Ceresil^® Canon (Solution) Instructions for Use

Instructions
Dosage forms

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

In the acute period of stroke, it reduces the volume of damaged tissue and improves cholinergic transmission.

In traumatic brain injury, it reduces the duration of post-traumatic coma and the severity of neurological symptoms, and also helps to shorten the duration of the recovery period.

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

In chronic cerebral ischemia, Citicoline is effective in treating 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.

Pharmacokinetics

After parenteral administration, the plasma concentration of choline increases significantly. 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.

When administered intravenously and intramuscularly, Citicoline is metabolized in the liver to form choline and cytidine. 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 air. 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 air – the excretion rate decreases rapidly after approximately 15 hours and then decreases much more slowly.

Indications

Acute period of ischemic stroke (as part of complex therapy); recovery period of ischemic and hemorrhagic strokes; traumatic brain injury, acute (as part of complex therapy) and recovery period; cognitive and behavioral disorders in degenerative and vascular brain diseases.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
F07	Personality and behavioral disorders due to disease, damage or dysfunction of the brain
I63	Cerebral infarction
I69	Sequelae of cerebrovascular diseases
S06	Intracranial injury
T90	Sequelae of injuries of head

ICD-11 code	Indication
6E68	Secondary emotionally labile personality disorder
6E6Z	Unspecified secondary mental or behavioral syndromes
8B11	Cerebral ischemic stroke
8B25.Z	Sequelae of cerebrovascular disease, unspecified
NA07.Z	Intracranial injury, unspecified
NA0Z	Head injury, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer parenterally via slow intravenous injection, intravenous drip infusion, or intramuscularly.

For the acute period of ischemic stroke, use 1000 mg every 12 hours or 2000 mg once daily.

In traumatic brain injury, administer 500 mg to 2000 mg daily based on injury severity and clinical response.

For cognitive and behavioral disorders of vascular or degenerative origin, the typical dose is 500 mg to 1000 mg daily.

Adjust the total daily dose between 500 mg and 2000 mg according to the specific indication and patient status.

Initiate treatment as early as possible; the duration of therapy depends on the clinical condition and rate of recovery.

For oral administration, the daily dose is also 500 mg to 2000 mg.

Divide the total daily oral dose for administration once or twice daily.

Determine the frequency of administration and treatment course length based on the diagnosed condition and therapeutic goals.

Adverse Reactions

Allergic reactions: very rarely – rash, skin itching, anaphylactic shock.

Nervous system disorders: very rarely – headache, dizziness, insomnia, agitation, hallucinations. In some cases, the drug may stimulate the parasympathetic system and also briefly change blood pressure.

Digestive system disorders: very rarely – nausea, vomiting, diarrhea, decreased appetite, change in liver enzyme activity.

General reactions: very rarely – feeling of heat, tremor, shortness of breath, numbness in paralyzed limbs, edema.

Contraindications

Hypersensitivity to citicoline; vagotonia (predominance of tone of the parasympathetic part of the autonomic nervous system); children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

During pregnancy, use is possible only if the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

If it is necessary to use citicoline during lactation, the issue of discontinuing breastfeeding should be considered, since data on the excretion of citicoline in breast milk are not available.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

Dose adjustment is not required.

Special Precautions

Citicoline should not be used simultaneously with medicines containing meclofenoxate.

Drug Interactions

Citicoline enhances the effects of levodopa.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Ceresil^® Canon [Canonpharma Production, CJS (Russia)]
Oral solution 100 mg/1 ml: sachet 10 ml 3, 6, 10 or 30 pcs.; bottle 30 ml with dosing syringe

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Manufactured By

Canonpharma Production, CJS (Russia)

AVZ S-P. LLC (Russia)

Dosage Form

Ceresil^® Canon

Oral solution 100 mg/1 ml: sachet 10 ml 3, 6, 10 or 30 pcs.; bottle 30 ml with dosing syringe

Dosage Form, Packaging, and Composition

Oral solution as a clear, colorless liquid with a banana odor.

	1 ml
Citicoline sodium	104.5 mg,
Equivalent to citicoline content	100 mg

Excipients : banana flavor (essence “Banana”) – 0.4 mg, glycerol – 50 mg, potassium sorbate – 3 mg, methylparahydroxybenzoate – 1.45 mg, sodium saccharin – 0.2 mg, sodium citrate – 6 mg, propylparahydroxybenzoate – 0.25 mg, sorbitol – 200 mg, citric acid solution 50% – to pH 5.9-6.1, purified water – to 1 ml.

10 ml – multilayer sachets (3) – cardboard packs.
10 ml – multilayer sachets (6) – cardboard packs.
10 ml – multilayer sachets (10) – cardboard packs.
10 ml – multilayer sachets (30) – cardboard packs.
30 ml – colorless glass bottles (1) with a dosing syringe – cardboard packs.

Ceresil^® Canon [Canonpharma Production, CJS (Russia)]
Solution for intravenous and intramuscular administration 125 mg/ml: amp. 4 ml 3, 5, or 10 pcs.
Solution for intravenous and intramuscular administration 250 mg/ml: amp. 4 ml 3, 5 or 10 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Manufactured By

RKNPC MZ RF – EPMBP FSBI (Russia)

Armavir Biopharmaceutical Plant, FSE (Russia)

Dosage Forms

	Ceresil^® Canon	Solution for intravenous and intramuscular administration 125 mg/ml: amp. 4 ml 3, 5, or 10 pcs.
		Solution for intravenous and intramuscular administration 250 mg/ml: amp. 4 ml 3, 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for IV and IM administration clear, colorless.

	1 amp.
Citicoline sodium	522.5 mg,
Equivalent to citicoline content	500 mg

Excipients : sodium hydroxide solution 1M or hydrochloric acid solution 1M – to pH 6.5-7.1, water for injections – to 4 ml.

4 ml – glass ampoules (3) – contour cell packaging (1) – cardboard packs.
4 ml – glass ampoules (5) – contour cell packaging (1) – cardboard packs.
4 ml – glass ampoules (5) – contour cell packaging (2) – cardboard packs.
4 ml – glass ampoules (10) – contour cell packaging (1) – cardboard packs.

Solution for IV and IM administration clear, from colorless to greenish-yellowish.