Instructions for Teuton injection solution 1000 mg/4 ml ampoule 4 ml No. 5
Composition
active ingredient: citicoline;
1 ampoule (4 ml) contains citicoline (in the form of citicoline sodium) 500 mg or 1000 mg;
Excipients: sodium hydroxide or hydrochloric acid, water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: transparent colorless or yellowish solution.
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.
ATX code N06B X06.
Pharmacological properties
Pharmacodynamics.
Citicoline stimulates the biosynthesis of structural phospholipids of neuronal membranes, which is confirmed by magnetic resonance spectroscopy. Citicoline improves the functioning of such membrane mechanisms as ion pumps and receptors, without the regulation of which normal conduction of nerve impulses is impossible. Due to its stabilizing effect on the neuronal membrane, citicoline exhibits anti-edematous properties that contribute to the reabsorption of brain edema.
Clinical 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 neuronal energy reserves and inhibits apoptosis, which improves cholinergic transmission.
It has been experimentally proven that citicoline also exhibits a preventive neuroprotective effect in focal cerebral ischemia.
Clinical studies have shown that citicoline significantly increases functional recovery rates in patients with acute cerebrovascular accident, which coincides, according to neuroimaging data, with a slowdown in the growth of ischemic brain damage. 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, helps reduce the manifestations of amnesia, cognitive and other neurological disorders associated with cerebral ischemia.
Pharmacokinetics.
Citicoline is well absorbed after oral, intramuscular and intravenous administration. Plasma choline levels increase significantly after administration by the above routes. Absorption after oral administration is almost complete and bioavailability is almost the same as after intravenous administration.
Depending on the route of administration, the drug is metabolized in the intestine, liver to 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. Having reached the brain, citicoline is incorporated into cellular, cytoplasmic and mitochondrial membranes, participating in the construction of the phospholipid fraction.
Only a small amount of the dose is excreted in the urine and feces (less than 3%). Approximately 12% of the dose is excreted in exhaled CO2. There are two phases in the excretion of the drug in the urine: the first phase is approximately 36 hours, in which the rate of excretion decreases rapidly, and the second phase, in which the rate of excretion decreases much more slowly. The same phasic pattern is observed in the excretion of CO2, the rate of excretion of exhaled CO2 decreases rapidly after about 15 hours, then it decreases much more slowly.
Indication
- Stroke, acute phase of cerebrovascular disorders and treatment of 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 any component of the drug.
Increased tone of the parasympathetic nervous system.
Interaction with other medicinal products and other types of interactions
The drug should not be used simultaneously with drugs containing meclofenoxate. It enhances the effect of levodopa.
Application features
In case 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.
The 500 mg/4 ml formulation contains less than 23 mg/ampoule of sodium, i.e. essentially sodium-free. The 1000 mg/4 ml formulation contains 45.04 mg/ampoule of sodium. Caution should be exercised when administering to patients on a controlled sodium diet.
Use during pregnancy or breastfeeding
There are no sufficient data on the use of the drug Tevtona in pregnant women. Data on the excretion of citicoline into breast milk and its effect on the fetus are absent. Therefore, during pregnancy or breastfeeding, the drug can 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 some 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 drug should be used for intravenous or intramuscular administration, administered intravenously in the form of a slow intravenous injection (over 3-5 minutes, depending on the prescribed dose) or intravenously drip (40-60 drops per minute).
The recommended dose for adults is 500-2000 mg/day, depending on the severity of the patient's condition.
The maximum daily dose is 2000 mg.
In acute and emergency conditions, the maximum therapeutic effect is achieved when the drug is administered in the first 24 hours.
The duration of treatment depends on the course of the disease and is determined by the doctor.
No dose adjustment is required for elderly patients.
The drug is compatible with all intravenous isotonic solutions, as well as with hypertonic glucose solutions.
This solution is for single use only. The solution should be administered immediately after opening the ampoule. Any unused solution should be discarded.
If necessary, continue treatment with the drug in the form of a solution for oral administration.
Children.
Experience with the drug in children is limited, so the drug should only be prescribed when the expected benefit outweighs any potential risk.
Overdose
Cases of overdose have not been described.
Side effects
Very rare (< 1/10,000) (including patient reports).
From the central and peripheral nervous system
Severe headache, vertigo, hallucinations.
Cardiovascular system
Arterial hypertension, arterial hypotension, tachycardia.
Respiratory system
Dyspnea.
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, changes at the injection site.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
5 years.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Incompatibility.
Do not use solvents not listed in the “Method of administration and dosage” section.
Packaging
4 ml of solution in an ampoule, 5 ampoules in a contour blister pack, 1 contour blister pack together with instructions for medical use in a cardboard box.
Vacation category
According to the recipe.
Producer
K.T. Rompharm Company S.R.L.
Location of the manufacturer and address of its place of business.
Eroilor St. No. 1A, Otopeni, 075100, Ilfov County, Romania - Romfarm 1 and Romfarm 2 buildings.
Applicant
"FORCE-PHARMA DISTRIBUTION" LLC.
Location of the applicant.
Ukraine, 03127, Kyiv, Holosiivskyi Avenue, 132.
