Ceraxon solution for oral administration 100 mg/ml pack 10 ml N10
Registration Certificate Holder
FERRER INTERNACIONAL (Spain)
Dosage form
Medicine - Ceraxon®
Description
Oral solution
in the form of a clear, colorless liquid with a characteristic strawberry odor.
1 pack (10 ml)
citicoline sodium 1045 mg, equivalent to citicoline 1000 mg
Excipients
: sorbitol - 2000 mg, glycerol - 500 mg, methyl parahydroxybenzoate - 14.5 mg, propyl parahydroxybenzoate - 2.5 mg, sodium citrate dihydrate - 60 mg, sodium saccharinate - 2 mg, strawberry flavor (strawberry essence 1487-S-Lucta) - 4.08 mg, potassium sorbate - 30 mg, citric acid solution 50% - up to pH 5.9-6.1, purified water - up to 10 ml.
10 ml - sachets of combined material (6) - cardboard packs. 10 ml - sachets of combined material (10) - cardboard packs.
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 diseases of the brain.
Contraindications for use
- pronounced vagotonia (predominance of the tone of the parasympathetic part of the autonomic nervous system);
- children and adolescents under 18 years of age (due to the lack of sufficient clinical data);
- rare hereditary diseases associated with fructose intolerance;
- hypersensitivity to the components of the drug.
pharmachologic effect
Nootropic drug. Citicoline, being a precursor of key ultrastructural components of the cell membrane (mainly phospholipids), has a wide 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 affecting the mechanisms of apoptosis.
In the acute period of stroke, citicoline reduces the volume of brain tissue damage and improves cholinergic transmission.
In case of traumatic brain injury, it reduces the duration of post-traumatic coma and the severity of neurological symptoms; in addition, citicoline helps to reduce the duration of the recovery period.
In chronic cerebral hypoxia, citicoline is effective in the treatment of cognitive disorders such as memory impairment, lack of initiative, and difficulties in performing daily activities and self-care. Increases the level of attention and consciousness, and also reduces the manifestation of amnesia.
Ceraxon® is effective in the treatment of sensory and motor neurological disorders of degenerative and vascular etiology.
Drug interactions
Citicoline enhances the effects of levodopa.
Ceraxon® should not be prescribed concomitantly with medications containing meclofenoxate.
Dosage regimen
The drug is taken with meals or between meals. Before use, the drug can be diluted in a small amount of water (120 ml or 1/2 cup).
Acute period of ischemic stroke and traumatic brain injury:
The recommended dose is 1000 mg (10 ml or 1 sachet) every 12 hours. The duration of treatment is at least 6 weeks.
Recovery period of ischemic and hemorrhagic strokes, recovery period of traumatic brain injury, cognitive and behavioral disorders in degenerative and vascular diseases of the brain:
The recommended dose is 500-2000 mg/day (5-10 ml 1-2 times/day or 1 sachet (1000 mg) 1-2 times/day). The dose and duration of treatment depend on the severity of the symptoms of the disease.
Elderly patients
No dose adjustment of Ceraxon® is required.
Rules for using a dosage syringe
1. Place the dosing syringe into the bottle (the syringe plunger is completely lowered).
2. Carefully pull the plunger of the dosing syringe until the solution level is equal to the corresponding mark on the syringe.
3. Before taking, the required amount of solution can be diluted in 1/2 glass of water (120 ml).
After each use, it is recommended to rinse the dosing syringe with water.
Rules for using the drug in sachets
1. Holding the bag vertically, carefully tear off its edge along the o.
2.The contents of the sachet can be drunk immediately after opening or before use can be diluted in 1/2 glass of water (120 ml).
Overdose
Due to the low toxicity of the drug, cases of overdose have not been described.
Side effect
Very rare (<1/10,000) (including individual cases):
allergic reactions (rash, skin itching, anaphylactic shock), headache, dizziness, feeling of heat, tremor, nausea, vomiting, diarrhea, hallucinations, swelling, shortness of breath, insomnia, agitation, loss of appetite, numbness in paralyzed limbs, changes in the activity of liver enzymes . In some cases, Ceraxon® can stimulate the parasympathetic system and also cause a short-term change in blood pressure.
