Sorbit (Solution) Instructions for Use

Marketing Authorization Holder

Biokhimik, JSC (Russia)

ATC Code

B05CX02 (Sorbit)

Active Substance

Sorbitol (BP British Pharmacopoeia)

Dosage Form

Sorbit

Solution for intravenous administration 200 mg/1 ml: vial 200 ml, 400 ml

Dosage Form, Packaging, and Composition

200 ml – vials (28) – cardboard boxes.
400 ml – vials (15) – cardboard boxes.

Clinical-Pharmacological Group

Sugar substitute

Pharmacotherapeutic Group

Diuretic agent

Indications

• For use as an irrigating solution during transurethral surgical procedures for the resection of the prostate gland, bladder tumors, and other urological interventions to provide a clear, electrolyte-free, and non-hemolytic field.
• As an osmotic diuretic to promote the excretion of water in the management of cerebral edema and glaucoma, or to enhance the renal excretion of certain toxic substances.
• As a solute for the preparation of peritoneal dialysis solutions in patients requiring renal replacement therapy.
• For use as a sugar substitute in parenteral nutrition regimens for patients with diabetes mellitus or conditions requiring strict control of blood glucose levels.

Contraindications

• Hypersensitivity to sorbitol or any of the excipients in the formulation.
• Patients with severe dehydration, anuria, or established acute renal failure not undergoing dialysis, due to the risk of fluid overload and worsening metabolic status.
• Patients with severe pulmonary edema or congestive heart failure (NYHA Class III-IV), as the osmotic load and potential for fluid shifts may exacerbate these conditions.
• Conditions associated with intracellular dehydration, such as hypernatremia, as sorbitol may worsen the electrolyte imbalance.
• Patients with hereditary fructose intolerance (HFI), as sorbitol metabolism can lead to the accumulation of fructose-1-phosphate, causing severe hypoglycemia, lactic acidosis, and hepatorenal failure.

Dosage Regimen

The dosage of Sorbit (sorbitol) solution is highly individualized and must be determined by a physician based on the patient’s clinical condition, fluid and electrolyte status, and therapeutic goals. This solution is for intravenous infusion only and should be administered under strict medical supervision.

For use as an irrigating fluid in transurethral resection of the prostate (TURP), the solution is used continuously to irrigate the surgical field. The total volume absorbed systemically must be monitored closely, as excessive absorption can lead to water intoxication and hyponatremia.

When used as an osmotic diuretic, the adult dosage typically ranges from 1.5 to 3.0 g/kg of body weight (approximately 7.5 to 15 ml/kg of the 200 mg/ml solution) administered as a slow intravenous infusion over several hours. The rate of infusion should not exceed 0.5 g/kg/hour to minimize the risk of vascular overload and adverse reactions.

For parenteral nutrition, the amount is calculated based on the patient’s total caloric requirements and metabolic capacity, often in combination with other energy sources like glucose and lipids. The infusion rate must be carefully controlled to prevent hyperosmolar syndrome and metabolic complications.

Dosage in pediatric patients, the elderly, and patients with renal or hepatic impairment requires extreme caution, and the dose must be adjusted accordingly, often starting at the lower end of the dosing range with close monitoring of fluid balance, serum electrolytes, and osmolality.

Adverse Reactions

Adverse reactions to intravenous sorbitol are primarily related to its osmotic and metabolic effects and are often dose-dependent.

Common reactions may include nausea, vomiting, headache, and dizziness. Patients may experience a sensation of thirst and dryness of the mouth due to the osmotic diuresis.

Serious metabolic and electrolyte disturbances can occur, most notably hyponatremia (dilutional), hyperkalemia or hypokalemia, and lactic acidosis, especially with large-volume infusions or in patients with compromised renal function. Excessive diuresis can lead to dehydration and hypovolemia.

Cardiovascular effects such as tachycardia, hypertension, or hypotension, and pulmonary edema may manifest due to rapid fluid shifts and vascular overload. Allergic-type reactions, including rash, urticaria, and anaphylaxis, are rare but possible.

During its use as an irrigant in urological surgery, systemic absorption can lead to the TURP syndrome, characterized by hyponatremia, fluid overload, neurological symptoms (confusion, blurred vision, convulsions), and cardiovascular complications. Close monitoring of the patient’s serum sodium and fluid status is imperative during and after the procedure.

Drug Interactions

Sorbitol solution can interact with other medications, primarily through its effects on fluid and electrolyte balance and its metabolism.

Concomitant use with other diuretics, especially loop diuretics or thiazides, may lead to an additive diuretic effect, increasing the risk of profound dehydration and severe electrolyte imbalances (e.g., hypokalemia, hyponatremia).

Drugs that can cause renal impairment, such as aminoglycoside antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), or contrast media, may increase the risk of sorbitol-induced toxicity, as reduced excretion can lead to accumulation.

Sorbitol may enhance the elimination of certain medications, such as lithium, by increasing urine flow, potentially reducing their serum concentrations and therapeutic efficacy. Monitoring of lithium levels is essential.

The solution is incompatible with whole blood and packed red blood cells and must not be administered simultaneously through the same infusion set, as it can cause hemolysis and pseudoagglutination.

Caution is advised when administered to patients receiving digitalis glycosides (e.g., digoxin), as hypokalemia induced by sorbitol can potentiate the toxic effects of digitalis on the heart.

Overdose

Overdose with Sorbit solution is characterized by a significant exaggeration of its pharmacological and adverse effects.

Symptoms of overdose include severe electrolyte disturbances (profound hyponatremia, hyperkalemia), metabolic acidosis (primarily lactic acidosis), pronounced dehydration from excessive diuresis, hypervolemia leading to pulmonary edema and congestive heart failure, and neurological manifestations such as severe headache, confusion, seizures, and coma.

Treatment is primarily supportive and symptomatic and must be initiated immediately. This includes discontinuation of the sorbitol infusion, careful monitoring of vital signs, fluid balance, serum electrolytes, osmolality, and blood gas analysis.

Specific measures may include the administration of hypertonic saline for severe, symptomatic hyponatremia, the use of loop diuretics to manage hypervolemia (if renal function is adequate), and correction of acidosis with sodium bicarbonate if severe. In cases of renal failure, hemodialysis may be required to remove sorbitol and correct metabolic abnormalities.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.