CYTOFLAVIN solution for intravenous administration 10ml ampoule No. 10
Pharmacodynamics Pharmacological effects are due to the complex effect of the components included in the drug CYTOFLAVIN®. CYTOFLAVIN® promotes activation of aerobic cell metabolism, which leads to an increase in the level of glucose utilization, promotes an increased level of beta-oxidation of fatty acids and the resynthesis of γ-aminobutyric acid in neurons. CYTOFLAVIN® increases the resistance of the membranes of nerve and glial cells to the effects of ischemia, which is expressed in a decrease in the concentration of neurospecific proteins that characterize the level of destruction of the main structural components of nervous tissue. CYTOFLAVIN® improves coronary and cerebral blood flow, activates metabolic processes in the central nervous system, restores impaired consciousness, promotes regression of neurological symptoms and improves cognitive functions of the brain. It has a quick awakening effect during post-anesthesia depression of consciousness. When using the drug CYTOFLAVIN® in the first 12 hours from the onset of stroke, a favorable course of ischemic and necrotic processes in the affected area (reduction of the lesion), restoration of neurological status and a decrease in the level of disability in the long-term period are observed. Pharmacokinetics When administered intravenously at a rate of about 2 ml/min (in terms of undiluted CYTOFLAVIN®), succinic acid and inosine are utilized almost instantly and are not detected in the blood plasma. Succinic acid - the peak concentration is determined within the first minute after administration, with a further rapid decrease without cumulation and a return of its level to background values due to metabolization to water and carbon dioxide. Inosine is metabolized in the liver to form inosine monophosphate, followed by its oxidation to uric acid. A small amount is excreted by the kidneys. Nicotinamide is rapidly distributed in all tissues, penetrates the placenta and into breast milk, is metabolized in the liver to form N-methylnicotinamide, and is excreted by the kidneys. The plasma half-life is about 1.3 hours, the equilibrium volume of distribution is about 60 liters, and the total clearance is about 0.6 l/min. Riboflavin is distributed unevenly: the largest amount is in the myocardium, liver, and kidneys. The plasma half-life is about 2 hours, the equilibrium volume of distribution is about 40 liters, and the total clearance is about 0.3 l/min. Penetrates through the placenta and into breast milk. Communication with plasma proteins - 60%. Excreted by the kidneys, partly in the form of a metabolite; in high doses - mainly unchanged.
Cytoflavin (amp. 10 ml No. 5 (pack dark st. contact cell))
A country
Russia
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Active substance
Inosine + Nicotinamide + Riboflavin + Succinic acid
Compound
1 ampoule contains: succinic acid 100 g, inosine (riboxin) 20 g, nicotinamide 10 g, sodium riboflavin phosphate (riboflavin) 2 g per 1 liter.
Excipients: meglumine (N-methylglucamine) - 165 g, sodium hydroxide - 34 g, water for injection - up to 1 l. The solution for intravenous administration is transparent, yellow.
pharmachologic effect
Pharmacological effects are due to the complex effect of the components included in the drug Cytoflavin®. Cytoflavin® increases the intensity of aerobic glycolysis, which leads to activation of glucose utilization and β-oxidation of fatty acids, and also stimulates the synthesis of β-aminobutyric acid in neurons. Cytoflavin® increases the resistance of the membranes of nerve and glial cells to ischemia, which is expressed in a decrease in the concentration of neurospecific proteins that characterize the level of destruction of the main structural components of nervous tissue. Cytoflavin® improves coronary and cerebral blood flow, activates metabolic processes in the central nervous system, restores impaired consciousness, promotes regression of neurological symptoms and improves cognitive functions of the brain. It has a quick awakening effect during post-anesthesia depression of consciousness. When using the drug Cytoflavin® in the first 12 hours from the onset of stroke, a favorable course of ischemic and necrotic processes in the affected area (reduction of the lesion), restoration of neurological status and a decrease in the level of disability in the long-term period are observed.
Indications for use
As part of complex therapy in adults: - cerebral infarction; — consequences of cerebrovascular diseases (cerebral infarction, cerebral atherosclerosis); - toxic and hypoxic encephalopathy in acute and chronic poisoning, endotoxicosis, depression of consciousness after anesthesia; — prevention and treatment of hypoxic encephalopathy during cardiac surgery using artificial circulation. As part of complex therapy in children in the neonatal period (including premature infants with a gestation period of 28-36 weeks): - for cerebral ischemia.
