Gleacer (Solution) Instructions for Use

Marketing Authorization Holder

Ecofarmplus, JSC (Russia)

ATC Code

N07AX02 (Choline alfoscerate)

Active Substance

Choline alfoscerate

Dosage Form

Gleacer

Solution for intravenous and intramuscular injection 1g/4 ml: amp. 3 or 5 pcs.

Dosage Form, Packaging, and Composition

4 ml – ampoules (3) – contour cell packaging (1) – cardboard packs.
4 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.

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 cleavage 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 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, 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); psychoorganic 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 Gleacer orally, intramuscularly, or intravenously as directed by a physician.

Determine the dosage regimen individually based on the specific indication, clinical presentation, disease characteristics, and patient tolerance to choline alfoscerate.

For acute cerebrovascular disorders, use a dose of 1 gram intravenously or intramuscularly once daily.

For the recovery phase of cerebrovascular events or for chronic conditions, administer 400 mg orally one to three times daily, or 1 gram intramuscularly once daily.

Adjust the dose for elderly patients based on renal function and overall clinical status.

Reduce the dosage if nausea occurs, as this may indicate dopaminergic activation.

For intravenous administration, dilute the contents of the ampoule in an appropriate infusion solution prior to use.

For intramuscular injection, administer the solution deeply into a large muscle mass.

The duration of treatment is determined by the physician and depends on the therapeutic response.

Do not use in children or adolescents under 18 years of age.

Discontinue use if hypersensitivity reactions occur.

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 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.