Alsexolin-injection

INSTRUCTIONS FOR MEDICAL USE

ALSEXOLIN

Trade name of the drug: Alsexoline

Active substance (INN): choline alfoscerate

Pharmaceutical form: solution for injection

Contents:

1 ampoule contains:

Active ingredient: choline alphoscerate 1000 mg/4 ml (in choline alphoscerate hydrate form – 1222.34 mg).

Excipients: Water for injection

Description: colorless or light yellow transparent solution.

Pharmacotherapeutic group: Nootropic medicine.

ATX CODE: N07AX02

Pharmacological properties

Pharmacodynamics

Cholinomimetic of central action with predominant effect on CNS. The drug contains 40.5% metabolically protected choline. Choline alphoscerate is split into choline and alphoscerate in the body under the influence of brain enzymes, which are biotransformed to glycerophosphate. Choline is involved in the synthesis of acetylcholine, improving the transmission of nerve impulses, and glycerophosphate is a precursor of phosphatidylcholine of neuronal membranes, resulting in improved membrane elasticity and receptor function.

The drug improves cerebral blood flow, enhances metabolic processes in the brain, activates brain reticular formation structures and restores consciousness after traumatic brain injury. It has preventive and corrective effect on factors of involutional psychoorganic syndrome, such as changes in phospholipid composition of neuronal membranes and decrease in cholinergic activity.

Pharmacokinetics

The drug penetrates easily through the blood-brain barrier, and accumulates mainly in the brain (45% of concentration in plasma), as well as in liver and lungs. Excretion is mainly via the lungs in the form of carbon dioxide (85%), the remainder being excreted by the kidneys and the intestine.

Indications for use

  • Acute period of craniocerebral injury with predominantly trunk lesions (including in case of impaired consciousness and coma);
  • Cerebral circulation disorders of ischemic type (acute and recovery period) and hemorrhagic type (recovery period);
  • degenerative and involutionary psychoorganic syndromes and consequences of cerebrovascular insufficiency, such as primary and secondary disorders of mnemastic functions, characterized by memory disorders, confusion, disorientation, decreased motivation, initiative and ability to concentrate; changes in the emotional and behavioral sphere: emotional lability, increased irritability, reduced interest; senile pseudomelancholia;
  • multi-infarct dementia.

Administration and dosages

The drug is intended for intramuscular and intravenous administration. In acute conditions, a daily dose of 1 g is administered by injection or intravenously – from 1 g to 3 g per day.

When administered intravenously, 4 ml of the drug are diluted in 50 ml of physiological solution; infusion rate is 60-80 drops/min. The duration of treatment is usually 10 days, but if necessary the treatment can be continued until positive dynamics appear.

Side effects

Nausea (result of dopaminergic stimulation), allergic reactions. Usually, the drug is well tolerated, even with long-term use.

Contraindications

  • Hypersensitivity to the drug components;
  • pregnancy and lactation.

Drug interactions

Drug interactions with other drugs have not been described.

Special indications

Usage during pregnancy and lactation

The drug is contraindicated for use in pregnancy. Breast-feeding should be discontinued during the treatment.

Administration in pediatrics

No experience in application in children.

Effect on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and to perform potentially dangerous activities.

Overdose

In case of overdose, nausea, restlessness and insomnia are registered, which pass after reduction of the dose or discontinuation of the treatment. Therapy is symptomatic.

Form of production

Solution for injection of 1000 mg/4ml №5, №10 (ampules).

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25oC. Keep out of the reach of children!

Shelf life

2 years. Do not use after the expiration date.

Conditions for dispensing from pharmacies

Released by doctor’s prescription

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