Cytoflavin injection 10ml, No. 5

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 during the neonatal period (including premature babies with a gestational age of 28-36 weeks):

• with cerebral ischemia.

For adults, CytoflavinЃ is administered only by intravenous 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.

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 severe cases of the disease, a single dose is increased to 20 ml.

With 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.

In case of toxic and hypoxic encephalopathy, the drug is administered in a volume of 10 ml per injection 2 times / day after 8-12 hours for 5 days. In a coma - in a volume of 20 ml for administration in a dilution of 200 ml of dextrose solution. With 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 is injected at a dilution of 200 ml of 5% dextrose solution 3 days before surgery, on the day of surgery, within 3 days after surgery.

In newborns (including premature infants) with cerebral ischemia, the daily dose of CytoflavinЃ 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 inject 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 estimated daily volume of solutions for basic therapy, the patient's hemodynamic state and indicators of the acid-base state. The average course of treatment is 5 days.

Active ingredients:

succinic acid - 100 g

inosine - 20 g

nicotinamide - 10 g

riboflavin (in the form of sodium riboflavin phosphate) 2 g

Excipients : meglumine (N-methylglucamine) - 165 g, sodium hydroxide - 34 g, water d / i - up to 1 l.

• pregnancy;

• breastfeeding period;

• hypersensitivity to the components of the drug.

The drug is not prescribed to patients in critical condition (except for the neonatal period), until the stabilization of central hemodynamics and / or when the partial pressure of oxygen in the arterial blood is below 60 mm Hg. Art.

The drug should be prescribed with caution for nephrolithiasis, gout, hyperuricemia.

Clinical and pharmacological group: A drug that improves brain metabolism

Pharmaco-therapeutic group: Other drugs for the treatment of diseases of the nervous system

pharmachologic effect

Pharmacological effects are due to the complex action of the components that make up the preparation CytoflavinЃ.

CytoflavinЃ enhances the intensity of aerobic glycolysis, which leads to the activation of glucose utilization and ?-oxidation of fatty acids, and also stimulates the synthesis of ?-aminobutyric acid in neurons.

CytoflavinЃ 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.

CytoflavinЃ 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. Has a quick awakening effect in post-anesthetic depression of consciousness.

When using the drug CytoflavinЃ in the first 12 hours from the onset of stroke, there is a favorable course of ischemic and necrotic processes in the affected area (decrease in the focus), restoration of the neurological status and a decrease in the level of disability in the long-term period.

Pharmacokinetics

With intravenous infusion at a rate of about 2 ml / min (in terms of undiluted CytoflavinЃ), succinic acid and inosine are utilized almost instantly and are not detected in blood plasma.

Succinic acid: Cmax 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 hypoxanthine and subsequent oxidation to uric acid. It is excreted in small quantities by the kidneys.

Nicotinamide is rapidly distributed in all tissues, crosses the placental barrier, and is excreted in breast milk. It is metabolized in the liver to form nicotinamide-N-methylnicotinamide, excreted by the kidneys. T1 / 2 from plasma is about 1.3 h, Vd in equilibrium is about 60 L, total clearance is about 0.6 L / min.

Riboflavin is distributed unevenly: the largest amount is in the myocardium, liver, kidneys. T1 / 2 from plasma is about 2 hours, Vd in equilibrium is about 40 L, total clearance is about 0.3 L / min. Penetrates through the placental barrier, excreted in breast milk. Plasma protein binding - 60%. It is excreted by the kidneys, partly as a metabolite; when used in high doses - mostly unchanged.

Indications

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 during the neonatal period (including premature babies with a gestational age of 28-36 weeks):

• with cerebral ischemia.

Dosage regimen

For adults, CytoflavinЃ is administered only by intravenous 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.

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 severe cases of the disease, a single dose is increased to 20 ml.

With 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.

