Molixan Solution, ampoules, 5 pcs, 2 ml, 30 mg/ml, for intravenous and intramuscular administration

Instructions for use

In the instructions for Molixan, the manufacturer not only provides a detailed description of the composition of the drug, its pharmacological properties, contraindications and indications for use, but also gives recommendations on the dosage and duration of the course of therapy in the presence of certain types of hepatitis. The injection schedule can be adjusted by the attending physician. Under no circumstances should you violate the recommendations or use the drug if there are contraindications.

pharmachologic effect

Molixan belongs to the category of hepatoprotective agents with immunomodulatory and antiviral effects. The drug has an effect at the cellular level. Course therapy allows you to restore the biochemical processes of cell metabolism. Molixan contains components that improve the patient's health status with hepatitis of various etiologies.

It is acceptable to use the drug as an addition to the main course of treatment for diseases of this category.

Pharmachologic effect:

• triggering cell proliferation, apoptosis and differentiation;
• regulation of the exchange of immunocompetent cells;
• reducing the intensity of the inflammatory process;
• inhibition of hepatocyte cytolysis;
• inducing apoptosis of cells affected by the virus;
• elimination of some consequences of toxic liver damage;
• restoration of the structure of kidney tissue;
• improving the exchange of macrophage and cytokine production;
• normalization of interferon exchange.

Hepatitis is a group of diseases of a completely different nature, in which the pathological process spreads to the entire liver tissue, as a result of which its functions are disrupted.

Indications for use

The main indications for prescribing Molixan are hepatitis C and B in the acute stage or in chronic form (as well as hepatitis of mixed etiology). The presence or absence of a delta agent is the basis for adjusting the injection regimen (the course of treatment is drawn up by a doctor). The drug can be used not only as an addition to the main therapy, but also during maintenance and restorative procedures for patients with an established diagnosis of hepatitis.

Directions for use and dosage

The dosage and scheme of use of Molixan depends on the stage and type of the disease present. The duration of treatment for acute and chronic hepatitis differs. The maximum therapeutic effect is achieved when injections are combined with other procedures.

The average duration of the course is three months (in some cases, Molixan is administered to patients for six months, but only if there are special indications).

Scheme of use of the drug:

• for viral hepatitis B of the chronic type, the drug is administered once a day, 10-30 mg (the average course of therapy is three months, the addition of antiviral chemotherapy is acceptable, injections are prescribed three times a week);
• for acute viral hepatitis B, injections are prescribed at 10-30 mg per day once (the course of therapy is limited to three months, it is recommended to supplement the injections with detoxification and symptomatic therapy, injections are given every other day);
• for viral hepatitis C of the chronic type, the dosage is increased to 30-60 mg twice a day (the duration of the course of therapy is 3-6 months, combination with antiviral chemotherapy is recommended, in most cases the drug is administered by injection three times a week);
• if there are special indications, the injection schedule can be prescribed individually (every other day, several times a week or once).

Release form and composition

Solution for injection 30 mg/ml 2 ml No. 5Molixan is available in the form of a solution intended for intramuscular and intravenous injections. The clear liquid has a characteristic odor of acetic acid. The volume of one ampoule is 1 or 2 ml.

The ampoules are placed in blister packs (five ampoules in a blister pack, one or two blister packs in one pack). The active ingredient in the solution is inosine glycyl-cysteinyl-disodium glutamate. The main composition of the drug is supplemented with several auxiliary components.

Excipients:

• purified water (for injection);
• diluted acetic acid;
• sodium acetate trihydrate.

Interaction with other drugs

The manufacturer does not note the interaction of Molixan with medications from other categories. The drug combines well with medications used to treat hepatitis of various etiologies and forms. An important nuance is the correct calculation of the dosage of the solution. Injections must be carried out under the supervision of a specialist.

Molixan®

In accordance with the resolution of the Government of the Russian Federation dated 04/03/20. N 441, from 04/18/20. to 05/12/20. A randomized clinical trial was conducted on the use of the drug Molixan® as part of complex therapy for patients with moderate to severe COVID-19, initiated by the National Medical Research Center of Cardiology (FSBI “National Medical Research Center of Cardiology”; No. MNCV-08-2020 dated 04/10/2020; principal investigator - Ph.D. medical sciences Rodnenkov Oleg Vladimirovich). When using the drug, the severity of the disease decreased already on 2-3 days. None of the patients required transfer to the intensive care unit. On days 3-5, Molixan® contributed to the normalization of blood oxygen saturation, pulse rate and respiration in patients in the main group compared to the control group. The drug reduced the need for oxygen therapy. These parameters, when compared in the main group (Molixan) and the control group, showed statistically significant differences. Both the main and control groups received comparable therapy according to the recommendations of the Russian Ministry of Health for the treatment of COVID-19.

