Nooprin^® (Solution) Instructions for Use

Marketing Authorization Holder

Valenta Pharm, JSC (Russia)

Manufactured By

Novosibkhimpharm, JSC (Russia)

ATC Code

N07AX02 (Choline alfoscerate)

Active Substance

Choline alfoscerate (Rec.INN registered by WHO)

Dosage Form

Nooprin®

Solution for intravenous and intramuscular administration 250 mg/1 ml: amp. 4 ml 3, 5, 6 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration transparent, colorless or slightly yellowish.

Excipients: water for injections – up to 1 ml.

4 ml – glass ampoules (3) – contour cell packaging (1) – cardboard packs.
4 ml – glass ampoules (3) – contour cell packaging (2) – cardboard packs.
4 ml – glass ampoules (5) – contour cell packaging (1) – cardboard packs.
4 ml – glass ampoules (5) – contour cell packaging (2) – cardboard packs.
4 ml – glass ampoules (10) – cardboard boxes.

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 breakdown 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 BBB. 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

Cerebral circulation 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 Nooprin^® via the intravenous or intramuscular route.

Determine the dosage regimen individually based on the specific indication, clinical presentation, and patient tolerance.

For acute cerebrovascular accidents (ischemic type, hemorrhagic type in recovery phase), administer 1000 mg (one 4 ml ampoule) once daily or twice daily intravenously or intramuscularly.

For chronic neurological conditions (psychoorganic syndrome, cognitive impairments, multi-infarct dementia), administer 500 mg to 1000 mg (2-4 ml) once daily intramuscularly or intravenously.

Adjust the dose downward if adverse reactions, such as nausea, occur.

For intravenous administration, dilute the contents of the ampoule in an appropriate volume of 0.9% Sodium Chloride solution or 5% Dextrose solution.

Administer the intravenous infusion at a slow rate, not exceeding 60-80 drops per minute.

The standard course of treatment typically ranges from 3 to 6 weeks.

Transition to oral choline alfoscerate formulations for maintenance therapy as clinically indicated.

Do not administer to individuals with a known hypersensitivity to choline alfoscerate.

Avoid use during pregnancy, lactation, and in patients under 18 years of age.

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 mechanisms

During the use of choline alfoscerate, patients should exercise caution when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Storage Conditions

Store at 15°C (59°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.