Composition, form of production and packaging
Solution for ingestion - a transparent colorless liquid with a characteristic strawberry odor.
1 ml
citicoline sodium 104.5 mg,
is equivalent to citicoline 100 mg
Auxiliary substances: sorbitol 200 mg, glycerol 50 mg, methylparahydroxybenzoate 1.45 mg, propyl parahydroxybenzoate 0.25 mg, sodium citrate dihydrate 6 mg, sodium saccharinate 0.2 mg, strawberry flavor 1487-S-Lucta 0.418 mg , potassium sorbate - 3 mg, citric acid solution 50% - up to pH 5.9-6.1, purified water - up to 1 ml.
30 ml - bottles of colorless glass (1) complete with syringe dosing - packs cardboard with partitions.
Solution for ingestion - a transparent colorless liquid with a characteristic strawberry odor.
1 pack. (10 ml)
citicoline sodium 1045 mg,
equivalent to citicoline 1000 mg
Auxiliary substances: sorbitol - 2000 mg, glycerol - 500 mg, methylparahydroxybenzoate - 14.5 mg, propylparahydroxybenzoate - 2.5 mg, sodium citrate dihydrate - 60 mg, sodium saccharinate - 2 mg, strawberry flavor (strawberry essence 1487-S-Lucta) 4.08 mg , potassium sorbate - 30 mg, citric acid solution 50% - up to pH 5.9-6.1, purified water - up to 10 ml.
10 ml - sachets from the combined material (10) - packs cardboard.
A solution for intravenous and / or injection is a clear, colorless liquid.
1 amp.
citicoline sodium 522.5 mg,
equivalent to citicoline 500 mg
Auxiliary substances: hydrochloric acid 1 M or sodium hydroxide 1 M - to pH 6.5-7.1, water d / and - up to 4 ml.
4 ml - ampoules of colorless glass (5) - packings of cellular contour (1) - packs cardboard.
A solution for intravenous and / or injection is a clear, colorless liquid.
1 amp.
citicoline sodium 1045 mg,
equivalent to citicoline 1000 mg
Auxiliary substances: hydrochloric acid 1 M or sodium hydroxide 1 M - to pH 6.5-7.1, water d / and - up to 4 ml.
4 ml - ampoules of colorless glass (5) - packings of cellular contour (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Nootropic preparation. Citicoline, being a precursor of the key ultrastructural components of the cell membrane (mainly phospholipids), has a wide spectrum of action: it facilitates the restoration of damaged cell membranes, inhibits the effect of phospholipases, prevents excessive formation of free radicals, and also prevents cell death by affecting the mechanisms of apoptosis.
In an acute period of stroke, citicoline reduces the amount of damage to the brain tissue, improves cholinergic transmission.
With craniocerebral trauma reduces the duration of post-traumatic coma and the severity of neurologic symptoms, besides this, citicoline helps reduce the duration of the recovery period.
In chronic brain hypoxia, citicoline is effective in the treatment of cognitive disorders, such as memory impairment, lack of initiative, difficulties arising from daily activities and self-care. Increases the level of attention and consciousness, and also reduces the manifestation of amnesia.
Ceraxon В® 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, with iv and / or injection. Absorption after oral administration is almost complete, and bioavailability is approximately the same as after intravenous administration.
Metabolism
When ingested, the drug is metabolized in the intestine and in the liver with the formation of choline and cytidine. After ingestion, the concentration of choline in the blood plasma increases significantly.
With iv and / or injection, citicoline is metabolized in the liver with the formation of choline and cytidine. After parenteral administration, the concentration of choline in the blood plasma increases significantly.
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. Citicoline penetrates the brain and is actively embedded in the cellular, cytoplasmic and mitochondrial membranes, forming part of the fraction of structural phospholipids.
Excretion
Only 15% of the administered dose of citicoline is excreted from the human body; less than 3% - kidneys and about 12% - with exhaled CO 2 .
In the excretion of citicoline with urine, two phases can be identified: the first phase, lasting about 36 hours, during which the rate of elimination rapidly decreases, and the second phase, during which the rate of excretion decreases much more slowly. The same is observed in exhaled CO 2 - the elimination rate decreases rapidly after about 15 hours, and then decreases much more slowly.
INDICATIONS
- acute period of ischemic stroke (as part of complex therapy);
- the recovery period of ischemic and hemorrhagic strokes;
- craniocerebral trauma, acute (as part of complex therapy) and the recovery period;
- cognitive and behavioral disorders in degenerative and vascular diseases of the brain.
DOSING MODE
Solution for oral administration
The drug is taken during meals or between meals. Before use, the preparation can be diluted in a small amount of water (120 ml or 1/2 cup).
