Encetron solution for oral administration 100mg / ml, 10ml No. 10 Solofarm

• Acute period of ischemic stroke (as part of complex therapy;

• the recovery period of ischemic and hemorrhagic strokes;

• traumatic brain injury, acute (as part of complex therapy) and recovery period;

• cognitive and behavioral disorders in degenerative and vascular diseases of the brain.

Oral solution, administered orally.

Before use, the drug can be diluted in a small amount of water (100-120 ml or 1/2 cup).

It is taken with meals or between meals.

Acute period of ischemic stroke or traumatic brain injury (TBI): 1000 mg (10 ml) every 12 hours.

The duration of treatment is at least 6 weeks.

The recovery period of ischemic and hemorrhagic strokes, the recovery period of TBI, cognitive and behavioral disorders in degenerative and vascular diseases of the brain: 500-2000 mg (5-20 ml) / day.

The dose and duration of treatment - depending on the severity of the symptoms of the disease.

When citicoline is prescribed to elderly patients, dose adjustment is not required.

The oral solution is colorless, yellowish or yellowish brown, transparent.

1 ml

citicoline sodium 104.5 mg,

which corresponds to a citicoline content of 100 mg

Excipients: liquid non-crystallizing sorbitol - 200 mg, anhydrous glycerol - 50 mg, sodium citrate (sodium citrate dihydrate) - 6 mg, anhydrous citric acid - up to pH 5.0-7.0, water d / and up to 1 ml.

• Hypersensitivity to any component of the drug;

• severe vagotonia (high tone of the parasympathetic part of the autonomic nervous system);

• children's age up to 18 years (due to the lack of sufficient clinical data).

pharmachologic effect

Citicoline, being a precursor of key ultrastructural components of the cell membrane (mainly phospholipids), has a broad spectrum of action - it helps to restore damaged cell membranes, inhibits the action of phospholipases, prevents excessive formation of free radicals, and also prevents cell death by affecting the mechanisms of apoptosis. In the acute period of stroke, citicoline reduces the amount of damage to the brain tissue, improves cholinergic transmission. In traumatic brain injury, it reduces the duration of post-traumatic coma and the severity of neurological symptoms, in addition, it helps to reduce the duration of the recovery period.

In chronic hypoxia of the brain, citicoline is effective in the treatment of cognitive disorders such as memory impairment, lack of initiative, difficulty in performing daily activities and self-care. Increases the level of attention and consciousness, and also reduces the manifestation of amnesia.

Citicoline is effective in the treatment of sensory and motor neurological disorders of degenerative and vascular etiology.

Pharmacokinetics

Suction

Citicoline is well absorbed when taken orally. Absorption after oral administration is almost complete, and bioavailability is practically the same as after intravenous administration.

Distribution

Citicoline is largely distributed in the structures of the brain, with the rapid introduction of choline fractions into structural phospholipids and cytidine fractions - into cytidine nucleotides and nucleic acids. Having reached the brain, citicoline is incorporated into the cellular, cytoplasmic and mitochondrial membranes, taking part in the construction of the phospholipid fraction.

Metabolism

Citicoline is metabolized in the intestine and liver to form choline and cytidine. After administration, the concentration of choline in the blood plasma increases significantly.

Withdrawal

Only 15% of the administered dose of citicoline is excreted from the human body: less than 3% - by the kidneys and about 12% - with exhaled CO2. In the excretion of the drug in the urine, two phases are distinguished: the first phase - about 36 hours, in which the rate of excretion decreases rapidly, and the second phase, in which the rate of excretion decreases much more slowly. The same phasicity is observed during elimination with CO2, the rate of excretion of exhaled CO2 rapidly decreases after about 15 hours, then it decreases much more slowly.

Side effect

Very rare: allergic reactions (rash, pruritus, anaphylactic shock), headache, dizziness, fever. Tremor, nausea, vomiting, diarrhea, hallucinations, edema, shortness of breath, insomnia, agitation, decreased appetite, numbness in paralyzed limbs, changes in the activity of liver enzymes. In some cases, citicoline can stimulate the parasympathetic system, as well as produce a short-term change in blood pressure.

If any of the side effects indicated in the instructions are aggravated or any other side effects not indicated in the instructions are noted, the patient should be informed by the doctor.

Application during pregnancy and lactation

There are insufficient data on the use of citicoline in pregnant women. During pregnancy, citicoline is prescribed only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

When using citicoline during lactation, women should decide on the termination of breastfeeding, since there is no data on the excretion of citicoline in breast milk.

Application in children

It is contraindicated for use in children under 18 years of age (due to the lack of sufficient clinical data).

Use in elderly patients

When citicoline is prescribed to elderly patients, dose adjustment is not required.

special instructions

Influence on the ability to drive vehicles and mechanisms

During the use of the drug, care should be taken when driving transport and when engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Overdose

Given the low toxicity of the drug, cases of overdose have not been described, even if the therapeutic doses are exceeded.

Drug interactions

Citicoline enhances the effects of levodopa.

Should not be used concomitantly with medicinal products containing meclofenoxate.