Mastodon

Citicoline (Tablets, Solution, Powder) Instructions for Use

ATC Code

N06BX06 (Citicoline)

Active Substance

Citicoline (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Psychoanaleptics; psychostimulants, agents used in attention deficit hyperactivity disorder, and nootropic agents; other psychostimulants and nootropic agents

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, 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 contributes to shortening 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, 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.

The urinary excretion of citicoline can be divided into two phases: 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

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 orally or parenterally (intravenously, intramuscularly).

For intravenous use, administer as a slow injection or drip infusion.

The typical daily dose ranges from 500 mg to 2000 mg.

Adjust the specific dose and duration based on the indication and clinical severity.

For the acute period of ischemic stroke, use a dose of 1000 mg every 12 hours.

Continue treatment for at least 6 weeks.

For traumatic brain injury in the acute phase, administer 1000-2000 mg daily.

For chronic neurological deficits and cognitive disorders, the standard oral dose is 500-1000 mg once or twice daily.

Divide the total daily dose if it exceeds 1000 mg.

Adhere strictly to the prescribed duration of therapy.

Adverse Reactions

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

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

From the digestive system: 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 the 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

Dosage 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

Marketing Authorization Holder

AlTro, LLC (Russia)

Manufactured By

Mosfarm LLC (Russia)

Dosage Forms

Bottle Rx Icon Citicoline Solution for intravenous and intramuscular administration 125 mg/ml: 4 ml amp. 3, 5, 10, 20, 50, or 100 pcs.
Solution for intravenous and intramuscular administration 250 mg/ml: 4 ml amp. 3, 5, 10, 20, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration in the form of a transparent, colorless liquid.

1 ml
Citicoline sodium 130.63 mg,
   Equivalent to citicoline content 125 mg

Excipients : sodium hydroxide solution 1M/hydrochloric acid solution 1M – to pH 6.5-7.5, water for injections – up to 1 ml.

4 ml – ampoules (3) – cardboard packs.
4 ml – ampoules (5) – cardboard packs.
4 ml – ampoules (10) – cardboard packs.
4 ml – ampoules (20) – cardboard packs.
4 ml – ampoules (50) – cardboard packs.
4 ml – ampoules (100) – cardboard packs.


Solution for intravenous and intramuscular administration in the form of a transparent, colorless liquid.

1 ml
Citicoline sodium 261.26 mg,
   Equivalent to citicoline content 250 mg

Excipients : sodium hydroxide solution 1M/hydrochloric acid solution 1M – to pH 6.5-7.5, water for injections – up to 1 ml.

4 ml – ampoules (3) – cardboard packs.
4 ml – ampoules (5) – cardboard packs.
4 ml – ampoules (10) – cardboard packs.
4 ml – ampoules (20) – cardboard packs.
4 ml – ampoules (50) – cardboard packs.
4 ml – ampoules (100) – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle Rx Icon Citicoline Solution for intravenous and intramuscular administration 125 mg/ml: amp. 4 ml 3, 5, 6, or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration in the form of a transparent, colorless liquid.

1 ml
Citicoline sodium 130.63 mg,
   Equivalent to citicoline content 125 mg

Excipients : hydrochloric acid 1M – to pH 6.7-7.1, water for injections – up to 1 ml.

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

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle Rx Icon Citicoline Solution for intravenous and intramuscular administration 250 mg/ml: amp. 4 ml 3, 5, 6, or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration in the form of a transparent, colorless liquid.

1 ml
Citicoline sodium 261.3 mg,
   Equivalent to citicoline content 250 mg

Excipients : hydrochloric acid 1M – to pH 6.7-7.1, water for injections – up to 1 ml.

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

Marketing Authorization Holder

Belmedpreparaty RUP (Republic of Belarus)

Dosage Forms

Bottle Rx Icon Citicoline Solution for intravenous and intramuscular administration 125 mg/ml: amp. 4 ml, 5 pcs per pack.
Solution for intravenous and intramuscular injection 250 mg/ml: amp. 4 ml, 5 pcs per pack.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration transparent, colorless or slightly yellowish.

