Reamberine, 1.5% 400 ml

Pharmacotherapeutic group: solutions affecting water-electrolyte balance.

The ATX code: B05BB

Pharmacological properties

Pharmacodynamics

REAMBERIN® has antihypoxic and antioxidant effects with a positive effect on aerobic processes in the cell, reducing free radical production and restoring energy potential of cells.

The drug activates the enzymatic processes of the Krebs cycle and promotes the utilization of fatty acids and glucose in cells, normalizes the acid-base balance and blood gas composition. It has a moderate diuretic effect.

Pharmacokinetics

In intravenous administration the drug is quickly utilized and does not accumulate in the body.

Indications

REAMBERIN® is used in adults and children from 1 year old as an antihypoxic and detoxifying agent in acute endogenous and exogenous intoxications of various etiologies.

Active ingredient

Composition

Active ingredient: meglumine sodium succinate – 15.00 g.

Auxiliary substances: sodium chloride – 6.00 g, potassium chloride – 0.30 g, magnesium chloride hexahydrate (in terms of anhydrous) – 0.12 g, sodium hydroxide – 1.788 g, succinic acid – to pH from 6.0 to 7.0, water for injection – to 1.0 l.

Ionic composition per 1 liter:

– sodium 147 mmol
– potassium 4.02 mmol
– magnesium 1.26 mmol
– chlorides 109 mmol
– succinate 46,0 mmol
– meglumine 44,7 mmol

Theoretical osmolarity 353 mOsm/L

How to take, the dosage

Adults: administered intravenously by drip at a rate of 1-4.5 ml/min (up to 90 drops per minute). Average daily dose is 10 ml/kg. The course of therapy is up to 11 days.

In children: administered intravenously by drip at a rate of 6-10 ml/kg per day at a rate of 3-4 ml/min. The course of therapy is up to 11 days.

Application in elderly patients. Studies in elderly patients have not been carried out. Because of this the drug should be started with slower speed of administration: 20-40 drops (1-2 ml) per minute.

The use in patients with renal insufficiency. No studies have been performed in patients with renal insufficiency. Because of this it is recommended to exercise caution when using the drug in such patients.

The use in alkalosis. If decompensated alkalosis is detected, the drug should be discontinued until normalization of acid-base state of blood.

Interaction

The drug combines well with antibiotics, water-soluble vitamins, glucose solution. It combines with drugs containing phosphates, sulfates or tartrates. It is not recommended to mix it in a bottle or container with other drugs. Intravenous administration of REAMBERIN® simultaneously with calcium preparations is unacceptable due to possible precipitation of calcium succinate.

Special Instructions

Due to activation of aerobic processes in the body by the drug, a decrease in blood glucose concentration and alkaline reaction of urine may occur. Patients with diabetes mellitus and patients with reduced glucose tolerance require periodic monitoring of blood glucose concentration. If the color of the solution changes or there is sediment the drug is unacceptable.

Impact on the ability to drive vehicles, operate machinery It is not recommended to drive vehicles and operate machinery during treatment with REAMBERIN®.

Contraindications

Adults: administered intravenously by drip at a rate of 1-4.5 ml/min (up to 90 drops per minute). Average daily dose is 10 ml/kg. The course of therapy is up to 11 days.

In children: administered intravenously by drip at a rate of 6-10 ml/kg per day at a rate of 3-4 ml/min. The course of therapy is up to 11 days.

Application in elderly patients. Studies in elderly patients have not been carried out. Because of this the drug should be started with slower speed of administration: 20-40 drops (1-2 ml) per minute.

The use in patients with renal insufficiency. No studies have been performed in patients with renal insufficiency. Because of this it is recommended to exercise caution when using the drug in such patients.

The use in alkalosis. If decompensated alkalosis is detected, the drug should be discontinued until normalization of acid-base state of blood.

Side effects

According to the World Health Organization, adverse effects 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 on the basis of available data).

If the drug is administered rapidly, undesirable effects are possible.

General disorders and disorders at the injection site: very rare – hyperthermia, chills, sweating, weakness, pain at the injection site, swelling, hyperemia, phlebitis.

Immune system disorders: very rarely – allergic reactions, angioedema, anaphylactic shock.

Skin and subcutaneous tissue disorders: very rare – allergic rash, urticaria, itching.

Respiratory system disorders, thoracic and mediastinal organs: very rare – shortness of breath, dry cough.

Chronic disorders: very rare – tachycardia, palpitations, shortness of breath, pain in the heart, pain in the chest.

Vascular disorders: very rare – arterial hypotension/hypertension, transient reactions in the form of a burning sensation and redness of the upper body.

Gastrointestinal disorders: very rare – nausea, vomiting, metallic taste in the mouth, abdominal pain, diarrhea.

Nervous system disorders: very rarely – dizziness, headache, seizures, tremors, paresthesia, agitation, anxiety.

To avoid adverse effects, 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.

If any of the undesired effects mentioned in the instructions worsen, or if you notice any other undesired effects not mentioned in the instructions, tell your doctor.

Overdose

There are no data on overdose of Reamberine.

Pregnancy use

The drug is contraindicated in pregnancy and lactation.