Ceraxon solution for intravenous and intramuscular administration of 1000 mg 4 ml ampoules 5 pcs.
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Active ingredients
Citicoline
Release form
Solution
Composition
4 ml solution contains: active substance: citicoline sodium (equivalent to 1000 mg of citicoline), excipients: 1M, hydrochloric acid or 1M sodium, hydroxide - to pH 6.7–7.1, water for injection - up to 4 ml.
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 about 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 the drug. Severe vagotonia (predominant tone of the parasympathetic part of the autonomic nervous system). Rare hereditary diseases associated with fructose intolerance. Children under 18 years old (due to the lack of sufficient clinical 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
The drug is administered intravenously in the form of a slow injection (within 3-5 minutes, depending on the prescribed dose) or drip infusion (40-60 drops per minute). The intravenous route of administration is preferable to intramuscular. For intramuscular administration, repeated administration of the drug in the same place should be avoided. 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. 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.
Side effects
Very rare (less than 1 / 10,000) (including individual cases) allergic reactions (rash, skin lesions, anaphylactic shock), headache, dizziness, hot flashes, tremors, nausea, vomiting, diarrhea, hallucinations, swelling, shortness of breath, insomnia, agitation, loss of appetite, numbness in the paralyzed limbs, changes in the activity of liver enzymes. In some cases, Ceraxon 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 instructions are aggravated, or any other side effects not mentioned in the instructions have been noticed, you should inform your doctor.
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 dangerousactivities that require special attention and speed of psychomotor reactions (including driving and other vehicles, working with moving machinery, the work of the dispatcher and the operator).