1 ml
Citicoline 125 mg
   (in terms of Citicoline sodium) 130.6 mg

Excipients : sodium hydroxide solution 1 M, hydrochloric acid solution 1 M, water for injections.

4 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.


Solution for intravenous and intramuscular administration transparent, colorless or slightly yellowish.

1 ml
Citicoline 250 mg
   (in terms of Citicoline sodium) 261.2 mg

Excipients : sodium hydroxide solution 1 M, hydrochloric acid solution 1 M, water for injections.

4 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

Dosage Forms

Bottle Rx Icon Citicoline Solution for intravenous and intramuscular administration 125 mg/1 ml: amp. 4 ml or 8 ml 5, 10, or 20 pcs.
Solution for intravenous and intramuscular administration 250 mg/1 ml: amp. 4 ml 5, 10, or 20 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration in the form of a transparent, colorless or with a yellowish, or brownish, or yellowish-brownish tint liquid.

1 ml
Citicoline sodium 130.63 mg,
   Equivalent to citicoline content 125 mg

Excipients : sodium hydroxide solution 1M or hydrochloric acid solution 1M (for pH adjustment – to 6.0-8.0), water for injections.

4 ml – ampoules of neutral glass (10) – cardboard boxes.
4 ml – ampoules of neutral glass (5) – contour cell packaging (1) – cardboard packs.
4 ml – ampoules of neutral glass (5) – contour cell packaging (2) – cardboard packs.
4 ml – ampoules of neutral glass (10) – contour cell packaging (1) – cardboard packs.
4 ml – ampoules of neutral glass (10) – contour cell packaging (2) – cardboard packs.
8 ml – ampoules of neutral glass (10) – cardboard boxes.
8 ml – ampoules of neutral glass (5) – contour cell packaging (1) – cardboard packs.
8 ml – ampoules of neutral glass (5) – contour cell packaging (2) – cardboard packs.
8 ml – ampoules of neutral glass (10) – contour cell packaging (1) – cardboard packs.
8 ml – ampoules of neutral glass (10) – contour cell packaging (2) – cardboard packs.


Solution for intravenous and intramuscular administration in the form of a transparent, colorless or with a yellowish, or brownish, or yellowish-brownish tint liquid.

1 ml
Citicoline sodium 261.25 mg,
   Equivalent to citicoline content 250 mg

Excipients : sodium hydroxide solution 1M or hydrochloric acid solution 1M (for pH adjustment – to 6.0-8.0), water for injections.

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

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Forms

Bottle Rx Icon Citicoline Solution for intravenous and intramuscular administration 125 mg/1 ml: amp. 4 ml 5 or 10 pcs.
Solution for intravenous and intramuscular administration 250 mg/1 ml: amp. 4 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration in the form of a transparent, colorless liquid.

1 ml
Citicoline sodium 130.63 mg,
   Equivalent to citicoline content 125 mg

Excipients: sodium hydroxide solution 1M or hydrochloric acid solution 1M – to pH 6.5-7.5, water for injections – to 1 ml.

4 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
4 ml – ampoules (10) – cardboard boxes.


Solution for intravenous and intramuscular administration in the form of a transparent, colorless liquid.

1 ml
Citicoline sodium 261.25 mg,
   Equivalent to citicoline content 250 mg

Excipients: sodium hydroxide solution 1M or hydrochloric acid solution 1M – to pH 6.5-7.5, water for injections – to 1 ml.

4 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
4 ml – ampoules (10) – cardboard boxes.

Marketing Authorization Holder

Pharmpotrebsoyuz, LLC (Russia)

Manufactured By

Bryntsalov-A, JSC (Russia)

Dosage Forms

Bottle Rx Icon Citicoline Solution for intravenous and intramuscular administration 125 mg/1 ml: amp. 4 ml 5 or 10 pcs.
Solution for intravenous and intramuscular administration 250 mg/1 ml: amp. 4 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration in the form of a transparent, colorless liquid.

