Choline alfoscerat solution for injection 250mg / ml, 4ml No. 5

- Disorders of cerebral circulation by 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 of attention.
- Violation of behavior and affective sphere in old age: emotional lability, increased irritability, decreased interest; senile pseudomelancholia.
- Multi-infarction dementia.

Intravenous (drip) or intramuscular (slow) at a dose of 1000 mg / day.

When administered intravenously, the contents of one ampoule (4 ml) are diluted in 50 ml of 0.9% sodium chloride solution, the infusion rate is 60-80 drops per minute. The duration of treatment is usually 10 days. If necessary, treatment can be continued as prescribed by a doctor, depending on the clinical picture and characteristics of the course of the disease, age and tolerability of the drug.

After stabilizing the patient's condition, it is possible to continue treatment with oral dosage forms of the drug.

Doses can be increased at the discretion of the attending physician.

for 1 ml:

Active ingredient: choline alfoscerate - 250.0 mg;
Excipient: water for injection - up to 1.0 ml.

- Hypersensitivity to the components of the drug.
- Pregnancy.
- Breastfeeding period.
- Children under 18 years of age (due to lack of data).

Trade name:

Choline alfoscerate

International non-proprietary name:

choline alfoscerate

Dosage form:

solution for intravenous and intramuscular administration

Composition

for 1 ml:

Active ingredient: choline alfoscerate - 250.0 mg;
Excipient: water for injection - up to 1.0 ml.

Description:

clear colorless or slightly yellowish solution

Pharmacotherapeutic group:

nootropic agent.

ATX code:

N07AX02

Pharmacological properties

Pharmacodynamics
Choline alfoscerate is a centrally acting cholinomimetic with a predominant effect on the central nervous system.

The preparation contains 40.5% of choline released from the compound in the brain; choline is involved in the biosynthesis of acetylcholine (one of the main mediators of nervous excitement). Alfoscerate biotransforms to glycerophosphate, which is a precursor of phospholipids.

Acetylcholine has a positive effect on the transmission of nerve impulses, and glycerophosphate is involved in the synthesis of phosphatidylcholine (membrane phospholipid), resulting in improved membrane elasticity and receptor function.

Choline alfoscerate enhances metabolic processes and activates the structures of the reticular formation of the brain.

It has a preventive and corrective effect on the factors of involutional psychoorganic syndrome, such as changes in the phospholipid composition of neuronal membranes and a decrease in cholinergic activity.

Pharmacodynamic studies have shown that choline alfoscerate acts on synaptic, including cholinergic transmission of nerve impulses (neurotransmission), neural membrane plasticity and receptor function.

Pharmacokinetics
Oral absorption - 88%; easily penetrates the blood-brain barrier, accumulates mainly in the brain (concentration in the brain reaches 45% of the level in the blood), lungs and liver; 85% is excreted by the lungs in the form of carbon dioxide, the rest (15%) is excreted by the kidneys and through the intestines.
Does not affect the reproductive cycle, does not have teratogenic and mutagenic effects.

Indications for use

- Disorders of cerebral circulation by 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 of attention.
- Violation of behavior and affective sphere in old age: emotional lability, increased irritability, decreased interest; senile pseudomelancholia.
- Multi-infarction dementia.

Contraindications

- Hypersensitivity to the components of the drug.
- Pregnancy.
- Breastfeeding period.
- Children under 18 years of age (due to lack of data).

Application during pregnancy and during breastfeeding

The use of the drug Choline alfoscerat during pregnancy and during breastfeeding is contraindicated.

Method of administration and dosage

Intravenous (drip) or intramuscular (slow) at a dose of 1000 mg / day.

When administered intravenously, the contents of one ampoule (4 ml) are diluted in 50 ml of 0.9% sodium chloride solution, the infusion rate is 60-80 drops per minute. The duration of treatment is usually 10 days. If necessary, treatment can be continued as prescribed by a doctor, depending on the clinical picture and characteristics of the course of the disease, age and tolerability of the drug.

After stabilizing the patient's condition, it is possible to continue treatment with oral dosage forms of the drug.

Doses can be increased at the discretion of the attending physician.

Side effect

From the digestive system: nausea (which is mainly a consequence of secondary dopaminergic activation), abdominal pain.
From the side of the nervous system: short-term confusion of consciousness (in this case, it is necessary to reduce the dose of the drug).
The drug is well tolerated even with prolonged use.

Overdose

Symptoms: nausea.
Increase in the severity of dose-dependent side effects is possible.
Treatment: symptomatic therapy. The effectiveness of dialysis has not been established.

Interaction with other medicinal products

Clinically significant interaction of the drug with other drugs has not been established.

special instructions

Nausea may be due to dopaminergic activation.
Efficacy and safety in children under 18 years of age has not been established.

Influence on the ability to drive vehicles and mechanisms

During the period of treatment, care must be taken when driving vehicles and when engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Release form

Solution for intravenous and intramuscular administration of 250 mg / ml.

4 ml in ampoules of neutral glass of the NS-3 brand with a capacity of 5 ml or in ampoules of medical glass of the first hydrolytic class.

5 ampoules are placed in a blister strip made of polyvinyl chloride film.

1 or 2 blister packs together with instructions for medical use are placed in a cardboard box for consumer packaging.

10 ampoules with instructions for medical use are placed in a cardboard box with a corrugated liner made of sack paper.

An ampoule scarifier is placed in each pack or box with ampoules.

When using ampoules with a notch, a break ring or a break point, the ampoule scarifier is not inserted.

Shelf life

3 years.
Do not use after the expiration date.

Vacation conditions

Dispensed by prescription.

Storage conditions

In a dark place at a temperature not exceeding 25 ? C.
Keep out of the reach of children.