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 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 yellow solution.

Pharmacotherapeutic group.

Agents acting on the nervous system. Psych analeptics. Psychostimulants, agents used in attention deficit hyperactivity disorder (ADHD) and nootropic agents. Other psychostimulant and nootropic agents. Citicoline. 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, without which normal conduction of nerve impulses is impossible. Due to its membrane-stabilizing effect, 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, inhibits apoptosis, and stimulates acetylcholine synthesis.

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

Clinical trials have shown that citicoline significantly improves functional recovery rates in patients with acute cerebrovascular disorders, which correlates with a slowed progression of cerebral ischemic lesions as demonstrated 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, helps reduce manifestations of amnesia, and alleviates cognitive and 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 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 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 administered dose is found 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—approximately 36 hours—during which the excretion rate rapidly decreases, and a second phase, during which the excretion rate declines much more slowly. A similar biphasic pattern is observed in excretion via CO₂, with the rate of exhaled CO₂ excretion rapidly decreasing after approximately 15 hours, followed by a much slower decline.

Clinical characteristics.

Indications.

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

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

Citicoline should not be used concomitantly with agents containing meclofenoxate. Citicoline enhances the effect of levodopa.

Special precautions for use.

In the case 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.

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

Use during pregnancy or breastfeeding.

Adequate data on the use of citicoline in pregnant women are lacking. Data on the passage of citicoline into breast milk are not available.

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 or infant.

Ability to influence the speed of reactions when driving vehicles or operating machinery.

In individual cases, certain adverse reactions affecting the central nervous system may impair 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.

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

Dose 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.

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.

Adverse reactions.

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

From the nervous system:

severe headache, vertigo, hallucinations.

From the cardiovascular system:

arterial hypertension, arterial hypotension, tachycardia.

From the respiratory system, thoracic organs and mediastinum:

dyspnea.

From the gastrointestinal tract:

nausea, vomiting, diarrhea.

From the immune system:

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

General disorders and administration site reactions:

chills, swelling, changes at the injection site.

Reporting suspected adverse reactions.

Reporting suspected adverse reactions after drug registration is very important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions through the national pharmacovigilance system.

Shelf life.

5 years.

Storage conditions.

Store at a temperature not exceeding 25 ºC, in a place inaccessible to children.

Incompatibility.

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

Packaging.

4 ml of solution in a glass ampoule; 5 ampoules in a blist er pack; 1 blister pack in a cardboard box.

Prescription status.

Prescription only.

Manufacturer.

K.O. Rompharm Company S.R.L., Romania /
S.C. Rompharm Company S.R.L., Romania.

Manufacturer's address and location of operations.

Otopeni city, Eroilor str. № 1A, 075100, jud. Ilfov /
Otopeni city, Eroilor str. № 1A, 075100, jud. Ilfov.

Marketing Authorization Holder.

WORLD MEDICINE, LLC, Ukraine /
WORLD MEDICINE, LLC, Ukraine.