Mode of application
For adults, Cytoflavin® is administered only intravenously in a dilution of 100-200 ml of 5-10% dextrose solution or 0.9% sodium chloride solution. The injection rate is 3-4 ml/min. In case of cerebral infarction, the drug is administered as early as possible from the onset of the disease in a volume of 10 ml per injection with an interval of 8-12 hours for 10 days. In severe cases of the disease, the single dose is increased to 20 ml. For the consequences of cerebrovascular diseases (cerebral infarction, cerebral atherosclerosis), the drug is administered in a volume of 10 ml per injection 1 time/day for 10 days. For toxic and hypoxic encephalopathy, the drug is administered in a volume of 10 ml per injection 2 times a day every 8-12 hours for 5 days. In a comatose state - in a volume of 20 ml per injection diluted with 200 ml of dextrose solution. In case of depression of consciousness after anesthesia - once in the same doses. In the treatment of hypoxic encephalopathy during cardiac surgery using artificial circulation, 20 ml of the drug diluted with 200 ml of a 5% dextrose solution is administered 3 days before surgery, on the day of surgery, and for 3 days after surgery. In children in the neonatal period (including premature infants) with cerebral ischemia, the daily dose of Cytoflavin® is 2 ml/kg. The calculated daily dose of the drug is administered intravenously (slowly) after dilution in a 5% or 10% dextrose solution (in a ratio of at least 1: - 5). The time of the first administration is the first 12 hours after birth; — the optimal time to start therapy is the first 2 hours of life. It is recommended to administer the prepared solution using an infusion pump at a rate of 1 to 4 ml/h, ensuring a uniform flow of the drug into the bloodstream throughout the day, depending on the calculated daily volume of solutions for basic therapy, the patient’s hemodynamic condition and acid-base parameters. The average course of treatment is 5 days.
Interaction
Succinic acid, inosine and nicotinamide (the active ingredients of Cytoflavin®) are compatible with other drugs. Riboflavin reduces the activity of doxycycline, tetracycline, oxytetracycline, erythromycin and lincomycin. Incompatible with streptomycin. Chlorpromazine, imipramine, amitriptyline, by blocking flavinokinase, disrupt the incorporation of riboflavin into flavin adenine mononucleotide and flavin adenine dinucleotide and increase its excretion in the urine. When used simultaneously, thyroid hormones accelerate the metabolism of riboflavin. When used together, Cytoflavin® reduces and prevents the development of side effects of chloramphenicol (hemopoiesis disorders, optic neuritis). Cytoflavin® is compatible with hematopoiesis-stimulating agents, antioxidants and anabolic steroids.
Side effect
According to WHO, undesirable effects are classified according to their frequency of development as follows: very often (? 1/10); often (?1/100- From the immune system: very rarely - hypersensitivity reactions, angioedema, anaphylactic shock. From the nervous system: very rarely - headache, dizziness, paresthesia, tremor. Mental disorders: very rarely - psychomotor agitation ( anxiety, increased motor activity) From the cardiovascular system: very rarely - tachycardia, short-term pain and discomfort in the chest, a feeling of increased or increased heart rate, increased or decreased blood pressure, hyperemia or pallor of the skin of varying severity. side of the respiratory system: very rarely - difficulty breathing, shortness of breath, suffocation, sore throat, dry cough, hoarseness, paresthesia in the nose, dysosmia. From the digestive system: very rarely - bitterness, dryness, metallic taste in the mouth, short-term pain and discomfort in the epigastric region, nausea, vomiting.From the skin and subcutaneous tissues: very rarely - itching, rash, swelling of the face, urticaria. Metabolic disorders: very rarely - transient hypoglycemia, hyperuricemia, exacerbation of gout. Children (including premature babies) may develop alkalosis during the neonatal period. Other: rarely - chills, feeling hot, weakness, increased body temperature, sweating, pain and redness along the vein. To avoid unwanted effects, it is recommended to adhere to the dosage regimen and rate of administration of the drug. If any of the undesirable effects indicated in the instructions are aggravated or any other undesirable effects not specified in the instructions are noted, the patient should inform the doctor.
Contraindications
- pregnancy; - period of breastfeeding; - hypersensitivity to the components of the drug. The drug is not prescribed to patients in critical condition (except for the neonatal period) until central hemodynamics are stabilized and/or when the partial pressure of oxygen in arterial blood decreases below 60 mmHg. Art. The drug should be prescribed with caution for nephrolithiasis, gout, and hyperuricemia.
