Praxis®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PRAKSIS® (PRAXIS)

Composition:

Active substance: citicoline;

One tablet contains sodium citicolline equivalent to citicoline (calculated as 100% substance) 500 mg;

Excipients: microcrystalline cellulose, sodium croscarmellose, hydrogenated castor oil, colloidal anhydrous silicon dioxide, magnesium stearate, talc, coating "SelecCoat™" (hypromellose, polyethylene glycol (macrogol) 6000, titanium dioxide (E 171)).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: oval-shaped, biconvex tablets with a film coating of white color.

Pharmacotherapeutic group.

Agents acting on the nervous system. Psychoanaleptics. Psychostimulants, drugs used in attention deficit hyperactivity disorder (ADHD) and nootropic agents. Other psychostimulant and nootropic agents. Citicoline. ATC code N06BX06.

Pharmacological Properties

Pharmacodynamics

Citicoline stimulates the biosynthesis of structural phospholipids in neuronal membranes, thereby improving membrane functions, including the activity of ion pumps and neurotransmitter receptors. Due to its membrane-stabilizing effect, citicoline exhibits anti-edematous properties and reduces cerebral edema. Citicoline inhibits the activity of certain phospholipases, prevents residual release of free radicals, protects membrane systems from damage, and maintains the body's antioxidant defense system.

Citicoline reduces the volume of damaged tissue by preventing cell death through modulation of apoptotic mechanisms and enhances cholinergic transmission. It also exerts a preventive neuroprotective effect in focal cerebral strokes.

Citicoline promotes rapid functional recovery in patients with acute cerebrovascular disorders by reducing ischemic brain tissue damage, as confirmed by radiological findings.

In traumatic brain injury, citicoline shortens the duration of the recovery period and reduces the severity of post-traumatic syndrome.

Citicoline enhances cerebral activity, reduces the degree of amnesia, and improves cognitive, sensory, and motor deficits associated with cerebral ischemia.

Pharmacokinetics

Citicoline is well absorbed after oral administration. Following intake, a significant increase in plasma choline levels is observed. The drug is almost completely absorbed when administered orally. Bioavailability after oral and parenteral administration is practically equivalent.

The drug is metabolized in the intestine and liver, forming choline and cytidine. After administration, citicoline is taken up by brain tissue, where choline acts on phospholipids and cytidine on cytidine nucleotides and nucleic acids. Citicoline rapidly reaches brain tissue and actively incorporates into cell membranes, cytoplasm, and mitochondria, stimulating phospholipid activity.

Only a small fraction of the administered dose is excreted in urine and feces (less than 3%). Approximately 12% of the administered dose is excreted via the respiratory tract. Elimination through urine and the respiratory tract occurs in two phases: the first phase—rapid elimination (in urine—within the first 36 hours; via respiratory tract—within the first 15 hours), and the second phase—slow elimination. The majority of the administered dose is incorporated into metabolic processes.

Clinical characteristics.

Indications.

• Stroke, acute phase of cerebral circulation disorders, as well as complications and consequences of cerebral circulation disorders.
• Traumatic brain injury and its neurological consequences.
• Cognitive and behavioral disorders due to chronic vascular and degenerative cerebral disorders.

Contraindications.

Hypersensitivity to citicoline or to any of the excipients.

Increased parasympathetic nervous system tone.

Interaction with other medicinal products and other forms of interaction.

Citicoline enhances the effect of levodopa. It should not be administered concurrently with medicinal products containing meclofenoxate.

Special precautions for use.

This medicinal product contains sodium. Caution should be exercised when administering to patients on a controlled sodium diet.

Use during pregnancy or breastfeeding.

There are insufficient data on the use of Praxis in pregnant women.

There are no data available on the excretion of citicoline in breast milk or its effects 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 affect reaction speed when driving or operating machinery.

In individual cases, certain adverse reactions from the central nervous system (CNS) may affect the ability to drive or operate complex machinery.

Dosage and Administration.

The recommended dose is from 500 to 2000 mg per day (1-4 tablets).

Dosage and duration of treatment depend on the severity of brain damage and are determined by a physician.

Elderly patients do not require dose adjustment.

Children.

Experience with the use of the drug in children is limited.

Overdose.

Cases of overdose have not been reported.

Adverse reactions

Adverse reactions occur very rarely (<1/10,000), including isolated cases.

Nervous system and peripheral nervous system: severe headache, vertigo, hallucinations.

Cardiovascular system: arterial hypertension, arterial hypotension, tachycardia.

Respiratory system: dyspnea.

Gastrointestinal tract: nausea, vomiting, diarrhea.

Immune system: allergic reactions, including: rash, hyperemia, exanthema, urticaria, purpura, pruritus, angioneurotic edema, anaphylactic shock.

General reactions: chills.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

7 tablets per blister. 2, 3, or 4 blisters per cardboard box.

Prescription status. Prescription only.

Manufacturer.

ASTRAFARM LLC, Ukraine.

Manufacturer's address and place of business.

6 Kyivska Street, Vyshneve, Kyiv-Sviatoshyn district, Kyiv region, 08132, Ukraine.