T-CHOLIN

Composition:

active ingredient: choline alfoscerate;

1 ml of solution contains 250 mg of choline alfoscerate (calculated as anhydrous alfoscerate choline);

excipient: water for injections.

Medicinal form. Solution for injection.

Basic physicochemical properties: transparent colorless or yellowish solution practically does not contain visible particles.

Pharmacotherapeutic group. Means affecting the nervous system. Parasympathomimetics. Choline alfoscerate. ATX code N07A X02.

Pharmacological properties

Pharmacodynamics. Choline alfoscerate is a drug that belongs to the group of central cholinomimetics with a predominant effect on the central nervous system (CNS). Choline alfoscerate, as a carrier of choline and a precursor to phosphatidylcholine, is potentially capable of preventing and correcting biochemical damage, which is of particular importance among the pathogenic factors of psychoorganic involution syndrome, i.e. it can affect the reduced cholinergic tone and the changed phospholipid composition of nerve cell membranes. The composition of the medicinal product includes 40.5% of metabolically protected choline. Metabolic protection ensures the release of choline in the brain. Choline alfoscerate has a positive effect on memory functions and cognitive abilities, as well as on indicators of emotional state and behavior, the deterioration of which was caused by the development of involutional brain pathology.

The mechanism of action is based on the fact that when choline enters the body, alfoscerate is split under the action of enzymes into choline and glycerophosphate: choline is used in the biosynthesis of acetylcholine, one of the main mediators of nervous excitement; glycerophosphate is a precursor of phospholipids (phosphatidylcholine) of the neuron membrane. Thus, choline alfoscerate improves the transmission of nerve impulses in cholinergic neurons, has a positive effect on the plasticity of neuronal membranes and the function of receptors. Choline alfoscerate improves cerebral blood circulation, enhances metabolic processes in the brain, activates the structures of the reticular formation of the brain and restores consciousness in case of traumatic brain injury.

Pharmacokinetics. When choline alfoscerate is administered, almost 88% of the dose is absorbed on average. The drug accumulates mainly in the brain (45% of the concentration of the drug in the blood), lungs and liver. Elimination occurs mainly through the lungs in the form of carbon dioxide (CO2). Only 15% of the drug is excreted with urine and bile.

Clinical characteristics

Indication. Acute period of severe craniocerebral trauma with mainly stem-level damage (impaired consciousness, comatose state, focal hemispheric symptoms, symptoms of brain stem damage).

Degenerative-involutional brain-psychoorganic syndromes or secondary consequences of cerebrovascular insufficiency, i.e. primary and secondary disorders of mental activity in the elderly, characterized by memory impairment, confusion, disorientation, decreased motivation and initiative, decreased ability to concentrate; changes in the emotional and behavioral spheres: emotional instability, irritability, indifference to the environment; pseudomelancholia in elderly people.

Contraindication. Increased sensitivity to the components of the drug.

Psychotic syndrome, severe psychomotor agitation.

Period of pregnancy or breastfeeding.

Interaction with other medicinal products and other types of interactions. Clinically significant interaction of the drug with other drugs has not been established.

Special Instructions

Use during pregnancy or breastfeeding. The drug is contraindicated for use during pregnancy or breastfeeding.

The ability to influence the speed of reaction when driving vehicles or other mechanisms. The drug does not affect the ability to drive vehicles or work with other mechanisms.

Method of use and doses. In acute conditions, T-CHOLIN® should be administered intramuscularly or intravenously (slowly) at 1 g (1 ampoule) per day for 15–20 days. Then, after stabilization of the patient’s condition, switch to the medicinal form in capsules.

Children. There is no experience of using the drug T-CHOLIN® in children.

Overdose. In case of an overdose of the drug T-CHOLIN®, which can be manifested by nausea, restlessness, excitement, insomnia, the dose should be reduced. The therapy is symptomatic.

Side effects. Usually, the drug is well tolerated even with long-term use. Injection site reactions are possible. During the first days or weeks of treatment, the following manifestations of adverse reactions may occur: anxiety, agitation, insomnia. These symptoms are temporary and do not require discontinuation of treatment, but a temporary dose reduction may be necessary.

Nausea (mainly due to secondary dopaminergic activation), decreased blood pressure, headache, very rarely abdominal pain and short-term confusion may occur. In this case, it is necessary to reduce the dose of the drug.

Hypersensitivity reactions are possible, including rash, itching, urticaria, angioedema, reddening of the skin.

Reporting of suspected adverse reactions

Post-marketing reporting of adverse reactions is important. This makes it possible to monitor the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical workers, as well as patients or their legal representatives should be notified of all cases of suspected adverse reactions and lack of effectiveness of the medicinal product through the automated information system on pharmacovigilance at the link: https://aisf.dec.gov.ua

Shelf life. 4 years.

Storage conditions. Store in the original packaging at a temperature not higher than 25 ºС. Keep out of the reach of children.

Incompatibility. Do not mix in the same container with other medicinal products.

Packaging. 4 ml in an ampoule, 3 ampoules in a contoured envelope; 1 contoured envelope in a cardboard pack.

Leave category. By prescription.

Manufacturer. K.T. Romfarm Company S.R.L. / S.C. Rompharm Company S.R.L.

The location of the manufacturer and the address of the place of its activity

St. Eroilor No. 1A, Otopeni, 075100, Ilfov District, Romania – Romfarm 1 and Romfarm 2 building.

The applicant LLC “BFC “SALUTARIS”.

The location of the applicant and the address of the place of his activity. Ukraine, 01042, Kyiv, Druzhby Narodiv Boulevard, 9.

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