Overdose
There were no symptoms of an overdose of the drug Cytoflavin®. In case of overdose, symptomatic therapy is carried out.
special instructions
Administration of the drug to newborn (premature) children should be carried out under the control of indicators of the acid-base state of capillary blood at least 2 times a day (both before and during therapy). Serum lactate and glucose levels should be monitored whenever possible. The rate of administration of a solution containing Cytoflavin® should be reduced or the infusion should be temporarily stopped in newborn (premature) children: - those on mechanical ventilation, when signs of mixed (respiratory-metabolic) alkalosis appear, threatening the development of cerebrovascular accidents; - with preserved spontaneous breathing and respiratory support using the method of continuous positive airway pressure (CPAP) or receiving an air-oxygen mixture through a mask when laboratory signs of metabolic alkalosis appear, threatening the appearance or increase in frequency of apnea attacks. In patients with diabetes mellitus, treatment should be carried out under the control of blood glucose. Possible intense yellow coloration of urine. Effect on the ability to drive vehicles and operate machinery The drug does not affect the ability to drive vehicles.
Storage conditions
Room temperature
Dispensing conditions in pharmacies
On prescription
CYTOFLAVIN®
In adults
CYTOFLAVIN® is used only intravenously by drip in a dilution of 100-200 ml of 5-10% dextrose solution or 0.9% sodium chloride solution.
The injection rate is 3^4 ml/min.
1. In case of cerebral infarction
the drug is administered as early as possible from the onset of the disease in a volume of 10 ml per injection with an interval of 8-12 hours for 10 days. In severe cases of the disease, the single dose is increased to 20 ml.
2. For the consequences of cerebrovascular diseases (cerebral infarction, cerebral atherosclerosis)
the drug is administered in a volume of 10 ml per injection once a day for 10 days.
3. For toxic and hypoxic encephalopathy
the drug is administered in a volume of 10 ml per injection twice a day every 8-12 hours for 5 days. In a comatose state - in a volume of 20 ml per injection diluted with 200 ml of dextrose solution. In case of post-anesthesia depression of consciousness - once in the same doses. In the treatment of hypoxic encephalopathy during cardiac surgery using artificial circulation, 20 ml of the drug diluted with 200 ml of a 5% dextrose solution is administered 3 days before surgery, on the day of surgery, and for 3 days after surgery.
4. For the prevention of cognitive impairment after major surgery in elderly patients
the drug is administered in a volume of 20 ml per injection diluted with 200 ml of 0.9% sodium chloride solution. The course of treatment is 7 days according to the following scheme: first administration - one day before surgery; the second is intraoperative administration after induction of anesthesia (start of infusion within 30 minutes from the start of the operation), then within 5 days after the operation. In the future, it is recommended to use the drug "CYTOFLAVIN® enteric-coated tablets" 2 tablets 2 times a day with an interval between doses of 8-10 hours for 25 days.
In children (including premature infants)
in the neonatal period with cerebral ischemia, the daily dose of CYTOFLAVIN® is 2 ml/kg. The calculated daily dose of the drug is administered intravenously (slowly) after dilution in a 5% or 10% dextrose solution (in a ratio of at least 1:5). The time of the first administration is the first 12 hours after birth; The optimal time to start therapy is the first 2 hours of life. It is recommended to administer the prepared solution using an infusion pump at a rate of 1 to 4 ml/h, ensuring a uniform flow of the drug into the bloodstream throughout the day, depending on the calculated daily volume of solutions for basic therapy, the patient’s hemodynamic state and acid-base parameters. The course of treatment averages 5 days.
Dosages from the instructions, methods of use of Cytoflavin
Options for therapeutic manipulations, their duration and doses depend on the form of the prescribed medications:
- Tablets - twice a day, 2 units, in the morning and evening, with a 7-hour break between doses. The medicine is used half an hour before meals, without chewing. The standard course does not exceed 25 days; if necessary, treatment is repeated after an interval of one month.
- The solution in ampoules is administered intravenously through a dropper; the use of injections is prohibited. The medication is diluted in 300 ml of sodium chloride or glucose solution. The daily dosage for adults is 10-20 ml, depending on the severity of the condition. The duration of therapy does not exceed 10 days.
For newborns and premature infants, droppers are used at a rate of 2 ml of product per kilogram of body weight. Therapeutic manipulations last 5 days, Cytoflavin is dripped for 2-12 hours in a row.
The instructions show that during clinical studies, not a single obvious case of overdose was recorded. The drug is not used during pregnancy; it can be prescribed when hypoxia in the fetus is determined.
