Instructions for use Lyra oral solution 100 mg/ml sachet 10 ml No. 10
Composition
active ingredient: citicoline;
1 ml of the drug contains citicoline sodium - 104.5 mg, calculated as citicoline - 100 mg;
excipients: methyl parahydroxybenzoate (E 218); propyl parahydroxybenzoate (E 216); potassium sorbate; sodium citrate; citric acid, monohydrate; sorbitol (E 420); sodium saccharin; strawberry flavoring; glycerin; purified water.
Dosage form
Oral solution.
Main physicochemical properties: transparent, colorless to yellowish solution.
Pharmacotherapeutic group
Psychostimulants, drugs used for attention deficit hyperactivity disorder (ADHD), nootropics. Other psychostimulants and nootropics. ATC code N06B X06.
Pharmacological properties
Pharmacodynamics.
Citicoline stimulates the biosynthesis of structural phospholipids in the membrane of neurons, 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 membrane of neurons, 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 has a preventive neuroprotective effect in focal cerebral ischemia.
Clinical studies have shown that citicoline significantly increases functional recovery rates in patients with acute 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, 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 nature 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
Patients with hereditary fructose intolerance should not take Lyra®, oral solution, as the preparation contains sorbitol. Methylparaben (E 218) and propylparaben (E 216), which are contained in the preparation, may cause allergic reactions (usually delayed).
This medicinal product contains 1.2 mmol sodium per 5 ml of the preparation. Caution should be exercised when administering this medicinal product to patients on a controlled sodium diet.
Use during pregnancy or breastfeeding
There are no adequate data on the use of citicoline in pregnant women. There are no data on the excretion of citicoline into breast milk and 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 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
Internally. The recommended dose for adults is from 500 mg (5 ml) to 2000 mg (20 ml) per day, which should be divided into 2-3 doses. Take regardless of meals.
The required amount of solution (draw into a syringe-doser or use the contents of one sachet) should be mixed with a small amount of water and taken using a syringe-doser. It is necessary to rinse the syringe-doser with water after each use.
The dosage of the drug and the duration of treatment depend on the severity of the brain lesions and are determined individually by the doctor.
Elderly patients do not require dose adjustment.
Children.
Experience with the use of citicoline in children is limited.
Overdose
Cases of overdose have not been described.
Adverse reactions
Very rare (<1/10,000) (including patient reports).
From the side of the central and peripheral nervous system: severe headache, vertigo, hallucinations.
From the cardiovascular system: arterial hypertension, arterial hypotension, tachycardia.
Respiratory system: shortness of breath.
On the part of the digestive system: 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
2 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in original packaging at a temperature not exceeding 25 °C. Do not freeze or refrigerate. Keep out of the reach of children.
Packaging
30 ml or 60 ml in a bottle. 1 bottle in a pack.
Or 10 ml in sachets. 10 sachets in a pack.
Vacation category
According to the recipe.
Producer
JSC "Farmak".
Location of the manufacturer and its business address.
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
