Instructions for Tikolin film-coated tablets 500 mg No. 30
Composition
active ingredient: citicoline;
1 tablet contains citicoline sodium, which is equivalent to 500 mg of citicoline;
excipients: talc, magnesium stearate, colloidal anhydrous silica, croscarmellose sodium, hydrogenated castor oil, microcrystalline cellulose, titanium dioxide (E 171), polyethylene glycol 6000 (macrogol 6000), hypromellose.
Dosage form
Film-coated tablets.
Main physicochemical properties: oval-shaped, biconvex, white to almost white tablets, film-coated.
Pharmacotherapeutic group
Psychostimulants. Drugs used for attention deficit hyperactivity disorder (ADHD), nootropics. Other psychostimulants and nootropics.
ATX code N06B X06.
Pharmacological properties
Pharmacodynamics.
Citicoline stimulates the biosynthesis of structural phospholipids of neuronal membranes, which is confirmed by magnetic resonance spectroscopy. Citicoline improves the functioning of membrane mechanisms such as ion pumps and receptors, without the regulation of which normal conduction of nerve impulses is impossible. Due to its stabilizing effect on the neuronal membrane, citicoline exhibits anti-edematous properties that contribute to the reabsorption of brain edema.
Clinical 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 neuronal energy reserves and inhibits apoptosis, which improves cholinergic transmission.
It has been experimentally proven that citicoline also has a preventive neuroprotective effect in focal cerebral ischemia.
Clinical studies have shown that citicoline significantly increases functional recovery rates in patients with acute cerebrovascular accident, 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, helps reduce the manifestations of amnesia, cognitive and other neurological disorders associated with cerebral ischemia.
Pharmacokinetics.
Citicoline is well absorbed after oral, intramuscular and intravenous administration. Plasma choline levels increase significantly after administration by the above routes. Absorption after oral administration is almost complete and bioavailability is almost the same as after intravenous administration.
Depending on the route of administration, the drug is metabolized in the intestine, liver to 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. Having reached 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 excreted in the urine and feces (less than 3%). Approximately 12% of the dose is excreted in exhaled CO2. There are two phases in the excretion of the drug in the urine: the first phase is approximately 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 the excretion of CO2, the rate of excretion of exhaled CO2 decreases rapidly after about 15 hours, then it decreases much more slowly.
Indication
Stroke, acute phase of cerebrovascular disorders and treatment of complications and consequences of cerebrovascular disorders;
traumatic brain injury and its neurological consequences;
cognitive impairment and behavioral disorders due to chronic vascular and degenerative cerebral disorders.
Contraindication
Hypersensitivity to any component of the drug;
increased tone of the parasympathetic nervous system.
Interaction with other medicinal products and other types of interactions
Do not use Tikolin® simultaneously with drugs containing meclofenoxate. The drug enhances the effect of levodopa.
Application features
Tikolin® contains 1.2 mmol (26 mg) sodium per tablet. Caution should be exercised when administering the drug to patients on a controlled sodium diet.
Use during pregnancy or breastfeeding
There are no sufficient data on the use of the drug Tikolin® in pregnant women. Data on the excretion of citicoline into breast milk and its effect on the fetus are absent. Therefore, during pregnancy or breastfeeding, the drug is prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus.
Ability to influence reaction speed when driving vehicles or other mechanisms
In some cases, some adverse reactions from the central nervous system may affect the ability to drive or operate complex machinery.
Method of administration and doses
The recommended dose for adults is 500 to 2000 mg (1–4 tablets) per day.
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 use of the drug in children is limited.
Overdose
Cases of overdose have not been described.
Side effects
Adverse reactions occur very rarely (< 1/10,000) (including patient reports).
From the side of the central and peripheral nervous system: severe headache, vertigo, hallucinations.
From the cardiovascular system: arterial hypertension, arterial hypotension, tachycardia.
Respiratory, thoracic and mediastinal disorders: dyspnea.
Gastrointestinal: nausea, vomiting, diarrhea.
On the part of the immune system: allergic reactions, including rash, hyperemia, exanthema, urticaria, purpura, itching, angioedema, anaphylactic shock.
General reactions: chills.
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 30 °C in the original packaging.
Keep out of reach of children.
Packaging
7 tablets in a blister. 4 blisters together with instructions for medical use in a cardboard pack.
10 tablets in a blister. 3 blisters together with instructions for medical use in a cardboard pack.
Vacation category
According to the recipe.
Producer
LLC NVF "MICROCHEM" (production section (all stages of the production process)).
Location of the manufacturer and address of its place of business.
Ukraine, 93400, Luhansk region, Severodonetsk city, Promyslova st., building 24-v.
Applicant.
LLC NVF "MICROCHEM".
Location of the applicant.
Ukraine, 01013, Kyiv, Budindustrii St., Building 5.
You can report an adverse event when using a medicinal product by calling + 38 (050) 309-83-54 (24 hours a day).
