Remaxol, 400 ml

Pharmacotherapeutic group: metabolic agent

ATX code: A05BA

Pharmacological properties

Pharmacodynamics

REMAXOL® is a balanced infusion solution with hepatoprotective effect. The action of the drug accelerates transformation of anaerobic processes into aerobic ones, improves energy supply of hepatocytes, increases synthesis of macroergens, increases resistance of hepatocyte membranes to lipid peroxidation, restores antioxidant protection enzyme activity. REMAXOL® decreases cytolysis, which is manifested by a decrease in indicator enzymes: aspartate-minotransferases, alanine aminotransferases. REMAXOL® promotes reduction of bilirubin and its fractions, improves excretion of direct bilirubin into bile. It reduces activity of excretory enzymes of hepatocytes – alkaline phosphatase and gamma-glutamyl transpeptidase, promotes oxidation of cholesterol into bile acids.

Pharmacokinetics

In intravenous drip administration the natural components included are rapidly distributed in the body tissues, being utilized almost immediately. Products of metabolism are excreted with urine and do not accumulate in the body.

Indications

Intrahepatic cholestasis syndrome in chronic diffuse liver diseases (alcoholic liver disease, toxic liver damage, liver fibrosis and sclerosis, fatty liver degeneration, chronic hepatitis).

Other liver dysfunctions due to acute or chronic damage (toxic, alcoholic, viral, drug-induced hepatitis).

Pharmacological effect

Pharmacotherapeutic group: metabolic agent

ATX code: A05VA

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

REMAXOL® is a balanced infusion solution with a hepatoprotective effect. Under the influence of the drug, the transition of anaerobic processes to aerobic ones is accelerated, the energy supply of hepatocytes is improved, the synthesis of macroergs increases, the resistance of hepatocyte membranes to lipid peroxidation increases, and the activity of antioxidant enzymes is restored. REMAXOL® reduces cytolysis, which is manifested in a decrease in indicator enzymes: aspartate aminotransferases, alanine aminotransferases. REMAXOL® helps reduce bilirubin and its fractions, improves the excretion of direct bilirubin into bile. Reduces the activity of excretory enzymes of hepatocytes – alkaline phosphatase and gamma-glutamyl transpeptidase, promotes the oxidation of cholesterol into bile acids.

PHARMACOKINETICS

When administered intravenously, the natural components included in the composition are quickly distributed in the tissues of the body, being utilized almost instantly. Metabolic products are excreted in the urine and do not accumulate in the body.

Special instructions

If the color of the solution changes or there is a precipitate, the use of the drug is unacceptable. Impact on the ability to drive vehicles and machinery If an undesirable reaction develops – dizziness (very rare), it is necessary to stop working with precision mechanisms, driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Active ingredient

Inosine, Meglumine, Methionine, Nicotinamide, Succinic acid

Composition

Active ingredients:

succinic acid –5.280 g;

meglumine (N-methylglucamine) – 8.725 g;

inosine (riboxin) – 2.0 g;

methionine – 0.75 g;

nicotinamide – 0.25 g.

Excipients:

sodium chloride – 6.0 g;

potassium chloride – 0.30 g;

magnesium chloride hexahydrate (in terms of anhydrous) – 0.12 g;

sodium hydroxide – 1.788 g;

water for injections up to – 1.0 l.

Pregnancy

Preclinical studies have not shown direct or indirect effects on pregnancy, embryo/fetal development, childbirth or postnatal development. Controlled studies of the use of the drug during pregnancy have not been conducted. REMAXOL® should not be prescribed during pregnancy. You should refrain from breastfeeding when prescribing REMAXOL® to a woman.

Contraindications

Individual intolerance to the components of the drug, pregnancy, breastfeeding, childhood.

With caution
– For nephrolithiasis, gout, hyperuricemia.

Side Effects

According to the World Health Organization, adverse reactions are classified according to the frequency of their development as follows:
– very frequent (≥ 1/10);
– frequent (≥ 1/100 – < 1/10);
– uncommon (≥ 1/1000 – < 1/100);
– rare (≥ 1/10000 – < 1/1000);
– very rare (< 1/10000);
– frequency unknown (cannot be determined based on available data).

General disorders and disorders at the injection site: very rarely – a feeling of heat. Disorders of the skin and subcutaneous tissues: very rarely – allergic rash, itching, urticaria. Disorders of the respiratory system, chest and mediastinal organs: very rarely – sore throat.

Vascular disorders: very rarely – hyperemia of the skin of varying severity.

Gastrointestinal disorders: very rarely – dry mouth, nausea.

Nervous system disorders: very rarely – headache, dizziness.

Metabolic and nutritional disorders: very rarely – hypoglycemia, hyperuricemia.

To avoid the occurrence of undesirable reactions, it is recommended to follow the dosage regimen and rate of administration of the drug. If adverse reactions occur, it is recommended to reduce the rate of drug administration. If any of the adverse reactions indicated in the instructions worsen or you notice any other adverse reactions not listed in the instructions, notify your doctor.

Interaction

Mixing in one bottle with other drugs for intravenous administration is not recommended.

Storage conditions

In a place protected from light at a temperature not exceeding 25 ºС. Keep out of the reach of children.

Shelf life

5 years in glass bottles, 2 years in containers made of multilayer polyolefin film. Do not use after the expiration date stated on the package.

Manufacturer

Polisan NTFF LLC, Russia