Cytoflavin, ampoules 10ml, 10pcs

Composition

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1 ml of the solution contains:

active ingredients:

succinic acid-100 mg,

nicotinamide-10 mg,

riboxin (inosine) – 20 mg,

riboflavin mononucleotide (riboflavin) – 2 mg;

excipients:

N-methylglucamine (meglumine) 165 mg;

sodium hydroxide 34 mg;

water for injection

Pharmacological action

Pharmacodynamics

Pharmacological effects are due to the complex effect of the components included in the preparation CYTOFLAVIN®. CYTOFLAVIN® promotes the activation of aerobic cell metabolism, which leads to an increase in the level of glucose utilization, contributes to an increased level of beta-oxidation of fatty acids and resynthesis of gamma-aminobutyric acid in neurons.

CYTOFLAVIN ® increases the resistance of nerve and glial cell membranes 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 disturbed consciousness, promotes regression of neurological symptoms and improves cognitive functions of the brain. It has a rapid awakening effect in post-sarcotic depression of consciousness.

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

With an intravenous infusion at a rate of about 2 ml/min (based on undiluted CYTOFLAVIN®), succinic acid and inosine are disposed of almost instantly and are not detected in blood plasma.

Succinic acid-the peak concentration is determined within the first minute after use, with a further rapid decrease without accumulation and its level returning to the background values due to metabolism to water and carbon dioxide.

Inosine is metabolized in the liver to form inosine monophosphate, followed by its oxidation to uric acid. In a small amount, it is excreted by the kidneys.

Nicotinamide is rapidly distributed in all tissues, passes through 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 greatest 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. Plasma protein binding is 60%. It is excreted by the kidneys, partly in the form of a metabolite; in high doses – mainly in unchanged form.

Indications

In adults in complex therapy: 1. Acute cerebrovascular accident. 2. Consequences of cerebrovascular diseases (consequences of brain infarction, cerebral atherosclerosis).3. Toxic and hypoxic encephalopathy in acute and chronic poisoning, endotoxicosis, post-sarcotic depression of consciousness, as well as for the prevention and treatment of hypoxic encephalopathy in cardiac surgery using artificial blood circulation. In children (including preterm children with a gestational age of 28-36 weeks) in complex therapy in the neonatal period: 1. In case of cerebral ischemia.

Use during pregnancy and lactation

It is not recommended to take during lactation and pregnancy, due to the lack of clinical data on the safety and effectiveness of the drug during this period.

Contraindications

Hypersensitivity, in patients on mechanical ventilation, with a decrease in the partial pressure of oxygen in arterial blood less than 60 mm Hg, during breastfeeding.

With caution – nephrolithiasis, gout, hyperuricemia.

Side effects

Children (including preterm infants) may develop acid-base balance disorders (alkalosis) during the neonatal period. With rapid drip use, undesirable reactions may occur that do not require discontinuation of the drug: hyperemia of the skin of varying degrees of 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 transient hypoglycemia, pruritus, hyperuricemia, exacerbation of gout.

Interaction

Succinic acid, inosine, nicotinamide, are compatible with other drugs.

Riboflavin: Reduces the activity of doxycycline, tetracycline, oxytetracycline, erythromycin and lincomycin.

Not compatible with streptomycin.

Chlorpromazine, imipramine, and amitriptyline inhibit the incorporation of riboflavin into flavinadenine mononucleotide and flavinadenine dinucleotide and increase its urinary excretion.

Thyroid hormones accelerate the metabolism of riboflavin.

Reduces and prevents side effects of chloramphenicol (hematopoiesis disorders, optic neuritis).

It is compatible with drugs that stimulate hematopoiesis, antihypoxants, and anabolic steroids.

How to take, course of use and dosage

In children (including premature infants) in the neonatal period with cerebral ischemia, the daily dose of CYTOFLAVIN® is 2 ml / kg / day. The calculated daily dose of the drug is administered intravenously by drip (slowly) after dilution in 5% or 10% dextrose solution (in a ratio of at least 1: 5). The time of first use is the first 12 hours after birth; the optimal time to start therapy is the first 2 hours of life. It is recommended to introduce the prepared solution using an infusion pump at a rate of 1 to 4 ml / hour, ensuring a uniform flow of the drug into the bloodstream during the day, depending on the estimated daily volume of solutions for basic therapy, the patient’s hemodynamics and acid-base state indicators. The average course of treatment is 5 days. In adults: CYTOFLAVIN® is used only by intravenous drip in a dilution of 100-200 ml of 5-10% dextrose solution or 0.9% sodium chloride solution. 1. In acute cerebrovascular accident, the drug is administered as early as possible from the onset of the disease in a volume of 10 ml per use with an interval of 8-12 hours for 10 days. In severe cases, the single dose is increased to 20 ml. 2. With the consequences of cerebrovascular diseases (consequences of a brain infarction, cerebral atherosclerosis), the drug is administered in a volume of 10 ml for use once a day for 10 days. 3. For toxic and hypoxic encephalopathy, the drug is administered in a volume of 10 ml for use twice a day after 8-12 hours for 5 days. In a comatose state in a volume of 20 ml for use in a dilution of 200 ml of dextrose solution. In post-sarcotic depression, once in the same doses. In the treatment of hypoxic encephalopathy during cardiac surgery using artificial blood circulation,20 ml of the drug is administered in a dilution of 200 ml of 5% dextrose solution 3 days before the operation, on the day of the operation,3 days after the operation.

Overdose

To date, no cases of overdose with CYTOFLAVIN have been established.

Special instructions

use 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, the serum lactate and glucose levels should be monitored.

The rate of use of a CYTOFLAVIN-containing solution should be reduced or temporarily discontinued in newborns (premature infants). :

– those who are on artificial ventilation, with signs of mixed (respiratory-metabolic) alkalosis, which is threatened by the development of cerebral circulatory disorders;  – with preserved spontaneous breathing and CPAP respiratory support, or in those receiving an air-oxygen mixture through a mask, if laboratory signs of metabolic alkalosis appear, which is threatened by the appearance or frequency of apnea attacks.

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

Intense yellow staining of urine is possible.

CYTOFLAVIN® does not affect the ability to drive vehicles.

Form of production

Solution for intravenous use

Storage conditions

In a dark place, at a temperature of 0-25 °C

Shelf life

2 years

Active ingredient

Inosine, Nicotinamide, Riboflavin, Succinic acid

Conditions of release from pharmacies

By prescription

Dosage form

solution for infusions

Purpose

For adults as directed by your doctor

Indications

Atherosclerosis, Stroke consequences, Cerebral circulation disorders