Ronocyt

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

Composition:

Active substance: citicoline;

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

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

Pharmaceutical form. Solution for injection.

Basic physico-chemical properties: clear, colorless or slightly yellowish solution.

Pharmacotherapeutic group

Drugs acting on 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 function of membrane mechanisms such as ion pumps and receptors, the regulation of which is essential for normal nerve impulse transmission. Due to its stabilizing effect on neuronal membranes, citicoline exhibits anti-edematous properties that promote reabsorption of cerebral 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 improving cholinergic transmission.

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

Clinical trials have shown that citicoline significantly increases functional recovery rates in patients with acute cerebrovascular disorders, which correlates with a slowing of the growth of ischemic brain lesions 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, and helps reduce symptoms of amnesia, cognitive deficits, and other neurological disorders associated with cerebral ischemia.

Pharmacokinetics

Citicoline is well absorbed after oral, intramuscular, or intravenous administration. As a result, plasma choline levels increase significantly. Absorption after oral administration is nearly complete, and its bioavailability is approximately equivalent to that following intravenous administration.

Citicoline is metabolized in the intestinal wall and liver, forming choline and cytidine. Citicoline is extensively distributed into brain structures, with rapid incorporation of choline fractions into structural phospholipids and cytidine fractions into cytidine nucleotides and nucleic acids. Citicoline penetrates the brain and is actively incorporated into cellular, cytoplasmic, and mitochondrial membranes, becoming part of the structural phospholipid fraction.

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. Two phases can be identified in the urinary excretion of citicoline: the first phase lasts about 36 hours, during which the excretion rate rapidly decreases, and the second phase, during which the excretion rate declines much more slowly. A similar pattern is observed in exhaled CO₂—the excretion rate rapidly decreases within 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 disturbances due to chronic vascular and degenerative cerebral disorders.

Contraindications

• Hypersensitivity to the active substance and/or to any of the excipients of the medicinal product.
• Increased parasympathetic nervous system tone.

Interaction with other medicinal products and other forms of interactions

Citicoline enhances the effect of levodopa.

Citicoline should not be used concomitantly with meclofenoxate and centrophenoxine.

Special precautions for use

In the 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.

When administered intravenously, the medicinal product should be given slowly (over 3–5 minutes, depending on the dose administered).

The medicinal product in the dosage of 500 mg/4 ml contains less than 23 mg per ampoule of sodium, i.e., it is practically sodium-free.

The medicinal product in the dosage of 1000 mg/4 ml contains 45.04 mg of sodium per ampoule. 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 citicoline in pregnant women. Data regarding the excretion of citicoline in breast milk and its effects on the fetus are lacking.

During pregnancy or breastfeeding, the medicinal product should be used only if the expected benefit to the woman outweighs the potential risk to the fetus/child.

Ability to affect reaction speed when driving vehicles or operating machinery

In individual cases, some adverse reactions of citicoline on the central nervous system may affect the ability to drive vehicles or operate machinery.

Method of Administration and Dosage

The medicinal product 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 citicoline 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 in elderly patients.

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

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

If necessary, treatment may be continued with the medicinal product Ronocyt in the form of an oral solution. The contents of the ampoule may be taken directly or dissolved in half a glass of water (120 ml).

Children

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

Overdose

Cases of overdose have not been reported.

In case of overdose, symptomatic therapy should be administered.

Adverse Reactions

Adverse reactions occur very rarely (<1/10,000) (including patient reports).

Central nervous system:

severe headache, vertigo, hallucinations.

Cardiovascular system:

arterial hypertension, arterial hypotension, tachycardia.

Respiratory system, thoracic organs and mediastinum:

dyspnea.

Gastrointestinal tract:

nausea, vomiting, diarrhea.

Immune system:

hypersensitivity reactions, including: rash, hyperemia, exanthema, urticaria, purpura, pruritus, angioneurotic edema, anaphylactic shock.

General disorders and administration site conditions:

chills, swelling.

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after registration of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via 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 in the original packaging and in a place inaccessible to children.

Incompatibilities

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

Packaging

4 ml in an ampoule; 5 ampoules in a contour cellular pack; 1 contour cellular pack in a cardboard box.

Prescription status

Prescription only.

Manufacturer

PharmaVision San. ve Tic. A.S. /
PharmaVision San. ve Tic. A.S.

Manufacturer's address and place of business

Davutpasa Cad. No:145 Zeytinburnu Istanbul, Turkey /
Davutpasa Cad. No:145 Zeytinburnu Istanbul, Turkey.