Ceremexin® (Solution) 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 drugs; other psychostimulants and nootropic drugs
Pharmacological Action
Citicoline, being a precursor to 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 a reduction in 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
| 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 the solution parenterally or orally.
For parenteral use, administer intravenously as a slow injection or drip infusion, or intramuscularly.
The daily dose ranges from 500 mg to 2000 mg.
Determine the specific dose and route based on the indication and clinical situation.
For oral administration, the daily dose is also 500 mg to 2000 mg.
Divide the total daily dose for administration one to four times daily.
In the acute period of ischemic stroke, use a dose of 1000 mg every 12 hours.
Continue treatment for at least six weeks.
For traumatic brain injury in the acute phase, administer 1000 mg to 2000 mg per day.
Adjust the duration of therapy according to the severity of symptoms and patient response.
For chronic neurological disorders, a typical dose is 500 mg to 1000 mg daily.
Treatment courses can extend for several months as clinically required.
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, changes 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 decided, since there are no data on the excretion of citicoline in breast milk.
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 30°C (86°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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
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.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Forms
 |
Ceremexin® | 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 – up to 1 ml.
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) – cardboard boxes with corrugated insert.
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 – up to 1 ml.
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) – cardboard boxes with corrugated insert.
Oral solution 100 mg/ml: vial 30 ml, 50 ml, or 100 ml
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Form
|
Ceremexin® | Oral solution 100 mg/ml: vial 30 ml, 50 ml, or 100 ml |
Dosage Form, Packaging, and Composition
Oral solution in the form of a transparent, colorless liquid with a characteristic strawberry smell.
| 1 ml | |
| Citicoline sodium | 104.5 mg, |
| Equivalent to citicoline content | 100 mg |
Excipients : sorbitol – 200 mg, glycerol – 50 mg, methylparahydroxybenzoate – 1.45 mg, propylparahydroxybenzoate – 0.25 mg, sodium citrate dihydrate – 6 mg, sodium saccharin – 0.2 mg, natural food flavor “Strawberry” (222181) – 0.408 mg, potassium sorbate – 3 mg, citric acid (50% solution) – to pH 5.5-6.5, purified water – up to 1 ml.
30 ml – vials (1) – cardboard packs.
50 ml – vials (1) – cardboard packs.
100 ml – vials (1) – cardboard packs.
![Ceremexin® [Solution] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Ceremexin® [Solution] 2")