1 ml
Citicoline (as sodium salt) 125 mg

Excipients: hydrochloric acid solution 1M or sodium hydroxide solution 1M (for pH adjustment), water for injections.

4 ml – ampoules of neutral colorless glass (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules of neutral colorless glass (5) – contour cell packs (2) – cardboard packs.


Solution for intravenous and intramuscular administration in the form of a transparent, colorless liquid.

1 ml
Citicoline (as sodium salt) 250 mg

Excipients: hydrochloric acid solution 1M or sodium hydroxide solution 1M (for pH adjustment), water for injections.

4 ml – ampoules of neutral colorless glass (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules of neutral colorless glass (5) – contour cell packs (2) – cardboard packs.

Marketing Authorization Holder

Ecofarmplus, JSC (Russia)

Dosage Forms

Bottle Rx Icon Citicoline Solution for intravenous and intramuscular administration 125 mg/ml: amp. 4 ml 5 pcs.
Solution for intravenous and intramuscular administration 250 mg/ml: amp. 4 ml 5 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration in the form of a transparent, colorless or slightly yellowish-greenish liquid.

1 ml
Citicoline sodium 130.625 mg,
   Equivalent to citicoline content 125 mg

Excipients: sodium hydroxide solution 1M/hydrochloric acid solution 1M – to pH 6.5-7.5, water for injections – to 1 ml.

4 ml – ampoules (5) – cardboard packs.


Solution for intravenous and intramuscular administration in the form of a transparent, colorless or slightly yellowish-greenish liquid.

1 ml
Citicoline sodium 261.25 mg,
   Equivalent to citicoline content 250 mg

Excipients: sodium hydroxide solution 1M/hydrochloric acid solution 1M – to pH 6.5-7.5, water for injections – to 1 ml.

4 ml – ampoules (5) – cardboard packs.

Marketing Authorization Holder

Ellara, LLC (Russia)

Dosage Forms

Bottle Rx Icon Citicoline Solution for intravenous and intramuscular administration 125 mg/1 ml: amp. 4 ml 3, 5, 6, 10, 12, 15, 20, or 25 pcs.
Solution for intravenous and intramuscular administration 250 mg/1 ml: amp. 4 ml 3, 5, 6, 10, 12, 15, 20, or 25 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration colorless or with a brownish tint, transparent.

1 ml
Citicoline sodium 130.4 mg,
   Calculated as Citicoline 125 mg

Excipients: hydrochloric acid solution 1M or sodium hydroxide solution 1M – to pH 6.5-7.5, water for injections – to 1 ml.

4 ml – ampoules of neutral glass (3) – contour cell packs (1) – cardboard packs.
4 ml – ampoules of neutral glass (3) – contour cell packs (2) – cardboard packs.
4 ml – ampoules of neutral glass (3) – contour cell packs (4) – cardboard packs.
4 ml – ampoules of neutral glass (3) – contour cell packs (5) – cardboard packs.
4 ml – ampoules of neutral glass (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules of neutral glass (5) – contour cell packs (2) – cardboard packs.
4 ml – ampoules of neutral glass (5) – contour cell packs (4) – cardboard packs.
4 ml – ampoules of neutral glass (5) – contour cell packs (5) – cardboard packs.
4 ml – ampoules of neutral glass (3) – cardboard packs.
4 ml – ampoules of neutral glass (5) – cardboard packs.
4 ml – ampoules of neutral glass (6) – cardboard packs.
4 ml – ampoules of neutral glass (10) – cardboard packs.


Solution for intravenous and intramuscular administration colorless or with a brownish tint, transparent.

1 ml
Citicoline sodium 260.7 mg,
   Calculated as Citicoline 250 mg

Excipients: hydrochloric acid solution 1M or sodium hydroxide solution 1M – to pH 6.5-7.5, water for injections – to 1 ml.

