Each mL contains: Citicoline 250 mg.
Psychostimulant and Nootropic.
Pharmacology: Pharmacodynamics: Citicoline, being the precursor of key ultrastructural components of a cellular membrane (mainly phospholipids), possesses wide range of activities, promotes restoration of the damaged cell membranes, inhibits action of phospholipases, what prevents excessive formation of free radicals and destruction of cells, affects the mechanisms of apoptosis.
In the acute period of stroke it reduces the volume of damaged tissue, improves cholinergic transmission. In head injury it reduces duration of a post-traumatic coma and intensity of neurologic symptoms.
Citicoline improves observed during hypoxia symptoms, such as memory impairment, emotional liability, lack of initiative, difficulties at conducting of daily actions and self-service.
The drug product does not influence breath, pulse and arterial pressure; therefore long treatment is possible.
Pharmacokinetics: Absorption: Citicoline is well absorbed following intravenous and intramuscular injection.
Distribution: Citicoline administered is widely distributed in brain structures, with a rapid incorporation of the choline fraction into structural phospholipids, and of the cytosine reaction into cytidine nucleotides and nucleic acids.
Metabolism: It is metabolised to choline and cytidine. Following parenteral administration, choline plasma concentration increases significantly.
Elimination: Only 15% of citicoline is eliminated from human body. Less than 3% is via kidneys; approximately 12% is eliminated with CO2.
Citicoline is effective in the following conditions: acute period of ischemic stroke; rehabilitation period after ischemic and hemorrhagic stroke; head injury, acute and rehabilitation period; cognitive abnormalities at degenerate and vascular diseases of brain.
Special indications: Mannitol or corticosteroids should be prescribed to decrease the intracranial pressure in brain damages.
Citicoline dose should not exceed 500 mg for single dose administration in intracranial hemorrhage (100-200 mg for 2-3 times daily).
It is prescribed intravenously in the form of a bolus intravenous injection (during 5 minutes) or slow intravenous infusion (40-60 drops per minute). The intravenous way of administration is more preferable, than intramuscular. It is necessary to avoid repeated administration of the drug to the same place during intramuscular administration.
Acute period of ischemic stroke and traumatic brain damage: Recommended dose after recognition is 100 mg for every 12 hours. Treatment period is not less than 6 weeks. 3-7 days after starting of treatment, intramuscular administration (1-2 injections per day) or oral administration (if swallow ability is damaged).
Rehabilitation period of ischemic and hemorrhagic stroke, rehabilitation period of traumatic brain damage, cognitive abnormalities at degenerate and vascular diseases of brain: Recommended dose is 500-2000 mg daily. Dose and treatment period depends on severity of symptoms.
At long-term impairment of consciousness continuous application of a drug from the first stages of disease is possible.
Geriatrics: No need for dose adjustment after administration of Cholivex.
Paediatric: Safety and efficacy have not been evaluated for children and teenage age below 18 years.
Solution for I.M./I.V. injection is designed for single administration. After ampoule is opened, solution should be used immediately.
Cholivex is compatible with I.V. isotonic solution and dextrose solutions.
Method of administration: Cholivex is administered by intramuscular injection or slow intravenous injection.
Taking into account low toxicity of the drug over dosage cases are not described, even in case of excess of therapeutic doses.
This is contraindicated to patients with known hypersensitivity to the product and must not be administered to patients with parasympathetic hypertonia.
Should not be administered together with medications containing meclofenoxate (known as clophenoxate).
It should not be used since adequate data is not available for usage in the pregnancy and lactation.
Cholivex should not be used with alcohol.
Effects on ability to drive and use machines: Patient should be careful during driving and similar things that high psychomotor reaction speed is required during the treatment.
General recommendation: Pregnancy category D.
Women of childbearing potential/Contraception: It should be used when benefits are superior to risks.
Pregnancy: During pregnancy the medicine should only be used when therapeutic benefits to mother are superior to risks for foetus.
Lactation: If administration of drug is necessary during lactation, situation occurred by discontinuing of lactating should be considered.
Reproductive ability/Fertility: There are no effects on reproductive ability and fertility.
From CNS and peripheral nervous system: sleeplessness, headache, dizziness, excitation, tremor, numbness in the paralyzed limbs.
From digestive system: nausea, appetite decrease, change of activity of hepatic enzymes.
Allergic reactions: rash, skin itch, anaphylactic shock.
The others: heat; in some cases - short-term hypotensive action, stimulation of parasympathetic nervous system.
Citicoline potentiates the effects of L-dopa. This drug should not be co-administered with meclofenoxate-including drug. Cholivex can be applied simultaneously with haemostatic agents, intracranial antihypertensive agents and with usual perfusion liquids.
Store at temperatures not exceeding 30°C.
N06BX06 - citicoline ; Belongs to the class of other psychostimulants and nootropics.
Cholivex soln for inj 250 mg/mL
5 mL x 5 × 1's
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