About the preparation

Mexidol® is a reference (original) Russian preparation with a powerful anti-ischemic effect. It is a unique development of leading scientists and clinicians, which was awarded in 2003 a prestigious prize of the Government of the Russian Federation “For the Development and Introduction into Medical Practice of Antioxidant Preparations for Treatment and Prevention of Cerebrovascular Diseases” (Decree of the Government of the Russian Federation of 18.02.2003 No. 112 “On Awarding Prizes of the Government of the Russian Federation in Science and Technology 2002”). For more than 20 years of successful clinical practice, Mexidol® has rightly earned recognition and trust of practicing physicians, patients and their relatives.

Mexidol® has repeatedly proved its efficacy and high safety profile in numerous scientific studies, including randomized double blind multi-center placebo-controlled parallel-group studies (randomized controlled clinical trial (RCT), 2006; RCT “EPIKA”, 2017; RCT “MEMO”, 2021). The preparation has helped to save thousands of patients.

Mexidol® is effective in treatment of acute and chronic diseases caused by ischemia and hypoxia of different genesis. Today the preparation is one of the main means of basic anti-ischemic therapy, owing to the universal mechanism of action and a wide range of pharmacological effects. Mexidol® is successfully employed in various fields of medicine: neurology, therapy, ophthalmology, cardiology, psychiatry, and narcology.

To take care of our patients a new dosage of the time-tested preparation was released in 2018 – a 250 mg tablet – Mexidol® FORTE 250. The unique one tablet double dose increases patients’ adherence to therapy thanks to a simplified pharmacotherapy regimen – now one 250 mg tablet instead of two 125 mg tablets!

In order to fully realize the therapeutic potential of the preparation a therapy has been recommended in the following succession: 14 days of injection (saturation phase), with subsequent transition to a 2 months tablet form (phase of maximizing therapeutic effect). Therapy period is 2 or 3 times a year.

The unique preparation Mexidol® development history cannot be ordinary. It begins with the award to the great Russian scientist Nikolay Nikolayevich Semenov and Cyril Hinshelwood in 1956 of the Nobel Prize in Chemistry “For Research in the Mechanism of Chemical Reactions”. Understanding the mechanisms of free radicals formation has served as a basis for the creation of the tissue ischemia control concept and the development of antioxidant and antihypoxant activity preparations.

In the early 1980s, L.D. Smirnov and V.I. Kuzmin of the State Institution “Research Institute of Pharmacology” of the Russian Academy of Medical Sciences, made a breakthrough in the history of domestic neuroprotection – 2-ethyl-6-methyl-3-hydroxypyridine succinate was synthesized. Under the guidance of academician A.V. Waldman of the Russian Academy of Medical Sciences its pharmacological effects were revealed, the mechanism of action was studied, preclinical toxicology and pharmacokinetics studies were performed, the trademark Mexidol® was determined, the preparation was registered in the USSR Ministry of Health, the first clinical trials were carried out and the preparation was introduced into medical practice. For the development and introduction of Mexidol into clinical practice, a group of specialists in 2003 was awarded the Prize of the Government of the Russian Federation “For the Development and Introduction into Medical Practice of Antioxidant Preparations for Treatment and Prevention of Cerebrovascular Diseases” (Decree of the Government of the Russian Federation No. 112 dated 18.02.2003 “On Awarding Prizes of the Government of the Russian Federation in Science and Technology 2002”).

Mexidol®, film-coated tablets, 125 mg

Mexidol® FORTE 250, film-coated tablets, 250 mg

Indications:

  • consequences of acute disorders of cerebral circulation, including after transitory ischemic attack, in the phase of subcompensation as preventive courses;
  • minor craniocerebral injury, consequences of craniocerebral trauma;
  • encephalopathies of various genesis (dyscirculatory, dismetabolic, posttraumatic, mixed);
  • vegetative dystonia syndrome;
  • mild cognitive disorders of atherosclerotic genesis;
  • anxiety disorders with neurotic and neurosis-like conditions;
  • ischemic heart disease as a part of complex therapy;
  • relief of withdrawal syndrome with alcoholism with prevalence of neurosis-like and vegetovascular disorders, post-withdrawal disorders;
  • conditions after acute intoxication by antipsychotic agents;
  • asthenic conditions, as well as for prevention of development of somatic diseases under the action of extreme factors and loads;
  • action of extreme (stressor) factors.