06/01/20. – 10.07.20. in a prospective open study, the prophylactic use of the drug in inhalation form was studied among medical workers in a group at increased risk of infection (working in the “red” zone), initiated by the North-Western State Medical University. I.I. Mechnikov. The incidence in the group that received the drug was 4.5 times less (2%; 2 out of 99 people got sick) than in the control group (9%; 24 out of 268 people who worked in the “red” zone got sick). The results are summarized in the article by Michael V. Dubina, Veronika V. Gomonova, Anastasia E. Taraskina, Natalia V. Vasilyeva, Sergey A. Sayganov. Pathogenesis-based pre-exposure prophylaxis associated with low risk of SARS-CoV-2 infection in healthcare workers at a designated COVID-19 hospital, posted in the global public database of full-text preprints of medical articles Medrxiv, awaiting publication in specialized journals (translation into Russian ).

06/08/20. – 10/12/20 clinical observations in patients with severe COVID-19 hospitalized or transferred to the intensive care unit of the Infectious Diseases Clinic of the Military Medical Academy named after. CM. Kirova (researcher - Doctor of Medical Sciences, Professor Roman Evgenievich Lakhin), showed that Molixan® reduces the need for high-flow oxygen therapy and shortens the length of stay in the intensive care unit.

The pathogenetic justification for the advisability of using the drug in the development of acute respiratory distress syndrome (ARDS), associated with severe COVID-19, was the “Study of the specific activity of the drug Molixan® on an experimental model of lipopolysaccharide-induced acute pneumonia in mature laboratory rats”, conducted on August 31. 2020. – November 25, 2020. at the Center for Preclinical and Clinical Research, Department of Molecular and Radiation Biophysics, St. Petersburg Institute of Nuclear Physics. B.P. Konstantinov National Research Center (NRC “Kurchatov Institute” - PNPI).

Treatment of ARDS with the drug Molixan® contributed to the prevention of the development and correction of pathomorphological changes in lung tissue. There was a statistically significant decrease in both the overall prevalence and severity of the inflammatory process in the lungs and a decrease in the intensity of inflammatory infiltration of the lung tissue. When using the drug, moderate and severe forms of development of the pathological process in the lungs were 3.5 times less common. The blood levels of inflammatory markers (C-reactive protein, interleukin-2), endothelin-1 (vasoconstrictor peptide) decreased, and the activity of antithrombin III increased. The use of the drug at a dose of 10 mg/kg body weight not only showed its anti-inflammatory effect, but was also not accompanied by mortality, deterioration in the condition of experimental animals, or negative dynamics of laboratory and pathomorphological parameters, which indicates the safety of its use.

Based on the results of the studies conducted, in order to bring the evidence base for the drug in line with modern international criteria of evidence-based medicine, the copyright holder of the drug Molixan® JSC "PHARMA VAM" decided to conduct a multicenter, prospective, double-blind, placebo-controlled, randomized, parallel-group clinical trial to study the safety and the effectiveness of the drug Molixan® as part of standard therapy in the treatment of patients with severe new coronavirus infection (COVID-19) (study code: MNCV-III/2-2020). The contract research organization (CleanPharmDevelopment LLC) plans to involve 18 clinical centers of the Russian Federation in this study.

Molixan® is a metabolic agent, has anti-inflammatory, antihypoxic, antifibrotic activity, improves microcirculation and rheological properties of blood, optimizes oxygen saturation of tissues. The uniqueness of the drug for COVID-19 is the possibility of a complex effect with one drug on different stages of the development of the disease (improving blood flow and microcirculation in tissues, normalizing ventilation and perfusion of the lungs, detoxification and anti-inflammatory effect), not limited to symptomatic therapy.

The medications indicated in the recommendations of the Ministry of Health of the Russian Federation for the treatment of patients with COVID-19 do not have an evidence base. The WHO-coordinated Solidarity study, conducted in 405 medical institutions in thirty countries and including more than 12 thousand patients, showed no or insignificant effect of the main previously recommended and actively used drugs against the nosocomial course of coronavirus infection COVID-19 (remdesivir, hydroxychloroquine, lopinavir /ritonavir, interferon drugs). Plasma transfusions from COVID-19 survivors also did not live up to expectations, according to The New England Journal of Medicine, one of the most influential and cited medical journals.

The search for new effective drugs and treatment regimens for patients with COVID-19 with a proven evidence base remains a priority in the context of the ongoing disease pandemic.

Side effects

Useful fiber and the ability of fruits to flush out toxins, as well as a shock dose of vitamins, are irreplaceable benefits for the liver and the entire body as a whole. Adverse symptoms after injections appear in rare cases. The solution may cause an allergic reaction, pain or swelling. The localization of such symptoms is limited to the injection site. Hypersensitivity to the components of the drug can cause an increase in the patient’s body temperature (the severity of this side effect depends on the individual characteristics of the body).

