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

Hepatitis

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

Other disorders of liver function due to acute or chronic liver damage (toxic, alcoholic, viral, medicinal hepatitis).

Active ingredient

Inosine, Meglumine, Methionine, Nicotinamide, Amber 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.

Auxiliary substances:

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;

Injectable water up to – 1.0 l.

How to take, the dosage

REMAXOL® is administered intravenously by IV drip at a rate of 40-60 drops (2-3 ml) per minute. In intrahepatic cholestasis syndrome in chronic diffuse liver diseases the drug is administered in 400 ml 1 time per day for 10 days.

In case of other liver function abnormalities due to acute or chronic liver damage the preparation is administered in a daily dose of 400 – 800 ml for 3-12 days depending on the disease severity.

Interaction

It is not recommended to mix in the same vial with other drugs for intravenous administration.

Special Instructions

In case of discoloration of the solution or presence of sediment the drug is unacceptable. Effect on ability to drive vehicles, mechanisms In case of development of an undesirable reaction – dizziness (very rare), it is necessary to refrain from operating precise mechanisms, driving vehicles and engaging in other potentially dangerous activities requiring increased concentration and speed of psychomotor reactions.

Contraindications

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

With caution
– In 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 to < 1/10);
– infrequent (≥ 1/1000 to < 1/100);
– rare (≥ 1/10000 to < 1/1000);
– very rare (< 1/10000);
– frequency unknown (cannot be determined based on available data).

General disorders and disorders at the site of administration: very rare – feeling of fever. Skin and subcutaneous tissue disorders: very rare – allergic rash, itching, urticaria. Respiratory system disorders, thoracic and mediastinal organs: very rare – throat irritation.

Vascular disorders: very rare – skin hyperemia of varying severity.

Gastrointestinal disorders: very rare – dry mouth, nausea.

Nervous system disorders: very rare – headache, dizziness.

Metabolism and nutrition disorders: very rarely – hypoglycemia, hyperuricemia.

To avoid adverse reactions, it is recommended to observe the dosing regimen and the rate of administration of the drug. In case of adverse reactions it is recommended to decrease the speed of administration of the drug. If any of the adverse reactions specified in the instructions worsen or if you notice any other adverse reactions not specified in the instructions, inform your physician.

Pregnancy use

Preclinical studies have shown no direct or indirect effects on pregnancy, embryo/fetal development, delivery, or postnatal development. Controlled studies on the use of the drug during pregnancy have not been conducted. REMAXOL® should not be administered during pregnancy. Refrain from breastfeeding if a woman is prescribed REMAXOL®.