Acute period of ischemic stroke and craniocerebral trauma: the recommended dose is 1000 mg (10 ml or 1 sachet) every 12 hours. The duration of treatment is at least 6 weeks.
The recovery period of ischemic and hemorrhagic strokes, the recovery period of craniocerebral trauma, cognitive and behavioral disorders in degenerative and cerebrovascular diseases of the brain: the recommended dose is 500-2000 mg / day (5-10 ml 1-2 times / day or 1 sachet ( 1000 mg) 1-2 times / day). The dose and duration of treatment depend on the severity of the symptoms of the disease.
Older patients are not required to adjust the dose of Ceraxon В® .
Rules for the use of a dosage syringe
1. Place the dosing syringe in the vial (the syringe plunger is completely lowered).
2. Gently pull the plunger of the metering syringe until the solution level is equal to the corresponding mark on the syringe.
3. Before taking the right amount of solution can be diluted in 1/2 cup water (120 ml).
After each use, it is recommended to rinse the dosage syringe with water.
Rules of use of the drug in bags
1. Hold the bag vertically, carefully tear off its edge at the mark "Open here."
2. The contents of the sachet can be drunk immediately after opening or before dilution can be diluted in 1/2 cup water (120 ml).
Solution for intravenous and / m administration
In / in the drug is administered as a slow injection (for 3-5 minutes, depending on the prescribed dose) or drip infusion (40-60 drops / min). In / in the route of administration is preferable than in / m. With the / m introduction, the repeated administration of the drug in the same place should be avoided.
Acute period of ischemic stroke and craniocerebral trauma: the recommended dose is 1000 mg every 12 hours from the first day after diagnosis; duration of treatment - at least 6 weeks. 3-5 days after the start of treatment (if the swallowing function is not broken), it is possible to switch to oral forms of the preparation Ceraxon В® .
The recovery period of ischemic and hemorrhagic strokes, the recovery period for craniocerebral trauma, cognitive and behavioral disorders in degenerative and cerebrovascular diseases of the brain: the recommended dose is 500-2000 mg / day (5-10 ml 1-2 times / day). The dose and duration of treatment depend on the severity of the symptoms of the disease.
Older patients are not required to adjust the dose of Ceraxon В® for IV or IM.
The solution for intravenous and / or injection in the ampoule is intended for single use. After opening the ampoule, the solution should be used immediately. The drug is compatible with all types of IV in isotonic solutions and dextrose solutions.
SIDE EFFECT
Very rarely (<1/10 000) (including individual cases): allergic reactions (rash, itchy skin, anaphylactic shock), headache, dizziness, heat, tremor, nausea, vomiting, diarrhea, hallucinations, swelling, dyspnea, insomnia , excitation, decreased appetite, numbness in the paralyzed limbs, changes in the activity of hepatic enzymes. In some cases, Ceraxon В® can stimulate the parasympathetic system, as well as cause a short-term change in blood pressure.
If any of the side effects indicated in the manual are aggravated, or any other side effects not indicated in the instructions were noticed, you should inform your doctor about it.
CONTRAINDICATIONS
- pronounced vagotonia (predominance of the tone of the parasympathetic part of the autonomic nervous system);
- Children and adolescence under 18 years (due to lack of sufficient clinical data);
- rare hereditary diseases associated with intolerance to fructose (for solution for oral administration);
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
Clinical data on the use of citicoline in pregnancy is not enough. Although in experimental animal studies there is no adverse effect, in pregnancy the drug is prescribed only if the expected benefit of therapy for the mother exceeds the potential risk to the fetus.
If it is necessary to use the drug during lactation, the question of stopping breastfeeding should be resolved, since there is no data on the isolation of citicoline with breast milk.
APPLICATION FOR CHILDREN
Contraindicated in children and adolescents under 18 years.
APPLICATION IN ELDERLY PATIENTS
Older patients are not required to adjust the dose of Ceraxon В® .
SPECIAL INSTRUCTIONS
In the solution for ingestion in the cold, an insignificant amount of crystals may form due to the temporary partial crystallization of the preservative. With further storage under the recommended conditions, the crystals dissolve within a few months. The presence of crystals does not affect the quality of the drug.
Impact on the ability to drive vehicles and manage mechanisms
During the treatment period, patients should be cautious in carrying out potentially dangerous activities requiring special attention and speed of psychomotor reactions (including driving and other vehicles, working with moving mechanisms, dispatcher and operator work).
OVERDOSE
Due to the low toxicity of the drug, overdose cases have not been described.
DRUG INTERACTION
Citicoline increases the effects of levodopa.
Do not prescribe Ceraxon В® concomitantly with drugs containing meclofenoxate.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 30 В° C. Shelf life - 3 years.
