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NEUROCYTIN® solution for infusion

Instruction manual

For medical use of a medicinal product

Neurocytin®

Structure:

Active substances:

1 ml of solution contains: citicoline sodium (in terms of citicoline) - 10 mg, sodium chloride - 6 mg, potassium chloride - 0.4 mg, calcium chloride dihydrate - 0.27 mg, sodium lactate - 3.2 mg. Theoretical osmolarity - 288.3 mOsmol;

excipients: water for injection.

Dosage form.

Solution for infusion.

Basic physical and chemical properties: clear, colorless or slightly yellowish liquid.

Pharmacological group.

Solutions for intravenous use. electrolytes in combination with other agents. code atx v05v v04.

Pharmacological properties.

Pharmacodynamics

Neurocytin is a saline solution with a balanced content of electrolytes and citicoline.

Citicoline stimulates the biosynthesis of structural phospholipids in the membrane of neurons, improves the functions of membranes, including the functioning of ion-exchange pumps and neuroreceptors. Due to the stabilizing effect on the membrane, citicoline has decongestant properties, therefore, it reduces brain edema. Research results showed that citicoline suppresses the activity of certain phospholipases, prevents the residual formation of free radicals, prevents damage to membrane systems and ensures the preservation of the protective antioxidant system.

Citicoline reduces the volume of damaged tissue, preventing cell death, affecting the mechanisms of apoptosis, and improves cholinergic transmission. Citicoline also has a prophylactic neuroprotective effect in focal brain strokes.

Citicoline promotes rapid functional rehabilitation of patients with acute cerebrovascular accident, reducing ischemic damage to brain tissue, which is confirmed by the results of x-ray studies. With traumatic brain injuries, citicoline shortens the duration of the recovery period and reduces the intensity of the post-traumatic syndrome. Citicoline helps to increase the level of brain activity, reduces the level of amnesia, improves the condition with cognitive, sensitive and motor disorders observed in brain ischemia.

The drug compensates for the deficit in the volume of circulating blood. Lactate, which is part of the drug, as a result of metabolic processes turns into bicarbonate anions, which slightly changes the reaction of the blood to the alkaline side. The solution also has a detoxifying effect as a result of a decrease in the concentration of toxic products in the blood and activation of diuresis.

Pharmacokinetics

Citicoline is well absorbed by oral, intramuscular and intravenous administration. After administration of the drug, a significant increase in the level of choline in the blood plasma is observed. Studies have shown that the bioavailability of the oral and parenteral routes of administration is almost the same.

The drug is metabolized in the intestines and liver with the formation of choline and cytidine. After administration, citicoline is absorbed by the brain tissues, while cholins act on phospholipids, and cytidine acts on cytidine nucleoids and nucleic acids. Citicoline quickly reaches brain tissue and actively integrates into cell membranes, cytoplasm and mitochondria, activating the activity of phospholipids.

Only a small amount of the administered dose is excreted in urine and feces (less than 3%). Approximately 12% of the administered dose is excreted 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 bulk of the dose of citicoline is involved in metabolic processes.

Other components of the drug (anions, cations) are excreted in the urine.

Clinical characteristics.

Indications.

- The acute phase of cerebrovascular accident, complications and consequences of cerebrovascular accident.

- Traumatic brain injury and its consequences.

- Neurological disorders (cognitive, sensory, motor) caused by cerebral pathology of degenerative and vascular origin.

Contraindications

- Hypersensitivity to the components of the drug;

- Increased tone of the parasympathetic nervous system;

- Hypervolemia, hypernatremia, hyperkalemia, hyperchloremia, alkalosis, lactic acidosis;

- Severe arterial hypertension, decompensated heart failure;

- Oliguria, anuria;

- Liver failure (due to a decrease in the formation of bicarbonate from lactate);

- Acute renal failure;

- Hypercalcemia;

- Extracellular hyperhydration;

- Pulmonary edema, cerebral edema.

Interaction with other drugs and other types of interactions.

Citicoline enhances the effect of levodopa. the drug should not be prescribed simultaneously with medicines containing meclofenoxate. when using potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (APF) and potassium preparations, the risk of developing hyperkalemia is increased. in case of simultaneous use with cardiac glycosides, the toxic effect of the latter is enhanced due to the presence of Ca ++ ions in the solution.

The drug is incompatible with cefamandol, amphotericin, ethyl alcohol, thiopental, aminocaproic acid, metaraminol, ampicillin, vibramycin and monocycline. It is possible to increase the delay in sodium in the body while using such drugs: non-steroidal anti-inflammatory drugs, androgens, anabolic hormones, estrogens, corticotropin, mineralocorticoids, vasodilators or ganglion blockers.

Due to the presence of lactate, which alkalizes the pH, neurocytin® with drugs whose renal elimination depends on pH should be used with caution. The renal clearance of salicylates, barbiturates, lithium may decrease, and sympathomimetics and stimulants (such as dexamphetamine sulfate, fenfluramine hydrochloride) may increase.

Features of the application.