If any of the side effects indicated in the instructions get worse, or any other side effects not listed in the instructions are noticed, you should inform your doctor.
special instructions
In the solution for oral administration in the cold, a small amount of crystals may form due to temporary partial crystallization of the preservative.
With further storage under recommended conditions, the crystals dissolve within several months. The presence of crystals does not affect the quality of the drug. Impact on the ability to drive vehicles and operate machinery
During treatment, patients should be careful when performing potentially dangerous activities that require special attention and speed of psychomotor reactions (including driving a car and other vehicles, working with moving mechanisms, working as a dispatcher and operator).
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 30°C.
Best before date
Shelf life: 3 years.
Use during pregnancy and breastfeeding
Restrictions during pregnancy - With caution. Restrictions when breastfeeding - Contraindicated.
There is insufficient clinical data on the use of citicoline during pregnancy. Although experimental studies on animals have not revealed any negative effects, during pregnancy the drug is prescribed only when the expected benefit of therapy for the mother outweighs the potential risk to the fetus.
If it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be decided, since there is no data on the excretion of citicoline in breast milk.
Use in elderly patients
Restrictions for elderly patients - No restrictions.
Elderly patients
No dose adjustment of Ceraxon® is required.
Use in children
Restrictions for children - Contraindicated. Contraindicated in children and adolescents under 18 years of age.
Terms of sale
The drug is available with a prescription.
Contacts for inquiries
TAKEDA (Japan)
Takeda Pharmaceuticals LLC
119048 Moscow, st. Usacheva, 2, building 1 Business, fl. 5 Tel. Fax E-mail
Cerakson solution for oral administration 100 mg/ml 10 ml pack/pack card x10
Marketing authorization holder: FERRER INTERNACIONAL, SA (Spain) Representative office: TAKEDA (Japan) ATX code: N06BX06 (Citicoline) Active substance: citicoline (citicoline) Rec.INN registered by WHO Dosage form CERAKSON® solution for oral administration 1000 mg/ 10 ml: pack. 6 or 10 pcs. reg. No.: LSR-000089 dated 05/31/07 - Validity period of reg. beat is not limited
Release form, composition and packaging Oral solution is a clear, colorless liquid with a characteristic strawberry odor.
1 ml citicoline sodium 104.5 mg, equivalent to citicoline 100 mg
Excipients: sorbitol - 200 mg, glycerol - 50 mg, methyl parahydroxybenzoate - 1.45 mg, propyl parahydroxybenzoate - 0.25 mg, sodium citrate dihydrate - 6 mg, sodium saccharinate - 0.2 mg, strawberry flavor (strawberry essence 1487-S-Lucta) - 0.408 mg , potassium sorbate - 3 mg, citric acid solution 50% - up to pH 5.9-6.1, purified water - up to 1 ml.
30 ml - colorless glass bottles (1) complete with a dosage syringe - cardboard packs with partitions.
The solution for oral administration is a clear, colorless liquid with a characteristic strawberry odor.
1 pack (10 ml) citicoline sodium 1045 mg, equivalent to citicoline 1000 mg
Excipients: sorbitol - 2000 mg, glycerol - 500 mg, methyl parahydroxybenzoate - 14.5 mg, propyl parahydroxybenzoate - 2.5 mg, sodium citrate dihydrate - 60 mg, sodium saccharinate - 2 mg, strawberry flavor (strawberry essence 1487-S-Lucta) - 4.08 mg , potassium sorbate - 30 mg, citric acid solution 50% - up to pH 5.9-6.1, purified water - up to 10 ml.
10 ml - sachets of combined material (6) - cardboard packs. 10 ml - sachets of combined material (10) - cardboard packs.
The solution for intravenous and intramuscular administration is a clear, colorless liquid.
