Composition, form of production and packaging
The solution for oral administration is transparent, pink in color, with a characteristic strawberry odor.
100 ml
citicoline sodium 10.45 g,
which corresponds to the content of citicoline 10 g
[PRING] sorbitol 20 g, glycerol 5 g, propylene glycol 1.04 g, methyl parahydroxybenzoate 0.16 mg, propyl parahydroxybenzoate 0.04 mg, potassium sorbate 0.14 g, sodium citrate dihydrate 0.6 g, sodium saccharinate 0.02 g, dye azorubin E122) - 0.0002 g, strawberry FRESA S.1487S aromatizer - 0.04 g, citric acid - up to pH 6.0, purified water - up to 100 ml.
10 ml - sachets of multi-layered material (5) - packs of cardboard.
10 ml - sachets of multilayered material (10) - packs cardboard.
30 ml - bottles of clear glass (1) with a pipette of the dosing - packs of cardboard.
The solution for intravenous and / or injection is clear, colorless.
1 amp.
citicoline sodium 522.5 mg,
which corresponds to the content of citicoline 500 mg
[PRING] hydrochloric acid or sodium hydroxide - to pH 6.5-7.5, water d / u - up to 4 ml.
4 ml - ampoules of colorless glass (5) - packings of cellular contour (1) - packs cardboard.
4 ml - ampoules of colorless glass (5) - packings of cellular contour (2) - packs cardboard.
The solution for intravenous and / or injection is clear, colorless.
1 amp.
citicoline sodium 1045 mg,
which corresponds to the content of citicoline 1000 mg
[PRING] hydrochloric acid or sodium hydroxide - to pH 6.5-7.5, water d / u - up to 4 ml.
4 ml - ampoules of colorless glass (5) - packings of cellular contour (1) - packs cardboard.
4 ml - ampoules of colorless glass (5) - packings of cellular contour (2) - 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 the predecessor 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, preventing the excessive formation of free radicals, and also preventing the death of cells, influencing the mechanisms of apoptosis.
In an acute period of stroke reduces the volume of damaged tissue, improves cholinergic transmission.
In case of craniocerebral trauma, 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.
Citicoline improves symptoms of hypoxia: memory impairment, emotional lability, lack of initiative, difficulties in performing daily activities and self-service.Effective in the treatment of cognitive, sensory and motor neurologic disorders of degenerative and vascular etiology.
In chronic cerebral ischemia, citicoline is effective in the treatment of 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.
PHARMACOKINETICS
Suction
Citicoline is well absorbed when taken orally. Absorption after oral administration is almost complete, and bioavailability is approximately 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. Citicoline penetrates the cephalic and actively integrates into cellular, cytoplasmic and mitochondrial membranes, forming part of the fraction of structural phospholipids.
Metabolism
After ingestion, the drug is metabolized in the intestine and in the liver with the formation of choline and cytidine.
With iv and / or injection, citicoline is metabolized in the liver with the formation of choline and cytidine.
After oral administration or parenteral (IV, IM), the concentration of choline in the blood plasma increases significantly.
Excretion
Only 15% of the administered dose of citicoline is excreted from the human body: less than 3% - by the kidneys and through the intestine and about 12% - with the exhaled air.
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 the exhaled air - the elimination rate rapidly decreases 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 (CCT), 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
Take with meals or between meals. Before use, the preparation can be diluted in a small amount of water (120 ml or 1/2 cup).
Assign 500-2000 mg per day (5-10 ml 1-2 times / day or 1 sachet 1-2 times / day).
The dose and duration of treatment are determined depending on the severity of the symptoms of the disease.
Older patients do not need a dose adjustment.
Instructions for the use of a pipette of the dosing
1. Place the pipette dispensing into the vial (the pipette piston is completely lowered).
2. Carefully pull the dispensing pipette by the piston until the solution level is equal to the corresponding mark on the pipette.
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 pipette with water dispensing.
Recommendations for the use of the drug Recognan В® in bags
1. Take Rekogan В® pectectin 1000 mg for the edge and shake.
2. Tear off the edge of the sachet in the place indicated by the dotted line.
3. Drink the contents of the sachet immediately after opening.
4. Or dissolve in half a glass of drinking water (120 ml) and drink.
Injection
The drug is administered iv or I / m.
IV in the form of a slow intravenous injection (within 3-5 minutes, depending on the prescribed dose) or IV injection (40-60 drops / min).
In / in the route of administration is preferable than in / m. With IV administration, the repeated administration of the drug to the same site should be avoided.
Acute period of ischemic stroke and traumatic brain injury: 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 drug Recognan В® .
The recovery period of ischemic and hemorrhagic strokes, the recovery period of TBI, cognitive and behavioral disorders in degenerative and cerebrovascular diseases of the brain: 500-2000 mg / day. Dose and duration of treatment, depending on the severity of the symptoms of the disease. It is possible to use oral forms of the drug Recognan В® .
Older patients do not need a dose adjustment.
The solution in the ampoule is intended for single use. It should be used immediately after opening the ampoule.
The drug is compatible with all types of infusion isotonic solutions and solutions of dextrose.
SIDE EFFECT
Incidence of adverse reactions: very rare (<1/10 000) (including individual cases).
Allergic reactions: a rash, skin itching, anaphylactic shock.
From the nervous system: headache, dizziness, insomnia, agitation, hallucinations. In some cases, the drug can stimulate the parasympathetic system, as well as short-term changes in blood pressure.
On the part of the digestive system: nausea, vomiting, diarrhea, decreased appetite, a change in the activity of hepatic enzymes.
Common reactions: a feeling of heat, tremors, shortness of breath, numbness in the paralyzed limbs, swelling.
If any of these side effects are aggravated, or any other side effects are seen, you should inform your doctor.
CONTRAINDICATIONS
- vagotonia (predominance of the tone of the parasympathetic part of the autonomic nervous system);
- rare hereditary diseases associated with intolerance to fructose (for oral administration);
- children and adolescents under 18 years of age (due to the lack of clinical data);
- Hypersensitivity to the components of the drug.
Information on the relative contraindications for the use of the drug inside there.
PREGNANCY AND LACTATION
Data on the use of citicoline during pregnancy is not enough. The appointment of the drug Recognan В® is possible only in cases where the expected benefit of therapy for the mother exceeds the potential risk to the fetus.
In studies on animals, no negative effect was detected.
When prescribing Rekognan В® during lactation, women should stop breastfeeding, as there is no data on the isolation of citicoline with human milk.
SPECIAL INSTRUCTIONS
Impact on the ability to drive vehicles and manage mechanisms
During the treatment period, patients should be cautious when carrying out potentially dangerous activities requiring increased attention and speed of psychomotor reactions (including vehicle management, work with moving mechanisms, dispatcher, operator).
OVERDOSE
Given the low toxicity of the drug, overdose cases have not been described.
DRUG INTERACTION
Citicoline increases the effects of levodopa.
Do not administer simultaneously 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 15 В° to 25 В° C. Shelf life of the solution for oral administration in vials is 3 years, in bags - 2 years. Shelf life of the injection solution is 3 years.