In case of toxic and hypoxic encephalopathy, the drug is administered in a volume of 10 ml per injection 2 times / day after 8-12 hours for 5 days. In a coma - in a volume of 20 ml for administration in a dilution of 200 ml of dextrose solution. With 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 is injected at a dilution of 200 ml of 5% dextrose solution 3 days before surgery, on the day of surgery, within 3 days after surgery.

In newborns (including premature infants) with cerebral ischemia, the daily dose of CytoflavinЃ 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 inject 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 estimated daily volume of solutions for basic therapy, the patient's hemodynamic state and indicators of the acid-base state. The average course of treatment is 5 days.

Side effect

According to the WHO, undesirable effects are classified according to their frequency of development as follows: very often (? 1/10); often (? 1 / 100- <1/10); infrequently (? 1 / 1000- <1/100); rarely (? 1 / 10000- <1/1000); very rare (<1/10000); the frequency is unknown (the frequency cannot be determined from the available data).

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 physical activity).

From the side of the cardiovascular system: very rarely - tachycardia, short-term pain and discomfort in the chest area, a feeling of increased or increased heart rate, an increase or decrease in blood pressure, hyperemia or pallor of the skin of varying severity.

From the respiratory system: very rarely - difficulty breathing, shortness of breath, choking, 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.

On the part of the skin and subcutaneous tissues: very rarely - itching, rash, swelling of the face, urticaria.

From the side of metabolism: very rarely - transient hypoglycemia, hyperuricemia, exacerbation of gout. In children (including premature babies), alkalosis may develop during the neonatal period.

General disorders and disorders at the injection site: rarely - chills, fever, weakness, fever, sweating, pain and redness along the vein.

In order to avoid the occurrence of undesirable effects, it is recommended to observe the dosage regimen and the rate of administration of the drug.

If any of the undesirable effects indicated in the instructions are aggravated or any other undesirable effects not indicated in the instructions are noted, the patient should inform the doctor about it.

Contraindications for use

• pregnancy;

• breastfeeding period;

• hypersensitivity to the components of the drug.

The drug is not prescribed to patients in critical condition (except for the neonatal period), until the stabilization of central hemodynamics and / or when the partial pressure of oxygen in the arterial blood is below 60 mm Hg. Art.

The drug should be prescribed with caution for nephrolithiasis, gout, hyperuricemia.

Application during pregnancy and lactation

The use of the drug during pregnancy and lactation (breastfeeding) is contraindicated.

Application for impaired renal function

The drug should be used with caution in nephrolithiasis.

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 / day (both before the start and during therapy). If possible, serum lactate and glucose should be monitored.

The rate of administration of the solution containing CytoflavinЃ should be reduced or the infusion should be temporarily stopped in newborn (premature) infants:

• being on mechanical ventilation, with the appearance of signs of mixed (respiratory-metabolic) alkalosis, which threatens the development of cerebral circulation disorders;

• with preserved spontaneous breathing and respiratory support by 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 increased frequency of apnea attacks.

In patients with diabetes mellitus, treatment should be carried out under the control of a blood glucose value.

Intense yellow coloration of urine is possible.

Influence on the ability to drive vehicles and mechanisms

Care must be taken when driving vehicles and working with precise mechanisms due to the possible development of side effects (dizziness, psychomotor agitation). With the development of these side effects, it is necessary to abandon driving vehicles and working with precise mechanisms.

Overdose

No cases of CytoflavinЃ drug overdose were observed.

In case of an overdose, symptomatic therapy is performed.

Drug interactions

Succinic acid, inosine and 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 incorporation of riboflavin into flavin adenine mononucleotide and flavin adenine dinucleotide and increase its excretion in the urine.

With simultaneous use, thyroid hormones accelerate the metabolism of riboflavin.

When used together, CytoflavinЃ reduces and prevents the development of side effects of chloramphenicol (hematopoietic disorders, optic neuritis).

CytoflavinЃ is compatible with hematopoietic stimulants, antioxidants and anabolic steroids.

Storage conditions

The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 25 ? C.

Shelf life

Shelf life is 2 years. Do not use after the expiration date printed on the package.

Terms of sale

The drug is available with a prescription.