CYTOFLAVIN metabolic agent - 10 ml solution for intravenous injection 5 amp

CYTOFLAVIN® is a metabolic agent. All Cytoflavin ingredients are natural body metabolites and stimulate tissue respiration.

Brand name: CYTOFLAVIN®

Dosage form: solution for intravenous use.

Therapeutic category: metabolic regulator.

CYTOFLAVIN® possesses anti-hypoxic activity, stimulating energy production in the cells; reduces free radical generation, and restores antioxidant enzyme activities.

Pharmacological effects of CYTOFLAVIN® are governed by the combined action of the ingredients, constituting it.

CYTOFLAVIN® improves coronary and cerebral blood flow; activates metabolic processes in central nervous system; promotes recovery of consciousness, reflex alterations, and paresthesia; improves intellectual and mental functions. It also greatly reduces postanesthetic arousal time in postanesthetic clouding of consciousness.

Administration of CYTOFLAVIN® within 12 hours after onset of cerebral stroke has beneficial effect on ischemic and necrotic lesions (diminution of lesion focus), normalizes neurologic status and significantly reduces the rate of disability in a long-term perspective.

Compound:

Active ingredients: succinic acid - 100 g, nicotinamide - 10 g, inosine - 20 g, riboflavin (riboflavin phosphate sodium) - 2 g;
Excipients: meglumine (N-methylglucamine) - 165 g, sodium hydroxide - 34 g, water for injection - up to 1.0 l.

Pharmacotherapeutic group: metabolic agent

Pharmacodynamics: 

Pharmacological effects are due to the complex effect of the constituents of the drug CYTOFLAVIN®
substances. CYTOFLAVIN® enhances the intensity of aerobic glycolysis, which leads to the activation of glucose utilization and α-oxidation of fatty acids, and also stimulates the synthesis of α-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 the nervous tissue.
CYTOFLAVIN® improves coronary and cerebral blood flow, activates metabolic processes in the central nervous system, restores disturbed consciousness, promotes regression of neurological symptoms and improves cognitive functions of the brain. It has a quick awakening effect in case of post-narcotic 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 (decrease in focus), restoration of neurological status and a decrease in the level of disability in the long-term period are observed.

Pharmacokinetics:

With intravenous infusion 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 blood plasma.
Succinic acid: the peak concentration is determined within the first minute after administration, with a further rapid decrease without cumulation and its level returning to background values as a result of enzymatic decomposition to water and carbon dioxide.
Inosine is metabolized in the liver with the formation of inosine monophosphate, followed by its oxidation to urinary
acids. In a small amount excreted by the kidneys. Nicotinamide is rapidly distributed in all tissues, crosses the placenta and into breast milk, is metabolized in the liver to form N-methylnicotinamide, and excreted by the kidneys. The plasma half-life is about 1.3 hours, the equilibrium volume of distribution is about 60 liters, the total clearance is about 0.6 l / min.
Riboflavin is unevenly distributed: the largest amount is in the myocardium, liver and kidneys. The half-life from plasma is about 2 hours, the equilibrium volume of distribution is about 40 liters, 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 - mostly unchanged.

Indications:

In adults in complex therapy:
- cerebral infarction;
- consequences of cerebrovascular diseases (cerebral infarction, cerebral atherosclerosis);
- toxic and hypoxic encephalopathy in acute and chronic poisoning, endotoxicosis, postanesthetic depression of consciousness, as well as for the prevention and treatment of hypoxic encephalopathy during cardiac surgery using cardiopulmonary bypass, for the prevention of cognitive disorders after major surgical interventions in elderly patients.

In children (including premature babies with a gestational age of 28-36 weeks) in complex therapy in the neonatal period:
- with cerebral ischemia

Contraindications:

Individual intolerance to the components of the drug, pregnancy, breastfeeding period. It is not prescribed for patients (except for the neonatal period) who are in critical condition until stabilization of central hemodynamics and / or when the partial pressure of oxygen in arterial blood decreases below 60 mm Hg. Art.

Carefully:

With nephrolithiasis, gout, hyperuricemia. If you have one of the listed diseases, be sure to consult your doctor before taking CYTOFLAVIN®.
Use during pregnancy and during breastfeeding
CYTOFLAVIN® is contraindicated during pregnancy and during breastfeeding.

Dosage and administration:

In adults CYTOFLAVIN® is used only intravenously in a dilution of 100-200 ml of 5-10% dextrose solution or 0.9% sodium chloride solution.

