Reynix

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT REYNIX (REYNIX)

Composition:

Active substance: choline alfoscerate;

1 ml of solution contains choline alfoscerate 250 mg;

Excipient: water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical characteristics: clear, colorless liquid.

Pharmacotherapeutic group. Agents acting on the nervous system. Parasympathomimetics. Choline alfoscerate. ATC code N07AX02.

Pharmacological properties.

Pharmacodynamics.

Choline alfoscerate is an agent belonging to the group of central cholinomimetics with a predominant effect on the central nervous system (CNS). As a carrier of choline and a precursor of phosphatidylcholine, choline alfoscerate may potentially prevent and correct biochemical impairments that are particularly significant among the pathogenic factors of psychorganic involutional syndrome; thus, it may influence reduced cholinergic tone and altered phospholipid composition of nerve cell membranes. The formulation contains 40.5% metabolically protected choline. Metabolic protection ensures the release of choline in the brain. Choline alfoscerate exerts a positive effect on memory functions and cognitive abilities, as well as on parameters of emotional state and behavior, the deterioration of which is caused by the development of brain involutional pathology.

The mechanism of action is based on the fact that after entering the body, choline alfoscerate is hydrolyzed by enzymes 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 phospholipids (phosphatidylcholine) of neuronal membranes. Thus, choline alfoscerate enhances nerve impulse transmission in cholinergic neurons and exerts a positive effect on neuronal membrane plasticity and receptor function. Choline alfoscerate improves cerebral blood flow, enhances metabolic processes in the brain, activates structures of the brain's reticular formation, and restores consciousness in traumatic brain injury.

Pharmacokinetics.

On average, nearly 88% of the administered dose of choline alfoscerate is absorbed. The drug accumulates predominantly in the brain (45% of the plasma concentration), 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, brainstem lesion signs).

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

Contraindications.

Known hypersensitivity to the drug or its components.

Psychotic syndrome, severe psychomotor agitation.

Pregnancy or lactation period.

Interaction with other medicinal products and other forms of interaction.

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 or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

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

Method of administration and dosage.

In acute conditions, administer intramuscularly or intravenously (slowly) 1 g (4 ml) daily for a period of 15 to 20 days. After stabilization of the patient's condition, switch to the oral dosage form of choline alfoscerate.

Children.

Due to insufficient experience with the use of the drug in pediatric practice, it is not recommended for use in children.

Overdose.

In case of choline alfoscerate overdose, which may manifest as nausea, restlessness, excitement, and insomnia, the dose of the drug should be reduced. Symptomatic therapy should be administered.

Adverse reactions.

The drug is usually well tolerated even with long-term use. Reactions at the site of administration may occur during treatment. During the first days or weeks of treatment, anxiety, agitation, and insomnia may develop. These symptoms are temporary and do not require discontinuation of treatment, but a temporary dose reduction may be considered.

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

Hypersensitivity reactions are possible, including rash, pruritus, urticaria, angioedema, and skin redness.

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after drug registration is important. It enables continuous monitoring of the benefit-risk balance of the drug. Healthcare and pharmacy professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of drug efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging; no special storage conditions required.

Keep out of reach and sight of children.

Incompatibility.

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

Packaging.

5 ampoules in a blister. 2 blisters per carton.

Prescription status. Prescription only.

Manufacturer.

Public Joint-Stock Company "Scientific and Production Center "Borshchahivsky Chemical and Pharmaceutical Plant".

Manufacturer's address and location of operations.

17 Myru Street, Kyiv, 03134, Ukraine.