Instructions for use Cytimax-Darnitsa solution for injection 250 mg/ml ampoule 4 ml No. 10
Composition
active ingredient: citicoline;
1 ml of solution contains citicoline sodium equivalent to citicoline 250 mg;
1 ampoule (2 ml) contains citicoline sodium equivalent to citicoline 500 mg;
1 ampoule (4 ml) contains citicoline sodium equivalent to citicoline 1000 mg;
Excipients: diluted hydrochloric acid or sodium hydroxide, water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: clear colorless or slightly yellowish liquid.
Pharmacotherapeutic group
Psychostimulants and nootropics. ATX code N06B X06.
Pharmacological properties
Pharmacodynamics.
The active ingredient of the drug – citicoline – stimulates the biosynthesis of structural phospholipids in the membrane of neurons, which contributes to the improvement of membrane functions, including the functioning of ion exchange pumps and neuroreceptors. Due to its stabilizing effect on the membrane, it exhibits anti-edematous properties, therefore reducing brain edema. Research results have shown that citicoline inhibits the activity of some phospholipases, prevents the residual occurrence of free radicals, prevents damage to membrane systems and ensures the preservation of the protective antioxidant system. It also reduces the volume of damaged tissue, preventing cell death, acting on apoptosis mechanisms, and improves cholinergic transmission.
Due to its properties, citicoline:
– has a preventive neuroprotective effect in focal brain strokes;
– promotes rapid functional rehabilitation of patients with acute cerebral circulation disorders, reducing ischemic damage to brain tissue, which is confirmed by the results of X-ray studies;
– shortens the duration of the recovery period and reduces the intensity of post-traumatic syndrome in case of traumatic brain injuries;
– helps increase the level of brain activity, reduces the level of amnesia, improves the condition of cognitive, sensitive and motor disorders observed in cerebral ischemia.
Pharmacokinetics.
After administration of the drug, a significant increase in choline levels in blood plasma is observed.
The drug is metabolized in the intestines and liver to form choline and cytidine. After administration, citicoline is absorbed by brain tissues, with cholines acting on phospholipids, cytidine on cytidine nucleoids and nucleic acids. Citicoline quickly reaches brain tissues and is actively incorporated into cell membranes, cytoplasm and mitochondria, activating the activity of phospholipids.
Only a small amount of the administered drug is excreted in the urine and feces (less than 3%) and approximately 12% through the respiratory tract. The excretion of the drug in the urine and through the respiratory tract has two phases: the first phase is rapid excretion (with urine - during the first 36 hours, through the respiratory tract - during the first 15 hours), the second phase is slow excretion. The main part of citicoline is involved in metabolic processes.
Indication
– Acute phase of cerebrovascular accidents and treatment of their consequences.
– Traumatic brain injury and its consequences.
– Neurological disorders (cognitive, sensitive, motor) caused by cerebral pathology of degenerative and vascular origin.
Contraindication
– Hypersensitivity to the active substance or to other components of the drug.
– Increased tone of the parasympathetic nervous system.
Interaction with other drugs and other types of interactions.
When citicoline and levodopa are used simultaneously, the effect of the latter is enhanced.
The drug should not be prescribed simultaneously with drugs containing meclofenoxate.
Application features
The drug should be used immediately after opening the ampoule. The ampoule is intended for single use only. Any remaining drug should be discarded.
In case of persistent intracranial hemorrhage, the dose of citicoline should not exceed 1000 mg per day and the intravenous infusion rate should not exceed 30 drops per minute.
Use during pregnancy or breastfeeding
There are no sufficient data on the use of the drug in pregnant women. It is not known whether citicoline passes into breast milk. During pregnancy or breastfeeding, the drug should be used 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 use other mechanisms.
Method of administration and doses
The drug is administered intravenously or intramuscularly. In the case of intravenous administration, the drug should be administered in the form of a slow intravenous injection (over 3-5 minutes, depending on the dose administered) or intravenous drip infusion (40-60 drops per minute).
The recommended dose for adults is 500-2000 mg per day. 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 recommended duration of treatment, at which the maximum therapeutic effect is observed, is 12 weeks. If necessary, treatment should be continued with citicoline in a dosage form for oral administration.
Elderly patients do not require dose adjustment.
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.
Children
There is insufficient data on the use of citicoline in children. The drug is used in cases of urgent need, when the expected benefit from use outweighs the possible risk.
Overdose
There are no data on cases of drug overdose.
Adverse reactions
From the cardiovascular system: arterial hypertension, arterial hypotension, tachycardia.
From the nervous system and psyche: severe headache, dizziness, hallucinations.
From the respiratory system: dyspnea.
From the digestive tract: nausea, vomiting, diarrhea.
Immune system, skin and subcutaneous tissue disorders: hypersensitivity reactions including rash, purpura, pruritus, angioedema, anaphylactic shock.
General disorders: chills, edema, fever, increased sweating, changes at the injection site.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ° C. Do not freeze.
Keep out of reach of children.
Incompatibility.
The drug should not be mixed with other medicines in the same container.
Packaging
2 ml (500 mg) or 4 ml (1000 mg) in an ampoule; 3 ampoules in a contour blister pack; 1 contour blister pack in a pack; 5 ampoules in a contour blister pack; 1 contour blister pack in a pack; 5 ampoules in a contour blister pack; 2 contour blister packs in a pack.
Vacation category
According to the recipe.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and address of its place of business
Ukraine, 02093, Kyiv, Boryspilska St., 13.
