Medication info

BMBSan (Sodium Bicarbonate)

Prescription medication
Ingredient · strength
Sodium Bicarbonate›1g / 1g
Manufacturer / importer
원광제약(주)
Appearance
White crystalline powder in a white polyethylene bag
Packaging
16.8 kilograms/box - 16.8 kilograms/box[(8.4 kilograms/PE bag × 2)]
Approval status
Active

MFDS item code 202303350 · Notified 2023.12.15

Summary

Main use
Effectiveness in preparing dialysate for hemodialysis in acute and chronic renal failure and detoxification of toxic substances
Who uses it
Adults
Adult dosage
1. When using the specified acetate-containing dialysate (Type A), this formulation can produce approximately 180L of bicarbonate type hemodialysis solution containing 38mEq/L of HCO3-. 2. In dialysis conducted using the acetate-containing dialysate (Type A) diluted in the ratio of 1: (this drug + purified water) 34, it is used as the dialysate. 3. The mixing ratio for preparing the dialysate for a single session (based on 6 hours) per patient is as follows. Type A: (Sodium Bicarbonate + Purified Water) = 5L : (650g + 170L) 4. For standard bicarbonate type hemodialysis, the electrolyte concentration is adjusted as follows using the dialysate supply device. Na+: 140mEq/L HCO3-: 34mEq/L

Ingredients

Manufacturer
원광제약(주)

Efficacy & effects

Effectiveness in preparing dialysate for hemodialysis in acute and chronic renal failure and detoxification of toxic substances

View approved original text

This medication is used to prepare the dialysate for hemodialysis using sodium bicarbonate in patients with acute and chronic renal failure. It is also used during hemodialysis for the detoxification of patients with toxic substance poisoning. In summary, this drug is used to prepare dialysate for hemodialysis for the elimination of waste products from the body of renal failure patients and for detoxification of toxic substances.

Dosage and Administration

Adult dosage

1. When using the specified acetate-containing dialysate (Type A), this formulation can produce approximately 180L of bicarbonate type hemodialysis solution containing 38mEq/L of HCO3-. 2. In dialysis conducted using the acetate-containing dialysate (Type A) diluted in the ratio of 1: (this drug + purified water) 34, it is used as the dialysate. 3. The mixing ratio for preparing the dialysate for a single session (based on 6 hours) per patient is as follows. Type A: (Sodium Bicarbonate + Purified Water) = 5L : (650g + 170L) 4. For standard bicarbonate type hemodialysis, the electrolyte concentration is adjusted as follows using the dialysate supply device. Na+: 140mEq/L HCO3-: 34mEq/L

Precautions

This drug should not be used in patients with low blood pressure and rapid heart rate. It should also be avoided in patients with pulmonary edema or abnormalities in the electrocardiogram, as well as in patients with high potassium levels or issues with blood clotting. Care should be taken when using in patients with severely impaired liver function or metabolic disorders due to diabetes. Particularly patients taking medications that affect the heart may experience side effects due to this drug, so caution is necessary. Patients with high levels of calcium and phosphorus in the blood should also exercise caution when using this medication prior to dialysis. Care must be taken in cases of poor nutritional status or in diabetic patients who face dietary restrictions or use hypoglycemic agents, as there is a risk of hypoglycemia. This drug can cause side effects such as hypoglycemia or hypercalcemia during dialysis, so appropriate treatment is needed in case symptoms occur. Bone disorders such as osteoporosis or osteomalacia may develop, so regular examinations and vitamin D supplementation are recommended. Symptoms associated with dialysis disequilibrium syndrome such as headaches, nausea, and seizures may occur, and measures such as adjusting the dialysis speed are needed if symptoms arise. Circulatory problems may cause a sudden drop in blood pressure or symptoms of shock; in such cases, dialysis should be stopped immediately, and appropriate treatment should be provided. This drug is used in the hemodialysis of chronic renal failure patients, particularly when there is severe metabolic acidosis or hypotension during dialysis. For diabetic patients with poor glycemic control, using this drug, which does not contain glucose, can be beneficial. During treatment, it is important to regularly conduct blood tests to check the status of electrolytes and blood glucose. Pregnant women or women of childbearing potential should use this drug cautiously as its safety may not be established, under the guidance of a physician. The safety in children has not been fully established, thus special care is needed when administering to pediatric patients. Elderly patients may develop bone disorders when using this drug long-term, so regular examinations and vitamin D supplementation are necessary. The diluent for dialysis should be clean and subjected to appropriate purification processes. Careful monitoring of the dialysis membrane for damage and bleeding tendency is also essential. This drug may precipitate when mixed with other dialysis electrolyte solutions, so it should not be mixed directly and should be diluted according to prescribed methods. If the concentration of the dialysate is too high or low, symptoms such as headaches, blood pressure changes, and numbness may occur, so concentrations must be adjusted accurately. Before use, it is safe to verify the electrolyte concentration and pH of the dialysate. The solution should be used immediately after preparation, and care should be taken to prevent the formation of insoluble substances during storage. This drug is not to be used for injection or peritoneal dialysis, and attention should be paid to maintaining the serum osmotic pressure and balance in dialysis patients. It is advisable to match the temperature to body temperature when using.

Side effects and when to seek care immediately

Serious side effects

Altered consciousness, seizures

Mild side effects

Hypoglycemia, hypercalcemia, osteoporosis, osteomalacia, fibrous osteitis, ectopic calcification, symptoms of dialysis disequilibrium syndrome (headache, nausea, vomiting, seizures, altered consciousness, malaise, fatigue), hypotension, increased blood pressure, headache, palpitations, sensation of limb weakness, general malaise, discomfort in the chest, sudden drop in blood pressure, altered consciousness

Not everyone experiences these, and they can vary from person to person.

Storage

This drug should be stored in a tightly sealed container to prevent air and moisture ingress. It should also be kept away from excessively hot or cold environments, ideally stored at room temperature between 1 and 30 degrees.

Appearance and packaging

Appearance

White crystalline powder in a white polyethylene bag

Package unit

16.8 kilograms/box - 16.8 kilograms/box[(8.4 kilograms/PE bag × 2)]

Same-ingredient medicines

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.