Bibaeksan (Sodium Bicarbonate)

Adult administration

1. When using the specified acetate-based dialysis solution (Solution A), this preparation can produce a bicarbonate dialysis solution containing 32 mEq/L of HCO3-. 2. For the acetate-based dialysis solution (Solution A), a dilution ratio of 1 : (this drug + purified water) 34 is used for blood dialysis with the bicarbonate dialysis supply device. 3. The mixing ratio for a one-time dialysis solution per patient (based on a 6-hour period) is as follows: Solution A : (Sodium Bicarbonate + purified water) = 5L : (650g + 170L)

This medication should not be used in patients with low blood pressure and rapid heart rate. Additionally, it should not be administered to patients with pulmonary edema or cardiac abnormalities, patients with high serum potassium levels, and patients with coagulation issues. It should be used with caution in patients with severe liver dysfunction or poor acetic acid metabolism due to severe diabetes, as improper metabolism of acetic acid may result in symptoms of low blood pressure. Patients taking digitalis preparations must be cautious as low serum potassium levels may lead to digitalis toxicity. Patients showing high levels of serum calcium and phosphate before blood dialysis should be administered this drug carefully, as it may increase the risk of ectopic calcification. Patients with insufficient caloric intake, dietary restrictions due to diabetes, or those taking hypoglycemic agents should be careful as they may exhibit symptoms of hypoglycemia. This drug can induce hypoglycemia during or after dialysis, so when symptoms appear, appropriate measures such as glucose injection or supplementation of carbohydrates are necessary. As serum calcium levels may increase, if hypercalcemia occurs, it is advisable to switch to a dialysis solution with low calcium concentration. Complications related to bones, such as osteoporosis, osteomalacia, and fibrous osteitis, may occur, thus appropriate treatment such as administration of active vitamin D3 preparations is needed. If ectopic calcification occurs, phosphate binders should be used to maintain serum phosphate levels within the normal range. Dialysis disequilibrium syndrome may cause headaches, nausea, vomiting, seizures, and confusion, necessitating reduction of dialysis speed when symptoms occur. Effects on the cardiovascular system may present with hypotension or shock, requiring dialysis to be stopped or efficiency adjusted, along with administration of fluids or vasopressors. Rarely, hypertension may occur, requiring appropriate measures such as administration of antihypertensive medications or switching to acetate-based dialysis solutions. This drug is used for blood dialysis in chronic renal failure patients, particularly when metabolic acidosis is not improved with high-acetate dialysis solutions or when difficulties arise in dialysis management due to dialysis disequilibrium syndrome or blood pressure reduction. It is suitable for patients with impaired glucose metabolism who cannot control hyperglycemia with dialysis solutions that do not contain glucose. It is important to regularly monitor electrolytes, acid-base balance, renal function, and blood sugar levels through blood tests. Women who are pregnant or may become pregnant should only use this medication when the benefits clearly outweigh the risks. Safety in children has not been established, so caution is needed. Elderly patients should consider the characteristics of this drug properly and initiate regular examinations for bone complications and, if necessary, administer active vitamin D3 preparations when used over a long term. The diluent for dialysis should be water that has undergone appropriate purification processes, with attention to potential damage to the dialysis membrane and bleeding tendencies. During preparation, do not directly mix the electrolyte solution for artificial kidney dialysis with this drug solution but prepare it accurately with the specified diluent. If the dilution concentration is too high, symptoms such as headache, palpitations, elevated blood pressure, and consciousness disorders may occur, while if it is too low, symptoms such as limb paralysis, general lethargy, chest discomfort, acute hypotension, and consciousness disturbances may develop, necessitating caution. It is advisable to check the electrolyte concentration and pH of the dialysis solution before use, and any remaining solution after use should not be reused. This drug should not be used for injections or peritoneal dialysis, and the dialysis solution should be used immediately after preparation. It is appropriate to maintain the temperature around body temperature during use.

Serious side effects

• Confusion
• seizures
• consciousness disturbance

Mild side effects

• Hypoglycemia
• hypercalcemia
• osteoporosis
• osteomalacia
• fibrous osteitis
• ectopic calcification
• headache
• nausea
• vomiting
• seizures

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is advisable to avoid excessively hot or cold places and store it at normal room temperature.

Appearance

White crystalline powder in polyethylene bag

Package unit

16 units/box [650g per unit], 12 units/box [900g per unit]