Sorbilact

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

Composition:

Active substances: 1 ml of solution contains: sorbitol 200 mg; sodium lactate (calculated as 100% substance) 19 mg; sodium chloride 6 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 – 1658 mOsmol/L; pH 6.00–7.60; ionic composition: 1 liter of the preparation contains: Na+ – 272.20 mmol;
K+ – 4.02 mmol; Ca++ – 0.90 mmol; Mg++ – 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 has anti-shock, energetic, detoxifying, alkalizing, diuretic effects and stimulates intestinal peristalsis.

The main pharmacologically active substances of the drug are sorbitol (in hypertonic concentration) and sodium lactate (in isotonic concentration). The hypertonic solution of sorbitol exerts a pronounced stimulatory effect on the smooth muscles of the intestine. 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 needs, while another part is stored as glycogen. The hypertonic sorbitol solution has a high osmotic pressure and a pronounced ability to enhance diuresis.

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

Sodium chloride exerts a detoxifying and rehydration effect, replenishing sodium and chloride ion deficits in various pathological conditions.

Calcium chloride replenishes calcium ion deficiency. Calcium ions are essential for the transmission of nerve impulses, contraction of skeletal and smooth muscles, myocardial function, bone tissue formation, and blood coagulation. They reduce cellular and vascular wall permeability, prevent the development of inflammatory reactions, and increase 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 a negative inotropic and dromotropic effect, as well as a moderate diuretic effect. It participates in the conduction of nerve impulses. It increases acetylcholine levels and causes excitation of the sympathetic division of the autonomic nervous system. It improves skeletal muscle contraction in muscular dystrophy and myasthenia.

Pharmacokinetics

Sorbitol is rapidly incorporated into general metabolism; 80–90% is utilized in the liver and stored as glycogen, 5% is deposited in brain tissue, cardiac muscle, and skeletal muscles, and 6–12% is excreted in urine. When administered intravascularly, sodium from sodium lactate is released, along with CO₂ and H₂O, which form sodium bicarbonate, leading to an increase in the blood's 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, only temporarily increasing circulating blood volume. It enhances diuresis.

Clinical characteristics.

Indications.

For reducing intoxication due to the hyperosmolarity of the solution, improving microcirculation, correcting acid-base balance, and enhancing hemodynamics in: traumatic, surgical, hemolytic, and burn shock; peritonitis and intestinal obstruction (pre- and postoperative periods); acute renal failure of various etiologies; sepsis; cholecystitis; various liver diseases (hepatitis, hepatic dystrophy, hepatic coma); increased intracranial pressure in cerebral edema.

Contraindications.

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

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.

During administration of the medicinal product, acid-base balance and blood electrolyte levels, liver function, and arterial pressure should be monitored. Exercise caution when administering to patients with calculous cholecystitis. The drug should be administered taking into account plasma and urine osmolarity as well as acid-base status. Sorbilact® administration in diabetic patients should be performed with monitoring of blood glucose levels.

The product contains sorbitol; therefore, this preparation 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 when driving or operating machinery.

Since the drug is intended for use under hospital conditions, data on such effects are not available.

Administration and Dosage.

Sorbilact® is administered intravenously by drip infusion to adults at a rate of 40−60 drops/min.

If necessary, bolus administration of the drug is permitted after performing a test by drip infusion at a rate of 30 drops/min. After administering 15 drops, the administration should be paused; if no reaction occurs within 3 minutes, Sorbilact® may be administered by bolus injection.

In traumatic, burn, postoperative, and hemolytic shock, administer to adults a single dose of 200−600 ml (3−10 ml/kg body weight), followed by repeated doses of 200−400 ml, initially by bolus injection, then by drip infusion.

In liver diseases, administer to adults a daily dose of 200 ml (3.5 ml/kg body weight) by drip infusion, or every other day.

In acute renal failure, administer to adults a single dose of 200−400 ml (2.5−6.5 ml/kg body weight) by drip or bolus infusion (repeated after 8−12 hours at a dose of 200 ml).

For prevention of postoperative intestinal paresis, administer to adults a single dose of 150−300 ml (2.5−5 ml/kg body weight) by drip infusion; repeated infusions of 200 ml of the drug every 12 hours during the first 2−3 postoperative days are possible.

For treatment of postoperative paresis, administer to adults 200−400 ml (3.5−6.5 ml/kg body weight) by drip infusion every 8 hours until normalization of intestinal motility.

In cerebral edema, administer to adults initially by bolus injection, then by drip infusion (60−80 drops per minute) at a dose of 5−10 ml/kg body weight.

In significant dehydration, intravenous infusions of Sorbilact® must be administered only by drip infusion (no more than 200 ml of solution per day).

Children.

There is insufficient data on experience with use in children.

Overdose.

Symptoms of alkalosis and dehydration may occur, which resolve spontaneously upon immediate discontinuation of the drug. If the infusion rate is exceeded, tachycardia, increased arterial pressure, dyspnea, headache, and abdominal pain may develop. These symptoms resolve spontaneously after discontinuation or significant reduction of the infusion rate. In case of dehydration, symptomatic therapy should be administered.

Adverse reactions.

Immune system side effects: anaphylactoid reactions, angioneurotic edema, hyperthermia.

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

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

Skin and subcutaneous tissue changes: skin rashes, urticaria, pruritus.

Gastrointestinal disorders: abdominal pain, nausea, vomiting.

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

Alkalosis or dehydration (due to the hyperosmolarity of the solution), collapse, and dehydration (due to enhanced diuresis) may occur.

Shelf life. 2 years.

Storage conditions.

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

Incompatibility.

Sorbilact® must not be mixed with phosphate- or carbonate-containing solutions.

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

Packaging.

200 ml or 400 ml in a bottle, 1 bottle per carton; 200 ml or 400 ml in bottles.

Prescription status. Prescription only.

Manufacturer.

LLC "Yuria-Pharm".

Manufacturer's address and location of business activity.

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