Neurotylin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NEUROTILIN (NEUROTILIN)

Composition:

Active substance: choline alfoscerate;

1 ml of the preparation contains 250 mg of choline alfoscerate;

Excipient: water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: clear, colorless solution.

Pharmacotherapeutic group.

Agents acting on the nervous system. Parasympathomimetics. Choline alfoscerate.

ATC code N07AX02.

Pharmacological properties.

Pharmacodynamics.

Neurotropil belongs to the group of central cholinomimetics with a predominant effect on the central nervous system (CNS). Choline alfoscerate, as a choline carrier and a precursor of phosphatidylcholine, has the potential to prevent and correct biochemical impairments that are particularly significant among the pathogenic factors of psychorganic involutional syndrome; thus, it can influence reduced cholinergic tone and altered phospholipid composition of nerve cell membranes. The drug formulation contains 40.5% metabolically protected choline. Metabolic protection ensures the release of choline in the brain. Neurotropil positively affects memory functions and cognitive abilities, as well as parameters of emotional state and behavior, which have been impaired due to the development of brain involutional pathology.

The mechanism of action is based on the fact that, upon entering the body, choline alfoscerate is enzymatically hydrolyzed into choline and glycerophosphate: choline participates in the biosynthesis of acetylcholine—one of the main mediators of nerve excitation; glycerophosphate serves as a precursor for neuronal membrane phospholipids (phosphatidylcholine). Thus, Neurotropil improves nerve impulse transmission in cholinergic neurons, positively influences neuronal membrane plasticity and receptor function. Neurotropil enhances cerebral blood flow, intensifies metabolic processes in the brain, activates structures of the brain's reticular formation, and restores consciousness following traumatic brain injury.

Pharmacokinetics.

On average, approximately 88% of the administered dose of Neurotropil is absorbed. The drug accumulates predominantly in the brain (45% of the drug concentration in blood), lungs, and liver. Elimination of the drug occurs mainly via the lungs in the form of carbon dioxide (CO₂). Only 15% of the drug is excreted in urine and bile.

Clinical characteristics.

Indications.

Acute period of severe traumatic brain injury with predominantly brainstem-level damage (impaired consciousness, coma, focal hemispheric symptoms, signs of brainstem injury).

Degenerative-involutional cerebral psychoorganic syndromes or secondary consequences of cerebrovascular insufficiency, i.e. primary and secondary cognitive impairments in elderly individuals characterized by memory disturbances, mental confusion, disorientation, reduced motivation and initiative, decreased ability to concentrate; emotional and behavioral changes: emotional instability, irritability, indifference to the surrounding environment; pseudomelancholia in elderly individuals.

Contraindications.

Known hypersensitivity to the medicinal product or to any of its components.

Psychotic syndrome, severe psychomotor agitation.

Pregnancy or breastfeeding period.

Interaction with other medicinal products and other types of interactions.

Clinically significant interaction of the drug with other medicinal products has not been established.

Special precautions.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy and breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

The drug does not affect the ability to drive or operate machinery.

Method of Administration and Dosage

In acute conditions, Neurorilin should be administered intramuscularly or intravenously (slowly) at a dose of 1 g (1 ampoule) per day for 15 to 20 days. After stabilization of the patient's condition, switch to the capsule form of the drug.

Children. There is no experience with the use of Neurorilin in children.

Overdose.

In case of Neurorilin overdose, which may manifest as nausea, restlessness, excitement, and insomnia, the dose of the drug should be reduced. Treatment is symptomatic.

Side effects

The drug is usually well tolerated even with long-term use. Injection site reactions may occur. During the first days or weeks of treatment, the following adverse reactions may appear: anxiety, agitation, insomnia. These symptoms are temporary and do not require discontinuation of treatment, although the dose may be temporarily reduced.

Nausea (mainly due to secondary dopaminergic activation), decreased arterial blood pressure, headache may occur. Very rarely abdominal pain and short-term confusion may occur. In such cases, the drug dose should be reduced.

Hypersensitivity reactions are possible, including rash, pruritus, urticaria, angioneurotic edema, skin redness.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Incompatibility.

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

Packaging.

4 ml in ampoules № 5 (5×1), № 10 (5×2) in blisters, in cardboard boxes.

Prescription status. Prescription only.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's location and address of business activity.

Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka Street, building 22.