4 ml – ampoules of neutral glass (3) – contour cell packs (1) – cardboard packs.
4 ml – ampoules of neutral glass (3) – contour cell packs (2) – cardboard packs.
4 ml – ampoules of neutral glass (3) – contour cell packs (4) – cardboard packs.
4 ml – ampoules of neutral glass (3) – contour cell packs (5) – cardboard packs.
4 ml – ampoules of neutral glass (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules of neutral glass (5) – contour cell packs (2) – cardboard packs.
4 ml – ampoules of neutral glass (5) – contour cell packs (4) – cardboard packs.
4 ml – ampoules of neutral glass (5) – contour cell packs (5) – cardboard packs.
4 ml – ampoules of neutral glass (3) – cardboard packs.
4 ml – ampoules of neutral glass (5) – cardboard packs.
4 ml – ampoules of neutral glass (6) – cardboard packs.
4 ml – ampoules of neutral glass (10) – cardboard packs.

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Avexima Siberia LLC (Russia)

Dosage Forms

Bottle Rx Icon Citicoline Avexima Solution for intravenous and intramuscular injection 125 mg/ml
Solution for intravenous and intramuscular injection 250 mg/ml

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular injection

1 ml
Citicoline sodium 130.625 mg,
   Calculated as Citicoline 125 mg

4 ml – ampoules (10 pcs.) – cardboard packs – Prescription only
4 ml – ampoules (5 pcs.) – cardboard packs – Prescription only


Solution for intravenous and intramuscular injection

1 ml
Citicoline sodium 261.25 mg,
   Calculated as Citicoline 250 mg

4 ml – ampoules (10 pcs.) – cardboard packs – Prescription only
4 ml – ampoules (5 pcs.) – cardboard packs – Prescription only

Marketing Authorization Holder

Medisorb, JSC (Russia)

Dosage Form

Bottle Rx Icon Citicoline Medisorb Oral solution 100 mg/1 ml: bottle 100 ml with dosing syringe

Dosage Form, Packaging, and Composition

Oral solution transparent, from colorless to yellowish-brownish tint, with a characteristic strawberry odor.

1 ml
Citicoline sodium 104.5 mg,
   Calculated as Citicoline 100 mg

Excipients: liquid non-crystallizing sorbitol 70% – 200 mg, glycerol (glycerin) – 50 mg, methylparaben – 1.45 mg, propylparaben – 0.25 mg, sodium citrate dihydrate – 6 mg, sodium saccharin – 0.2 mg, strawberry flavor “Strawberry DEL’AR® 10.01.555″ – 0.408 mg, potassium sorbate – 3 mg, citric acid monohydrate – to pH 5.5-6.5, purified water – to 1 ml.

100 ml – polyethylene terephthalate bottles (1) with a dosing syringe – cardboard packs.

Marketing Authorization Holder

Pharmacor Production, LLC (Russia)

Dosage Form

Bottle Rx Icon Citicoline-PHP Film-coated tablets, 500 mg: 10, 14, 20, 28, 30, 40, 42, 50, 56, 60, 70, 84, 90 or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, oval, biconvex with a score.

1 tab.
Citicoline sodium 522.52 mg
   Equivalent to citicoline content 500 mg

Excipients: microcrystalline cellulose, purified water, croscarmellose sodium, hydrogenated castor oil, colloidal silicon dioxide, magnesium stearate.
Film coating composition Opadry II85F48105 white (polyvinyl alcohol, macrogol, talc, titanium dioxide).

10 pcs. – contour cell pack (1) – cardboard packs.
10 pcs. – contour cell pack (2) – cardboard packs.
10 pcs. – contour cell pack (3) – cardboard packs.
10 pcs. – contour cell pack (4) – cardboard packs.
10 pcs. – contour cell pack (5) – cardboard packs.
10 pcs. – contour cell pack (6) – cardboard packs.
10 pcs. – contour cell pack (9) – cardboard packs.
14 pcs. – contour cell pack (1) – cardboard packs.
14 pcs. – contour cell pack (2) – cardboard packs.
14 pcs. – contour cell pack (3) – cardboard packs.
14 pcs. – contour cell pack (4) – cardboard packs.
14 pcs. – contour cell pack (5) – cardboard packs.
14 pcs. – contour cell pack (6) – cardboard packs.
20 pcs. – contour cell pack (1) – cardboard packs.
20 pcs. – contour cell pack (2) – cardboard packs.
20 pcs. – contour cell pack (3) – cardboard packs.
20 pcs. – contour cell pack (5) – cardboard packs.