Overdose

There have been no cases of Molixan overdose in medical practice. The drug may cause side effects if there is an individual intolerance to its components. The procedures are carried out under the supervision of a specialist. This nuance practically eliminates the risk of unreasonably exceeding dosages.

Contraindications

Molixan is not used in pediatric practice. The drug is not prescribed to women during pregnancy and lactation. An absolute contraindication for injections is the patient's individual intolerance to the active ingredient. The manufacturer does not note any other prohibitions on the use of Molixan in the treatment of hepatitis of various etiologies.

During pregnancy

Pregnancy and lactation are contraindications for the use of Molixan. The active ingredient of the drug is strictly prohibited for use in pediatrics (it can provoke a negative reaction in the body in a newborn child). During pregnancy, women are prescribed safer medications that cannot harm the fetus.

Before using MOLIXAN you should consult your doctor.

special instructions

Molixan injections may cause pain. To prevent this effect, it is recommended to supplement the procedure with the introduction of novocaine (1-2 ml). An isotonic sodium chloride solution is used as a carrier solution for Molixan injections (can be replaced with a 5% glucose solution). It is acceptable to use a dextrose solution as a solvent.

Influence on the ability to drive vehicles and operate machinery

The manufacturer does not note any negative effects.

Pregnancy and lactation

Not assigned.

Use in childhood

Not used in pediatric practice.

In case of liver dysfunction

The drug is intended for the treatment of hepatitis B and C.

If kidney function is impaired

No special instructions provided.

Conditions for dispensing from pharmacies

A prescription is required.

Molixan 30mg/ml 2ml 5 pcs. solution for intravenous and intramuscular administration

pharmachologic effect

It is an organic salt containing inosine (purine component) and disodium glycyl-cysteinyl-glutamate (peptide component) in a 1:1 ratio.
Molixan® regulates the thiol-disulfide metabolism of hepatocytes, induces the expression of enzymes of the first and second phases of xenobiotic detoxification, suppresses the replication of DNA and RNA viruses that cause hepatitis B and C, stimulates the production of alpha and gamma interferons by liver macrophages, interleukin-2 by T-lymphocytes.

The cytoprotective and immunomodulatory activities of the peptide and purine components of the Molixan® drug lead to inhibition of hepatocyte cytolysis and resolution of the inflammatory process during toxic and viral lesions of liver cells.

The peptide and purine components of Molixan® indirectly affect the metabolism, processes of proliferation, differentiation and apoptosis of liver cells, helping to restore the normal structure of liver tissue.

The drug has immunomodulatory, antiviral and hepatoprotective effects.

Composition and release form Molixan 30 mg/ml 2 ml 5 pcs. solution for intravenous and intramuscular administration

Solution - 1 amp.:

• Active substance: inosine glycyl-cysteinyl-glutamate disodium 30 mg.
• Excipients: sodium acetate trihydrate, diluted acetic acid (to pH 6.0), water for injection.

2 ml - glass ampoules (5) - contour cell packaging (1) - cardboard packs.

Description of the dosage form

The solution for intravenous and intramuscular administration is colorless or slightly colored, transparent, odorless or with a faint odor of acetic acid.

Directions for use and doses

The solution is intended for intravenous and intramuscular administration.

For acute viral hepatitis B, Molixan® is administered intravenously or intramuscularly at a single dose of 10 mg/day, every other day, throughout the entire course of symptomatic and detoxification therapy.

In severe forms of acute viral hepatitis B, Molixan® is administered intravenously or intramuscularly at a single dose of 20 mg/day, daily, throughout the entire course of symptomatic and detoxification therapy.

As part of complex antiviral therapy for chronic viral hepatitis B, Molixan® is administered intravenously or intramuscularly at a single dose of 30 mg/day, 3 times a week, every other day throughout the course of specific antiviral therapy.

In the monotherapy of chronic viral hepatitis B, resistant to specific antiviral therapy or when it is impossible for medical reasons, Molixan® is administered intravenously or intramuscularly in a single dose of 30 mg/day, 3 times a week, every other day, for a course of treatment 24 weeks.

As part of complex antiviral therapy for chronic viral hepatitis C, Molixan® is administered intravenously or intramuscularly at a single dose of 60 mg/day, 3 times a week, every other day throughout the course of specific antiviral therapy.

In the monotherapy of chronic viral hepatitis C, resistant to specific antiviral therapy or when it is impossible for medical reasons, Molixan® is administered intravenously or intramuscularly in a single dose of 60 mg/day, 3 times a week, every other day, for a course of treatment 24 weeks.

