Instructions Medotilin solution for injection 1000 mg/4 ml ampoule 4 ml No. 3
Composition
active ingredient: choline alfoscerate;
1 ampoule (4 ml) of solution contains choline alfoscerate (in hydrate form) 1000 mg;
excipient: water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: transparent colorless or pale yellow solution.
Pharmacotherapeutic group
Agents affecting the nervous system. Parasympathomimetics. Choline alfoscerate. ATX code N07A X02.
Pharmacological properties
Pharmacodynamics
The drug belongs to the group of central cholinomimetics with a predominant effect on the central nervous system (CNS). The active substance choline alfoscerate as a choline carrier and a precursor of phosphatidylcholine has the potential to prevent and correct biochemical damage, which is of particular importance among the pathogenic factors of psychoorganic involutional syndrome, i.e. it can affect the reduced cholinergic tone and the altered phospholipid composition of nerve cell membranes. The drug contains 40.5% metabolically protected choline. Metabolic protection ensures the release of choline in the brain. The drug 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 broken down by enzymes into choline and glycerophosphate: choline takes part in the biosynthesis of acetylcholine - one of the main mediators of nervous excitation; glycerophosphate is a precursor of phospholipids (phosphatidylcholine) of the neuronal membrane. Thus, the drug improves the transmission of nerve impulses in cholinergic neurons, has a positive effect on the plasticity of neuronal membranes and the function of receptors. It also improves cerebral blood flow, enhances metabolic processes in the brain, activates the structures of the reticular formation of the brain and restores consciousness in traumatic brain injury.
Pharmacokinetics
On average, almost 88% of the administered dose of choline alfoscerate is absorbed. It accumulates mainly in the brain (45% of the drug concentration in the blood), lungs and liver. Excretion occurs mainly through the lungs in the form of carbon dioxide (CO2). Only 15% of the choline alfoscerate dose is excreted in the urine and bile.
Indication
Acute period of severe traumatic brain injury with predominantly stem-level damage (impaired consciousness, coma, focal hemispheric symptoms, symptoms of brain stem damage). Degenerative-involutional cerebral psychoorganic syndromes or secondary consequences of cerebrovascular insufficiency, i.e. primary and secondary disorders of mental activity in elderly patients, characterized by memory impairment, confusion, disorientation, decreased motivation and initiative, decreased ability to concentrate. Changes in the emotional and behavioral sphere: emotional instability, irritability, indifference to the environment; pseudomelancholia in elderly patients.
Contraindication
Known hypersensitivity to the active substance or to any of the excipients of the medicinal product. Psychotic syndrome, severe psychomotor agitation. Pregnancy. Breastfeeding.
Interaction with other medicinal products and other types of interactions
Clinically significant interactions of choline alfoscerate with other drugs have not been established.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the ability to drive or use other mechanisms.
Use during pregnancy or breastfeeding
The drug is contraindicated for use during pregnancy or breastfeeding, although specific studies have not revealed any embryotoxic or teratogenic effects.
Method of administration and doses
The drug is intended for parenteral use.
Adults.
In acute conditions, the solution should be administered intramuscularly or intravenously (slowly) at a rate of 1 g (1 ampoule) per day for 15–20 days. Then, after the patient's condition has stabilized, switch to the oral form of choline alfoscerate.
Children
There is no experience with the use of choline alfoscerate in children.
Overdose
Symptoms.
Overdose may manifest as nausea, restlessness, agitation, and insomnia.
Treatment.
The dose of the drug should be reduced and symptomatic therapy should be carried out.
Adverse reactions
Choline alfoscerate is usually well tolerated even with long-term use.
Possible reactions at the injection site.
Nausea (mainly due to secondary dopaminergic activation), decreased blood pressure, headache, very rarely abdominal pain and short-term confusion may occur. In this case, the dose of the drug should be reduced.
Hypersensitivity reactions are possible, including rash, itching, urticaria, angioedema, and skin redness.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions that occur after the marketing authorisation of a medicinal product is very important. This allows the benefit/risk balance of the medicinal product to be continuously monitored. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Expiration date
4 years.
Storage conditions
Store at a temperature not exceeding 25 ºС in a dry, dark place out of the reach of children.
Packaging
4 ml of solution in a glass ampoule; 3 ampoules in a contour blister pack; 1 contour blister pack in a cardboard box.
Vacation category
According to the recipe.
Producer
Mefar Ilach San. A.Sh./Mefar Ilac San. AS
Location of the manufacturer and its business address
Ramazanoglu Mach. Ansar Jad. No. 20, 34906 Kurtkoy – Pendik/Istanbul, Turkey/Ramazanoglu Mah. Ensar Cad. No: 20, 34906 Kurtkoy – Pendik/Istanbul, Turkey.