Marketing Authorization Holder

Pharmacor Production, LLC (Russia)

Dosage Forms

Bottle Rx Icon Citicoline-PHP Powder for oral solution, orange flavored 500 mg: 10, 20, or 30 pcs.
Powder for oral solution, honey and lemon flavored 500 mg: 10, 20, or 30 pcs.
Powder for oral solution, orange flavored 1000 mg: 10, 20, or 30 pcs.
Powder for oral solution, honey and lemon flavored 1000 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Powder for oral solution (orange flavored) white or almost white with an orange aroma; the presence of white inclusions is allowed; upon dissolution, a transparent or opalescent solution with an orange aroma is formed; the presence of undissolved particles and flakes is allowed.

1 sachet
Citicoline sodium 522.5 mg
   Equivalent to citicoline content 500 mg

Excipients: sorbitol, purified water, orange flavor, anhydrous colloidal silicon dioxide.

4 g – heat-sealed sachets of combined material (10) – cardboard packs.
4 g – heat-sealed sachets of combined material (20) – cardboard packs.
4 g – heat-sealed sachets of combined material (30) – cardboard packs.


Powder for oral solution (honey and lemon flavored) white or almost white with a honey and lemon aroma; the presence of white inclusions is allowed; upon dissolution, a transparent or opalescent solution with a honey and lemon aroma is formed; the presence of undissolved particles and flakes is allowed.

1 sachet
Citicoline sodium 522.5 mg
   Equivalent to citicoline content 500 mg

Excipients: sorbitol, purified water, honey flavor, lemon flavor, anhydrous colloidal silicon dioxide.

4 g – heat-sealed sachets of combined material (10) – cardboard packs.
4 g – heat-sealed sachets of combined material (20) – cardboard packs.
4 g – heat-sealed sachets of combined material (30) – cardboard packs.


Powder for oral solution (orange flavored) white or almost white with an orange aroma; the presence of white inclusions is allowed; upon dissolution, a transparent or opalescent solution with an orange aroma is formed; the presence of undissolved particles and flakes is allowed.

1 sachet
Citicoline sodium 1045.5 mg
   Equivalent to citicoline content 1000 mg

Excipients: sorbitol, purified water, orange flavor, anhydrous colloidal silicon dioxide.

4 g – heat-sealed sachets of combined material (10) – cardboard packs.
4 g – heat-sealed sachets of combined material (20) – cardboard packs.
4 g – heat-sealed sachets of combined material (30) – cardboard packs.


Powder for oral solution (honey and lemon flavored) white or almost white with a honey and lemon aroma; the presence of white inclusions is allowed; upon dissolution, a transparent or opalescent solution with a honey and lemon aroma is formed; the presence of undissolved particles and flakes is allowed.

1 sachet
Citicoline sodium 1045.5 mg
   Equivalent to citicoline content 1000 mg

Excipients: sorbitol, purified water, honey flavor, lemon flavor, colloidal anhydrous silicon dioxide.

4 g – thermosealable sachets made of combined material (10) – cardboard packs.
4 g – thermosealable sachets made of combined material (20) – cardboard packs.
4 g – thermosealable sachets made of combined material (30) – cardboard packs.