Pharmacokinetics

The pharmacokinetics of the drug Molixan® when administered intravenously at a dose of 1 mg/kg is described by a two-part model with the following indicators for the peptide component of the organic salt of the drug Molixan®: Cmax of the peptide component in blood plasma - 170-180 μg/ml; elimination constant of the peptide component is 0.085 min-1; bioavailability of the peptide component - 90%; total clearance of the peptide component is 20 ml/kg/min; the average retention time of the peptide component is 6-8 minutes; T1/2 of the peptide component - 15-20 min. The components of the organic salt of the drug Molixan®, the peptide and purine components, are metabolized in the organs and tissues of the body to amino acids and purine base derivatives and excreted by the kidneys.

Indications for use Molixan 30 mg/ml 2 ml 5 pcs. solution for intravenous and intramuscular administration

Acute and chronic viral hepatitis B, C.

Contraindications

Pregnancy; breastfeeding period; childhood; hypersensitivity to the components of the drug.

Application Molixan 30 mg/ml 2 ml 5 pcs. solution for intravenous and intramuscular administration during pregnancy and lactation

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

Use in children

Contraindicated for children.

special instructions

Treatment with the drug should be carried out under regular medical supervision.

Isotonic sodium chloride solution or 5% glucose solution is used as a carrier solution for intravenous administration. As a solvent for intravenous administration, 0.9% sodium chloride solution or 5% dextrose solution is used.

Impact on the ability to drive vehicles and operate machinery

There was no negative impact on the ability to drive vehicles or machinery.

Overdose

No cases of overdose of Molixan® have been reported.

Side effects Molixan 30 mg/ml 2 ml 5 pcs. solution for intravenous and intramuscular administration

Allergic reactions: local hyperemia, burning, swelling is possible at the injection site. Some patients may experience a slight increase in body temperature (up to 37.1-37.5°C), pain at the injection site of the drug (in this case, the drug is administered along with 1-2 ml of a 0.25% procaine solution).

Drug interactions

No drug interactions have been identified between Molixan® and other drugs.

Analogs

Analogs of Molixan include drugs with identical pharmacological properties. When looking for a substitute, it is necessary to consider the reason for the need to abandon the main drug. If the solution provokes an allergic reaction, then analogues must be selected excluding identical components in the composition.

The best option is to consult a specialist for advice.

Article about the drug "Molixan"

The drug has immunomodulatory, antiviral and hepatoprotective effects.

Molixan improves blood oxygen saturation and reduces shortness of breath, helps restore the function of the liver, respiratory and cardiovascular systems, and reduces the need for oxygen therapy. Suitable for the prevention of coronavirus infection COVID-19.

Molixan for rehabilitation after coronavirus infection

Molixan has a high rehabilitation potential for the treatment of delayed health problems associated with coronavirus infection (pulmonary fibrosis, etc.), as well as for the treatment of concomitant diseases.

Molixan prevents the progression of coronavirus infection by affecting the pathogenesis (development) of the disease

restores detoxification processes and, thereby, improves the condition and well-being of patients

It is an organic salt containing inosine (purine component) and disodium glycyl-cysteinyl-glutamate (peptide component) in a 1:1 ratio.

Molixan regulates the thiol-disulfide metabolism of hepatocytes, induces the expression of enzymes of the first and second phases of xenobiotic detoxification, suppresses the replication of DNA and RNA viruses that cause hepatitis B and C, stimulates the production of alpha and gamma interferons by liver macrophages, interleukin-2 by T-lymphocytes.

The cytoprotective and immunomodulatory activities of the peptide and purine components of the drug Molixan lead to inhibition of hepatocyte cytolysis and resolution of the inflammatory process during toxic and viral lesions of liver cells.

The peptide and purine components of the drug Molixan indirectly affect the metabolism, processes of proliferation, differentiation and apoptosis of liver cells, helping to restore the normal structure of liver tissue.

In the treatment of acute alcohol intoxication (alcoholic coma) against the background of standard detoxification therapy, a drug containing this substance accelerates the time for patients to emerge from a coma, normalizes the bioelectrical activity of the brain and the conduction system of the heart, helps normalize the blood gas composition and acid-base balance, level lactate, potassium content, transaminase activity, alkaline phosphatase, GGT, concentration of bilirubin and its fractions, stops the development of changes characteristic of withdrawal syndrome, eliminates anxiety, vegetative-vascular disorders.

Reviews

Molixan is widely used in medical practice in the treatment of hepatitis of various forms and etiologies. The drug affects the liver at the cellular level. Due to this effect, local immunity increases and the general condition of the body improves. The high level of therapeutic properties of the drug is confirmed not only by specialists, but also by patients.

If you have experience using this drug, be sure to share it with other site visitors.

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