Instructions for Praxis film-coated tablets 500 mg blister No. 28
Composition
active ingredient: citicoline;
1 tablet contains citicoline sodium equivalent to citicoline (calculated as 100% substance) 500 mg;
excipients: microcrystalline cellulose, croscarmellose sodium, hydrogenated castor oil, colloidal anhydrous silicon dioxide, magnesium stearate, talc, “SeleCoatTM” coating (hypromellose, polyethylene glycol (macrogol) 6000, titanium dioxide (E 171)).
Dosage form
Film-coated tablets.
Main physicochemical properties: oval-shaped tablets with a biconvex surface, coated with a white film coating.
Pharmacotherapeutic group
Agents acting on the nervous system. Psychoanaleptics. Psychostimulants, agents for use in attention deficit hyperactivity disorder (ADHD) and nootropics. Other psychostimulants and nootropics. Citicoline. ATC code N06B X06.
Pharmacological properties
Pharmacodynamics.
Citicoline stimulates the biosynthesis of structural phospholipids in the membrane of neurons, which contributes to the improvement of membrane functions, including the functioning of ion-exchange pumps and neuroreceptors. Due to its stabilizing effect on the membrane, citicoline exhibits anti-edematous properties, reduces brain edema. Citicoline inhibits the activity of some phospholipases, prevents the residual release of free radicals, prevents damage to membrane systems and ensures the preservation of the protective antioxidant system.
Citicoline reduces the volume of damaged tissue, prevents cell death by acting on apoptosis mechanisms, and improves cholinergic transmission. Citicoline also has a preventive neuroprotective effect in focal brain strokes.
Citicoline promotes rapid functional rehabilitation of patients with acute cerebral circulation disorders, reducing ischemic damage to brain tissue, which is confirmed by the results of X-ray studies.
In case of traumatic brain injuries, citicoline shortens the duration of the recovery period and reduces the intensity of post-traumatic syndrome.
Citicoline helps increase the level of brain activity, reduces the level of amnesia, and improves the condition of cognitive, sensory, and motor disorders observed in cerebral ischemia.
Pharmacokinetics.
Citicoline is well absorbed when administered orally. After taking 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. Bioavailability is almost the same when administered orally and parenterally.
The drug is metabolized in the intestines and liver to form choline and cytidine. After administration, citicoline is absorbed by brain tissues, with cholines acting on phospholipids, cytidine on cytidine nucleoids and nucleic acids. Citicoline quickly reaches brain tissues and is actively incorporated into cell membranes, cytoplasm and mitochondria, activating the activity of phospholipids.
Only a small amount of the administered dose is excreted in the urine and feces (less than 3%). Approximately 12% of the administered dose is excreted through the respiratory tract. The excretion of the drug in the urine and through the respiratory tract has two phases: the first phase is rapid excretion (with urine - during the first
36 hours, through the respiratory tract - during the first 15 hours), the second phase is slow elimination. The main part of the drug dose is involved in metabolic processes.
Indication
Stroke, acute phase of cerebrovascular disorders, as well as complications and consequences of cerebrovascular disorders.
Traumatic brain injury and its neurological consequences.
Cognitive and behavioral disorders due to chronic vascular and degenerative cerebral disorders.
Contraindication
Hypersensitivity to citicoline or to any of the excipients.
Increased 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
This medicinal product contains sodium. Caution should be exercised when administered to patients on a controlled sodium diet.
Use during pregnancy or breastfeeding
There are no adequate data on the use of Praxis in pregnant women.
There are no data on the excretion of citicoline into breast milk and its effect on the fetus. Therefore, during pregnancy or breastfeeding, the drug should be prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus.
Ability to influence reaction speed when driving vehicles or other mechanisms
In individual cases, some adverse reactions from the central nervous system (CNS) 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).
Elderly patients do not require dose adjustment.
Children
Experience with the use of the drug in children is limited.
Overdose
No cases of overdose have been noted.
Side effects
Adverse reactions occur very rarely (<1/10,000), including isolated cases.
From the side of the central and peripheral nervous systems: severe headache, vertigo, hallucinations.
From the cardiovascular system: arterial hypertension, arterial hypotension, tachycardia.
Respiratory system: shortness of breath.
From the digestive tract: nausea, vomiting, diarrhea.
On the part of the immune system: allergic reactions, including: rash, hyperemia, exanthema, urticaria, purpura, itching, angioedema, anaphylactic shock.
General reactions: chills.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
7 tablets in a blister. 2, or 3, or 4 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
ASTRAPHARM LLC, Ukraine.
Address
08132, Kyiv region, Kyiv-Svyatoshynskyi district, Vyshneve town, Kyivska st., 6.
