Producer: JSC VEROPHARM Russia
Code of automatic telephone exchange: N02CC01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Description: tablets, coated, color, white or white with a grayish and cream shade, with a biconvex surface.
Each tablet contains in quality of active agent 0,05 g and 0,1 g of a sumatriptan in the form of succinate. Excipients: cellulose microcrystallic, sugar milk, potato starch, sodium carboxymethylstarch, magnesium stearate, oxypropyl-cellulose or oksipropilmetiltsellyuloz, polyvinylpirrolidone, polyethyleneglycol 4000, talc, titanium dioxide.
Pharmacodynamics. Interacts with 5-gidroksitriptaminovy receptors of the I type located in smooth muscles of walls of blood vessels of a brain, selectively narrows vessels in system of carotid arteries, inhibits activity of a trifacial. All this promotes decrease in expressiveness of a pain syndrome at migraine. The clinical effect is noted in 30 min.
Pharmacokinetics. At intake суматриптан it is quickly absorbed. 70% of the maximum serumal concentration are reached in 45 minutes. The average size of absolute bioavailability makes 14% owing to presistemny metabolism and incomplete absorption. Extent of linkng with proteins of plasma is small (14–21%), semi-removal time — 2 hours. The main metabolite (an indolacetic analog of a sumatriptan) is removed preferential with urine in the form of free acid and its glyukuronidny conjugate.
Indications to use:
Stopping of bad attacks of migraine (with aura and without it).
Route of administration and doses:
Inside. The tablet is swallowed entirely, washing down with water. Adult: a single dose of 0,05 g, in certain cases — 0,1 g. Maximum daily dose of 0,3 g. If symptoms of migraine do not disappear and do not decrease after reception of the first dose of drug, then it is not necessary to appoint reception of the second dose for stopping of the same attack. If symptoms decreased or passed, and then again renewed, it is possible to accept the second dose within the next 24 hours. The interval between doses makes not less than 2 hours.
Features of use:
Amigrenin it is not necessary to apply with the preventive purpose. Before purpose of a sumatriptan patients with for the first time the revealed migraine or which is atypically proceeding should exclude other potentially dangerous neurologic diseases. It must be kept in mind that the patients having migraine have a risk of development of a stroke or passing disturbances of cerebral circulation. It is not necessary to appoint to patients with an estimated heart disease without preliminary survey. The first 2–3 administrations of drug should be carried out under observation of the doctor (the spasm of coronary arteries is possible). At patients with hypersensitivity to streptocides at introduction of a sumatriptan the increased risk of development of allergic reactions is noted (from skin manifestations to an acute anaphylaxis). In the absence of effect on introduction of the first dose, it is necessary to specify the diagnosis. Experience of use of a sumatriptan for patients is more senior than 65 years is limited (the considerable difference in pharmacokinetics in comparison with younger patients is not observed). As Amigrenin's use can cause drowsiness, it is necessary to be careful during the driving of the car and work with mechanisms.
Feeling of a pricking, heat, weight, pressure or in various parts of a body a dermahemia and mucous membranes; dizziness, fatigue, weakness, drowsiness; a stenocardia attack, hypotonia, tachycardia, heartbeat, tranzitorny increase in the ABP, passing changes of an ECG of ischemic type, bradycardia, in isolated cases — Reynaud's syndrome; a sensation of discomfort in a stomach, a dysphagy, nausea, vomiting, ischemic colitis; vision disorders (diplopia, scotoma, decrease in visual acuity); allergic reactions: rash, urticaria, itch, erythema, anaphylaxis: change of functional hepatic trials; mialgiya.
Interaction with other medicines:
The concomitant use is inadmissible: the means containing ergot alkaloids; lithium drugs; inhibitors of the return neyronalny serotonin reuptake; MAO inhibitors.
Individual intolerance of drug, coronary heart disease, stenocardia; hemiplegic, basilar or ophthalmoplegic forms of migraine, occlusal diseases of peripheral arteries, uncontrollable arterial hypertension; a stroke or passing disturbance of cerebral circulation in the anamnesis; a liver failure, pregnancy, the breastfeeding period, children's age, advanced age (more than 65 years), simultaneous use with ergotamine and its derivatives.
With care — epilepsy (including any states with a reduced epileptic threshold), arterial hypertension (controlled), a concomitant use of drugs, MAO inhibitors, and the period up to 14 days after their cancellation.
In case of overdose it is necessary to observe the patient within 10 hours, carrying out if necessary symptomatic therapy.
List B. To store in dry, protected from light, the place, unavailable to children.
Period of validity 2 years. Not to apply after the expiry date specified on packaging.
According to the recipe
On 2 or 10 tablets in a blister strip packaging; on 1 blister strip packaging together with the application instruction in a pack. On 2 or 10 tablets in bank of light-protective glass. Each can together with the application instruction in a pack.