Cereton^® (Alpha-GPC) Instruction

International Non-Proprietary Name (INN): choline alfoscerate
Dosage form: solution for intravenous and intramuscular injections
Structure
In a 4 ml ampoule:
Active ingredient: сholine alphoscerate polyhydrate (on an anhydrous сholine alphoscerate basis) 1000 mg;
Excipients: water for injections.
Description
Clear, colorless liquid.
Pharmacological classification: nootropics
ATC code: N07AX02
Pharmacological action: nootropic

Pharmacodynamics

Nootropic medicine. Central cholinostimulator, which contains 40.5% of metabolically protected choline. Metabolic protection facilitates the release of choline in the brain. Provides the synthesis of acetylcholine and phosphatidylcholine in neuronal membranes, improves the blood flow and enhances metabolic processes in the central nervous system, activates reticular formation. Increases the linear velocity of blood flow on the side of a traumatic brain injury, promotes normalization of spatiotemporal characteristics of spontaneous bioelectric activity of the brain, regression of local neurological symptoms and restoration of consciousness; has a positive effect on the cognitive and behavioral responses of patients with cerebrovascular diseases (discirculatory encephalopathy and residual effects of cerebral circulation disorders). Provides a preventive and corrective effect on the pathogenetic factors of the involutional psychoorganic syndrome; changes the phospholipid composition of neuronal membranes and reduces the cholinergic activity. Stimulates dose-dependent ejection of acetylcholine under physiological conditions; participating in the synthesis of phosphotidylcholine (membrane phospholipid) it improves the synaptic transmission, plasticity of neuronal membranes, and receptors’ function. Does not affect the reproductive cycle and does not have a teratogenic, mutagenic effect.

Pharmacokinetics

Easily penetrates through the blood-brain barrier, 85% of the medicine is excreted by the lungs in the form of carbon dioxide; the rest (15%) is excreted by the kidneys and through the intestine.

Intended uses

• the acute the recovery period after a severe craniocerebral injury and an ischemic stroke, the recovery period after a hemorrhagic stroke, with local hemispheric symptoms or symptoms of brainstem lesion;
• psychoorganic syndrome against the degenerative and involuntary changes in the brain;
• cognitive disorders (impaired mental and memory function, confusion, disorientation, decreased motivation, initiative and ability to concentrate), including cases of dementia and encephalopathy;
• senile pseudo melancholia.

Contraindications

• hypersensitivity to the medicine;
• acute stage of hemorrhagic stroke;
• pregnancy;
• breastfeeding;
• age under 18 years old (due to the lack of data).

Dosage and administration

In acute conditions, the medicine is administered intravenously (slowly) or deeply intramuscularly (slowly) at a dose of 1000 mg (1 ampoule) a day for 10–15 days.

Side effects

The digestive tract
Rare: Constipation, diarrhea, dry mouth, pharyngitis.

The central nervous system
Rare: Headache, drowsiness, insomnia, agitation, anxiety, aggression, brain ischemia, dizziness, convulsions.

Dermatological reactions
Rare: Rashes, urticaria.

Other
Rare: Pain in the area of ​​injection, increased urination.

Allergic reactions are possible.

Nausea is possible (mainly because of dopaminergic activation). In this case, the dosage of administration should be reduced.

Overdose

Symptoms
Nausea.

Treatment
Symptomatic therapy.

Interaction with other drugs

No significant interaction with other medicines has been identified.

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation.

Influence on the ability to drive vehicles and operate machines

Cereton^® does not affect the speed of psychomotor reactions.

Terms of release from pharmacy

On prescription.

Storage conditions

At a temperature of no higher than 25°C. Keep out of the reach of children.

Shelf life

5 years. Do not use beyond the expiration date printed on the package.

Manufacturer

Sotex Farm, Russia. https://www.sotex.ru/