Teuton

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TEVTONA (TEVTONA)

Composition:

Active substance: citicoline;

1 ampoule (4 ml) contains citicoline (in the form of citicoline sodium) 500 mg or 1000 mg;

Excipients: sodium hydroxide or hydrochloric acid, water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: clear, colorless or slightly yellowish solution.

Pharmacotherapeutic group.

Medicinal products affecting the nervous system. Psychoanaleptics. Psychostimulants, drugs used in attention deficit hyperactivity disorder (ADHD) and nootropic agents. Other psychostimulant and nootropic agents. Citicoline.

ATC code N06B X06.

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 brain edema.

Clinical studies 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 preserves neuronal energy reserves and inhibits apoptosis, thereby enhancing cholinergic transmission.

Experimental evidence has demonstrated that citicoline also exerts a preventive neuroprotective effect in focal cerebral ischemia.

Clinical studies have shown that citicoline significantly improves functional recovery rates in patients with acute cerebrovascular disorders, which correlates, according to neuroimaging data, with slowing of the growth of cerebral ischemic lesions. 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, helps reduce symptoms of amnesia, and alleviates cognitive and other neurological disorders associated with cerebral ischemia.

Pharmacokinetics

Citicoline is well absorbed following oral, intramuscular, and intravenous administration. Plasma choline levels increase significantly after administration by the aforementioned 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 throughout 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 dose is excreted in urine and feces (less than 3%). Approximately 12% of the dose is excreted as exhaled CO₂. 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 excretion as exhaled CO₂: the rate of CO₂ excretion rapidly decreases after approximately 15 hours, then declines much more slowly.

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 any component of the drug.

Increased tone of the parasympathetic nervous system.

Interaction with other medicinal products and other types of interactions.

The drug should not be used simultaneously with preparations containing meclofenoxate. Enhances the effect of levodopa.

Special precautions for use.

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

The medicinal product in the dosage of 500 mg/4 ml contains less than 23 mg per vial of sodium, i.e. practically sodium-free. The medicinal product in the dosage of 1000 mg/4 ml contains 45.04 mg per vial of sodium. Caution should be exercised when administering to patients on a sodium-restricted diet.

Use during pregnancy or breastfeeding.

There are insufficient data on the use of the medicinal product Cereaxon in pregnant women. Data on the excretion of citicoline into breast milk and its effects on the fetus are lacking. Therefore, during pregnancy or breastfeeding, the drug should be prescribed only when the expected benefit to the mother outweighs the potential risk to the fetus.

Ability to affect reaction speed when driving or operating machinery.

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

Method of Administration and Dosage

The drug is intended for intravenous or intramuscular administration. For intravenous use, administer as a slow intravenous injection (over 3–5 minutes depending on the prescribed dose) or by intravenous infusion (40–60 drops per minute).

The recommended dose for adults is 500–2000 mg/day, depending on the severity of the patient's condition.

Maximum daily dose: 2000 mg.

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

The duration of treatment depends on the course of the disease and is determined by the physician.

Dosage adjustment is not required for elderly patients.

The drug is compatible with all intravenous isotonic solutions, as well as hypertonic glucose solutions.

This solution is intended for single use only. The solution should be administered immediately after opening the ampoule. Any unused solution must be discarded.

If necessary, treatment may be continued with the oral solution form of the drug.

Children.

Experience with the use of this drug in children is limited; therefore, the medicinal product should be prescribed only when the expected benefit outweighs any potential risk.

Overdose.

Cases of overdose have not been reported.

Adverse Reactions.

Very rare (< 1/10,000) (including patient reports).

Central and peripheral nervous system

Severe headache, vertigo, hallucinations.

Cardiovascular system

Arterial hypertension, arterial hypotension, tachycardia.

Respiratory system

Dyspnea.

Gastrointestinal tract

Nausea, vomiting, diarrhea.

Immune system

Allergic reactions, including: rash, hyperemia, exanthema, urticaria, purpura, pruritus, angioedema, anaphylactic shock.

General reactions

Chills, changes at the injection site.

Reporting of adverse reactions after drug registration is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

5 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Incompatibilities.

Do not use solvents not specified in the section "Administration and dosage".

Packaging.

4 ml of solution in an ampoule, 5 ampoules in a contour cellular pack, 1 contour cellular pack with the instruction for medical use in a cardboard box.

Prescription status. Prescription only.

Manufacturer.

K.T. Rompharm Company S.R.L.

Manufacturer's address and location of its business activity.

Strada Eroilor No. 1A, Otopeni, 075100, Ilfov County, Romania – Rompharm 1 and Rompharm 2 buildings.

Marketing Authorization Holder.

FORC-PHARMA DISTRIBUTION LLC.

Address of the Marketing Authorization Holder.

132, Hryshka Street, Kyiv, 03127, Ukraine.