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Composition:


active ingredient: edaravone;


1 ml of the solution contains 1.5 mg of edaravone;


excipients: sodium metabisulfite (E 223), sodium chloride, sodium hydroxide, phosphoric acid, water for injection.


Dosage form. Solution for injection.


Basic physical and chemical properties: clear, colorless or slightly yellowish liquid.


Pharmacotherapeutic group. Other medications for the treatment of diseases of the central nervous system. ATX N07 XX.


Pharmacological properties.


Pharmacodynamics.


Free radicals, such as hydroxyl radicals (OH), are among the main factors of vascular disorders in the brain associated with ischemia; in ischemia or hemorrhage, at the time of patency restoration, due to an abnormal increase in arachidonic acid production, the amount of free radicals produced increases. These free radicals cause peroxidation of unsaturated fatty acids, which are part of the lipids of cell membranes, damaging them, which leads to impaired brain function.


In the acute stage of ischemic brain infarction, the drug shows a protective effect, suppressing the occurrence and development of ischemic cerebrovascular disorders, such as brain edema, neurological symptoms, and slow neuronal death.


The etiology of the onset and development of amyotrophic lateral sclerosis (ALS) is currently not definitively determined. However, it has been suggested that oxidative stress caused by free radicals may be an etiological factor for this pathology. Edaravone, due to its inhibitory effect on lipid peroxidation by binding free radicals, demonstrates inhibition of disease development by reducing oxidative damage to brain cells (vascular endothelial cells/nerve cells).

Clinical characteristics.


Indications.


Relief of neurological symptoms, manifestations of activity disorders in everyday life and functional disorders associated with acute ischemic stroke.


Slowing the progression of functional disorders in patients with amyotrophic lateral sclerosis.


Contraindications.


Severe form of renal failure.


Hypersensitivity to the components of the drug.


Interactions with other drugs and other types of interactions.


When used concomitantly with antibiotics with a renal type of excretion (cefazolin sodium, cefotiam hydrochloride, piperacillin sodium, etc.), there is a possibility of increased renal dysfunction, in the case of combined use, careful monitoring should be carried out, regularly analyzing the functioning of the kidneys.


Xavron should be dissolved in 100 ml of saline sodium chloride solution before Administration. Mixing the drug with other intravenous solutions containing various sugars can lead to a decrease in the concentration of edaravone.


The drug should not be mixed with parenteral nutrition solutions and/or solutions containing amino acids, as well as administered through the same Infusion Systems.


The drug should not be mixed with anticonvulsants, including diazepam, sodium phenytoin, etc., due to the possibility of turbidity formation. Also, do not mix with potassium canrenoate.


Application features.


The use of the drug should be carried out under the careful supervision of doctors who have experience in using this drug.


During therapy, acute renal failure or impaired renal function, severe hepatic dysfunction, and/or disseminated intravascular coagulation (DIC) may worsen, which may be fatal.


There are few cases of prescribing this drug to patients with severe ALS above grade 4 and patients whose Forced Vital Capacity has decreased to less than 70% of theoretically normal, so its effectiveness and safety have not been proven. When prescribing Xavron to such patients, an informed decision should be made, taking into account the risks and benefits.


Cases of recurrent cerebral embolism or brain hemorrhage have been reported during or after administration of the drug.


At the beginning of treatment with the drug, blood urea nitrogen (ASA), creatinine, ASAT, alt, LDH, creatine kinase, red blood cells should be determined, a kidney function test and platelet analysis should be performed.


During the administration of edaravone, liver, kidney and blood function tests should be performed regularly, and if abnormal changes in the test parameters or oliguria are detected, the drug should be stopped immediately and appropriate measures should be taken. In addition, careful monitoring of the patient's condition should continue even after the end of injections.


In patients with amyotrophic lateral sclerosis (ALS), as the disease progresses, there is a possibility of detecting a decrease in serum creatinine levels due to muscle atrophy, so instead of comparing a single serum creatinine value with a control value, changes in serum creatinine values should be monitored to make sure that there is or is not a tendency to worsen.


In addition, since the ASA value varies depending on the amount of water in the body, instead of comparing a single ASA value with a control value, you should monitor the change in ASA to make sure that there is or is not a tendency to worsen.


In patients with muscle atrophy, before and during injections, in addition to measuring serum creatinine and Asa, renal function should be evaluated using tests that do not depend on changes in muscle mass, such as calculating the estimated glomerular filtration rate of cystatin C in serum, calculating urine creatinine clearance.


