Neocerebron

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT NEOTREBROX (NEOCEBRON)

Composition:

Active substance: citicoline;

1 ampoule (4 ml) contains sodium citicoline equivalent to citicoline 500 mg or 1000 mg;

Excipient: water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: clear, colorless solution, free from visible particles.

Pharmacotherapeutic group. Psychostimulants, drugs used in attention deficit hyperactivity disorder (ADHD), nootropic agents. Other psychostimulant and nootropic agents. ATC code N06BX06.

Pharmacological Properties.

Pharmacodynamics.

Citicoline stimulates the biosynthesis of structural phospholipids in neuronal membranes, as confirmed by magnetic resonance spectroscopy data. Citicoline improves the functioning of membrane mechanisms such as ion pumps and receptors, the regulation of which is essential for normal nerve impulse conduction. Due to its stabilizing effect on neuronal membranes, citicoline exhibits anti-edematous properties that promote reabsorption of cerebral edema.

Research findings have shown that citicoline inhibits the activation of certain phospholipases (A1, A2, C, and D), reducing the formation of free radicals, preventing the destruction of membrane systems, and preserving antioxidant defense systems such as glutathione.

Citicoline maintains neuronal energy reserves and inhibits apoptosis, thereby enhancing cholinergic transmission.

Experimental studies have demonstrated that citicoline also exerts a preventive neuroprotective effect in focal cerebral ischemia.

Research results have shown that citicoline significantly improves functional recovery rates in patients with acute cerebrovascular disorders, which correlates with a slowing of ischemic brain lesion progression as evidenced by neuroimaging. In patients with traumatic brain injury, citicoline accelerates recovery and reduces the duration and severity of post-traumatic syndrome.

Citicoline improves levels of attention and consciousness, promotes reduction of amnesia, and ameliorates cognitive and other neurological deficits associated with cerebral ischemia.

Pharmacokinetics.

Citicoline is well absorbed following oral, intramuscular, and intravenous administration. Plasma choline levels increase significantly after administration by these routes. Absorption after oral administration is nearly complete, and bioavailability is practically equivalent to that achieved with intravenous administration.

Depending on the route of administration, the drug is metabolized in the intestine and liver into choline and cytidine. After administration, citicoline is widely distributed into brain structures, with rapid incorporation of the choline fraction into structural phospholipids and the cytidine fraction into cytidine nucleotides and nucleic acids. Upon reaching the brain, citicoline integrates into cellular, cytoplasmic, and mitochondrial membranes, participating in the formation of phospholipid fractions.

Only a small amount of the administered dose is excreted in urine and feces (less than 3%). Approximately 2% of the administered dose is excreted as CO₂ in exhaled air. The excretion of the drug in urine occurs in two phases: the first phase lasts approximately 36 hours, during which the excretion rate rapidly decreases, and the second phase, during which the excretion rate declines much more slowly. A similar biphasic pattern is observed in CO₂ excretion. The rate of exhaled CO₂ excretion rapidly decreases after approximately 15 hours, then declines much more slowly thereafter.

Clinical characteristics.

Indications.

• Stroke, acute phase of cerebral circulation disorders, and treatment of complications and consequences of cerebral circulation disorders.
• Traumatic brain injury and its neurological consequences.
• Cognitive disorders and behavioral disorders due to chronic vascular and degenerative cerebral disorders.

Contraindications.

Hypersensitivity to the components of the drug.

Increased tone of the parasympathetic nervous system.

Interaction with other medicinal products and other forms of interaction.

Enhances the effect of levodopa. The drug should not be administered simultaneously with medicinal products containing meclofenoxate.

Special precautions.

In cases of established intracranial hemorrhage, the dose should not exceed 1000 mg per day and the intravenous infusion rate should not exceed 30 drops per minute.

Use during pregnancy or breastfeeding.

There are insufficient data on the use of citicoline in pregnant women. There is no information on the excretion of citicoline in breast milk or its effects on the fetus. Therefore, during pregnancy or breastfeeding, the drug should be administered only if the expected benefit to the mother outweighs the potential risk to the fetus.

Ability to affect reaction rate when driving or operating machinery.

In individual cases, certain adverse reactions affecting the central nervous system may impair the ability to drive or operate complex machinery.

Dosage and Administration

For intravenous or intramuscular administration.

The recommended dose for adults is 500 mg to 2000 mg per day.

The maximum daily dose is 2000 mg.

In acute conditions, maximum therapeutic effect is achieved when the drug is administered within the first 24 hours.

If necessary, treatment may be continued with citicoline for oral administration. The dosage and duration of treatment depend on the severity of brain damage and are determined individually by the physician.

Intravenous administration is performed as a slow intravenous injection (over 3–5 minutes, depending on the administered dose) or by intravenous infusion (40–60 drops per minute).

Elderly patients do not require dose adjustment.

Children

There is insufficient data on the use of the drug in children. The drug should be used only in cases of extreme necessity, when the expected benefit outweighs the potential risk.

Overdose

Cases of overdose have not been reported.

Adverse Reactions

Adverse reactions occur very rarely (< 1/10,000), including isolated cases.

Central and peripheral nervous system disorders: severe headache, dizziness, hallucinations.

Cardiovascular disorders: arterial hypertension, arterial hypotension, tachycardia.

Respiratory system disorders: dyspnea.

Gastrointestinal disorders: nausea, vomiting, diarrhea.

Immune system disorders: allergic reactions, including: rash, hyperemia, exanthema, urticaria, purpura, pruritus, angioneurotic edema, anaphylactic shock.

General disorders: chills, reactions at the injection site.

Shelf life

5 years.

Storage conditions

Store at a temperature not exceeding 25°C in the original packaging.

Keep out of reach of children.

Incompatibilities

The preparation should not be mixed with other medicinal products in the same container.

Packaging

500 mg/4 ml: 4 ml of the preparation in an ampoule, 5 ampoules in a blister pack, 1 pack in a cardboard box.

1000 mg/4 ml: 4 ml of the preparation in an ampoule, 3 ampoules in a blister pack, 1 pack in a cardboard box.

Prescription status By prescription only.

Manufacturer/Applicant

Manufacturer:

ESSETI FARMACEUTICI SRL

Applicant:

EURO-FARMA SRL

Manufacturer's address and place of business / Applicant's address

Manufacturer's address:

Via Campobello, 15 - 00071 Pomezia (RM), Italy

Applicant's address:

Via Granglia 8 - 10127 Turin, Italy.