1 amp. citicoline sodium 522.5 mg, equivalent to citicoline 500 mg
Excipients: hydrochloric acid 1 M or sodium hydroxide 1 M - up to pH 6.7-7.1, water for injection - up to 4 ml.
4 ml - colorless glass ampoules (3) - contour cell packaging (1) - cardboard packs. 4 ml - colorless glass ampoules (5) - contour cell packaging (1) - cardboard packs. 4 ml - colorless glass ampoules (10) - contour cell packaging (2) - cardboard packs.
The solution for intravenous and intramuscular administration is a clear, colorless liquid.
1 amp. citicoline sodium 1045 mg, equivalent to citicoline 1000 mg
Excipients: hydrochloric acid 1 M or sodium hydroxide 1 M - up to pH 6.7-7.1, water for injection - up to 4 ml.
4 ml - colorless glass ampoules (3) - contour cell packaging (1) - cardboard packs. 4 ml - colorless glass ampoules (5) - contour cell packaging (1) - cardboard packs. 4 ml - colorless glass ampoules (10) - contour cell packaging (2) - cardboard packs.
Clinical-pharmacological group: Nootropic drug Pharmaco-therapeutic group: Nootropic drug
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 diseases of the brain.
ICD-10 codes ICD-10 code Indication F07 Personality and behavioral disorders caused by disease, damage or dysfunction of the brain I63 Cerebral infarction (ischemic cerebrovascular accident) I69 Consequences of cerebrovascular diseases S06 Intracranial injury T90 Consequences of head injuries
Dosage regimen Oral solution
The drug is taken with meals or between meals. Before use, the drug can be diluted in a small amount of water (120 ml or 1/2 cup).
Acute period of ischemic stroke and traumatic brain injury: the recommended dose is 1000 mg (10 ml or 1 sachet) every 12 hours. Duration of treatment is at least 6 weeks.
Recovery period of ischemic and hemorrhagic strokes, recovery period of traumatic brain injury, cognitive and behavioral disorders in degenerative and vascular diseases of the brain: the recommended dose is 500-2000 mg/day (5-10 ml 1-2 times/day or 1 sachet ( 1000 mg) 1-2 times/day). The dose and duration of treatment depend on the severity of the symptoms of the disease.
Elderly patients do not require dose adjustment of Ceraxon®.
Rules for using a dosage syringe
1. Place the dosing syringe into the bottle (the syringe plunger is completely lowered).
2. Carefully pull the plunger of the dosing syringe until the solution level is equal to the corresponding mark on the syringe.
3. Before taking, the required amount of solution can be diluted in 1/2 glass of water (120 ml).
After each use, it is recommended to rinse the dosing syringe with water.
Rules for using the drug in sachets
1. Holding the bag vertically, carefully tear off its edge along the o.
2.The contents of the sachet can be drunk immediately after opening or before use can be diluted in 1/2 glass of water (120 ml).
Solution for intravenous and intramuscular administration
The drug is administered intravenously as a slow injection (over 3-5 minutes, depending on the prescribed dose) or drip infusion (40-60 drops/min). The intravenous route of administration is preferable to the intramuscular route. When administered intramuscularly, repeated administration of the drug in the same place should be avoided.
Acute period of ischemic stroke and traumatic brain injury: the recommended dose is 1000 mg every 12 hours from the first day after diagnosis, treatment duration is at least 6 weeks. 3-5 days after the start of treatment (if swallowing function is not impaired), it is possible to switch to oral forms of the drug Ceraxon®.
Recovery period for ischemic and hemorrhagic strokes, recovery period for traumatic brain injury, cognitive and behavioral disorders in degenerative and vascular diseases of the brain: the recommended dose is 500-2000 mg/day (5-10 ml 1-2 times/day). The dose and duration of treatment depend on the severity of the symptoms of the disease.
Elderly patients do not require dose adjustment of Ceraxon® for intravenous or intramuscular administration.
A solution for intravenous and intramuscular administration in an ampoule is intended for single use. After opening the ampoule, the solution should be used immediately. The drug is compatible with all types of intravenous isotonic solutions and dextrose solutions.
