Gliatab^®-250 (Solution) Instructions for Use

Marketing Authorization Holder

Deko Company, LLC (Russia)

ATC Code

N07AX02 (Choline alfoscerate)

Active Substance

Choline alfoscerate (Rec.INN registered by WHO)

Dosage Form

Gliatab^®-250

Solution for intravenous and intramuscular injection 250 mg/ml: amp. 4 ml 3, 5, or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration	1 ml
Choline alfoscerate	250 mg

4 ml – ampoules (3) – contour cell packaging (1) – cardboard packs.
4 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.
4 ml – ampoules (10) – 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 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 and 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 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, 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); 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

Open the list of ICD codes

ICD-10 code	Indication
F01	Vascular dementia
F03	Unspecified dementia
F07	Personality and behavioral disorders due to disease, damage or dysfunction of the brain
G93.4	Unspecified encephalopathy
I61	Intracerebral hemorrhage (cerebrovascular accident of hemorrhagic type)
I63	Cerebral infarction
I69	Sequelae of cerebrovascular diseases

ICD-11 code	Indication
6D81	Dementia due to cerebrovascular disease
6D8Z	Dementia, unknown or unspecified cause
6E68	Secondary emotionally labile personality disorder
6E6Z	Unspecified secondary mental or behavioral syndromes
8B00.Z	Intracerebral hemorrhage of unspecified site, unspecified
8B11	Cerebral ischemic stroke
8B25.Z	Sequelae of cerebrovascular disease, unspecified
8E47	Encephalopathy, not elsewhere classified
8E4A.0	Paraneoplastic or autoimmune disorders of the central nervous system, including brain and spinal cord
8E63	Post-cardiopulmonary bypass encephalopathy

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally, intramuscularly, or intravenously as directed by a physician.

Establish the dosage regimen individually based on the indication, clinical presentation, disease course, and patient tolerance.

For acute cerebrovascular disorders, administer 1,000 mg (4 ml) intravenously or intramuscularly once daily.

Continue the acute phase treatment for the period determined by the physician, typically for several weeks.

For the recovery phase of cerebrovascular disorders and for chronic conditions, administer 400 mg intramuscularly once or twice daily or switch to oral administration.

The recommended oral dose is 400 mg three times daily, taken between meals.

For geriatric patients with cognitive or behavioral disorders, use the oral route at a dose of 400 mg three times daily.

The maximum daily intramuscular or intravenous dose should not exceed 1,000 mg.

The maximum daily oral dose should not exceed 1,200 mg.

The duration of treatment is determined by the physician based on therapeutic response and can extend for several months.

If nausea occurs, reduce the dose as this may indicate dopaminergic activation.

Do not adjust the dosage or administration frequency without medical consultation.

Adverse Reactions

Digestive system: nausea, abdominal pain.

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

Use in children and adolescents under 18 years of age is contraindicated.

Special Precautions

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

Effect on ability to drive vehicles and operate machinery

During the use of choline alfoscerate, patients should exercise caution when driving vehicles and operating 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.

Medical Disclaimer