The rate of administration is 3-4 ml / min.
1. In case of cerebral infarction, the drug is administered as early as possible from the onset of the development of the disease in a volume of 10 ml per injection with an interval of 8-12 hours for 10 days. In a severe form of the course of the disease, a single dose is increased to 20 ml.
2. With 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. In case of toxic and hypoxic encephalopathy, the drug is administered in a volume of 10 ml per injection twice a day after 8-12 hours for 5 days. In a coma - in a volume of 20 ml per injection in a dilution of 200 ml of dextrose solution. With post-anesthetic depression of consciousness - once in the same doses. In the treatment of hypoxic encephalopathy during cardiac surgery using cardiopulmonary bypass, 20 ml of the drug is administered at a dilution of 200 ml of 5% dextrose solution 3 days before surgery, on the day of surgery, within 3 days after surgery.
4. For the prevention of cognitive disorders after major surgical interventions in elderly patients, the drug is administered in a volume of 20 ml per injection in a dilution of 200 ml of 0.9% sodium chloride solution. The course of treatment - 7 days according to the scheme: the first injection - a day before the operation; the second - intraoperative administration after the introduction of anesthesia (the beginning of the 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 babies) 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 drip (slowly) after dilution in 5% or 10% dextrose solution (in a ratio of at least 1:5). The time of the first injection 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 during the day, depending on the calculated daily volume of solutions for basic therapy, the patient's hemodynamic state and indicators of the acid-base state. The course of treatment is an average of 5 days.

Side effects:

According to the World Health Organization, adverse reactions are classified according to the frequency of their development as follows:
- very frequent (? 1/10);
- frequent (? 1/100 - < 1/10);
- infrequent (? 1/1000 - < 1/100);
- rare (? 1/10000 - < 1/1000);
- very rare (< 1/10000);
- frequency unknown (cannot be determined from available data).

Immune system disorders: very rarely - hypersensitivity reactions, anaphylactic shock.
Nervous system disorders: very rarely - headache, dizziness, paresthesia, tremor, hypoesthesia.
Mental disorders: very rarely - psychomotor agitation (anxiety, increased motor activity).
Cardiac disorders: very rarely - tachycardia, short-term pain and discomfort in the chest area, a feeling of increased or increased heart rate.
Vascular disorders: very rarely - increase or decrease in blood pressure, hyperemia or pallor of the skin of varying severity.
Respiratory system disorders chest and mediastinum: very rarely - shortness of breath (shortness of breath), suffocation, sore throat, dry cough, hoarseness, paresthesia in the nose, dysosmia, bronchospasm.

Gastrointestinal disorders: very rarely - bitterness, dryness, metallic taste in the mouth, short-term pain and discomfort in the epigastric areas, nausea, vomiting, oral hypesthesia, dyspepsia.
Skin and subcutaneous tissue disorders: very rarely - pruritus, rash, swelling of the face, urticaria, angioedema, sweating.
Metabolic and nutritional disorders: very rarely - transient hypoglycemia, hyperuricemia, exacerbation of gout. In children (including premature babies) in the period newborns may develop alkalosis.
General disorders and disorders at the injection site: rarely - chills, fever, weakness, fever, pain and redness along the vein.
Laboratory and instrumental data: very rarely - rapid breathing.
In order to avoid the occurrence of unwanted reactions, it is recommended to observe the dosing regimen and the rate of administration drug.
If any of the adverse reactions indicated in the instructions are aggravated or you notice any other adverse reactions not listed in the instructions, tell your doctor.

Overdose:

There were no cases of overdose. In case of overdose, carry out symptomatic therapy.
drug interaction
Succinic acid, inosine, nicotinamide are compatible with other drugs.
Riboflavin reduces the activity of doxycycline, tetracycline, oxytetracycline, erythromycin and lincomycin.

Incompatible with streptomycin.

Chlorpromazine, imipramine, amitriptyline, due to the blockade of flavinokinase, disrupt the inclusion of riboflavin in
flavin adenine mononucleotide and flavin adenine dinucleotide and increase its excretion in the urine. Thyroid hormones speed up the metabolism of riboflavin. Reduces and prevents side effects of chloramphenicol (impaired hematopoiesis, optic neuritis). Compatible with drugs that stimulate hematopoiesis, antihypoxants, anabolic steroids.
special instructions
The introduction 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). If possible, serum lactate and glucose levels should be monitored. 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 artificial lung ventilation - with the appearance of signs of mixed (respiratory-metabolic) alkalosis, threatening the development of cerebrovascular accidents;
- with preserved spontaneous breathing and respiratory support by the method of constant positive pressure
in the respiratory tract (CPAP) or receiving an air-oxygen mixture through a mask - when laboratory signs of metabolic alkalosis appear, threatening the appearance or increase in apnea attacks. In patients with diabetes mellitus, treatment should be carried out under the control of blood glucose. Perhaps intense staining of urine in yellow.

Influence on the ability to drive vehicles, mechanisms:

Care must be taken when driving vehicles and operating precision machinery due to
possible development of side effects (dizziness, psychomotor agitation). With the development of these side effects, it is necessary to refuse to drive vehicles and work with precise mechanisms.

Storage temperature: 2℃ to 25℃

Form release:

Solution for intravenous administration in ampoules of 10 ml of colorless or brown glass. 5 ampoules in a blister pack, open or thermally sealed with a cover film or aluminum foil; 1 or 2 blister packs together with instructions for use in a carton box.

Guaranteed authenticity and quality:

100% Original from POLYSAN (Russian Federation)

Development and production:

POLYSAN (Russian Federation)