Ceraxon solution for intravenous and intramuscular administration of 500 mg 4 ml ampoules 5 pcs.
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Active ingredients
Citicoline
Release form
Solution
Composition
Active ingredient: Citicolin Concentration of active ingredient (mg): 500 mg
Pharmacological effect
Nootropic drug. Citicoline, being the precursor of the 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 stroke Citicoline reduces the amount of damage to the brain tissue, improves cholinergic transmission. When traumatic brain injury decreases The duration of post-traumatic coma and the severity of neurological symptoms, in addition, citicoline reduces the recovery period. In chronic hypoxia of the brain, citicoline is effective in treating cognitive disorders, such as memory impairment, lack of initiative, difficulties in performing daily activities and self-care. It increases the level of attention and consciousness, as well as reduces the manifestation of amnesia. Ceraxon is effective in treating sensory and motor neurological disorders of degenerative and vascular etiology.
Pharmacokinetics
Absorption Cicicolin is well absorbed when i / w and v / m administered. Metabolism Cicicolin is metabolized in the liver to form choline and cytidine. After parenteral administration, the concentration of choline in the blood plasma increases significantly. The distribution of tsiticolin 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. Excretion 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, 2 phases can be distinguished: the first phase, lasting about 36 hours, during which the elimination rate rapidly decreases, and the second phase,during which the rate of excretion decreases much more slowly. The same is observed in exhaled CO2 — the elimination rate decreases rapidly after approximately 15 hours, and then decreases much more slowly.
Indications
- acute period of ischemic stroke (as part of complex therapy); - recovery period of ischemic and hemorrhagic strokes; - traumatic brain injury, acute (as part of complex therapy) and the recovery period; - cognitive and behavioral disorders in degenerative and vascular diseases of the brain.
Contraindications
- severe vagotonia (predominance of the parasympathetic part of the vegetative nervous system); - children's and teenage age up to 18 years (due to the lack of sufficient clinical data); - hypersensitivity to the drug.
Precautionary measures
Do not use in childhood and adolescence
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 the therapy for the mother outweighs the potential risk to the fetus. If necessary, the use of the drug during lactation should resolve the issue of stopping breastfeeding, because allocation of citicoline in breast milk are absent.
Dosage and administration
Solution for ingestionThe drug is taken during meals or between meals. Before use, the drug can be diluted in a small amount of water (120 ml or 1/2 cup). The acute period of ischemic stroke and traumatic brain injury: the recommended dose is 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 traumatic brain injury, cognitive and behavioral disorders in degenerative and vascular 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. Elderly patients do not require dose adjustment of the drug Cerakson. Rules for the use of a dosing syringe1.Place the dosing syringe into the vial (the syringe piston is fully lowered). 2. Gently pull on the plunger of the dosing syringe until the level of the solution is equal to the corresponding mark on the syringe. 3. Before taking the right amount of solution can be diluted in 1/2 cup of water (120 ml). After each use, it is recommended to wash the dosing syringe with water. The solution for IV and IM injection / is injected into the drug as a slow injection (within 3-5 minutes, depending on the prescribed dose) or drip infusion (40-60 drops per minute ). In / in the route of administration is preferable to the / m. When i / m injection should be repeated administration of the drug in the same place. The acute period of ischemic stroke and traumatic brain injury: the recommended dose is 1000 mg every 12 hours from the first day after diagnosis; treatment duration is at least 6 weeks. 3-5 days after the start of treatment (if the function of swallowing is not impaired), it is possible to switch to oral forms of the drug Ceraxon. The recovery period of ischemic and hemorrhagic strokes, the recovery period for traumatic brain injury, cognitive and behavioral disorders in degenerative and vascular 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. Elderly patients do not require dose adjustment of the drug Cerakson with intravenous or intramuscular injection. Solution for in / in and in / m the introduction of the ampoule is designed for single use. After opening the vial, the solution should be used immediately. The drug is compatible with all types of isotonic solutions and solutions of dextrose.
Side effects
Side effects are very rare (<1/10 000), including isolated cases. Allergic reactions: rash, pruritus, anaphylactic shock. On the part of the nervous system: headache, dizziness, tremor, hallucinations, insomnia, agitation, numbness in paralyzed limbs, a stimulating effect on the parasympathetic system. On the part of the digestive system: nausea, vomiting, diarrhea, loss of appetite, changes in the activity of liver enzymes. Other: fever, short-term change in blood pressure, swelling, shortness of breath.
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 concurrently 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 mechanisms, the work of the dispatcher and operator).