In the case of sustained intracranial hemorrhage, do not exceed a dose of 100 ml per day and an infusion rate of 30 drops per minute.

Blood should be monitored for electrolytes, pH and pCO2, lactate. The use of intravenous solutions can cause overloading with a liquid and / or solution, hyperhydration, congestion and pulmonary edema. The risk of dilution develops inversely with the concentration of electrolytes. The risk of developing an overload with a solution that causes congestion with peripheral edema and pulmonary edema is directly proportional to the concentration of electrolytes.

In case of any manifestations of a hypersensitivity reaction, immediately stop the administration of the solution and carry out the necessary treatment.

Since the drug contains sodium lactate, it should be used with extreme caution in patients prone to hypernatremia (for example, adrenocortical insufficiency, diabetes insipidus or massive tissue damage), and in patients with heart diseases; due to the content of sodium ions, the solution should be used with caution in elderly patients, patients with arterial hypertension, renal and cardiovascular failure, congestive heart failure, especially in the postoperative period, patients with hypoxia and liver failure, as well as patients with clinical conditions, accompanied by sodium retention and edema, patients receiving corticosteroids or corticotropin.

Due to the potassium content, caution is required when applying the solution to patients with heart diseases and clinical conditions accompanied by a delay in potassium in the body. Prescribing calcium, it is necessary to control the work of the heart with the help of an ECG, especially in patients receiving digitalis. Serum calcium levels do not always reflect tissue levels of calcium.

In patients with reduced renal excretory function, the appointment of a solution can lead to a delay in sodium or potassium.

Due to the presence of calcium ions in the preparation, caution is needed when it is prescribed with blood preparations through the likelihood of coagulation. Prescribe calcium parenterally to patients who receive cardiac glycosides, with extreme caution.

Lactate is a substrate for gluconeogenesis, therefore, blood glucose levels in patients with type II diabetes should be carefully monitored.

Use during pregnancy or lactation.

There is no data on the use of neurocytin in pregnant women. data on the excretion of the drug into breast milk and its effect on the fetus are unknown. therefore, during pregnancy and lactation, the drug is prescribed only when the expected benefit to the mother outweighs the potential risk to the fetus.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

In some cases, some adverse reactions from the central nervous system may affect the ability to drive vehicles or work with mechanisms.

Dosage and administration.

For intravenous administration.

The recommended dose for adults is from 50 ml to 200 ml per day in the form of a drip infusion (40-60 drops per minute).

Treatment: the first 2 weeks of 50-100 ml 2 times a day. The maximum daily dose is 200 ml.

In acute and emergency conditions, the maximum therapeutic effect is achieved if the drug is used in the first 24 hours.

Doses and duration of treatment depend on the severity of brain damage and are set individually.

Elderly patients do not require dose adjustment.

Children.

There is insufficient data regarding the use of the drug in children.

Overdose.

An overdose or too rapid administration of the solution can lead to a violation of the water-electrolyte balance, the phenomena of alkalosis, cardiopulmonary decompensation. in this case, the administration of the drug should be stopped immediately. conduct symptomatic therapy.

The introduction of excess lactate can lead to the development of metabolic alkalosis, which, in turn, may be accompanied by hypokalemia.

Symptoms: mood changes, fatigue, shortness of breath, muscle weakness, polydipsia, polyuria, impaired thinking, arrhythmia. Muscle hypertonicity, twitching, and tetanic cramps can develop in patients with hypocalcemia.

Adverse Reactions

Mental disorders: hallucinations.

From the nervous system: severe headache, dizziness.

From the cardiovascular system: arterial hypertension, arterial hypotension, tachycardia.

From the respiratory system: dyspnea.

From the digestive tract: nausea, vomiting, diarrhea.

Electrolyte imbalance: a change in the level of electrolytes (potassium, calcium, sodium, chlorine) in the blood serum, metabolic alkalosis, chloride acidosis.

Common disorders: hypervolemia.

On the part of the immune system: chills, edema, allergic reactions, including: rash, purpura, itching, angioedema, anaphylactic shock; fever, sweating, coughing, sneezing, shortness of breath, localized or generalized urticaria.

Changes in the place of infusion: inflammation, swelling, rash, itching, erythema, pain, burning, numbness at the site of infusion.

Mental disorders: panic attack.

In case of adverse reactions, the administration of the solution should be discontinued, the patients condition assessed and appropriate assistance provided.

Shelf life.

2 years.

Storage conditions.

Store at a temperature not exceeding 30 ° C in the original packaging. Keep out of the reach of children.

Incompatibility.

The drug should not be mixed with other drugs in the same container, including phosphate and carbonate solutions.

Packaging.

50 ml, 100 ml, 200 ml in a bottle; 1 bottle per pack; 100 ml or 200 ml in containers.

Vacation category.

On prescription.

Manufacturer.

LLC Yuri-Farm

The location of the manufacturer and his address of the place of business.

Ukraine, 18030, Cherkasy, st. Verbovetsky, 108.

Tags: Neurocytin