Instructions for Ronocyte oral solution 100mg/ml 10ml No. 10
Composition
active ingredient: citicoline;
1 ml of solution contains citicoline (in the form of citicoline sodium) 100 mg;
Excipients: sorbitol solution, non-crystallizing (E 420); glycine; methyl parahydroxybenzoate (E 218); propyl parahydroxybenzoate (E 216); sodium citrate dihydrate; sodium saccharin; strawberry flavor; potassium sorbate; citric acid, monohydrate; purified water.
Dosage form
Oral solution.
Main physicochemical properties: homogeneous transparent 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 of neuronal membranes, which is confirmed by magnetic resonance spectroscopy. Due to this mechanism of action, citicoline improves the functioning of such membrane mechanisms as the work of ion exchange pumps and receptors, the modulation of which is necessary for the normal conduction of nerve impulses.
Due to its stabilizing effect on the neuronal membrane, citicoline exhibits anti-edema properties that help reduce brain edema.
Experimental studies have shown that citicoline inhibits the activation of some 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 preserves the energy reserves of neurons, inhibits apoptosis, and stimulates the synthesis of acetylcholine.
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 in patients with acute ischemic stroke, which coincides with a slowdown in the growth of ischemic brain damage volume 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, cognitive and neurological disorders associated with cerebral ischemia, and helps reduce the manifestations of amnesia.
Pharmacokinetics
When administered orally, citicoline is almost completely absorbed. After its administration, a significant increase in choline levels in the blood plasma is observed.
Citicoline is metabolized in the intestines and liver to form choline and cytidine.
After administration, it 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. In the brain, citicoline is incorporated into cellular, cytoplasmic and mitochondrial membranes, integrating into the structure of the phospholipid fraction.
Only a small amount of the dose is found in the urine and feces (less than 3%). Approximately 12% of the dose is excreted through exhaled CO2. During the excretion of citicoline with urine, two phases are distinguished: in the first phase, which lasts for 36 hours, the rate of excretion decreases rapidly, in the second phase the rate of excretion decreases much more slowly. The same phasic nature is observed with excretion through the respiratory tract. The rate of CO2 excretion decreases rapidly, for 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 the active substance and/or to the excipients 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.
Citicoline should not be used concomitantly with drugs containing meclofenoxate.
Application features
The medicine contains sorbitol, therefore it should not be used in patients with hereditary fructose intolerance.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate, which are part of the medicinal product, may cause allergic reactions (usually of the delayed type).
This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially sodium-free.
Use during pregnancy or breastfeeding
There are no adequate data on the use of citicoline in pregnant women. Data on the excretion of citicoline into breast milk and its effect on the fetus are unknown. During pregnancy or breastfeeding, the drug can be used only if the expected therapeutic benefit to the mother outweighs the potential risk to the fetus/child.
Ability to influence reaction speed when driving vehicles or other mechanisms
In individual cases, some adverse reactions from the central nervous system may affect the ability to drive or use other mechanisms.
Method of administration and doses
The medicine is intended for oral use. The solution should be taken directly from the bottle or diluted in half a glass of water (120 ml), regardless of food intake.
The recommended dose for adults is 500 mg (5 ml) to 2000 mg (20 ml) per day, which should be divided into 2-3 doses, depending on the severity of symptoms.
The dosage and 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 the drug in children is limited.
Overdose
No cases of citicoline overdose have been reported.
Side effects
Adverse reactions occur very rarely (<1/10,000), including isolated cases.
From the nervous system:
severe headache, vertigo, hallucinations.
From the cardiovascular system:
arterial hypertension, arterial hypotension, tachycardia.
From the respiratory system, chest organs and mediastinum:
dyspnea.
From the digestive tract:
nausea, vomiting, diarrhea.
On the part of the immune system:
allergic reactions, including: rash, hyperemia, exanthema, purpura.
General reactions:
chills, swelling.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions that occur after the registration of a medicinal product is very important. This allows for continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions through the national pharmacovigilance system.
Expiration date
5 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging and out of the reach of children.
Packaging
10 ml in a bottle; 10 bottles in a cardboard box.
Vacation category
According to the recipe.
Producer
WORLD MEDICINE ILACH SAN. VE TIJ. A.Sh./WORLD MEDICINE ILAC SAN. VE TIC. AS
Location of the manufacturer and address of its place of business
15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey/15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey.
Applicant
WORLD MEDICINE, LLC, Ukraine.
