Detoxant®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DETOXANT® (DETOXANT)

Composition:

Active substances: 1 ml of solution contains sorbitol 60.0 mg, sodium (S)-lactate solution (calculated as 100% substance) 19.0 mg, sodium chloride 6.0 mg, calcium chloride dihydrate (calculated as calcium chloride) 0.1 mg, potassium chloride 0.3 mg, magnesium chloride hexahydrate (calculated as magnesium chloride) 0.2 mg;

Excipient: water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless liquid; theoretical osmolarity – 891 mOsmol/L; pH 6.00–7.60; ionic composition: 1 L of the preparation contains Na+ – 272.20 mmol, K+ – 4.02 mmol, Ca2+ – 0.90 mmol, Mg2+ – 2.10 mmol, Cl− – 112.69 mmol, Lac− – 169.55 mmol.

Pharmacotherapeutic group. Solutions affecting electrolyte balance. Electrolytes in combination with other agents. ATC code B05B B04.

Pharmacological Properties

Pharmacodynamics

The medicinal product Detoxant® exerts rheological, anti-shock, detoxifying, alkalinizing, and intestinal peristalsis-stimulating effects. The main pharmacologically active ingredients of the medicinal product are sorbitol and sodium lactate. In the liver, sorbitol is initially converted into fructose, which is further transformed into glucose and then into glycogen. Part of the sorbitol is used to meet immediate energy demands, while the remainder is stored as glycogen. An isotonic sorbitol solution exerts a disaggregating effect, thereby improving microcirculation and tissue perfusion.

In contrast to bicarbonate solutions, correction of metabolic acidosis with sodium lactate occurs more gradually as it is incorporated into metabolism, avoiding sharp pH fluctuations. The effect of sodium lactate becomes apparent 20–30 minutes after administration.

Sodium chloride exerts a rehydrating effect and replenishes sodium and chloride ion deficits in various pathological conditions.

Calcium chloride replenishes calcium ion deficiency. Calcium ions are essential for nerve impulse transmission, skeletal and smooth muscle contraction, myocardial function, bone tissue formation, and blood coagulation. They reduce cellular and vascular wall permeability, prevent inflammatory reactions, and enhance the body's resistance to infections.

Potassium chloride restores water-electrolyte balance. It exerts negative chronotropic and bathmotropic effects; at high doses, it also exerts negative inotropic and dromotropic effects, as well as a moderate diuretic effect. It participates in the conduction of nerve impulses. It increases acetylcholine levels and stimulates the sympathetic division of the autonomic nervous system. It improves skeletal muscle contraction in muscular dystrophy and myasthenia.

Magnesium is the second most abundant cation in intracellular fluid. Magnesium chloride is an essential cation for metabolism, participating in energy-dependent enzymatic processes, protein molecule synthesis, oxidative phosphorylation, muscle contraction, and nerve impulse transmission. It exerts an antispasmodic effect and promotes cholesterol elimination from the body.

Pharmacokinetics

Sorbitol is rapidly incorporated into general metabolism. Approximately 80–90% is utilized in the liver and stored as glycogen, 5% accumulates in brain tissue, myocardium, and skeletal muscle, and 6–12% is excreted in urine. When administered intravenously, sodium lactate releases sodium, CO₂, and H₂O, which form sodium bicarbonate, thereby increasing the blood alkaline reserve.

The distribution and elimination of sodium (Na⁺) and chloride (Cl⁻) are largely controlled by the kidneys, which maintain a balance between intake and excretion. Sodium chloride is rapidly eliminated from the vascular system, only temporarily increasing circulating blood volume. It enhances diuresis.

Plasma calcium concentration is regulated by parathyroid hormone, calcitonin, and vitamin D. Approximately 47% of plasma calcium exists in the ionized, physiologically active form, about 6% forms complexes with anions such as phosphate or citrate, and the remainder is bound to proteins, primarily albumin. Changes in plasma albumin concentration—increased (as in dehydration) or decreased (as commonly seen in malignant tumors)—affect the proportion of ionized calcium. Thus, total plasma calcium concentration is generally regulated by plasma albumin levels. Excess calcium is primarily excreted by the kidneys. Unabsorbed calcium is eliminated in feces, including via bile and pancreatic secretions. A small amount is excreted in sweat, as well as through skin, hair, and nails. Calcium crosses the placenta and is excreted in breast milk.

Factors affecting potassium shifts between intracellular and extracellular fluids, such as acid-base imbalances, may alter the relationship between plasma concentration and total body stores. Normally, potassium is excreted by the kidneys in urine (secreted in the distal tubules in exchange for sodium or hydrogen ions), with the remainder eliminated in feces and a small amount in sweat. The kidneys have a poor ability to retain potassium, and minimal potassium excretion in urine continues even during severe depletion.

