Remaxol^® (Solution) Instructions for Use

Marketing Authorization Holder

Polisan NTFF, LLC (Russia)

Contact Information

POLISAN NTFF LLC (Russia)

ATC Code

A05BA (Drugs for the treatment of liver diseases)

Dosage Form

Remaxol®

Solution for infusion: bottle 400 ml 1 pc., polymer containers 400 ml 5 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion transparent, colorless, with a slight characteristic odor.

Excipients: sodium chloride, potassium chloride, magnesium chloride hexahydrate (calculated as anhydrous), sodium hydroxide, water for injections.

400 ml – glass bottles with a capacity of 500 ml (1) – cardboard packs^×.
400 ml – multilayer polymer film containers (5) – cardboard boxes.

^× Application of a first-opening control label is allowed.

Clinical-Pharmacological Group

Hepatoprotective agent

Pharmacotherapeutic Group

Means for the treatment of diseases of the liver and biliary tract; agents for the treatment of liver diseases, lipotropic agents

Pharmacological Action

A balanced infusion solution with hepatoprotective action.

Under the action of the drug, the transition of anaerobic processes to aerobic ones is accelerated, the energy supply of hepatocytes is improved, the synthesis of macroergic compounds is increased, the resistance of hepatocyte membranes to lipid peroxidation is increased, and the activity of antioxidant defense enzymes is restored. Remaxol^® reduces cytolysis, which is manifested in a decrease in the level of indicator enzymes: ALT and AST.

Remaxol^® helps to reduce the content of bilirubin and its fractions, improves the excretion of direct bilirubin into bile. It reduces the activity of excretory enzymes of hepatocytes – ALP and GGT, and promotes the oxidation of cholesterol to bile acids.

Preclinical safety data

Remaxol^®, solution for infusion, is an almost non-toxic drug and belongs to class 5 of practically non-toxic medicinal substances.

In an acute experiment, with intravenous and oral administration of the drug to mice and rats of both sexes in doses up to 20000 mg/kg, it was not possible to achieve lethality.

Daily intravenous administration of the drug for 30 days in doses of 5044 and 12610 mg/kg to rats and in doses of 576.5 and 5765 mg/kg to dogs of both sexes did not lead to the development of pathological shifts in the general condition and behavior of the animals, did not have a toxic effect on cardiovascular activity, morphological composition, biochemical and other parameters of peripheral blood and bone marrow, on the functional state of the liver and kidneys, protein, carbohydrate, fat and electrolyte types of metabolism, did not cause dystrophic, destructive, focal sclerotic changes in the parenchymal cells and stroma of internal organs, and was not accompanied by a local irritant effect.

In an experimental study, the drug did not have an embryotoxic effect, did not affect the reproductive function of experimental animals, did not show sensitizing and immunotoxic properties, and did not show genotoxic properties. Administration of the drug to experimental animals was not accompanied by a local irritant effect and did not cause allergic reactions.

Pharmacokinetics

With intravenous drip administration, the natural components included in the composition are quickly distributed in the body’s tissues, being utilized almost instantly.

Metabolites are excreted in the urine and do not accumulate in the body.

Indications

Intrahepatic cholestasis syndrome in chronic diffuse liver diseases

• Alcoholic liver disease;
• Toxic liver damage;
• Fibrosis and sclerosis of the liver;
• Fatty degeneration of the liver;
• Chronic hepatitis.

Other liver function disorders due to its acute or chronic damage

• Toxic, alcoholic, viral, drug-induced hepatitis.

ICD codes

Dosage Regimen

Remaxol^® is administered intravenously by drip at a rate of 40-60 drops (2-3 ml) per minute.

For intrahepatic cholestasis syndrome in chronic diffuse liver diseases, the drug is administered at 400 ml once a day for 10 days.

For other liver function disorders due to its acute or chronic damage, the drug is administered in a daily dose of 400 to 800 ml for 3-12 days, depending on the severity of the disease.

