ЦERAKSON

Active material: Citicoline
When ATH: N06BX06
CCF: Nootropics
ICD-10 codes (testimony): F07, I61, I63, S06, T90
When CSF: 02.14.01
Manufacturer: FERRER INTERNACIONAL S.A. (Spain)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Oral solution – transparent liquid pink, with a characteristic smell of strawberry.

Excipients: sorbitol, glycerol, metilparagidroksiʙenzoat, propilparagidroksibenzoat, glycerol formaly, sodium citrate dihydrate, sodium saccharin, carmine dye (Ponceau 4-R), strawberry flavor (1487-S-Lucta эссенция клубничная), potassium sorbate, lemon acid 50% solution, Purified water.

30 ml – bottles (1) complete with a syringe dosing – packs cardboard.

Solution for in / and the / m clear, colorless.

Excipients: hydrochloric acid 1 M sodium hydroxide or 1 M (to pH 6.7-7.1), water d / and.

4 ml – ampoule (5) – packings Valium planimetric (1) – packs cardboard.

Solution for in / and the / m clear, colorless.

Excipients: hydrochloric acid 1 M sodium hydroxide or 1 M (to pH 6.7-7.1), water d / and.

4 ml – ampoule (5) – packings Valium planimetric (1) – packs cardboard.

Pharmacological action

Nootropics.

Citicoline, As a precursor of the key components of the cell membrane ultrastructural (primarily phospholipids), It has a broad spectrum of activity: It helps to restore damaged cell membranes, It inhibits the action of phospholipases, preventing excessive formation of free radicals, and also prevents cell death, acting on the mechanisms of apoptosis.

In the acute phase of stroke reduces the amount of damaged tissue, improving cholinergic transmission.

With traumatic brain injury reduces the duration of post-traumatic coma and severity of neurological symptoms.

Citicoline improves the symptoms observed during hypoxia: memory impairment, emotional lability, bezыniciativnostь, difficulty in carrying out daily activities and self-care.

Цerakson^® effective in treating cognitive, sensory and motor neurological degenerative disorders and vascular aetiology.

Pharmacokinetics

Because citicoline is a natural compound, which is contained in the body, classic pharmacokinetic study can not be performed due to the complexity of quantifying the exogenous and endogenous citicoline.

In a pharmacokinetic study in healthy volunteers with the appointment into tagging¹⁴-citicoline was observed almost complete its absorption. During 5 days after the appointment of the dose excreted in the faeces <1% the prescribed dose.

Testimony

- Ischemic stroke (acute phase);

- Ischemic and hemorrhagic stroke (recovery period);

- Traumatic brain injury (acute and recovery period);

- Cognitive disorders in degenerative and vascular diseases of the brain.

Dosage regimen

Oral solution is applied at a dose 200-300 mg (2-3 ml) 3 times / day using a metering syringe.

Solution for in / and the / m. B / administered as a slow I / injection (during 5 m) or / drip (40-60 drop / min.). At stroke and traumatic brain injury in the acute period – by 1000-2000 mg / day depending on the severity of the disease within 3-7 days, with subsequent transition to the / m introduction or ingestion.

/ M: 1-2 injection / day. When i / m administration to avoid the re-introduction of the drug at the same place.

Ingestion and / in the introduction of the drug is preferred, than i / m administration.

Side effect

From the central and peripheral nervous system: insomnia, headache, dizziness, excitation, tremor, numbness in limbs paralyzed.

From the digestive system: nausea, decreased appetite, changes in liver enzymes.

Allergic reactions: rash, itchy skin, anaphylactic shock.

Other: fever; in some cases – transient hypotensive effect, stimulation of the parasympathetic nervous system.

Contraindications

- Vagotonia (the predominance of parasympathetic part of the autonomic nervous system);

- Childhood and adolescence up 18 years (due to lack of data);

- Hypersensitivity to the drug.

Pregnancy and lactation

Controlled trials of Tseraksona^® during pregnancy was conducted. Although the evidence of risk to the fetus when using the drug has not been received, prescribed drug during pregnancy only, the expected benefit outweighs the potential risk.

If necessary, use during lactation should decide the issue of termination of breastfeeding, since the data on the allocation of citicoline with a woman's milk is not available.

Cautions

Effects on ability to drive vehicles and management mechanisms

Citicoline has no effect on the ability to drive vehicles and use mechanisms.

Overdose

Due to the low toxicity of the drug overdose cases have been observed, even in the case of exceeding the therapeutic dose.

Drug Interactions

Citicoline enhances the effects of L-dihydroxyphenylalanine.

It should appoint Tserakson^® simultaneously with drugs, containing meclofenoxate.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children at or above 30 ° C. Shelf life – 3 year.