Alcmerat

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

Composition:

Active substance: choline alfoscerate;

1 ml of solution contains choline alfoscerate 250 mg;

Excipient: water for injections.

Pharmaceutical form. Injection solution.

Main physicochemical properties: colorless or yellowish transparent liquid.

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

Pharmacological Properties

Pharmacodynamics

Alcemerat is a drug belonging to the group of central cholinomimetics with a predominant effect on the central nervous system (CNS). Alcemerat, as a choline carrier and a precursor of phosphatidylcholine, has the potential to prevent biochemical damage that plays a significant role among the pathogenic factors of psychorganic involutional syndrome, as well as to correct such damage; that is, it may influence reduced cholinergic tone and altered phospholipid composition of nerve cell membranes. The drug consists of 40.5% metabolically protected choline. Metabolic protection ensures the release of choline in the brain. Alcemerat exerts a positive effect on memory functions and cognitive abilities, as well as on parameters of emotional state and behavior, the deterioration of which has been caused by the development of brain involutional pathology.

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

Pharmacokinetics

After administration, approximately 88% of the dose 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, comatose state, focal hemispheric symptoms, signs of brainstem injury).

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

Contraindications.

Known hypersensitivity to the drug or its components.

Pregnancy or breastfeeding period.

Psychotic syndrome with severe psychomotor agitation.

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, Alcmerat should be administered intramuscularly or intravenously (slowly) at a dose of 1 g (1 ampoule) daily for 15–20 days. After stabilization of the patient's condition, treatment should be switched to the capsule form of the drug.

Children.

There is no experience with the use of Alcmerat in children.

Overdose.

Overdose of choline alfoscerate may manifest as nausea, restlessness, excitement, and insomnia. In such cases, the dose of the drug should be reduced. Symptomatic therapy should be administered.

Side effects.

The drug is generally well tolerated, even during prolonged use. Possible side effects include nausea (mainly due to secondary dopaminergic activation), decreased arterial pressure, headache, and very rarely abdominal pain and short-term confusion. In such cases, the dose should be reduced.

Local reactions at the injection site may occur. During the first days or weeks of treatment, side effects such as anxiety, agitation, and insomnia may appear. These symptoms are temporary and do not require discontinuation of treatment, although a temporary dose reduction may be considered.

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

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Incompatibility.

Should not be used in the same container with other medicinal products.

Packaging.
4 ml in an ampoule; 5, 10, or 100 ampoules per pack, or 5 ampoules in a blister, 1 or 2 blisters per pack.

Prescription status.

By prescription only.

Manufacturer.

Private Joint-Stock Company "Lekhym-Kharkiv".

Manufacturer's address and place of business.

36 Severina Pototskoho Street, Kharkiv, Kharkiv Oblast, 61115, Ukraine.