Lactoxil®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LACTOXYL® (LACTOXYLUM)

Composition:

Active substances: xylitol, sodium lactate, sodium chloride, calcium chloride, potassium chloride, magnesium chloride;

100 ml of solution contain xylitol 7.5 g; sodium lactate 1.05 g; sodium chloride 0.288 g; calcium chloride 0.01 g; potassium chloride 0.03 g; magnesium chloride 0.01 g;

Excipient: water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless liquid; theoretical osmolarity – 790 mOsm/L; pH – 6.0–7.6.

Ion composition of the preparation: Na+ – 143.0 mmol/L, K+ – 4.0 mmol/L, Ca++ – 0.9 mmol/L, Mg++ – 1.1 mmol/L, Cl- – 57.2 mmol/L, CH3CH(OH)COO- – 93.7 mmol/L. Energy value – 300 kcal/L.

Pharmacotherapeutic group. Supplementary solutions for intravenous administration. Electrolytes in combination with other agents. ATC code B05XA31.

Pharmacological Properties

Pharmacodynamics

Lactoxil® exerts rheological, anti-shock, detoxifying, alkalizing effects and stimulates intestinal peristalsis. The main active ingredients in the preparation are xylitol and sodium lactate. Xylitol is a five-carbon sugar alcohol which, when administered intravenously, rapidly enters general metabolism. 80% of xylitol is metabolized in the liver and stored as glycogen. The remainder is utilized by tissues of other organs (kidneys, heart, pancreas, adrenal glands, brain) and excreted in urine. An isotonic solution of xylitol exerts a deaggregating effect, thereby improving microcirculation and tissue perfusion. As a carbohydrate metabolite, xylitol is a pentitol and directly enters the pentose phosphate metabolic pathway. Unlike fructose and sorbitol, xylitol does not cause a reduction in hepatic nucleotides (ATP, ADP, AMP). It is also safe for administration to patients with fructose intolerance or deficiency of the enzyme fructose-1,6-diphosphatase. Xylitol is considered to exert a more pronounced anti-ketogenic and nitrogen-sparing effect than glucose and is equally well utilized both pre- and post-operatively. Since xylitol is an energy source with insulin-independent metabolism, has anti-ketogenic and lipotropic properties, it is recommended for use as a parenteral nutrition agent, particularly in patients who have undergone gastrointestinal tract surgery. The maximum rate of xylitol utilization is 0.25 g/kg body weight/hour.

Sodium lactate belongs to slowly-acting alkalizing agents. When administered intravascularly, sodium lactate releases sodium, CO₂, and H₂O, which form bicarbonate, leading to an increase in blood alkaline reserve. In contrast to sodium bicarbonate solution, correction of metabolic acidosis with sodium lactate occurs more gradually, as it is incorporated into metabolism, and does not cause abrupt pH fluctuations. Numerous studies have demonstrated that sodium lactate positively affects cardiac function, regeneration processes, and respiratory blood function, exerts a detoxifying effect, promotes increased diuresis, and improves liver and kidney function. The effects of sodium lactate become 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, contraction of skeletal and smooth muscles, myocardial activity, bone tissue formation, and blood coagulation. They reduce cellular and vascular wall permeability, prevent the development of inflammatory reactions, and enhance the body's resistance to infections.

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

Pharmacokinetics

It should be noted that due to its composition, Lactoxil® belongs to the group of multi-component hypertonic solutions. After intravenous administration, the drug increases blood osmotic pressure, enhances fluid evacuation from tissues into the vascular bed, increases metabolic processes, improves hepatic detoxification function, enhances cardiac activity, and increases diuresis.

Xylitol is rapidly incorporated into general metabolism. 80–90% is utilized in the liver and stored as glycogen; 5% is deposited in brain tissue, myocardium, and skeletal muscle; 6–12% is excreted in urine. When introduced into the bloodstream, sodium lactate releases sodium, CO₂, and H₂O, which form sodium bicarbonate, thereby increasing blood alkaline reserve. Only half of the administered sodium lactate (the L-isomer) is metabolically active; the other half (the D-isomer) is not metabolized and is excreted in urine.

Sodium chloride is rapidly eliminated from the vascular bed, temporarily increasing circulating blood volume only.

Clinical characteristics.

Indications.

For improvement of capillary blood flow for prevention and treatment of traumatic, surgical, hemolytic, toxic, and burn shock; in acute blood loss and burn disease; in infectious diseases accompanied by intoxication; in exacerbation of chronic hepatitis; in sepsis; for preoperative preparation and in the postoperative period; for improvement of arterial and venous circulation; for correction of acid-base balance; for partial coverage of carbohydrate requirements in cases of impaired glucose utilization; as a means to meet the body's caloric needs in partial and complete parenteral nutrition.

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

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

Special precautions for use.

The drug should be administered under monitoring of blood acid-base balance and electrolyte levels, liver function, and arterial pressure. Exercise caution when administering to patients with calculous cholecystitis. In patients with diabetes mellitus, administration of the drug should be carried out under blood glucose monitoring.

Use during pregnancy or breastfeeding.

There are no data regarding contraindications during pregnancy and breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

Since the drug is intended for use in a hospital setting, data on such effects are not available.

Method of Administration and Dosage

Lactoxil® should be administered intravenously by drip infusion to adults at a rate of 40–60 drops per minute. If necessary, bolus (rapid) administration of the drug is permitted after performing a test via drip infusion at a rate of 30 drops per minute. After administering 15 drops, the infusion should be stopped; if no reaction occurs within 3 minutes, Lactoxil® may then be administered by bolus injection.

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

In chronic hepatitis, administer to adults 400 ml (6–7 ml/kg of body weight) by drip infusion.

In acute blood loss, administer to adults 1200–1600 ml (up to 20 ml/kg of body weight). In such cases, Lactoxil® infusions should be performed as rapidly as possible in a specialized emergency ambulance.

In the preoperative period and after various surgical procedures – administer 400 ml (6–7 ml/kg of body weight) by drip infusion over 3–5 days.

In thrombo-obstructive diseases of blood vessels – administer at a dosage of 8–10 ml/kg body weight by drip infusion, repeated every other day, up to 10 infusions per treatment course.

For parenteral nutrition of patients, including patients with diabetes mellitus – administer 600–1000 ml (10–15 ml per kg of patient's body weight) once or twice daily.

Children

There is insufficient data on experience with use in children.

Overdose

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

Adverse reactions.

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

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

Nervous system disorders: tremor, headache, dizziness, general weakness.

Skin disorders: skin rashes, urticaria, pruritus.

Shelf life. 2 years.

Storage conditions. Store at a temperature not exceeding 25 °C. Keep out of reach of children. Do not freeze.

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

Packaging. 200 ml or 400 ml in bottles.

Prescription status. Prescription only.

Manufacturer: LLC "Yuria-Pharm".

Manufacturer's address and place of business:

108, Kobzarska Street, Cherkasy, Cherkasy region, 18030, Ukraine. Tel.: (044) 281-01-01.