Kholibrein (Solution) Instructions for Use

Marketing Authorization Holder

Severnaya Zvezda NAO (Russia)

ATC Code

N07AX02 (Choline alfoscerate)

Active Substance

Choline alfoscerate (Rec.INN registered by WHO)

Dosage Form

Kholibrein

Solution for intramuscular injection and infusion 1000 mg

Dosage Form, Packaging, and Composition

Solution for intramuscular injection and infusion

4 ml – ampoules (10 pcs.) – cardboard packs – By prescription
4 ml – ampoules (5 pcs.) – cardboard packs – By prescription

Clinical-Pharmacological Group

Nootropic drug. Central-acting cholinomimetic

Pharmacotherapeutic Group

Other agents for the treatment of nervous system diseases; parasympathomimetics; other parasympathomimetics

Pharmacological Action

Cholinomimetic. It is a precursor of acetylcholine. It acts primarily 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, approximately 88% of the choline alfoscerate dose is absorbed on average, with rapid distribution to organs and tissues.

It penetrates the blood-brain barrier. 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, and the remaining amount (15%) is excreted through the kidneys and 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 intramuscularly or intravenously via infusion. The dosage regimen is set individually based on the clinical picture and patient tolerance.

For acute cerebrovascular disorders, administer 1000 mg (one 4 ml ampoule) intramuscularly or intravenously once daily. Continue this regimen for the duration of the acute phase as determined by the physician.

For chronic cerebrovascular insufficiency and cognitive impairments, administer 500-1000 mg (0.5-1 ampoule) intramuscularly or intravenously once daily. Adjust the dose based on therapeutic response and tolerability.

For long-term therapy, the treatment course typically lasts 4-6 weeks. Repeat courses may be administered as clinically indicated.

If nausea occurs, reduce the dose to improve tolerability. This adverse effect is often dose-dependent and related to central dopaminergic activation.

For intramuscular injection, administer the solution deeply into the gluteal muscle. For intravenous infusion, dilute the required dose in 50-100 ml of 0.9% sodium chloride solution or 5% dextrose solution. Administer the infusion slowly.

Do not use the solution if it is discolored or contains particulate matter. Use immediately after opening the ampoule. Do not mix with other medicinal products in the same syringe or infusion bag.

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 machinery

During the use of choline alfoscerate, patients should exercise caution when driving vehicles and machinery, 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 30°C (86°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.