If renal dysfunction occurs during the injection, the drug should be discontinued immediately and appropriate measures should be taken in cooperation with doctors who have sufficient knowledge and experience in the treatment of renal dysfunction.


If there are complications during the injection, such as infection, and additional antibiotics need to be taken, careful consideration should be given to continuing the injection of the drug, and in the case of continuing injections, laboratory parameters should be especially carefully monitored. In addition, even after the end of Drug Administration, you should carefully check and carefully monitor (for more information, see the section "interactions with other drugs and other types of interactions").


Since fever, cough, difficulty breathing and acute lung dysfunction accompanied by chest X-ray abnormalities may occur during treatment, the patient's condition should be carefully monitored, and if such symptoms appear, the drug should be discontinued and appropriate measures should be taken, such as the administration of adrenal corticosteroids.


Elderly patients require particularly careful monitoring, as many deaths have been observed among patients in this category.


Xavron should be used with caution in the following categories of patients::


- with impaired renal function and/or dehydration, due to a high risk of acute renal failure;


- with an infection (kidney failure may worsen due to deterioration of the patient's general condition);


- with impaired liver function (possible deterioration of liver failure);


- with heart diseases (possible deterioration of the disease, as well as the development of kidney failure);


- with severe impaired consciousness (patients do not respond to external stimulation);


- elderly patients (deaths were reported in this category of patients).


Use during pregnancy or lactation.


The safety of using the drug during pregnancy has not been established. Prescribing the drug to pregnant women is not desirable.


Women during the period of use of the drug should refrain from breastfeeding, since the drug penetrates into breast milk.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


The drug is intended for use in a hospital setting, so there are no such data.


Dosage and administration.


Neurological symptoms associated with acute ischemic stroke, manifestations of daily activity disorders, relief of various dysfunctions: 30 mg of edaravone (1 ampoule) twice a day, morning and evening, by intravenous infusion for 30 minutes. Before Administration, the contents of the ampoule should be dissolved in 100 ml of 0.9% Sodium Chloride. Therapy should be started within 24 hours after the onset of symptoms, and the duration of treatment should be at least 14 days.


Inhibitory effect on the progression of dysfunction in amyotrophic lateral sclerosis (ALS): prescribe 60 mg of edaravone (2 ampoules), by intravenous infusion for 60 Minutes, 1 time a day. Before Administration, the contents of the ampoule should be dissolved in a sufficient volume of 0.9% Sodium Chloride. As a rule, the period of administration of the drug and the rest period in total are 28 days and are considered as 1 course, such courses are repeated. The first course consists of 14 days of taking the drug, followed by 14 days of break and rest, the second course and subsequent courses consist of 10 days of Drug Administration for 14 days, after which the rest period begins for 14 days.


In patients with acute ischemic stroke, the duration of therapy may be shortened, depending on the patient's clinical condition.


Elderly patients.


Since elderly patients generally have reduced physiological functions, in case of side effects, you should stop taking the drug and take appropriate measures. Many examples have been published that elderly patients often have deaths, so monitoring should be especially careful.


Children. The safety of using the drug for children has not been established.


There is insufficient experience of use in acute ischemic stroke in children; in ALS, there is no experience of clinical use in children.


Overdose.


Cases of overdose have not been described.


Adverse reactions.


From the urinary system: acute renal failure, nephrotic syndrome.


From the skin: rash, redness, swelling, itching, erythema.


From the hepatobiliary system: impaired liver function, liver failure, fulminant hepatitis, jaundice.


Nervous system disorders: insomnia, headache.


From the cardiovascular system: increased blood pressure.


From the blood: agranulocytosis, DIC syndrome, decreased red blood cell count, leukocytosis, leukopenia, decreased hematocrit, decreased hemoglobin, thrombocytosis, thrombocytopenia.


From the respiratory system: acute lung damage syndrome, accompanied by pyrexia, cough, dyspnoea, chest X-ray abnormalities.


From the gastrointestinal system: nausea, vomiting.


Musculoskeletal disorders: rhabdomyolysis.


Immune system disorders: shock, anaphylaxis (urticaria, low blood pressure, difficulty breathing, etc.).


Changes in laboratory parameters: increased levels of Alt, ASAT, LDH, Elisa-glutamyltranspeptidase, ALP, bilirubin, creatinine, uric acid in the blood serum, glucosuria, hematuria, proteinuria.


Changes at the injection site: redness at the injection site, swelling at the injection site.


Common disorders: hyperthermia.

Tags: Edaravon