Approximately 50–60% of magnesium is distributed in bone, and 1–2% in extracellular fluid. About 30% of magnesium is bound to albumin. Magnesium is not metabolized. It is excreted by the kidneys, although the rate of excretion may vary. Magnesium crosses the placenta and is excreted in breast milk.

Clinical characteristics.

Indications.

• To improve capillary blood flow for the prevention and treatment of traumatic, surgical, hemolytic, toxic, and burn shock, in acute blood loss, and burn disease;
• in infectious diseases accompanied by intoxication, including as part of complex therapy in patients with community-acquired pneumonia, purulent peritonitis, sepsis; in exacerbation of chronic hepatitis;
• for preoperative patient preparation and in the postoperative period;
• to improve arterial and venous circulation for the prevention of thromboses, thrombophlebitis, endarteritis, and Raynaud's disease.

Contraindications.

Individual hypersensitivity to the components of the drug. Detoxant® must not be used in alkalosis, or in cases where infusion of large volumes of fluid is contraindicated (cerebral hemorrhage, thromboembolism, cardiovascular decompensation, grade III arterial hypertension, decompensated heart defects, terminal renal failure), dehydration, oliguria.

Interaction with other medicinal products and other forms of interactions.

Do not use as a solvent or carrier for other medicinal products.

Special precautions for use.

When using the drug, it is necessary to monitor acid-base balance and blood electrolyte levels, liver function, and arterial pressure. Administer with caution to patients with calculous cholecystitis.

The drug contains sorbitol; therefore, it should not be used in patients with rare hereditary fructose intolerance.

Use during pregnancy or breastfeeding.

There are no data regarding contraindications during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

Since the drug is administered under hospital conditions, data on such influence are not available.

Administration and Dosage.

Administer Detoxant® to adults by intravenous infusion at a rate of 40–60 drops per minute. If necessary, rapid intravenous injection of the drug is permitted after performing a test infusion at a rate of 30 drops/min. After administering 15 drops, the administration should be paused; if no reaction occurs within 3 minutes, Detoxant® may be administered by rapid intravenous injection.

In cases of traumatic, burn, postoperative, and hemolytic shock, administer to adults a single dose of 600–1000 mL (10–15 mL/kg body weight), followed by repeated doses of 600–1000 mL (10–15 mL/kg body weight), initially by rapid injection, then by infusion.

In cases of purulent peritonitis, administer to adults 400–1200 mL by intravenous infusion.

In community-acquired pneumonia and exacerbation of chronic hepatitis, administer to adults 400 mL (6–7 mL/kg body weight) by infusion.

In acute blood loss, administer to adults 1500–1800 mL (up to 25 mL/kg body weight). In such cases, Detoxant® infusions are recommended to be administered pre-hospital in a specialized emergency ambulance.

In the preoperative period and after various surgical procedures – 400 mL (6–7 mL/kg body weight) by infusion for 3–5 days.

In thromboobliterative diseases of blood vessels – at a dose of 8–10 mL/kg body weight by infusion, repeated every other day, up to 10 infusions per treatment course.

Children.

Insufficient data on experience of use in children.

Overdose.

Symptoms of alkalosis may occur, which resolve spontaneously upon immediate discontinuation of the drug. Occasionally, collapse and dehydration (due to enhanced diuresis) may develop. If the infusion rate is exceeded, tachycardia, increased arterial pressure, dyspnea, headache, chest pain, and abdominal pain may occur. These symptoms rapidly resolve after stopping or significantly reducing the infusion rate.

Side effects.

Immune system disorders: anaphylactoid reactions, angioneurotic edema, hyperthermia.

Cardiovascular system disorders: increased or decreased blood pressure, tachycardia, dyspnea, acrocyanosis.

Neurological disorders: tremor, headache, dizziness, general weakness.

Skin and subcutaneous tissue disorders: skin rashes, urticaria, itching sensation.

Gastrointestinal disorders: nausea, vomiting.

General disorders: reactions at the site of administration, including pain and burning.

Reporting of suspected side effects

Reporting suspected side effects after marketing authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, should report any suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Do not freeze!

Incompatibility.

The medicinal product Detoxant® must not be mixed with phosphate- and carbonate-containing solutions.

Packaging.

200 ml or 400 ml in a glass bottle (flask).

Prescription status. Prescription only.

Manufacturer.

JSC "Halychpharm", Ukraine.

Manufacturer's address and location of its business activities.

6/8 Opryshkivska St., Lviv, 79024, Ukraine.