Marketing Authorization Holder

Trivium-XXI, LLC (Russia)

Manufactured By

Armavir Biopharmaceutical Plant, FSE (Russia)

Dosage Forms

Bottle Rx Icon Citicoline Trivium® Solution for intravenous and intramuscular injection 125 mg/ml
Solution for intravenous and intramuscular injection 250 mg/ml

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular injection

1 ml
Citicoline sodium 130.625 mg,
   In terms of Citicoline 125 mg

4 ml – ampoules (10 pcs.) – cardboard packs – Prescription only
4 ml – ampoules (100 pcs.) – cardboard boxes – Prescription only
4 ml – ampoules (100 pcs.) – cardboard packs – Prescription only
4 ml – ampoules (125 pcs.) – cardboard boxes – Prescription only
4 ml – ampoules (125 pcs.) – cardboard packs – Prescription only
4 ml – ampoules (200 pcs.) – cardboard boxes – Prescription only
4 ml – ampoules (200 pcs.) – cardboard packs – Prescription only
4 ml – ampoules (250 pcs.) – cardboard boxes – Prescription only
4 ml – ampoules (250 pcs.) – cardboard packs – Prescription only
4 ml – ampoules (5 pcs.) – cardboard packs – Prescription only
4 ml – ampoules (50 pcs.) – cardboard boxes – Prescription only
4 ml – ampoules (50 pcs.) – cardboard packs – Prescription only
4 ml – ampoules (500 pcs.) – cardboard boxes – Prescription only
4 ml – ampoules (500 pcs.) – cardboard packs – Prescription only


Solution for intravenous and intramuscular injection

1 ml
Citicoline sodium 261.25 mg
   Equivalent to citicoline content 250 mg

4 ml – ampoules (10 pcs.) – cardboard packs – Prescription only
4 ml – ampoules (100 pcs.) – cardboard boxes – Prescription only
4 ml – ampoules (100 pcs.) – cardboard packs – Prescription only
4 ml – ampoules (125 pcs.) – cardboard boxes – Prescription only
4 ml – ampoules (125 pcs.) – cardboard packs – Prescription only
4 ml – ampoules (200 pcs.) – cardboard boxes – Prescription only
4 ml – ampoules (200 pcs.) – cardboard packs – Prescription only
4 ml – ampoules (250 pcs.) – cardboard boxes – Prescription only
4 ml – ampoules (250 pcs.) – cardboard packs – Prescription only
4 ml – ampoules (5 pcs.) – cardboard packs – Prescription only
4 ml – ampoules (50 pcs.) – cardboard boxes – Prescription only
4 ml – ampoules (50 pcs.) – cardboard packs – Prescription only
4 ml – ampoules (500 pcs.) – cardboard boxes – Prescription only
4 ml – ampoules (500 pcs.) – cardboard packs – Prescription only

Marketing Authorization Holder

Velpharm, LLC (Russia)

Dosage Forms

Bottle Rx Icon Citicoline Velpharm Solution for intravenous and intramuscular injection 125 mg/ml: 4 ml amp., 3, 5, 6 or 10 pcs.
Solution for intravenous and intramuscular injection 250 mg/ml: 4 ml amp., 3, 5, 6 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for IV and IM administration as a clear, colorless liquid.

1 ml
Citicoline sodium 130.63 mg,
   Equivalent to citicoline content 125 mg

Excipients: 1M hydrochloric acid solution or 1M sodium hydroxide solution, water for injections.

4 ml – ampoules (3) – contour cell packs (1) – cardboard packs.
4 ml – ampoules (3) – contour cell packs (2) – cardboard packs.
4 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
4 ml – ampoules – contour cell packs (20) – cardboard boxes (for hospitals).
4 ml – ampoules – contour cell packs (48) – cardboard boxes (for hospitals).
4 ml – ampoules – contour cell packs (50) – cardboard boxes (for hospitals).
4 ml – ampoules – contour cell packs (96) – cardboard boxes (for hospitals).
4 ml – ampoules – contour cell packs (100) – cardboard boxes (for hospitals).


Solution for IV and IM administration as a clear, colorless liquid.

1 ml
Citicoline sodium 261.25 mg,
   Equivalent to citicoline content 250 mg

Excipients: 1M hydrochloric acid solution or 1M sodium hydroxide solution, water for injections.

4 ml – ampoules (3) – contour cell packs (1) – cardboard packs.
4 ml – ampoules (3) – contour cell packs (2) – cardboard packs.
4 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
4 ml – ampoules – contour cell packs (20) – cardboard boxes (for hospitals).
4 ml – ampoules – contour cell packs (48) – cardboard boxes (for hospitals).
4 ml – ampoules – contour cell packs (50) – cardboard boxes (for hospitals).
4 ml – ampoules – contour cell packs (96) – cardboard boxes (for hospitals).
4 ml – ampoules – contour cell packs (100) – cardboard boxes (for hospitals).

