Praxis

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

Composition:

Active substance: citicoline;

1 ampoule (4 ml) of the medicinal product contains citicoline 500 mg or 1000 mg;

Excipients: concentrated hydrochloric acid or sodium hydroxide; water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical characteristics: clear, colorless solution.

Pharmacotherapeutic group. Psychostimulants, agents used in attention deficit hyperactivity disorder (ADHD), nootropic agents. Other psychostimulant and nootropic agents. ATC code N06BX06.

Pharmacological Properties

Pharmacodynamics

Citicoline stimulates the biosynthesis of structural phospholipids in neuronal membranes, as confirmed by magnetic resonance spectroscopy data. Due to this mechanism of action, citicoline improves the functioning of membrane mechanisms such as ion-exchange pumps and receptors, the modulation of which is necessary for normal nerve impulse conduction.

Thanks to its stabilizing effect on neuronal membranes, citicoline exhibits properties that promote a reduction in cerebral edema.

Citicoline inhibits the activation of certain phospholipases (A1, A2, C, and D), reduces the formation of free radicals, prevents the destruction of membrane systems, and preserves antioxidant defense systems such as glutathione.

Citicoline maintains neuronal energy reserves, inhibits apoptosis, and stimulates acetylcholine synthesis.

It has been demonstrated that citicoline also exerts a preventive neuroprotective effect in focal cerebral ischemia.

It is known that citicoline significantly enhances functional recovery in patients with acute ischemic stroke, which correlates with a slowing of the growth in volume of ischemic brain damage as shown by neuroimaging.

In patients with traumatic brain injury, citicoline accelerates recovery and reduces the duration and severity of post-traumatic syndrome.

Citicoline improves levels of attention and consciousness, as well as cognitive and neurological disorders associated with cerebral ischemia, and helps reduce symptoms of amnesia.

Pharmacokinetics

After administration, a significant increase in plasma choline levels is observed. The drug is metabolized in the intestine and liver, forming choline and cytidine.

Following administration, citicoline is widely distributed into 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 integrates into cellular, cytoplasmic, and mitochondrial membranes, becoming incorporated into the phospholipid fraction.

Only a small amount of the administered dose is found in urine and feces (less than 3%). Approximately 12% of the dose is excreted as exhaled CO₂. Renal excretion of the drug occurs in two phases: the first phase lasts 36 hours, during which the elimination rate decreases rapidly, and the second phase, during which the elimination rate decreases much more slowly. A similar biphasic pattern is observed in elimination via the respiratory tract. The rate of CO₂ excretion decreases rapidly, within approximately 15 hours, and then declines much more slowly.

Clinical characteristics.

Indications.

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

Contraindications.

• Hypersensitivity to citicoline or to other components of the medicinal product.
• Increased tone of the parasympathetic nervous system.

Interaction with other medicinal products and other types of interactions.

Citicoline enhances the effect of levodopa. The drug should not be administered simultaneously with medicinal products containing meclofenoxate.

Special precautions for use.

When administered intravenously, the medicinal product should be injected slowly (over 3–5 minutes depending on the dose administered).

When administered intravenously by infusion, the infusion rate should be 40–60 drops per minute.

In cases of persistent intracranial hemorrhage, the dose should not exceed 1000 mg per day and the intravenous infusion rate should not exceed 30 drops per minute.

This medicinal product contains 4.096 mmol (or 94.2 mg) of sodium per 2000 mg dose of citicoline. Caution should be exercised when administering the product to patients on a sodium-restricted diet.

Use during pregnancy or breastfeeding.

There are insufficient data on the use of citicoline in pregnant women. Data on the excretion of citicoline in breast milk and its effects on the fetus are unknown. During pregnancy or breastfeeding, the medicinal product should be prescribed only when the expected therapeutic benefit for 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 may affect the ability to drive or operate complex machinery.

Method of administration and dosage.

The recommended dose for adults is from 500 mg to 2000 mg per day depending on the severity of symptoms.

The medicinal product is intended for intramuscular or intravenous use. Intravenous administration may be performed either by slow injection (over 3–5 minutes depending on the administered dose) or by infusion (administration rate of 40–60 drops per minute).

The duration of treatment depends on the course of the disease and is determined by the physician.

Elderly patients do not require dose adjustment.

The injection solution is intended for single use only. The product should be used immediately after opening the ampoule. Any unused portion must be discarded. The medicinal product may be mixed with all isotonic solutions for intravenous administration as well as with hypertonic glucose solution.

Children.

Experience with the use of this medicinal product in children is limited.

Overdose.

Due to the low toxicity of the medicinal product, intoxication is not expected, even if therapeutic doses have been accidentally exceeded.

In case of overdose, symptomatic treatment should be administered.

Side effects.

Side effects occur very rarely (<1/10,000), including isolated cases.

Psychiatric disorders: hallucinations.

Nervous system disorders: severe headache, vertigo.

Cardiovascular disorders: arterial hypertension, arterial hypotension.

Respiratory system disorders: dyspnea.

Gastrointestinal disorders: nausea, vomiting, occasional diarrhea.

Skin and subcutaneous tissue disorders: rash, hyperemia, exanthema, purpura.

General disorders: chills, edema.

Reporting of side effects.

Reporting of adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions.

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

Keep out of reach of children.

Incompatibility.

Do not use solvents not specified in the section "Method of administration and dosage."

Packaging. 4 ml in an ampoule; 5 ampoules in a blister pack; 1 blister pack in a cardboard box.

Prescription status. Prescription only.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address and location of business activity.

22 Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.