Side effects Very rare (<.1/10,000) (including individual cases): allergic reactions (rash, itching, anaphylactic shock), headache, dizziness, feeling of heat, tremor, nausea, vomiting, diarrhea, hallucinations, swelling, shortness of breath, insomnia, agitation, loss of appetite, numbness in paralyzed limbs, changes in the activity of liver enzymes. In some cases, Ceraxon® can stimulate the parasympathetic system and also cause a short-term change in blood pressure.
If any of the side effects indicated in the instructions get worse, or any other side effects not listed in the instructions are noticed, you should inform your doctor.
Contraindications for use: severe vagotonia (predominance of the tone of the parasympathetic part of the autonomic nervous system),
- children and adolescents under 18 years of age (due to the lack of sufficient clinical data),
- rare hereditary diseases associated with fructose intolerance (for oral solution),
- hypersensitivity to the components of the drug.
Use during pregnancy and lactation There is not enough clinical data on the use of citicoline during pregnancy. Although experimental studies on animals have not revealed any negative effects, during pregnancy the drug is prescribed only when the expected benefit of therapy for the mother outweighs the potential risk to the fetus.
If it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be decided, since there is no data on the excretion of citicoline in breast milk.
Use in children Contraindicated in children and adolescents under 18 years of age.
Use in elderly patients Elderly patients do not require dose adjustment of Ceraxon®. Special instructions In the solution for oral administration in the cold, a small amount of crystals may form due to temporary partial crystallization of the preservative. With further storage under recommended conditions, the crystals dissolve within several months. The presence of crystals does not affect the quality of the drug.
Impact on the ability to drive vehicles and operate machinery
During the treatment period, patients should be careful when performing potentially hazardous activities that require special attention and speed of psychomotor reactions (including driving a car and other vehicles, working with moving mechanisms, working as a dispatcher and operator).
Overdose Due to the low toxicity of the drug, cases of overdose have not been described.
Drug interactions Citicoline enhances the effects of levodopa.
Ceraxon® should not be prescribed concomitantly with medications containing meclofenoxate.
Conditions for dispensing from pharmacies The drug is dispensed with a prescription.
Conditions and periods of storage The drug should be stored out of the reach of children at a temperature not exceeding 30°C. Shelf life: 3 years.
Ceraxon solution for oral administration 100 mg/ml 10 ml sachets N 10
Active substance
citicoline
ATX code
N06BX06 (Citicoline)
Dosage forms
oral solution
Release form, packaging and composition of the drug
Oral solution
- a clear, colorless liquid with a characteristic strawberry odor.
| 1 ml | |
| citicoline sodium | 104.5 mg, |
| equivalent to citicoline | 100 mg |
[PRING] sorbitol - 200 mg, glycerol - 50 mg, methyl parahydroxybenzoate - 1.45 mg, propyl parahydroxybenzoate - 0.25 mg, sodium citrate dihydrate - 6 mg, sodium saccharinate - 0.2 mg, strawberry flavor (strawberry essence 1487-S-Lucta) - 0.408 mg , potassium sorbate - 3 mg, citric acid solution 50% - up to pH 5.9-6.1, purified water - up to 1 ml.
30 ml - colorless glass bottles (1) complete with a dosage syringe - cardboard packs with partitions.
Oral solution
- a clear, colorless liquid with a characteristic strawberry odor.
| 1 pack (10 ml) | |
| citicoline sodium | 1045 mg, |
| equivalent to citicoline | 1000 mg |
[PRING] sorbitol - 2000 mg, glycerol - 500 mg, methyl parahydroxybenzoate - 14.5 mg, propyl parahydroxybenzoate - 2.5 mg, sodium citrate dihydrate - 60 mg, sodium saccharinate - 2 mg, strawberry flavor (strawberry essence 1487-S-Lucta) - 4.08 mg , potassium sorbate - 30 mg, citric acid solution 50% - up to pH 5.9-6.1, purified water - up to 10 ml.
