Alfacholine-Lekpharm (Solution) Instructions for Use

Marketing Authorization Holder

Lekpharm, SOOO (Republic of Belarus)

ATC Code

N07AX02 (Choline alfoscerate)

Active Substance

Choline alfoscerate (Rec.INN registered by WHO)

Dosage Form

Alfacholine-Lekpharm

Solution for intravenous and intramuscular administration 250 mg/1 ml: amp. 4 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration transparent, colorless or slightly yellowish.

Excipients : water for injections – up to 1 ml.

4 ml – ampoules of colorless glass (5) – contour cell packs (1) – cardboard boxes.
4 ml – ampoules of colorless glass (5) – contour cell packs (2) – cardboard boxes.

Clinical-Pharmacological Group

Nootropic drug. Central-acting cholinomimetic

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

Cholinomimetic. It is a precursor of acetylcholine. It acts mainly on cholinergic receptors in the CNS. Glycerophosphate, which is formed during the breakdown of choline alfoscerate, is a precursor of neuronal membrane phospholipids ( phosphatidylcholine).

It facilitates the transmission of nerve impulses in cholinergic neurons, improves the plasticity of neuronal membranes and receptor function.

Pharmacokinetics

After oral administration, an average of about 88% of the choline alfoscerate dose is absorbed, with rapid distribution in organs and tissues. It penetrates the BBB.

It accumulates mainly in the brain (the concentration in the brain reaches 45% of that in plasma), lungs and liver. 85% is excreted by the lungs as carbon dioxide, the remaining amount ( 15%) is excreted through the kidneys and through the intestines.

Indications

Cerebrovascular disorders of the ischemic type (acute and recovery period) and hemorrhagic type (recovery period); psycho-organic syndrome against the background of involutional and degenerative processes of the brain; consequences of cerebrovascular insufficiency or primary and secondary cognitive impairments in the elderly, characterized by memory impairment, confusion, disorientation, decreased motivation and initiative, decreased concentration; behavioral and affective disorders in old age – emotional lability, increased irritability, decreased interest; senile pseudomelancholia; multi-infarct dementia.

ICD codes

Dosage Regimen

Administer Alfacholine-Lekpharm via intravenous or intramuscular routes.

For acute cerebrovascular disorders (ischemic type), administer 1000 mg (4 ml) intravenously once or twice daily.

For the recovery period of cerebrovascular disorders and for chronic conditions, administer 500-1000 mg (2-4 ml) intramuscularly daily.

Adjust the dose and duration of therapy individually based on the clinical picture, disease severity, and patient tolerance.

For intravenous administration, dilute the solution in 50-100 ml of 0.9% sodium chloride solution or 5% dextrose solution. Infuse slowly.

If nausea occurs, reduce the administered dose.

Do not use in patients with hypersensitivity to choline alfoscerate.

Contraindicated during pregnancy, lactation, and in patients under 18 years of age.

Adverse Reactions

From the digestive system nausea, abdominal pain.

From the nervous system short-term confusion.

Contraindications

Hypersensitivity to choline alfoscerate; pregnancy, breastfeeding period; children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Nausea may be a consequence of dopaminergic activation. If nausea occurs, the dose of choline alfoscerate should be reduced.

Effect on the ability to drive vehicles and mechanisms

During the use of choline alfoscerate, patients should exercise caution when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.