CERAXON FOR INJECTIONS

Ceraxon for injection - official instructions for use


BUY CERAXON FOR INJECTIONS


Registration number:


JICP-002287/07

Trade name of the preparation: Ceraxon®

International Nonproprietary Name (INN): citicoline

Dosage form:

Solution for intravenous and intramuscular injection

Composition


Solution for intravenous and intramuscular injection of 500 mg in 4 ml:

Active substance: citicoline sodium 522.5 mg (equivalent to 500 mg of citicoline).

Auxiliary substances: hydrochloric acid 1 M or sodium hydroxide 1 M to pH 6.7 - 7.1; Water for injection up to 4 ml.


Solution for intravenous and intramuscular administration of 1000 mg in 4 ml:

Active substance: citicoline sodium 1045 mg (equivalent to 1000 mg of citicoline). Auxiliary substances: hydrochloric acid 1 M or sodium hydroxide 1 M to pH 6.7 - 7.1; Water for injection up to 4 ml.


Description


Transparent colorless liquid.


Pharmacotherapeutic group:

Nootropic remedy

ATX Code: N06BX06

Pharmacological properties


Pharmacodynamics


Citicoline, being the predecessor of the key ultrastructural components of the cell membrane (mainly phospholipids), has a wide spectrum of action - it helps to repair damaged cell membranes, inhibits the effect of phospholipases, prevents excessive formation of free radicals, and also prevents cell death by affecting the mechanisms of apoptosis. In an acute period of stroke citicolitin reduces the amount of damage to the brain tissue improves cholinergic transmission. With craniocerebral trauma reduces the duration of post-traumatic coma and the severity of neurologic symptoms, besides, it helps to reduce the duration of the recovery period.


In chronic brain hypoxia, citicoline is effective in the treatment of cognitive disorders such as memory impairment, lack of initiative, difficulties arising from daily activities and self-care. 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


Suction

Citicoline is well absorbed by intravenous and intramuscular injection.


Metabolism

With intravenous and intramuscular injection, citicoline is metabolized in the liver with the formation of choline and cytidine. After administration, the concentration of choline in the blood plasma is significantly increased.


Distribution

Citicoline is largely distributed in the structures of the brain, with the rapid introduction of choline fractions into structural phospholipids and cytidine fractions into cytidine nucleotides and nucleic acids. Citicoline penetrates the brain and is actively embedded in the cellular, cytoplasmic and mitochondrial membranes, forming part of the fraction of structural phospholipids.


Excretion

Only 15% of the administered dose of citicoline is excreted from the human body: less than 3% - by the kidneys and about 12% - with exhaled CO2.


In the excretion of citicoline with urine, two phases can be identified: the first phase, lasting about 36 hours, during which the rate of elimination rapidly decreases, and the second phase, during which the rate of excretion decreases much more slowly. The same is observed in exhaled CO2 - the elimination rate rapidly decreases after about 15 hours, and then decreases much more slowly. The same is observed in exhaled CO2 - the elimination rate rapidly decreases after about 15 hours, and then decreases much more slowly.


Indications for use


Acute period of ischemic stroke (as part of complex therapy).

The recovery period of ischemic and hemorrhagic strokes.

Craniocerebral injury (TBI), acute (as part of complex therapy) and the recovery period.

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

Contraindications


Do not prescribe to patients with severe vagotonia (predominance of the parasympathetic part of the autonomic nervous system) and hypersensitivity to any of the components of the drug.


Due to the lack of sufficient clinical data, it is not recommended for use in children under 18 years of age.


Application in pregnancy and during breastfeeding


Sufficient data on the use of citicoline in pregnant women are absent. Although no adverse effects have been identified in animal studies, during the pregnancy, the drug Ceraxon® is prescribed only in cases where the expected benefit to the mother exceeds the potential risk to the fetus.


When appointing Ceraxon® during lactation, women should stop breastfeeding, as there is no data on the isolation of citicoline with human milk.

Dosing and Administration


The drug is administered intravenously or intramuscularly.


Intravenously, the drug is administered in the form of a slow intravenous injection (within 3-5 minutes, depending on the prescribed dose) or intravenous drip infusion (40-60 drops per minute).


Intravenous route of administration is preferable to intramuscular. When intramuscular introduction should be avoided repeated administration of the drug in the same place.


Recommended dosing regimen


Acute period of ischemic stroke and craniocerebral trauma (CCT):

1000 mg every 12 hours from the first day after the diagnosis, duration of treatment is not less than 6 weeks. 3-5 days after the start of treatment (if the swallowing function is not broken), it is possible to switch to oral forms of the preparation Ceraxon®.


The recovery period of ischemic and hemorrhagic strokes, the recovery period of TBI, cognitive and behavioral disorders in degenerative and cerebrovascular diseases of the brain:

500-2000 mg per day. Dosage and duration of treatment, depending on the severity of the symptoms of the disease. It is possible to use oral forms of the drug Ceraxon®.


Elderly patients


When prescribing Ceraxon® to elderly patients, dose adjustment is not required. The solution in the ampoule is intended for single use. It should be used immediately after opening the ampoule.


The drug is compatible with all types of intravenous isotonic solutions and dextrose solutions.


Side effect


The incidence of adverse adverse reactions (CPD)


Very rare (<1/10000) (including individual cases): allergic reactions (rash, itchy skin, anaphylactic shock), headache, dizziness, heat, tremor, nausea, vomiting, diarrhea, hallucinations, swelling, dyspnea, insomnia, Stimulation, decreased appetite, numbness in paralyzed limbs, changes in hepatic enzyme activity. In some cases, Ceraxon® can stimulate the parasympathetic system, as well as produce a short-term change in blood pressure.


If any of the side effects indicated in the manual are aggravated, or any other side effects not indicated in the instructions were noticed, you should inform your doctor about it.


Overdose


Given the low toxicity of the drug, overdose cases have not been described.


Interaction with other drugs.


Citicoline increases the effects of levodopa.


Do not use simultaneously with medicines containing meclofenoxate.


special instructions


During the treatment period, care should be taken when performing potentially hazardous activities requiring special attention and quick reactions (driving and other vehicles, working with moving mechanisms, dispatcher and operator work, etc.).


Form of issue


Solution for intravenous and intramuscular injection 500 mg / 4 ml and 1000 mg / 4 ml. By 4.0 ml in colorless glass ampoules of neutral glass (hydrolytic type I) with a protective plastic tube and a white band for breaking ampoules. 3 or 5 ampoules (contour cell pack of PVC) or 10 ampoules (2 contoured PVC packs) with instructions for use are placed in a cardboard box.


Storage conditions


Store at a temperature not exceeding 30 ° C. Keep out of the reach of children.


Shelf life


3 years.

Do not use after the expiry date printed on the package.


Terms of leave from pharmacies


On prescription.


Manufacturer


Ferrer International, S.A.

Gran Via Carlos III, 94, 08028 Barcelona, ​​Spain.

Ferrer Internacional, S.A. Gran Via Carlos III, 94, 08028 Barcelona, ​​Spain.


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