Antimigren-Zdorovye, tab. of 50 mg No. 1/tab. 50 of mg No. 1х3
Producer: LLC Pharmaceutical Company Zdorovye Ukraine
Code of automatic telephone exchange: N02C C01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
International and chemical names: суматриптан; sumatriptan; 3-[2 (dimethylamines) ethyl] - N-skatole-5-metansulfanamida succinate;
main physical and chemical properties: tablets, coated, white with a creamy shade цвета.состав: 1 tablet contains a sumatriptan in the form of a sumatriptan of succinate of 50 mg or 100 mg; excipients: tselaktoza, potato starch, to sodium of a kroskarmelloz, povidone (polyvinylpirrolidone low-molecular medical), silicon dioxide colloid anhydrous (aerosil), calcium stearate, titanium dioxide, gipromelloz (gidroksipropilmetiltsellyuloz).
Pharmacodynamics. Activates serotonergic anti-nociceptive mechanisms of a brainstem, selectively excites 5HT1D-serotoninovy receptors of vessels of a brain (a firm meninx of a basilar artery), oppresses activation of trigeminal system and reduces accumulation of the specific stimulating protein in trifacial kernels. Causes selective narrowing of the vessels of system of the carotid artery supplying with blood extra-and intracranial fabrics, including and a meninx expanded during an attack without influencing at the same time a brain blood stream. Pathological expansion of these vessels is the main origins of an attack of migraine at the person. The specified effects of drug stop or weaken an attack of migraine and are the cornerstone of protivomigrenozny activity of a sumatriptan. Stops in 50-70% of cases the heaviest attack of migraine in 20-30 minutes (at most in an hour) after oral administration, in 2-3 hours efficiency of the patient is recovered completely. Eliminates the migrena associated with the attack nausea and photophobia. Does not affect other subtypes of serotoninovy receptors (5HT2-5HT7), and also adrenergic, benzdiazepinovy, muskarinovy and dopamine receptors.
Pharmacokinetics. After oral administration суматриптан it is quickly soaked up
in a digestive tract, in 45 minutes its concentration in blood reaches 70%
from maximum. However, its absolute bioavailability at peroral
reception makes only about 15% owing to presistemny metabolism and incomplete absorption.
The maximum concentration in blood after reception of 100 mg averages 54 ng/ml and is reached within 2-2,5 hours (at a migraine attack slightly quicker, than between attacks). Linkng with proteins of a blood plasma rather low – 14-21%. It is removed preferential (97%) in the form of inactive metabolites.
Indications to use:
Stopping of a bad attack of migraine (with aura or without it) and the accompanying symptoms at adults.
Route of administration and doses:
Drug is accepted as soon as possible after emergence of an attack of migraine, but it is equally effective at any stage of an attack.
The adult appoint, as a rule, 50 mg, in some cases – 100 mg. If symptoms of migraine do not disappear or do not decrease after reception of the first dose, drug is not recommended to be accepted repeatedly for stopping of an attack which proceeds. However, if symptoms of an attack passed or decreased after the first dose, drug can be accepted repeatedly for stopping of the subsequent attacks within the next 24 hours, but not earlier than in 2 hours after reception of the first dose. During any 24-hour period the maximum dose of the drug Antimigren-Zdorovye should not exceed 300 mg.
Features of use:
Antimigren-Zdorovye it is necessary to appoint only in that case when the diagnosis of migraine does not raise doubts. It is impossible to exceed the recommended doses. Drug is not used at a hemiplegic, basilar and ophthalmoplegic form of migraine. Drug is not intended for use for the purpose of prevention of an attack of migraine. Antimigren-Zdorovye it is necessary to appoint with care the patient with epilepsy or with other forms of a convulsive syndrome (including in the anamnesis); to patients with controlled arterial hypertension because of danger of tranzitorny increase in the general peripheric resistance of vessels and arterial pressure; to the patients belonging to risk group of development of pathology of cardiovascular system (women during the postclimacteric period, men are more senior than 40 years, the person with risk factors of an ischemic heart disease); at abnormal liver functions or kidneys or other diseases at which essential changes of absorption, metabolism and removal of a sumatriptan are possible. After administration of drug there can be such passing phenomena as feeling of constraint in breasts and pain with irradiation in a neck; in such cases it is necessary to conduct diagnostic examination for the purpose of clarification of communication of these symptoms with an ischemic heart disease. With care appoint to drivers of transport and persons whose work demands exact coordination of movements.
From cardiovascular system. Arterial hypotension, bradycardia, a heart consciousness, tachycardia, tranzitorny increase in arterial pressure are occasionally possible, it is very rare – disturbances of a cordial rhythm, passing changes of an ECG of ischemic type, a spasm of coronary arteries.
From the alimentary system. At certain patients slight increase of activity of enzymes of a liver, a dysphagy, a sensation of discomfort in a stomach are possible.
From the central nervous system. Are occasionally possible – inflows, dizziness, weakness (usually poorly or are moderately expressed and short-term), in some cases - convulsive attacks (usually at the anamnesis of such patients there is epilepsy or organic lesions of a brain which are connected with risk of development of a convulsive syndrome, for example, after craniocereberal injuries), sometimes after administration of drug the diplopia, a nystagmus, decrease in visual acuity is noted, it is very rare – short-term partial loss of sight (at the same time it must be kept in mind that vision disorders can be connected with a migraine attack).
Allergic reactions. Are occasionally possible – skin rash, an itch, an erythema.
Others. Occasionally – pain, feeling of a pricking, burning, weight, pressure or compression which are passing and can arise in any part of a body, including a thorax and a throat.
Interaction with other medicines:
The concomitant use with ergotamine or its derivatives can cause a long vasospasm therefore drug can be used not earlier than in 24 hours after ergotamine reception, and the means containing ergotamine or its derivatives can be applied not earlier than in 6 hours after administration of drugs of a sumatriptan. Interaction between sumatriptany and MAO inhibitors is possible (Pyrazidolum, Melipraminum, etc.), their simultaneous use is contraindicated. Patients have separate messages on development of weakness, a hyperreflexia and a lack of coordination after a concomitant use of a sumatriptan and selective serotonin reuptake inhibitors (fluoxetine, etc.). Interaction of a sumatriptan with propranolol, flunariziny, pizotifeny and ethanol is noted.
The Coronary Heart Disease (CHD), including myocardial infarction, postinfarction cardiosclerosis, Printsmetal's stenocardia, or existence of the cardiological symptoms allowing to assume an ischemic heart disease. Uncontrollable arterial hypertension. Occlusal diseases of peripheral vessels. Passing disturbances of cerebral circulation or a stroke (including in the anamnesis). The expressed abnormal liver functions and kidneys. A concomitant use of the drugs containing ergotamine or its derivatives (including метисергид). A concomitant use of inhibitors of a monoaminooxidase (MAO) and the period up to 14 days after their cancellation. Pregnancy, the lactation period (it is not recommended to nurse the child within 24 hours after administration of drug). The age of patients up to 14 years is also more senior than 65 years. The increased individual sensitivity to drug.
Cases of overdose of a sumatriptan at oral administration are not known so far. The symptoms given in the section "Side effect" are possible. At overdose it is necessary to carry out symptomatic therapy. To provide medical observation within 10 hours. Efficiency of a hemodialysis and peritoneal dialysis is not established.
To store in the dry, protected from light place at a temperature from 15ºС to 25 ºС. To store in the place, unavailable to children.
Period of validity – 2 years.
According to the recipe
On 1 or 6 tablets at a blister strip packaging; No. 1, No. 1х3, No. 6 in a pack.