Solution for intravenous and intramuscular injections, 50 mg/ml

Indications:

  • acute cerebrovascular disorders;
  • craniocerebral traumas, consequences of craniocerebral traumas;
  • dyscirculatory encephalopathy;
  • vegetative dystonia syndrome;
  • mild cognitive disorders of atherosclerotic genesis;
  • anxiety disorders with neurotic and neurosis-like conditions;
  • acute myocardial infarction (from the first days) as a part of complex therapy;
  • primary open angle glaucoma of various stages, as a part of complex therapy;
  • relief of withdrawal syndrome with alcoholism with prevalence of neurosis-like and vegetovascular disorders, post-withdrawal disorders;
  • acute intoxication with antipsychotic drugs;
  • acute pyoinflammatory processes of the abdominal cavity (acute necrotic pancreatitis, peritonitis) as a part of complex therapy.

Mexidol® is produced at leading manufacturing pharmaceutical facilities in the RF, which operate in accordance with the production and quality control standards of GMP (Good Manufacturing Practices). Quality control of the substance and finished products is carried out in accordance with requirements.

Mexidol®, solution for intravenous and intramuscular injections, 50 mg/ml (2 ml and 5 ml ampoules), is produced at four production sites:

FSUE (Federal State Unitary Enterprise) “Moscow Endocrine Plant”

FSUE “Moscow Endocrine Plant” has a 70-year history of successful work in the area of circulation of medicinal products. During this time, it was accumulated a huge experience in development and production of them – from manufacture of substances to release of finished dosage forms.

The Company was one of the first in Russia, which started implementing production and quality control standards – “Good Manufacturing Practice” (GMP). In accordance with requirements, quality control of the finished product is ensured.

Today the Company hold strong positions at pharmaceutical market, production of the plant are recognizable and in demand.

LLC “Ellara”

LLC “Ellara” is characterized by a high level of production organization and quality control. Production of LLC “Ellara” is represented by the Department for production of injection drugs that meet modern requirements.

LLC “Elara” pays special attention to developing and increasing availability of medicines, searching for solutions for efficient use of company resources, which allows maintaining a high level of production organization and quality control.

FSOE (Federal State-Owned Enterprise) “Armavir Biofactory”

FSOE “Armavir Biofactory” was founded in 1921 and for more than 85 years it has been the largest biotechnological enterprise in Russia, specializing in production of medicines and veterinary drugs. Since 1999, the Company has organized the production of medicines in accordance with requirements of GMP. Production facilities, technological, analytical equipment and engineering systems are accredited and certified.

Preparations: Mexidol®, film-coated tablets 125 mg No. 30 and No. 50 and Mexidol® FORTE 250, film-coated tablets 250 mg No. 40 are produced at CJSC (Closed Joint Stock Company) “ZiO-Zdorovie”.

CJSC “ZiO-Zdorovie” is a modern Russian pharmaceutical company, on which equipment of leading global manufacturers is installed, qualified and committed staff work, validation of all equipment and all technological processes has been done and control at all stages of production is carried out. As a result of the audit, the Company “International Society for Pharmaceutical Engineering (ISPE)” confirmed compliance of production of CJSC “ZiO-Zdorovie” with the European Union Medicinal Products Manufacture (GMP EU).

The presence of both injection and tablet forms of preparations allows consistent therapy to be done in order to maximize the therapeutic potential of the preparation, and the presence in the portfolio of a wide range of dosages of Mexidol® brand allows an individual approach to each patient to be applied.