Marketing Authorization Holder

Binnopharm JSC (Russia)

Dosage Forms

Bottle Rx Icon Citicoline-Alium Solution for intravenous and intramuscular injection 500 mg/4 ml: amp., 3, 5, 6 or 10 pcs.
Solution for intravenous and intramuscular injection 1000 mg/4 ml: amp., 3, 5, 6 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for IV and IM administration as a clear, colorless liquid.

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

Excipients: 1M hydrochloric acid solution or 1M sodium hydroxide solution – to pH 6.5-7.5, water for injections – to 4 ml.

4 ml – ampoules made of neutral colorless glass (3) – contour cell packs (1) – cardboard packs.
4 ml – ampoules made of neutral colorless glass (3) – contour cell packs (2) – cardboard packs.
4 ml – ampoules made of neutral colorless glass (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules made of neutral colorless glass (5) – contour cell packs (2) – cardboard packs.


Solution for IV and IM administration as a clear, colorless liquid.

1 amp.
Citicoline sodium 1045 mg,
   Equivalent to citicoline content 1000 mg

Excipients: 1M hydrochloric acid solution or 1M sodium hydroxide solution – to pH 6.5-7.5, water for injections – to 4 ml.

4 ml – ampoules made of neutral colorless glass (3) – contour cell packs (1) – cardboard packs.
4 ml – ampoules made of neutral colorless glass (3) – contour cell packs (2) – cardboard packs.
4 ml – ampoules made of neutral colorless glass (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules made of neutral colorless glass (5) – contour cell packs (2) – cardboard packs.

Marketing Authorization Holder

Mir Chemical and Pharmaceutical Concern, LLC (Russia)

Manufactured By

NPC Eskom, PJSC (Russia)

Dosage Forms

Bottle Rx Icon Citicoline-Escom Solution for intravenous and intramuscular injection 125 mg/1 ml: amp. 4 ml, 3, 5, 10 or 20 pcs.
Solution for intravenous and intramuscular injection 250 mg/1 ml: amp. 4 ml, 3, 5, 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Solution for IV and IM administration as a colorless, clear liquid.

1 ml
Citicoline sodium 130.63 mg,
   In terms of Citicoline 125 mg

Excipients: 1M hydrochloric acid solution or 1M sodium hydroxide solution – to pH 6.5-7.5, water for injections – to 1 ml.

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


Solution for IV and IM administration as a colorless, clear liquid.

1 ml
Citicoline sodium 261.26 mg,
   In terms of Citicoline 250 mg

Excipients: 1M hydrochloric acid solution or 1M sodium hydroxide solution – to pH 6.5-7.5, water for injections – to 1 ml.

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

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Bottle Rx Icon Citicoline-Vertex Oral solution 100 mg/ml: 30 ml or 100 ml fl. 1, 3 or 6 pcs.

Dosage Form, Packaging, and Composition

Oral solution as a clear or slightly opalescent colorless or light yellow liquid with a characteristic strawberry odor.

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

Excipients: sorbitol – 200 mg, glycerol – 50 mg, sodium citrate (sodium citrate dihydrate) – 6 mg, potassium sorbate – 3 mg, methylparaben – 1.45 mg, strawberry flavor 1487S – 0.4 mg, propylparaben – 0.25 mg, sodium saccharin – 0.2 mg, citric acid monohydrate – to pH 5 – 7, purified water – to 1 ml.

30 ml – bottles (1) – cardboard packs.
30 ml – bottles (3) – cardboard packs.
30 ml – bottles (6) – cardboard packs.
100 ml – bottles (1) – cardboard packs.
100 ml – bottles (3) – cardboard packs.
100 ml – bottles (6) – cardboard packs.

Table of Contents

TABLE OF CONTENTS