Neurokson of the tab. of p/o of 500 mg No. 20

Neurokson of a tablet of 500 mg No. 20

Instruction for use

Structure

Active ingredient: citicoline.

1 tablet supports a tsitikolin of monosodium salt (in terms of tsitikolin) 500 mg.

Excipients: microcrystalline cellulose, sodium of a kroskarmelloz, the castor oil of a poliyetoksilyovan hydrogenated with the mineral carrier magnesium alyumometasilikaty, talc, silicon dioxide hydrophobic, magnesium stearate, mix for a covering of Aquarius PrimeBKN318029 White containing a hydroksipropilmetiltsellyuloza, hydroxypropyl cellulose, triglycerides with an average length of a chain, the titan dioxide.

Dosage form

Tablet, coated.

Pharmacodynamics

Tsitikolin stimulates with

biosynthesis of structural phospholipids of membranes of neurons that is confirmed with data of magnetic and resonant spectroscopy. Thanks to this mechanism of action tsitikolin shows functioning of such membrane mechanisms as operation of ion-exchange pumps and receptors which modulation is necessary for normal carrying out nervous impulses. As a result of the stabilizing action on a membrane of neurons tsitikolin has the antiedematous properties promoting a wet brain reabsorption.

Results of pilot studies demonstrate what tsitikolin inhibits activation of some types of a phospholipase (A1, A2, C and D), reducing education of free radicals, prevents destruction of membrane systems and keeps antioxidant protective systems, such as glutathione.

Tsitikolin keeps a stock of energy of neurons, inhibits apoptosis and stimulates synthesis of acetylcholine.

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it is Experimentally proved that tsitikolin also shows preventive neurotyre-tread action in focal ischemia of a brain.

Clinical trials showed that tsitikolin authentically raises indicators of functional recovery at patients with an acute ischemic disorder of cerebral circulation that matches delay of growth of an ischemic brain damage according to neuroimaging.

At patients with a craniocereberal injury tsitikolin is accelerated by restoration, reduces duration and intensity of a posttraumatic syndrome.

Tsitikolin improves the level of attention and consciousness, reduces severity of the cognitive and neurologic disorders connected with brain ischemia, promotes reduction of manifestations of amnesia.

Pharmacokinetics

Tsitikolin is well absorbed by

at oral introduction. After administration of medicament the substantial increase of level of sincalines in blood plasma is observed. At oral administration of the tablet "Neurokson" are almost completely soaked up. Results of researches demonstrate that bioavailability at peroral and in in ways of introduction almost identical.

Drug "Neurokson" (tablets) is metabolized by

in intestines and a liver with formation of sincaline and cytidine.

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After introduction tsitikolin it is widely distributed in structures of a brain with fast inclusion of fraction of sincaline in structural phospholipids and fractions of cytidine in cytidine nucleotides and nucleic acids. In a brain tsitikolin it is built in cellular, cytoplasmic and mitochondrial membranes, participating in creation of fraction of phospholipids.

Only insignificant quantity of a dose is defined in urine and Calais (3%). About 12% of a dose are removed through FROM 2 expired air. At medicament discharge with urine define two phases: the first — during 36 h in which clearance rate decreases quickly and the second — clearance rate decreases much more slowly. The same staging is observed at discharge through airways. Clearance rate FROM 2 decreases quickly during about 15 h, and then decreases much more slowly.

Indication

Stroke, sharp phase of disturbances of cerebral circulation and their neurologic consequences. Craniocereberal injury and its neurologic consequences. Cognitive disturbances and behavior disorders owing to chronic vascular and degenerative cerebral disorders.

Use

Neurokson of a tablet: the recommended dose makes 500–2000 mg/days (1–4 tablets).

Dose of medicament and duration of treatment depend on weight of damages of a brain, are established by the doctor.

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Solution for oral administration. Accept inside. The recommended dose for adults makes from 500 mg (5 ml) to 2000 mg (20 ml) a day in 2-3 receptions.

needs to use Drug by means of the dosing syringe according to the following scheme:

• before use should squeeze the piston of the dosing syringe completely;
• to delay the piston and to gather a necessary dose, considering that the amount of liquid in the syringe has to correspond to the appointed dose;
• needs to take the medicament directly or to part on a half-glass of water (120 ml), irrespective of meal.

needs to wash the dosing syringe with water after each use.

Dose of medicament and duration of treatment depend on weight of damages of a brain and are established individually.

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Solution for injections. The recommended dose for adults makes from 500 to 2000 mg/days depending on weight of symptoms.

Drug is appointed in oil or in / century. In/in it can be entered slowly injektsionno (within 3–5 min. depending on the entered dose) or by drop infusion (speed — 40–60 drops a minute).

Maximum daily dose — 2000 mg.

Period of treatment depends on the course of the disease and is defined by the doctor.

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only for single use. To use medicament right after opening of an ampoule. Residues of medicine need to be destroyed. Drug can be mixed with all isotonic solutions for in/in introductions and also with hypertensive solution of glucose.

If necessary treatment is continued by medicament in the form of solution for intake.

Contraindication

Hypersensitivity to a tsitikolin or other components of drug. The raised tone of parasympathetic nervous system.

Side effects

Arise very seldom (1/10,000), including isolated cases.

from mentality: hallucinations.

from nervous system: profound headache, dizziness.

from a cardiovascular system: AG, arterial hypotension, tachycardia.

from a respiratory system: dispnoe.

from a digestive tract: nausea, vomiting, incidental diarrhea.

Allergic reactions, including rash, an itching, a Quincke's disease, an acute anaphylaxis, reddening, a small tortoiseshell, a dieback, a purpura.

General disturbances: fever, hypostasis, changes in the injection site.

Special instructions

In a case in/in uses the medicament should be administered slowly (within 3–5 min. depending on the appointed dose).

At use in/in by drop infusion speed of injection has to make 40–60 drops a minute.

in case of steady intracraneal hemorrhage should not exceed a dose of 1000 mg/days and speed in/in injections (30 drops a minute).

to Patients with an inherited disorder of tolerance to fructose should not accept Neurokson, solution for oral administration as it contains sorbite. Methylparaben and propilparagidroksibenzoat, available as a part of drug, allergic reactions (usually slowed down type) can cause.

Use of the tablets "Neurokson" during pregnancy and feeding by a breast. There are no sufficient data on use of a tsitikolin for pregnant women. It should not be applied, except emergency cases. During pregnancy medicament is appointed only when the expected therapeutic advantage exceeds potential risk. Data on penetration of a tsitikolin into breast milk and its action on a fruit are unknown.

Children. Experience of use of medicament for children is limited therefore it is appointed only when the expected advantage exceeds any potential risk.

Ability to influence speed of response at control of vehicles or work with other mechanisms. In individual cases some side reactions from central nervous system can affect ability to run vehicles and to work with mechanisms.

Interaction

Tsitikolin enhances effect of a levodopa. It is not necessary to appoint along with the medicines containing Meclofenoxatum.

Cases of overdose are noted by

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Storage conditions

Neurokson of a tablet of 500 mg No. 20 — in original packing at a temperature not above 25 °C.

Solution for oral administration — in original packing at a temperature not above 30 °C. Not to freeze and not to cool. In the course of storage the emergence of easy opalescence which disappears when keeping medicament at the room temperature (≈20 °C) is possible.

Solution for injections — in original packing at a temperature not above 30 °C.