Sorbilact^® (Solution) Instructions for Use

Marketing Authorization Holder

YURIA-PHARM, LLC (Ukraine)

Contact Information

YURIA-PHARM LLC (Ukraine)

ATC Code

B05XA31 (Electrolytes in combination with other drugs)

Dosage Form

Sorbilact®

Solution for infusion: fl. 200 ml or 400 ml

Dosage Form, Packaging, and Composition

Solution for infusion transparent, colorless.

Excipients : water for injections.

200 ml – glass bottles (1) – cardboard packs.
400 ml – glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Plasma substitute

Pharmacotherapeutic Group

Plasma substitute

Pharmacological Action

Plasma-substituting drug. It has anti-shock, energetic, detoxifying, alkalinizing, diuretic and stimulating intestinal peristalsis action.

The main pharmacologically active substances are Sorbitol (in hypertonic concentration) and Sodium lactate (in isotonic concentration). In the liver, Sorbitol is first converted to fructose, which is then converted to glucose, and then to glycogen. Part of sorbitol is used for urgent energy needs, another part is stored as a reserve in the form of glycogen. Hypertonic sorbitol solution has high osmotic pressure and a pronounced ability to enhance diuresis.

Unlike bicarbonate solution, correction of metabolic acidosis with sodium lactate occurs more slowly, as it is included in the metabolism, without causing sharp pH fluctuations. The action of sodium lactate appears 20-30 minutes after administration.

Sodium chloride is a plasma-substituting agent, exhibits detoxifying, rehydrating action, eliminates the deficiency of sodium and chloride ions in various pathological conditions.

Calcium chloride eliminates the deficiency of calcium ions. Calcium ions are necessary for the process of nerve impulse transmission, contraction of skeletal and smooth muscles, myocardial activity, bone tissue formation, and blood clotting. It reduces the permeability of cells and the vascular wall, prevents the development of inflammatory reactions, increases the body’s resistance to infections and can significantly enhance phagocytosis.

Potassium chloride restores water-electrolyte balance. It exhibits negative chrono- and bathmotropic action, in high doses – negative ino-, dromotropic and moderate diuretic action. It takes part in the process of nerve impulse conduction. It increases the content of acetylcholine and causes excitation of the sympathetic part of the autonomic nervous system. It improves the process of contraction of skeletal muscles in muscular dystrophy, myasthenia.

Pharmacokinetics

Sorbitol is quickly included in the general metabolism, 80-90% of which is utilized in the liver and accumulates in the form of glycogen. 5% is deposited in the tissues of the brain, heart muscle and skeletal muscles. 6-12% is excreted in the urine.

When introduced into the vascular bed, Sodium lactate interacts with carbon dioxide and water, forming sodium bicarbonate, which leads to an increase in the alkaline reserve of the blood. Only half of the administered sodium lactate (L isomer) is considered active, and the other half (D isomer) is not metabolized and is excreted in the urine.

Sodium chloride is quickly excreted from the vascular bed, only temporarily increasing the circulating blood volume. It enhances diuresis.

Indications

• To reduce intoxication, improve microcirculation, correct acid-base status, improve hemodynamics in traumatic, surgical, hemolytic and burn shock;
• Peritonitis and intestinal obstruction (in the pre- and postoperative period);
• Acute renal failure of various etiologies;
• Thyrotoxicosis, sepsis;
• Various liver diseases (hepatitis, cholecystitis, acute and subacute liver dystrophy, hepatic coma);
• Increased intracranial pressure in case of cerebral edema.

ICD codes

Dosage Regimen

For traumatic, burn, postoperative and hemolytic shock – 200-400 ml and 600 ml (3-10 ml/kg body weight), once, first as a bolus, then – as a drip infusion.

For liver diseases – in a dose of 200 ml (3.5 ml/kg body weight) as a drip infusion once and repeatedly, daily or every other day.

For acute renal failure – in a single dose of 200-400 ml (up to 2.5-6.5 ml/kg body weight) as a drip infusion or bolus (repeatedly after 8-12 hours).

For prevention of postoperative intestinal paresis – 150-300 ml (2.5-5 ml/kg body weight) for a single administration, as a drip infusion; repeated infusions of the drug every 12 hours during the first 2-3 days after surgery are possible.

For treatment of postoperative paresis – in a dose of 200-400 ml (3.5-6.5 ml/kg body weight) as a drip infusion, every 8 hours until normalization of intestinal motility.

For cerebral edema – first as a bolus, and then as a drip infusion (60-80 drops/min) in a dose of 5-10 ml/kg body weight.

In case of significant dehydration, intravenous infusions of Sorbilact^® should be carried out only as a drip infusion (no more than 200 ml/day).

For children under 6 years of age, administration of the drug is recommended at a dose of 10 ml/kg body weight, for children aged 6 to 12 years – at a dose that is half the adult dose, for children over 12 years of age the drug dose is the same as for adults.

Adverse Reactions

Possible alkalosis or dehydration (due to the hyperosmolarity of the solution), allergic reactions (skin rash, itching).

Contraindications

• Alkalosis;
• In cases where the infusion of large volumes of fluid is contraindicated (cerebral hemorrhage, thromboembolism, cardiovascular decompensation, stage III arterial hypertension);
• Hypersensitivity to the components of the drug.

With caution, the drug should be prescribed to patients with impaired liver function, peptic ulcer disease, hemorrhagic colitis.

Use in Pregnancy and Lactation

Data on the use of the drug Sorbilact^® during pregnancy and breastfeeding are not available.

Use in Hepatic Impairment

With caution, the drug should be prescribed to patients with impaired liver function.

Pediatric Use

For children under 6 years of age, administration of the drug is recommended at a dose of 10 ml/kg body weight, for children aged 6 to 12 years – at a dose that is half the adult dose, for children over 12 years of age the drug dose is the same as for adults.

Special Precautions

The drug is used under the control of acid-base status and blood electrolyte parameters, as well as the functional state of the liver.

Use with caution in patients with calculous cholecystitis.

The drug is used taking into account the osmolarity of blood and urine, as well as the acid-base status.

Administration of the drug Sorbilact^® to patients with diabetes mellitus should be carried out under the control of blood glucose levels.

Overdose

Symptoms: phenomena of alkalosis occur, which quickly disappear on their own provided that the administration of the drug is immediately stopped.

Treatment: in case of dehydration, symptomatic therapy is carried out.

Drug Interactions

Sorbilact^® should not be mixed with phosphate- and carbonate-containing solutions.

It is not used as a carrier solution for other drugs.

Storage Conditions

List B. The drug should be stored in a dry, light-protected place, out of the reach of children, at a temperature from 2°C (35.6°F) to 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.