Imigran

Imigran – drug with protivomigrenozny action, an agonist of serotoninovy _{5-HT1-receptors}.

Form of release and structure

Dosage forms:

• Tablets, coated: an oval biconvex form with a plain surface on one party, on another the text is engraved: on tablets of pink color – "GX ES3", almost white or white color – "GX ET2" (on 2 pieces in blisters, in a cardboard pack 1 blister);
• Spray nasal: transparent liquid from dark yellow till light yellow color (in one-time dosers, in the blister 1 doser, in a cardboard pack 1 blister).

Active ingredient of Imigran – суматриптан:

• 1 tablet: 50 mg or 100 mg (in the form of a sumatriptan of succinate of 70 mg and 140 mg respectively);
• 1 doser: 10 mg, 20 mg.

Auxiliary components:

• Tablets: croscarmellose sodium, lactose anhydrous, lactoses monohydrate, cellulose microcrystallic, magnesium stearate;
• Spray: sodium phosphate disubstituted anhydrous, sodium hydroxide, sulphuric acid, potassium phosphate monosubstituted, the water purified.

In addition as a part of a cover of tablets with an engraving:

• "GX ES3" (50 mg): опадрай pink YS-1-1441-G, ferrous oxide red, titanium dioxide, triacetin, methylhydroxypropyl cellulose;
• "GX ET2" (100 mg): опадрай white OY-S-7393, titanium dioxide, methylhydroxypropyl cellulose.

Indications to use

Tablets, coated
Elimination of a pain syndrome of bad attacks of migraine with aura or without it.

Spray nasal
Stopping of attacks of migraine with aura or without it.

Contraindications

• The Coronary Heart Disease (CHD), including Printsmetal's stenocardia, a myocardial infarction, a postinfarction cardiosclerosis (including in the presence of symptoms or suspicions on existence of an ischemic heart disease);
• Ophthalmoplegic, basilar and hemiplegic forms of migraine;
• Occlusal pathologies of peripheral vessels;
• Uncontrollable arterial hypertension;
• Stroke or passing disturbance of cerebral circulation (including the anamnesis);
• Severe form of a renal failure and/or liver;
• The accompanying therapy by monoamine oxidase inhibitors (MAO) and the period up to two weeks after their cancellation;
• Simultaneous use with the drugs containing ergotamine or its derivatives including метисергид;
• The age up to 18 years is also more senior than 65 years;
• Pregnancy period;
• Hypersensitivity to drug components.

With care it is necessary to appoint Imigran sick with controlled arterial hypertension (risk of tranzitorny increase in the arterial pressure (AP) and general peripheric vascular resistance), epilepsy and any pathologies with reduction of the threshold of convulsive readiness, during breastfeeding (a lactation after administration of drug not earlier than in 24 hours).

Route of administration and dosage

Tablets, coated
Pill is taken inside, swallowing entirely and washing down with enough water.

Imigran's effect at any stage of an attack is identical, but it is desirable to apply it at emergence of the first symptoms of migraine.

The recommended dosing for stopping of a bad attack of migraine – 50-100 mg once. In the absence of clinical effect it is impossible to accept a repeated dose for removal of a pain syndrome of the proceeding attack.

When resuming symptoms after stopping of the first attack, the second dose can be accepted within the next 24 hours, observing an interval between doses not less than 2 hours.

The maximum dose should not exceed 300 mg within 24 hours.

Spray nasal
Spray is applied intranazalno, injecting the appointed dose into one nostril.

Accurately, without pressing the blue button, it is necessary to withdraw the doser from the blister. Having strong pressed a finger one nostril to a nasal partition, it is necessary to breathe through the mouth quietly. To insert a tip of the doser into the open nasal course which is (previously cleared) on depth about 1 cm. Not to throw back the head, to close a mouth. During a quiet breath through a nose to press with effort to the blue button a thumb. Then within 10-20 seconds it is necessary to inhale quietly through a nose and to exhale a mouth.

The dose of drug depends on clinical implication of an attack and can make 10 mg or 20 mg of a sumatriptan.

If the attack of migraine did not manage to be stopped the first dose, the second dose should not be applied.

If after temporary improvement owing to use of the first dose symptoms of a disease renewed, then the second dose can be entered within the next 24 hours, at the same time it is necessary to observe an interval between doses not less than 2 hours.

Intranazalno can enter no more than 2 doses on 20 mg within 24 hours.