Special patient groups

Elderly patients

Studies in elderly patients have not been conducted. In this regard, caution is recommended when using the drug in such patients.

Patients with renal impairment

Studies in patients with renal impairment have not been conducted. In patients with impaired renal function, no change in the dosage regimen is required.

Children

The safety and efficacy of Remaxol^® in children aged 0 to 18 years have not been established. Data are not available.

Adverse Reactions

The most frequently reported adverse reactions include a feeling of heat, skin hyperemia of varying severity, sore throat, nausea, and dry mouth. These reactions occur at the time of application, resolve on their own when the rate of administration is reduced or the infusion is completed, and occur rarely (≥1/10000, but <1/1000).

Tabulated summary of adverse reactions

The classification of the frequency of adverse reactions is defined as follows: very common (≥1/10); common (from ≥1/100, but <1/10); uncommon (from ≥1/1000, but <1/100); rare (from ≥1/10000, but <1/1000); very rare (<1/10000); frequency not known (cannot be estimated from the available data).

Adverse reactions are presented in Table 1 according to the system organ class.

Table 1. Adverse reactions observed in patients using Remaxol^®

To avoid the occurrence of adverse reactions, it is recommended to follow the dosing regimen and the rate of administration of the drug.

If adverse reactions occur, it is recommended to reduce the rate of administration of the drug.

Description of selected adverse reactions

Very rare cases of hypersensitivity (allergic rash, urticaria) have been noted in patients receiving Remaxol^®. If these adverse reactions occur, the patient should discontinue treatment with Remaxol^® and prescribe appropriate alternative therapy. Patients should be warned that they should not take Remaxol^® anymore.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after drug registration to ensure continuous monitoring of the benefit-risk balance of the drug. Healthcare professionals are recommended to report any suspected adverse drug reactions through the national adverse reaction reporting systems of the member states of the Eurasian Economic Union.

Contraindications

• Hypersensitivity to inosine, meglumine, methionine, nicotinamide, succinic acid or to any of the excipients that make up the drug;
• Pregnancy;
• Breastfeeding period.

With caution

In nephrolithiasis, gout, hyperuricemia.

Use in Pregnancy and Lactation

Pregnancy

Preclinical studies have not shown a direct or indirect effect on pregnancy, embryonic/fetal development, childbirth or postnatal development. Controlled studies of the use of the drug during pregnancy have not been conducted. The use of Remaxol^® during pregnancy is contraindicated.

Breastfeeding period

The use of Remaxol^® during breastfeeding is contraindicated.

Use in Renal Impairment

In patients with impaired renal function, no change in the dosage regimen is required. The drug should be prescribed with caution in nephrolithiasis.

Pediatric Use

Contraindicated for use in children under 18 years of age.

Geriatric Use

Studies in elderly patients have not been conducted. In this regard, caution is recommended when using the drug in such patients.

Special Precautions

If the color of the solution changes or if a precipitate is present, the use of the drug is unacceptable.

Excipients

This drug contains 58.8 mmol (1,352.4 mg) of sodium in 400 ml; 117.6 mmol (2,704.8 mg) of sodium in 800 ml. This should be taken into account in patients on a sodium-restricted diet.

This drug contains 1.608 mmol (62.712 mg) of potassium in 400 ml; 3.216 mmol (125.424 mg) of potassium in 800 ml. This should be taken into account in patients with reduced renal function and in patients on a potassium-restricted diet.

Effect on ability to drive vehicles and mechanisms

If an adverse reaction – dizziness (very rare) develops, it is necessary to refrain from working with precise mechanisms, driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

No cases of overdose have been observed.

In case of overdose, symptomatic therapy should be administered.

Drug Interactions

Remaxol^® is not recommended to be mixed in the same vial with other drugs for intravenous administration.

Storage Conditions

The drug should be stored in the original packaging (pack, box) to protect from light, at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life of the drug in glass bottles is 5 years, in multilayer polymer film containers – 3 years. Do not use after the expiration date indicated on the packaging.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.