood pressure (shortly after administration), flushing. The respiratory system and the thoracic organs : often – shortness of breath; mild, transient irritation or burning sensation in the nose or throat, nose bleeding. On the part of the gastrointestinal tract : often – nausea, vomiting (cause-and-effect relationship has not been proved). On the part of the musculoskeletal system and connective tissue disorders : often – a feeling of heaviness (usually transient, may be intense and occur in any part of the body including the chest and throat). General and local reactions : often – pain, feeling cold or hot, a feeling of pressure or constriction (usually transient, may be intense and occur in any part of the body including the chest and throat). Often, weakness, fatigue (usually slightly or moderately expressed, transitory). Laboratory findings : very rarely -neznachitelnye deviation indicators liver function tests. Post-marketing surveillance Immune system : very rarely – hypersensitivity reactions, including skin manifestations and anaphylaxis Nervous system : very rarely – seizures (in some cases observed in patients with a seizure history or concomitant conditions predisposing to seizures, in some of the risk factors of patients have been identified), tremor, dystonia, nystagmus, scotoma. from a sight organ : very rare -melkanie, diplopia, blurred vision. Blindness (usually transient). However, visual disorders may be caused by a migraine attack itself. Since the cardiovascular system : very rarely – bradycardia, tachycardia, fibrillation, arrhythmias, transient ECG changes, coronary vasospasm, angina , myocardial infarction. Very rarely – hypotension, Raynaud’s syndrome. On the part of the gastrointestinal tract : rarely – ischemic colitis, dysphagia, abdominal discomfort.
Reception Imigran oral dose of 400 mg oral masteron did not cause any side effects other than those listed above.
In case of overdose Imigran should monitor the patient’s condition is not less than 10 hours and spend symptomatic therapy if necessary. No data on the effect of hemodialysis or peritoneal dialysis on plasma concentrations of sumatriptan.
Imigran should be used only if the diagnosis of migraine is not in doubt.
Imigran Tablets should not be used prophylactically.
In patients with previously diagnosed with migraine or patients with atypical migraine is necessary to exclude other neurological disorders. It should be noted that patients with migraine are at increased risk of certain cerebrovascular disorders (eg stroke, or transient ischemic attack).
After receiving sumatriptan may experience transient pain and tightness in the chest, extending to the neck. If there is reason to believe that these symptoms are a manifestation of coronary heart disease, it is necessary to conduct appropriate diagnostic testing.
Sumatriptan should not be administered to patients with the risk of cardiovascular disease without prior examination with a view to its elimination (in postmenopausal women, men over the age of 40 years and patients with risk factors for coronary heart disease). The survey is not always possible to identify heart disease in some patients. In very rare cases, patients may experience serious side effects to the cardiovascular system, a history that has not been observed for cardiovascular disease.
It should be administered with caution to patients with controlled hypertension, since in some cases there was a transient increase in blood pressure and peripheral vascular resistance; in patients suffering from such diseases that can significantly change the absorption, metabolism or excretion of the drug (eg, renal or hepatic function).
There are very rare reports resulting from post-marketing surveillance, the development of serotonin syndrome (including mental disorder, autonomic lability and neuromuscular disorders) resulting from concomitant use of selective serotonin reuptake inhibitors (SSRI) and sumatriptan. It was also reported on the development of serotonin syndrome on the background of co-administration of triptans with selective serotonin reuptake inhibitors and norepinephrine (SNRI). In the case of co-administration with drugs of the SSRI / SNRIs should be closely monitored condition of the patient.
Imigran should be used with caution in patients with epilepsy or organic brain damage in history with a reduction in seizure threshold.
The concomitant use of other triptans / 5-HT 1 agonists sumatriptan is not recommended.
in patients with hypersensitivity to sulfonamides receive Imigran may cause allergic reactions that range from skin manifestations of anaphylaxis. Data on cross-sensitivity is limited, however, caution should be exercised in the appointment of Imigran such patients.
The abuse of drugs intended for the relief of migraine attacks, associated with increasing headaches in susceptible patients (headache associated with the abuse of drugs). It should consider discontinuation of the drug.
Do not exceed the recommended dose of Imigran.
INTERACTION WITH OTHER DRUGS
There was no interaction between sumatriptan with propranolol, flunarizine, pizotifenom and ethyl alcohol.
When concomitantly with ergotamine celebrated long spasm of blood vessels.
Sumatriptan can not assign earlier than 24 hours after taking the drugs containing ergotamine; Conversely, drugs oral masteron containing ergotamine, you can assign no sooner than 6 hours after administration of sumatriptan.
Perhaps the interaction between sumatriptan and MAOIs and their concurrent use is contraindicated.
There are very rare reports resulting from post-marketing surveillance, the development of serotonin syndrome ( including mental disorders, vegetative lability and neuromuscular disorders) resulting from concomitant use of selective serotonin reuptake inhibitors (SSRI) and sumatriptan. It was also reported on the development of serotonin syndrome on the background of co-administration of triptans with selective serotonin reuptake inhibitors and norepinephrine (SNRI).
Effects on ability to drive and / or other mechanisms
in patients with migraine may occur drowsiness, associated, with both the disease itself and the reception Imigran, so they need to be especially careful while driving and working with moving machinery.
coated tablets 50 mg and 100 mg. 2 tablets in A1 / A1 blister. 1 blister with instructions for use in a cardboard box.
The temperature is not above 30 ° C. Keep out of the reach of children.
3 years. Do not use the drug after the expiry date printed on the package
Conditions of supply of pharmacies