Balance (Solution) Instructions for Use

ATC Code

B05DB (Hypertonic solutions)

Pharmacotherapeutic Group

Blood substitutes and perfusion solutions; peritoneal dialysis solutions; hypertonic solutions

Pharmacological Action

Peritoneal dialysis is a long-term therapy involving the continuous use of peritoneal dialysis solutions.

The basic principle underlying any peritoneal dialysis technique is the use of the peritoneum as a semi-permeable membrane, through which the exchange of solutes and water between the blood and the dialysis solution is possible by diffusion and convection, in accordance with their physicochemical properties.

The electrolyte composition of the solution is largely similar to the physiological composition of blood serum, although it is adapted (particularly in terms of potassium content) for use in patients with uremia to enable renal replacement therapy by the intraperitoneal exchange of metabolites and fluid.

Substances normally excreted in the urine, such as nitrogenous metabolites (urea, creatinine, inorganic phosphates, uric acid, other solutes and water), are removed from the body with the dialysate solution. Water balance can be maintained by using solutions with different glucose concentrations, which provide fluid removal (ultrafiltration).

Metabolic acidosis, characteristic of end-stage renal failure, is balanced by the presence of lactate in the solution. Complete metabolism of lactate leads to the formation of bicarbonate.

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Indications

End-stage (decompensated) chronic renal failure of various origins that can be treated with peritoneal dialysis.

ICD codes

Dosage Regimen

For intraperitoneal use only.

Administer the solution exclusively via the peritoneal route.

The specific method of therapy, frequency of application, and duration of the solution’s intraperitoneal dwell are determined by the attending physician based on the patient’s clinical status.

Adjust the prescribed volume for each exchange according to the patient’s individual tolerance and ultrafiltration requirements.

Select the glucose concentration (1.5%, 2.5%, or 4.25%) to achieve the desired fluid removal; use higher concentrations for greater ultrafiltration.

Ensure the solution is at or near body temperature prior to instillation.

Maintain strict aseptic technique during all connections to prevent peritonitis.

Monitor the effluent dialysate for volume and clarity after each exchange; report cloudy effluent immediately.

For pediatric patients, calculate the infusion volume based on body surface area or weight, typically 600-1100 mL/m² per exchange.

In geriatric patients, consider the increased risk of abdominal wall hernias when determining infusion volumes.

Regularly assess serum electrolytes, acid-base status, and residual renal function to adjust the dialysis prescription.

Adverse Reactions

Procedure-related peritoneal infection, water-electrolyte imbalance, metabolic acidosis, hyperazotemia.

Contraindications

Recent abdominal surgery or wound, history of abdominal surgery with fibrous adhesions, severe abdominal burns, intestinal perforation; extensive inflammatory lesions of the abdominal skin (dermatitis); inflammatory bowel diseases (Crohn’s disease, ulcerative colitis, diverticulitis); peritonitis; internal or external abdominal fistulas; abdominal wall hernias (umbilical, inguinal, or other locations); intra-abdominal tumors; intestinal obstruction; respiratory diseases (especially pneumonia); sepsis; severe hyperlipidemia; rare cases of uremia that are not amenable to peritoneal dialysis therapy; cachexia and significant weight loss, especially if adequate protein replenishment is not guaranteed; in patients who are physically or mentally unable to perform the peritoneal dialysis procedure according to the doctor’s instructions.

Contraindications depending on the drug used: lactic acidosis, severe hypokalemia, severe hypocalcemia, severe hypercalcemia, hypovolemia, arterial hypotension.

If any of the above disorders develop during the peritoneal dialysis procedure, the decision on how to continue treatment should be made by the attending physician.

Use in Pregnancy and Lactation

When considering the possibility of performing peritoneal dialysis during pregnancy, it is necessary to weigh the benefit of treatment against the potential risks and complications for the mother and child.

Given the benefit of peritoneal dialysis for the mother and the possible risk to the child, temporary discontinuation of breastfeeding should be considered.

Pediatric Use

For children, the volume of the solution should be prescribed according to age and body surface area.

Geriatric Use

There are no special recommendations for the dosage regimen in elderly patients. The increased frequency of hernia development in elderly patients should be considered before initiating peritoneal dialysis therapy.

Special Precautions

Before starting use, the benefits and risks of peritoneal dialysis should be carefully assessed, depending on the drug used: secondary hyperparathyroidism (therapy should include phosphate-binding agents containing calcium and/or vitamin D to ensure adequate calcium intake); hypocalcemia (a temporary or permanent switch to a peritoneal solution with a higher calcium content may be necessary if adequate calcium intake is not possible with oral calcium-containing phosphate-binding drugs and/or vitamin D preparations); hypercalcemia resulting from the use of calcium-containing phosphate-binding drugs and/or vitamin D preparations (a temporary or permanent switch to a peritoneal dialysis solution with a lower calcium content may be necessary); loss of electrolytes due to vomiting and/or diarrhea (a temporary switch to a peritoneal dialysis solution containing potassium may be necessary); if the patient is receiving therapy with cardiac glycosides (serum potassium levels should be monitored regularly; in case of severe hypokalemia, the need to switch the patient to a potassium-containing peritoneal dialysis solution and provide dietary advice to the patient should be considered); polycystic kidney disease in which the kidneys are enlarged in size.

During peritoneal dialysis, the loss of proteins, amino acids, and vitamins, especially water-soluble ones, is inevitable. To avoid deficiency, the patient should be provided with a complete diet or dietary supplements.

During long-term peritoneal dialysis, the transport characteristics of the peritoneal membrane may change, primarily indicated by the loss of ultrafiltration. In severe cases, peritoneal dialysis should be discontinued and hemodialysis initiated.

Regular monitoring of the following parameters is recommended: body weight for early recognition of overhydration and dehydration; serum concentrations of sodium, potassium, calcium, magnesium, phosphate, acid-base balance, blood gases and blood proteins; serum creatinine and urea; parathyroid hormone and other bone metabolism indicators; blood glucose; residual renal function to adapt peritoneal dialysis treatment.

The dialysate after the procedure should be checked for clarity and volume. Cloudy dialysate and/or abdominal pain are indicators of peritonitis.

Encapsulating peritoneal sclerosis is considered a known rare complication of peritoneal dialysis, which in rare cases can be fatal.

Drug Interactions

The use of peritoneal dialysis solutions with dextrose may lead to loss of effectiveness of other medicines if they are removed during peritoneal dialysis. Dose adjustment may be necessary.

With concomitant therapy with cardiac glycosides, careful monitoring of potassium concentration is necessary. A pronounced decrease in serum potassium levels may lead to an increase in the frequency of adverse reactions associated with the use of cardiac glycosides.

The use of diuretics may help preserve residual renal function but may also lead to water-electrolyte imbalance.

In patients with diabetes mellitus, the daily dose of insulin or oral hypoglycemic drugs should be adjusted to account for the increased glucose load.

Concomitant use of medicines containing calcium or vitamin D may lead to hypercalcemia.

Storage Conditions

Store at 8°C (46°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.