Side effects

Tablets, coated

• Nervous system: dizziness, inflows, weakness (passing, are usually expressed poorly or moderately); seldom – feeling of fatigue, drowsiness; in some cases – convulsive attacks (is more often at patients in the anamnesis with the epilepsy or structural damages of a brain capable to cause development of epilepsy); sometimes – a diplopia, a nystagmus, scotoma, flashing before eyes, decrease in visual acuity; very seldom – passing partial loss of sight (it is necessary to consider that the attack of migraine can cause a vision disorder);
• Cardiovascular system: bradycardia, arterial hypotension, a heart consciousness, tranzitorny increase in the ABP (right after reception of a tablet), tachycardia (including ventricular); in some cases – disturbances of a cordial rhythm, passing changes of an electrocardiography (ECG) of ischemic type, a spasm of coronary arteries, a myocardial infarction, Reynaud's syndrome;
• Alimentary system: perhaps – nausea, vomiting (connection using Imigran is not established); seldom – ischemic colitis; in some cases – slight increase of activity of enzymes of a liver, a sensation of discomfort in a stomach, a dysphagy;
• Allergic reactions: in some cases – an erythema, skin rash, an itch on skin, an anaphylaxis;
• Others: perhaps – pain, feeling of heat and/or a pricking, passing feeling of weight, compression, pressure in any part of a body, including a throat and a thorax.

Spray nasal

• Nervous system: often – drowsiness, dizziness, sensitivity disturbances (including decrease in sensitivity, paresthesia);
• Cardiovascular system: often – inflows, passing increase in the ABP (soon after an instillation);
• Respiratory system: often – slight burning sensation and passing irritation of a mucous membrane of a nose and/or throat, short wind, nasal bleeding;
• Alimentary system: often – nausea, vomiting; very seldom – insignificant disturbances of indicators of hepatic tests;
• General reactions: often – fatigue, weakness, feelings of pain, weight, cold, heat, pressure or tightening (various degree of intensity, have passing character, can arise in any part of a body).

The side effects from spray use gained in post-market researches:

• Nervous system: very seldom – convulsive attacks (were observed, how at patients with convulsive attacks and states in the anamnesis, and patients without risk factors), dystonia, a tremor, a nystagmus;
• Organ of sight: very seldom – a diplopia, decrease in visual acuity, flashing, scotoma, a blindness (usually passing);
• Cardiovascular system: very seldom – tachycardia, bradycardia, trembling, tranzitorny changes on an ECG, arrhythmia, stenocardia, a coronary vasospasm, a myocardial infarction, Reynaud's syndrome, hypotonia;
• Alimentary system: very seldom – a dysphagy, ischemic colitis, a sensation of discomfort in a stomach;
• Allergic reactions: very seldom – hypersensitivity reactions.

Special instructions

Imigran it is possible to apply only at the exact diagnosis of an attack of migraine.

Use for the purpose of prevention is contraindicated!

Disturbance of the mode of dosing is forbidden.

In the absence of clinical effect of the first dose it is necessary to specify the diagnosis.

At purpose of drug stopping of a headache at patients with not diagnosed migraine or atypical symptoms of migraine, requires a preliminary exception of other potentially dangerous neurologic pathologies. It is necessary to consider that at migraine there is a risk of developing of a stroke, passing disturbances of cerebral circulation and other cerebrovascular complications.

Without preliminary survey for the purpose of an exception of cardiovascular diseases at patients of risk group (the postclimacteric period at women, the man aged after 40 years, predisposition to an ischemic heart disease) it is not necessary to appoint drug.

Emergence of side effect in the form of the intensive, irradiating in a neck pain and feeling of constraint in a breast can be a symptom of manifestation of an ischemic heart disease therefore it is necessary to conduct diagnostic examination.

With care it is necessary to use drug at functional disorders of kidneys or a liver (because of possible essential disturbance of absorption, metabolism, excretion of a sumatriptan), controlled arterial hypertension (as there is a risk of tranzitorny increase in the ABP and peripheric vascular resistance).

Careful control of a condition of the patient at a concomitant use of inhibitors of the return serotonin reuptake is required.

At hypersensitivity to a sumatriptan development of skin allergic manifestations up to an acute anaphylaxis is possible.

In the period of an attack of migraine and Imigran's use the patient should manage with extra care vehicles and mechanisms.

Medicinal interaction

The accompanying therapy with ergotamine causes a long vasospasm therefore суматриптан it is necessary to apply in 24 hours after reception of the means containing ergotamine, and drugs containing ergotamine can be used only in 6 hours after a sumatriptan.

Because of possible interaction simultaneous use with MAO inhibitors is contraindicated.

At Imigran's combination and other triptanovy drugs with selective serotonin reuptake inhibitors there is a risk of development of a serotoninovy syndrome with possible frustration of mentality, vegetative lability and neuromuscular disturbances.

Interaction with ethanol, flunariziny, propranolol, pizotifeny is not recorded.

Terms and storage conditions

To protect from children.

To store at a temperature: tablets – to 30 °C, spray – 2-30 °C, in the place protected from light.

Period of validity: tablets on 50 mg – 3 years, on 100 mg – 4 years; spray – 3 years.