Instructions Neuroxon film-coated tablets 500 mg blister No. 20
Composition
active ingredient: citicoline;
1 tablet contains citicoline monosodium salt (calculated as citicoline) 500 mg;
excipients: microcrystalline cellulose, croscarmellose sodium, polyethoxylated castor oil, hydrogenated with a mineral carrier magnesium aluminometasilicate, talc, colloidal hydrophobic silicon dioxide, magnesium stearate, coating mixture "Aquarius Prime BKN318029 White", containing hydroxypropyl methylcellulose, hydroxypropyl cellulose, medium chain triglycerides, titanium dioxide.
Dosage form
Film-coated tablets.
Main physicochemical properties: white, oval-shaped, film-coated tablets with a biconvex surface.
Pharmacotherapeutic group
Psychostimulants, drugs used for attention deficit hyperactivity disorder (ADHD), and nootropics. ATC code N06B X06.
Pharmacological properties
Pharmacodynamics
Citicoline stimulates the biosynthesis of structural phospholipids of neuronal membranes, which is confirmed by magnetic resonance spectroscopy. Due to this mechanism of action, citicoline exhibits the functioning of such membrane mechanisms as the work of ion exchange pumps and receptors, the modulation of which is necessary for the normal conduction of nerve impulses. Due to its stabilizing effect on the neuronal membrane, citicoline exhibits anti-edematous properties that contribute to the reabsorption of brain edema.
Experimental studies have shown that citicoline inhibits the activation of certain phospholipases (A1, A2, C, and D), reducing the formation of free radicals, preventing the destruction of membrane systems, and preserving antioxidant defense systems such as glutathione.
Citicoline preserves the energy reserves of neurons, inhibits apoptosis, and stimulates the synthesis of acetylcholine.
It has been experimentally proven that citicoline also exhibits a preventive neuroprotective effect in focal cerebral ischemia.
Clinical studies have shown that citicoline significantly increases functional recovery rates in patients with acute ischemic stroke, which coincides with a slowdown in the growth of ischemic brain damage according to neuroimaging data.
In patients with traumatic brain injury, citicoline accelerates recovery and reduces the duration and intensity of post-traumatic syndrome.
Citicoline improves the level of attention and consciousness, cognitive and neurological disorders associated with cerebral ischemia, and helps reduce the manifestations of amnesia.
Pharmacokinetics
Citicoline is well absorbed after oral administration. After administration of the drug, a significant increase in plasma choline levels is observed. When administered orally, the drug is almost completely absorbed. Studies have shown that the bioavailability is almost the same after oral and intravenous administration.
The drug is metabolized in the intestines and liver to form choline and cytidine.
After administration, citicoline is widely distributed in brain structures with rapid incorporation of the choline fraction into structural phospholipids and the cytidine fraction into cytidine nucleotides and nucleic acids. In the brain, citicoline is incorporated into cellular, cytoplasmic and mitochondrial membranes, participating in the construction of the phospholipid fraction.
Only a small amount of the dose is found in the urine and feces (less than 3%). Approximately 12% of the dose is excreted in exhaled CO2. During the excretion of the drug with urine, two phases are distinguished: the first phase - for 36 hours, in which the rate of excretion decreases rapidly, and the second phase - in which the rate of excretion decreases much more slowly. The same phasic nature is observed in excretion through the respiratory tract. The rate of CO2 excretion decreases rapidly for about 15 hours, then decreases much more slowly.
Indication
Stroke, acute phase of cerebrovascular disorders and their neurological consequences. Traumatic brain injury and its neurological consequences. Cognitive and behavioral disorders due to chronic vascular and degenerative cerebral disorders.
Contraindication
Hypersensitivity to citicoline or other components of the drug. High tone of the parasympathetic nervous system.
Interaction with other medicinal products and other types of interactions
Citicoline enhances the effect of levodopa. It should not be administered simultaneously with drugs containing meclofenoxate.
Ability to influence reaction speed when driving vehicles or other mechanisms
In individual cases, some adverse reactions from the central nervous system may affect the ability to drive or operate complex machinery.
Use during pregnancy or breastfeeding
There are no adequate data on the use of citicoline in pregnant women. Citicoline should not be used unless clearly necessary. During pregnancy, the drug should be prescribed only if the expected therapeutic benefit outweighs the potential risk. Data on the penetration of citicoline into breast milk and its effect on the fetus are unknown.
Method of administration and doses
The recommended dose is 500 to 2000 mg per day (1–4 tablets).
The dosage of the drug and the duration of treatment depend on the severity of the brain lesions and are determined by the doctor.
Elderly patients do not require dose adjustment.
Children
Experience with the drug in children is limited, so the drug should only be prescribed when the expected benefit outweighs any potential risk.
Overdose
No cases of overdose have been noted.
Adverse reactions
Adverse reactions occur very rarely (<1/10,000), including isolated cases.
From the psyche: hallucinations.
From the nervous system: severe headache, dizziness.
From the cardiovascular system: arterial hypertension, arterial hypotension, tachycardia.
From the respiratory system: dyspnea.
On the part of the digestive tract: nausea, vomiting, episodic diarrhea.
Allergic reactions, including rash, itching, angioedema, anaphylactic shock, flushing, urticaria, exanthema, purpura.
General disorders: chills, edema.
Expiration date
2 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
10 tablets in a blister, 2 blisters in a pack.
Vacation category
According to the recipe.
Producer
PJSC "Kyivmedpreparat".
Location of the manufacturer and its business address
Ukraine, 01032, Kyiv, Saksaganskoho St., 139.
