Instructions for use Ceraxon film-coated tablets 500 mg No. 20
Composition
active ingredient: citicoline;
1 tablet contains 522.5 mg of citicoline sodium, which is equivalent to 500 mg of citicoline;
excipients: talc; magnesium stearate; colloidal anhydrous silicon dioxide; croscarmellose sodium; hydrogenated castor oil; microcrystalline cellulose;
shell: talc; magnesium stearate; titanium dioxide (E 171); polyethylene glycol 6000; methacrylate copolymer (type A).
Dosage form
Film-coated tablets.
Main physicochemical properties: white, oblong tablets, film-coated, embossed with "C500".
Pharmacotherapeutic group
Psychostimulants, drugs used for attention deficit hyperactivity disorder (ADHD), nootropics.
ATX code N06B X06.
Pharmacological properties
Pharmacodynamics
Citicoline stimulates the biosynthesis of structural phospholipids of neuronal membranes, which is confirmed by magnetic resonance spectroscopy. Due to this mechanism of action, citicoline stimulates the functioning of such membrane mechanisms as the work of ion exchange pumps and receptors, the modulation of which is necessary for the normal conduction of nerve impulses. Due to its stabilizing effect on the neuronal membrane, citicoline exhibits anti-edematous properties that contribute to the reabsorption of brain edema.
Experimental studies have shown that citicoline inhibits the activation of certain phospholipases (A1, A2, C, and D), reducing the formation of free radicals, preventing the destruction of membrane systems, and preserving antioxidant defense systems such as glutathione.
Citicoline preserves the energy reserves of neurons, inhibits apoptosis, and stimulates the synthesis of acetylcholine.
It has been experimentally proven that citicoline also exhibits a preventive neuroprotective effect in a model of focal cerebral ischemia.
Clinical studies have shown that citicoline significantly increases functional recovery rates in patients with acute ischemic stroke, which coincides with a slowdown in the growth of ischemic brain damage according to neuroimaging data.
In patients with traumatic brain injury, citicoline accelerates recovery and reduces the duration and intensity of post-traumatic syndrome.
Citicoline improves the level of attention and consciousness, reduces cognitive and neurological disorders associated with cerebral ischemia, and helps reduce the manifestations of amnesia.
Pharmacokinetics
Citicoline is well absorbed when administered orally. After administration of the drug, a significant increase in the level of choline in the blood plasma is observed. When administered orally, the drug is almost completely absorbed. Studies have shown that the bioavailability is almost the same when administered orally and intravenously.
The drug is metabolized in the intestines and liver to form choline and cytidine.
After administration, citicoline is widely distributed in brain structures with rapid incorporation of the choline fraction into structural phospholipids and the cytidine fraction into cytidine nucleotides and nucleic acids. In the brain, citicoline is incorporated into cellular, cytoplasmic and mitochondrial membranes, becoming part of the phospholipid fraction.
Only a small amount of the dose is found in the urine and feces (less than 3%). Approximately 12% of the dose is excreted in exhaled CO2. During the excretion of the drug with urine, two phases are distinguished: the first phase is 36 hours, during which the rate of excretion decreases rapidly, and the second phase is in which the rate of excretion decreases much more slowly. The same phasic nature is observed in excretion through the respiratory tract. The rate of CO2 excretion decreases rapidly for about 15 hours, then decreases much more slowly.
Indication
- Stroke, acute phase of cerebrovascular accidents and their neurological consequences.
- Traumatic brain injury and its neurological consequences.
- Cognitive and behavioral disorders due to chronic vascular and degenerative cerebral disorders.
Contraindication
- Hypersensitivity to citicoline or other components of the drug.
- High tone of the parasympathetic nervous system.
Interaction with other medicinal products and other types of interactions
Citicoline enhances the effect of levodopa. It should not be administered simultaneously with drugs containing meclofenoxate.
Application features
The medicine contains hydrogenated castor oil, which may cause stomach upset and diarrhea. Therefore, patients with inflammatory bowel diseases should use the medicine with extreme caution.
Use during pregnancy or breastfeeding
There are no adequate data on the use of citicoline in pregnant women. Citicoline should not be used during pregnancy unless clearly necessary. During pregnancy, the drug is prescribed only if the expected therapeutic benefit outweighs the potential risk. There is no data on the penetration of citicoline into breast milk and its effect on the fetus.
Ability to influence reaction speed when driving vehicles or other mechanisms
In individual cases, some adverse reactions from the central nervous system may affect the ability to drive or operate complex machinery.
Method of administration and doses
The recommended dose is 500 to 2000 mg per day (1–4 tablets), depending on the severity of symptoms and the patient's condition.
The dosage of the drug and the duration of treatment are determined by the doctor.
Elderly patients do not require dose adjustment.
Children
Experience with the drug in children is limited, so the drug is prescribed only when the expected benefit outweighs any potential risk.
Overdose
No cases of overdose have been reported.
Adverse reactions
Adverse reactions occur very rarely (<1/10,000), including isolated cases.
From the psyche: hallucinations.
From the nervous system: severe headache, dizziness.
From the cardiovascular system: arterial hypertension, arterial hypotension.
From the respiratory system: dyspnea.
On the part of the digestive tract: nausea, vomiting, episodic diarrhea.
Skin and subcutaneous tissue disorders: allergic reactions, including rash, itching, angioedema, anaphylactic shock, flushing, urticaria, exanthema, purpura.
General disorders: chills, edema.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 30 ° C. Keep out of the reach of children!
Packaging
5 tablets in a blister; 2 or 4 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
Ferrer Internacional, SA, Spain.
Location of the manufacturer and its business address
Joan Buscalla, 1–9, Sant Cugat del Valles, 08173 Barcelona, Spain / Joan Buscalla, 1–9, Sant Cugat del Valles, 08173 Barcelona, Spain.
