Cytoflavin injection 10ml, No. 10

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BIDL3179569
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Expiration Date: 05/2027

Russian Pharmacy name:

Цитофлавин раствор для инъекций 10мл, №10

Cytoflavin injection 10ml, No. 10

In adults (as part of complex therapy)

  • acute disorders of cerebral circulation;

  • consequences of cerebrovascular diseases (cerebral infarction, cerebral atherosclerosis);

  • toxic and hypoxic encephalopathy in acute and chronic poisoning, endotoxicosis, post-anesthetic depression of consciousness, as well as for the prevention and treatment of hypoxic encephalopathy during cardiac surgery using artificial circulation.

In newborns (including premature babies with a gestational age of 28Ц36 weeks) in complex therapy

  • cerebral ischemia.

Intravenous drip in a dilution of 100-200 ml of 5-10% dextrose solution or 0.9% sodium chloride solution.

Adults

In case of acute disturbance of cerebral circulation, 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 once a 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 a 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 post-anesthetic depression - 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, 3 days after surgery.

Children (including premature babies)

For newborns with cerebral ischemia, the daily dose of CytoflavinЃ is 2 ml / kg / day. The calculated daily dose of the drug is injected intravenously (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.

Intravenous solution1 l
active substances:
succinic acid100 g
nicotinamide10 g
riboxin (inosine)20 g
riboflavin mononucleotide (riboflavin)2 g
excipients: N-methylglucamine (meglumine) - 165 g; sodium hydroxide - 34 g; water for injection - up to 1 l

  • individual intolerance to the components of the drug;

  • patients (except for the neonatal period) who are in critical condition, before stabilization of central hemodynamics and / or when the partial pressure of oxygen in arterial blood is less than 60 mm Hg. Art .;

  • pregnancy;

  • lactation period.

With care: nephrolithiasis; gout; hyperuricemia. If the patient has one of the listed diseases, it is necessary to consult a doctor before taking CytoflavinЃ.

pharmachologic effect

Pharmacological action - neurometabolic .

Pharmacodynamics

Pharmacological effects are due to the complex effect of the components included in the preparation CytoflavinЃ.

CytoflavinЃ promotes activation of aerobic cell metabolism, which leads to an increase in the level of glucose utilization, increases the level of beta-oxidation of fatty acids and GABA resynthesis in neurons.

CytoflavinЃ 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 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 after 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.

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 1 min after administration, with further rapid reduction without cumulation and the 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. It is excreted in small quantities 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 is excreted by the kidneys. T1 / 2 from plasma is about 1.3 h, Vss 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, Vss is about 40 l, total clearance is about 0.3 l / min. Penetrates through the placenta and into breast milk. Communication with plasma proteins - 60%. It is excreted by the kidneys, partly in the form of a metabolite; in high doses - mostly unchanged.

Indications for CytoflavinЃ

In adults (as part of complex therapy)

  • acute disorders of cerebral circulation;

  • consequences of cerebrovascular diseases (cerebral infarction, cerebral atherosclerosis);

  • toxic and hypoxic encephalopathy in acute and chronic poisoning, endotoxicosis, post-anesthetic depression of consciousness, as well as for the prevention and treatment of hypoxic encephalopathy during cardiac surgery using artificial circulation.

In newborns (including premature babies with a gestational age of 28Ц36 weeks) in complex therapy

  • cerebral ischemia.

Contraindications

  • individual intolerance to the components of the drug;

  • patients (except for the neonatal period) who are in critical condition, before stabilization of central hemodynamics and / or when the partial pressure of oxygen in arterial blood is less than 60 mm Hg. Art .;

  • pregnancy;

  • lactation period.

With care: nephrolithiasis; gout; hyperuricemia. If the patient has one of the listed diseases, it is necessary to consult a doctor before taking CytoflavinЃ.

Application during pregnancy and lactation

It can be used during pregnancy in the absence of allergic reactions to the components of the drug.

Side effects

With a rapid drip, undesirable reactions may appear that do not require discontinuation of the drug: flushing of the skin of varying severity, a feeling of heat, bitterness and dry mouth, sore throat.

Rare adverse reactions include: short-term pain and discomfort in the epigastric region and chest area, difficulty breathing, nausea, headache, dizziness, tingling in the nose, dysosmia, pale skin of varying severity.

Allergic reactions are also possible in the form of pruritus, transient hypoglycemia, hyperuricemia, exacerbation of gout.

In newborns (including premature babies), it is possible to develop violations of the acid-base balance (alkalosis).

Interaction

Succinic acid, inosine, nicotinamide are compatible with other drugs. The drug is compatible with drugs that stimulate hematopoiesis, antihypoxants, anabolic steroids. Reduces and prevents the side effects of chloramphenicol (hematopoietic disorder, optic neuritis).

Riboflavin reduces the activity of doxycycline, tetracycline, oxytetracycline, erythromycin and lincomycin. Incompatible with streptomycin.

Chlorpromazine, imizine, 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.

Thyroid hormones speed up the metabolism of riboflavin.

Method of administration and dosage

B / drip in a dilution of 100-200 ml 5-10% dextrose or 0.9% sodium chloride solution.

Adults

In case of acute disturbance of cerebral circulation, 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 once a 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 a 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 post-anesthetic depression - 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, 3 days after surgery.

Children (including premature babies)

For newborns with cerebral ischemia, the daily dose of CytoflavinЃ is 2 ml / kg / day. The calculated daily dose of the drug is injected intravenously (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.

Overdose

Overdose cases were not observed.

Treatment: symptomatic therapy.

special instructions

The introduction of the drug to newborns (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 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, with the threat of the development of cerebral circulation disorders;

- with preserved spontaneous breathing and respiratory support by the CPAP method ( Continuous Positive Airways Pressure ) or in patients receiving an air-oxygen mixture through a mask when laboratory signs of metabolic alkalosis appear, with the threat of the appearance or increased frequency of apnea attacks.

In patients with diabetes mellitus, treatment is carried out under the control of blood glucose indicators.

Intense yellow coloration of urine is possible.

Impact on the ability to drive vehicles. CytoflavinЃ does not affect the ability to drive vehicles.

Release form

Solution for intravenous administration. In ampoules made of colorless or brown glass, 5 or 10 ml. 5 amp. in one-side blister strip packaging, open blister strip packaging or thermally glued with a cover film or aluminum foil. 1 or 2 contour packs in a cardboard box.

Manufacturer

LLC Scientific and Technological Pharmaceutical Firm POLISAN (LLC NTFF POLISAN). 192102, St. Petersburg, st. Salova, 72, bldg. 2, lit. AND.

Tel./fax: (812) 710-82-25.

Consumer claims should be sent to the manufacturer.

Conditions of dispensing from pharmacies

On prescription.

Storage conditions of the drug CytoflavinЃ

In a dark place at a temperature not exceeding 25 ? C.

Keep out of the reach of children.

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