Ronocit^® (Solution) Instructions for Use

ATC Code

N06BX06 (Citicoline)

Active Substance

Citicoline (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

Citicoline, being a precursor of key ultrastructural components of the cell membrane (mainly phospholipids), has a broad spectrum of action: it promotes the restoration of damaged cell membranes, inhibits the action of phospholipases, prevents the excessive formation of free radicals, and also prevents cell death by acting on apoptosis mechanisms.

In the acute period of stroke, Citicoline reduces the volume of brain tissue damage and improves cholinergic transmission.

In traumatic brain injury, it reduces the duration of post-traumatic coma and the severity of neurological symptoms, and also contributes to a reduction in the duration of the recovery period.

In chronic cerebral hypoxia, Citicoline is effective in the treatment of cognitive disorders, such as memory impairment, lack of initiative, and difficulties in performing daily activities and self-care.

It increases the level of attention and consciousness, and also reduces the manifestation of amnesia.

Citicoline is effective in the treatment of sensory and motor neurological disorders of degenerative and vascular etiology.

Pharmacokinetics

Absorption

Citicoline is well absorbed after oral administration. Absorption after oral administration is almost complete, and bioavailability is approximately the same as after intravenous administration.

Distribution

Citicoline is largely distributed in the structures of the brain, 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, forming part of the structural phospholipid fraction.

Metabolism

The drug is metabolized in the intestine and liver to form choline and cytidine. After administration, the plasma concentration of choline increases significantly.

Excretion

Only 15% of the administered dose of citicoline is excreted from the human body: less than 3% by the kidneys and through the intestines, and about 12% in exhaled carbon dioxide.

Two phases can be distinguished in the urinary excretion of citicoline: the first phase, lasting about 36 hours, during which the excretion rate decreases rapidly, and the second phase, during which the excretion rate decreases much more slowly.

The same is observed in exhaled carbon dioxide – the excretion rate decreases rapidly after about 15 hours, and then decreases much more slowly.

Indications

• Acute period of ischemic stroke (as part of complex therapy);
• Recovery period after ischemic and hemorrhagic strokes;
• Traumatic brain injury (TBI), acute (as part of complex therapy) and recovery period;
• Cognitive and behavioral disorders in degenerative and vascular brain diseases.

ICD codes

Dosage Regimen

Solution

Ronocit^® oral solution is prescribed orally.

Before use, the drug can be diluted in a small amount of water (120 ml or 1/2 glass). The drug is taken with meals or between meals.

Acute period of ischemic stroke and TBI 1000 mg (10 ml) every 12 hours. The duration of treatment is at least 6 weeks.

Recovery period after ischemic and hemorrhagic strokes, recovery period of TBI, cognitive and behavioral disorders in degenerative and vascular brain diseases 500-2000 mg per day (5-10 ml 1-2 times/day). The dosage and duration of treatment depend on the severity of the disease symptoms.

When prescribing the drug to elderly patients, no dose adjustment is required.

Adverse Reactions

Adverse reactions (ARs) are grouped by system and organ in accordance with the MedDRA dictionary and the WHO classification of AR frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), frequency not known (frequency cannot be estimated from the available data).

Psychiatric disorders very rare – hallucinations, insomnia, agitation.

Nervous system disorders very rare – headache, dizziness, parasympathetic system reactions, tremor, numbness in paralyzed limbs.

Vascular disorders very rare – arterial hypotension, arterial hypertension.

Respiratory, thoracic and mediastinal disorders very rare – dyspnea.

Gastrointestinal disorders very rare – decreased appetite, nausea, vomiting, diarrhea.

Skin and subcutaneous tissue disorders very rare – hyperemia, purpura, anaphylactic shock, urticaria, rash, skin itching.

Hepatobiliary disorders very rare – change in liver enzyme activity.

General disorders and administration site conditions very rare – chills, feeling of heat, edema.

Contraindications

• Hypersensitivity to any of the components of the drug;
• Patients with pronounced vagotonia (predominance of the tone of the parasympathetic part of the autonomic nervous system);
• Age under 18 years (due to the lack of sufficient clinical data);
• Rare hereditary diseases associated with fructose intolerance.

Use in Pregnancy and Lactation

Sufficient data on the use of citicoline in pregnant women are not available. Although no negative effects have been identified in animal studies, Ronocit^® is prescribed during pregnancy only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

When prescribing the drug during lactation, women should stop breastfeeding, as there are no data on the excretion of citicoline in breast milk.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Geriatric Use

No dose adjustment is required for elderly patients.

Special Precautions

When cold, a small amount of crystals may form due to temporary partial crystallization of the preservative. Upon further storage under recommended conditions, the crystals dissolve within a few months. The presence of crystals does not affect the quality of the drug.

Effect on ability to drive vehicles and operate machinery

During treatment with the drug, caution should be exercised when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions (including driving vehicles and operating machinery, work as a dispatcher and operator).

Overdose

Given the low toxicity of the drug, cases of overdose have not been described, even in cases of exceeding therapeutic doses.

Drug Interactions

Citicoline enhances the effects of levodopa.

It should not be used simultaneously with medicines containing meclofenoxate.

Storage Conditions

The drug should be stored out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 5 years. Do not use after the expiration date stated on the packaging.

Dispensing Status

The drug is dispensed by prescription.

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.