Ceraxon solution for oral administration vials of 30 ml
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Active ingredients
Citicoline
Release form
Solution
Composition
Ceraxon - solution for intravenous and intramuscular administration: 4 ml contain citicoline sodium 522.5 and 1045 mg, excipients: 1M hydrochloric acid or 1M sodium hydroxide - to pH 6.7-7.1, water for injection - up to 4 ml, 4 ml ampoules in neutral glass, 3 ampoules in a blister strip, 1 carton in a carton pack or 5 ampoules in a blister pack, 1 or 2 cartons in a carton pack, Cerakson - oral solution 100 mg / ml: 1 fl. contains citicoline sodium 10.45 g, excipients: sorbitol, glycerol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, glycerol formal, sodium citrate dihydrate, sodium saccharinate, crimson dye (Ponce 4-R), strawberry flavoring (strawberry extract 1487-s-1487-s-strawberry-17--st). potassium sorbate, citric acid 50% solution, purified water - up to 100 ml, in vials of colorless transparent glass, 30 ml each.
Pharmacological effect
Nootropic drug. Citicoline, being a precursor of key ultrastructural components of the cell membrane (mainly phospholipids), has a wide spectrum of action: it helps to restore damaged cell membranes, inhibits the action of phospholipases, preventing excessive formation of free radicals, and also prevents cell death by acting on the mechanisms of apoptosis. In the acute period of a stroke, citicoline reduces the amount of damage to brain tissue, improves cholinergic transmission. In traumatic brain injury, it reduces the duration of post-traumatic coma and the severity of neurological symptoms, besides citicoline reduces the duration of the recovery period. In chronic cerebral hypoxia, citicoline is effective in the treatment of cognitive disorders, such as memory impairment, lack of initiative, difficulties encountered in performing daily activities and self-care. Increases the level of attention and consciousness, and also reduces the manifestation of amnesia. Ceraxon is effective in treating sensory and motor neurological disorders of degenerative and vascular etiology.
Pharmacokinetics
Cytikolin absorption is well absorbed when a / in and / m introduction.Metabolism: Citicoline is metabolized in the liver to form choline and cytidine. After parenteral administration, the concentration of choline in the blood plasma increases significantly. Distribution: Citicoline is largely distributed in brain structures, with the rapid introduction of choline fractions into structural phospholipids and cytidine fractions - into cytidine nucleotides and nucleic acids. Citicoline penetrates the brain and actively integrates into the cellular, cytoplasmic and mitochondrial membranes, forming part of the structural phospholipid fraction. 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 citicoline in the urine can be divided into 2 phases: the first phase, lasting about 36 hours, during which the rate of excretion decreases rapidly, and the second phase, during which the excretion rate decreases much slower. The same is observed in exhaled CO2 — the elimination rate decreases rapidly after approximately 15 hours, and then decreases much more slowly.
Indications
The acute period of ischemic stroke (as part of complex therapy). The recovery period of ischemic and hemorrhagic strokes. TBI, acute (as part of complex therapy) and the recovery period. Cognitive and behavioral disorders in degenerative and vascular diseases of the brain.
Contraindications
Hypersensitivity to any of the components of Cerakson. Patients with vagotonia (predominance of the parasympathetic component of the autonomic nervous system). Children under 18 years of age (due to lack of data).
Precautionary measures
In the cold, a small amount of crystals may form due to temporary partial crystallization of the preservative, which do not affect the quality of the preparation.
Use during pregnancy and lactation
Clinical data on the use of citicoline during pregnancy is not enough. Although no negative effects have been identified in experimental animal studies, during pregnancy, the drug is prescribed only when the expected benefit of therapy for the mother outweighs the potential risk to the fetus. If necessary, use of the drug during lactation should decide on the termination of breastfeeding, since data on the allocation of citicoline in breast milk are not available.
Dosage and administration
Solution for intravenous and intramuscular administration Ceraxon is administered intravenously, in the form of a slow intravenous injection (within 5 min) or drip intravenous infusion (40-60 drops per minute) for stroke and TBI in the acute period - 1000 2000 mg daily, depending on the severity of the disease for 3-7 days, followed by a transition to the i / m administration or reception. In / in and oral route of administration is preferable to the / m. V / m: 1-2 injections per day. When i / m injection should be repeated administration of the drug in the same place. Cerakson oral solution is taken inside, 200-300 mg (2-3 ml) 3 times a day. (The drug is prescribed using a dosing syringe).
Side effects
Allergic reactions (rash, itchy skin, anaphylactic shock), insomnia, headache, dizziness, agitation, tremor, numbness in paralyzed limbs, nausea, decreased appetite, changes in liver enzymes, fever. In some cases, Cerakson can stimulate the parasympathetic system, as well as provide a short-term hypotensive effect.
Overdose
Due to the low toxicity of the drug overdose cases are not described.
Interaction with other drugs
Citicoline enhances the effects of levodopa. Ceraxon should not be administered simultaneously with drugs containing meklofenoksat.
special instructions
Impact on the ability to drive vehicles and control mechanisms: During the period of treatment, patients should be careful when performing potentially hazardous activities that require special attention and speed of psychomotor reactions (including driving and other vehicles, working with moving machinery, work dispatcher and operator).