10 ml - sachets of combined material (6) - cardboard packs. 10 ml - sachets of combined material (10) - cardboard packs.
Clinical and pharmacological group
Nootropic drug
Pharmacotherapeutic group
Nootropic drug
pharmachologic effect
Suction
Citicoline is well absorbed when taken orally. Absorption after oral administration is almost complete, and bioavailability is approximately the same as after intravenous administration.
Metabolism
The drug is metabolized in the intestines and liver with the formation of choline and cytidine. After oral administration, the concentration of choline in the blood plasma increases significantly.
Distribution
Citicoline is widely distributed in brain structures, 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 fraction of structural phospholipids.
Removal
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.
The excretion of citicoline in urine can be divided into 2 phases: a first phase, lasting about 36 hours, during which the rate of excretion decreases rapidly, and a second phase, during which the rate of excretion decreases much more slowly. The same is observed in exhaled CO2 - the rate of elimination decreases rapidly after about 15 hours and then decreases much more slowly.
Indications for use
- 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 diseases of the brain.
Dosage
The drug is taken with meals or between meals. Before use, the drug can be diluted in a small amount of water (120 ml or 1/2 cup).
Acute period of ischemic stroke and traumatic brain injury:
The recommended dose is 1000 mg (10 ml or 1 sachet) every 12 hours. The duration of treatment is at least 6 weeks.
Recovery period of ischemic and hemorrhagic strokes, recovery period of traumatic brain injury, cognitive and behavioral disorders in degenerative and vascular diseases of the brain:
The recommended dose is 500-2000 mg/day (5-10 ml 1-2 times/day or 1 sachet (1000 mg) 1-2 times/day). The dose and duration of treatment depend on the severity of the symptoms of the disease.
Elderly patients
No dose adjustment of Ceraxon® is required.
Rules for using a dosage syringe
1. Place the dosing syringe into the bottle (the syringe plunger is completely lowered).
2. Carefully pull the plunger of the dosing syringe until the solution level is equal to the corresponding mark on the syringe.
3. Before taking, the required amount of solution can be diluted in 1/2 glass of water (120 ml).
After each use, it is recommended to rinse the dosing syringe with water.
Rules for using the drug in sachets
1. Holding the bag vertically, carefully tear off its edge along the o.
2.The contents of the sachet can be drunk immediately after opening or before use can be diluted in 1/2 glass of water (120 ml).
Contraindications
- pronounced vagotonia (predominance of the tone of the parasympathetic part of the autonomic nervous system);
- children and adolescents under 18 years of age (due to the lack of sufficient clinical data);
- rare hereditary diseases associated with fructose intolerance;
- hypersensitivity to the components of the drug.
Overdose
Due to the low toxicity of the drug, cases of overdose have not been described.
Side effects
Very rare (<1/10,000) (including individual cases):
allergic reactions (rash, skin itching, anaphylactic shock), headache, dizziness, feeling of heat, tremor, nausea, vomiting, diarrhea, hallucinations, swelling, shortness of breath, insomnia, agitation, loss of appetite, numbness in paralyzed limbs, changes in the activity of liver enzymes . In some cases, Ceraxon® can stimulate the parasympathetic system and also cause a short-term change in blood pressure.
If any of the side effects indicated in the instructions get worse, or any other side effects not listed in the instructions are noticed, you should inform your doctor.
Overdose
Citicoline enhances the effects of levodopa.
Ceraxon® should not be prescribed concomitantly with medications containing meclofenoxate.
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 30°C. Shelf life: 3 years.
Conditions for dispensing from pharmacies
The drug is available with a prescription.
Special Instructions
In the solution for oral administration in the cold, a small amount of crystals may form due to temporary partial crystallization of the preservative. With further storage under recommended conditions, the crystals dissolve within several months. The presence of crystals does not affect the quality of the drug.
Impact on the ability to drive vehicles and operate machinery
During the treatment period, patients should be careful when performing potentially hazardous activities that require special attention and speed of psychomotor reactions (including driving a car and other vehicles, working with moving mechanisms, working as a dispatcher and operator).
