Medication info

Frezole (B) Liquid (Sodium Bicarbonate)

Prescription medication주사
Ingredient · strength
Sodium Bicarbonate›8.4g / 100mL
Manufacturer / importer
대한약품공업(주)
Appearance
A colorless and transparent liquid filled in a plastic container.
Packaging
12.6L/container
Approval status
Active

MFDS item code 200500379 · Notified 2005.06.21 · Insurance code 645102491

Summary

Main use
Dialysis solution preparation results in dialysis effect in cases of acute and chronic renal failure and detoxification of poisons.
Who receives it
Adults
Adult administration
When using the prescribed buffered acetate dialysis solution (Solution A), this formulation can create a bicarbonate-based dialysis solution containing 35 mEq/L of HCO3-. For mixing, the dilution ratio of acetate dialysis solution (Solution A) 1 : this solution 1.225 : purified water 32.775 is used for the dialysis solution when utilizing a bicarbonate dialysis delivery device.

Ingredients

Manufacturer
대한약품공업(주)

Efficacy & effects

Dialysis solution preparation results in dialysis effect in cases of acute and chronic renal failure and detoxification of poisons.

View approved original text

This medication is used to prepare a dialysis solution for patients with acute and chronic renal failure receiving bicarbonate dialysis. It is also utilized for preparing dialysis solutions during cases of toxic substance poisoning, aiding in detoxification of harmful substances in the body. Therefore, this drug plays an important role in blood dialysis for treating renal failure and in treatment for poisoning.

How it is given

Adult administration

When using the prescribed buffered acetate dialysis solution (Solution A), this formulation can create a bicarbonate-based dialysis solution containing 35 mEq/L of HCO3-. For mixing, the dilution ratio of acetate dialysis solution (Solution A) 1 : this solution 1.225 : purified water 32.775 is used for the dialysis solution when utilizing a bicarbonate dialysis delivery device.

Precautions

This medication should not be used in patients with very low blood pressure or those with a fast heartbeat. It is also not safe to administer to patients with pulmonary edema or abnormal ECG findings. Patients with high serum potassium levels and blood coagulation disorders should also not be given this drug. Patients with severe liver impairment or severe diabetes causing acid metabolism problems should use this drug with caution. Patients on cardiac medications such as digitalis should be careful of the risk of drug toxicity due to changes in potassium levels. Patients with high serum calcium and phosphorus levels before dialysis should also be administered this drug cautiously as it may lead to calcification. Patients with malnutrition or dietary restrictions due to diabetes should be monitored for the risk of hypoglycemia. When using this drug, signs of hypoglycemia may occur, so blood sugar management should be performed. If necessary, actions such as administering a glucose injection or supplying sugar are required. As the serum calcium levels may rise, it is advisable to switch to dialysis solutions with lower calcium concentrations. Because complications related to bones, such as osteoporosis or osteomalacia, may occur, proper treatment including administration of vitamin D3 is necessary. Should ectopic calcification occur, treatments to maintain serum phosphorus levels within the normal range are crucial. Symptoms of dialysis disequilibrium syndrome such as headache, nausea, vomiting, seizures, and altered consciousness may appear; hence, if such symptoms occur, measures such as reducing dialysis intensity are required. Due to cardiovascular anomalies, blood pressure may drop sharply or shock symptoms may appear, necessitating cessation of dialysis or intensity adjustment along with the administration of fluids and blood pressure-regulating medications. Rarely, blood pressure may increase, in which case antihypertensive agents or adjustments to the dialysis solution components may be needed. This drug is used for hemodialysis in chronic renal failure patients, especially when improvements in acidosis are difficult or when low blood pressure during dialysis, disequilibrium syndrome, etc., occur. For patients with blood sugar control issues due to metabolic abnormalities, this drug, which does not contain glucose, may be beneficial. Regular blood tests for electrolytes, acid-base balance, and blood sugar are needed during dialysis. Women who are pregnant or may become pregnant should use this medication only when the benefits outweigh the risks as its safety has not been established. Safety in pediatrics has also not been established, so caution is advised. Elderly patients using this medication long-term may develop bone complications, necessitating regular monitoring and administration of vitamin D3. The dialysis dilution water must use high-quality purified water, and attention should be given to the presence of dialysis membrane damage and tendencies toward postoperative bleeding. During preparation, sodium bicarbonate solution should not be directly mixed with other electrolyte solutions, and the prescribed diluent must be used to accurately adjust concentrations. Caution is needed as overly high or low concentrations may lead to side effects such as headaches, blood pressure changes, and consciousness disturbances. The electrolyte concentration and pH of the dialysis solution must be verified before use, and leftover solution should not be used. This medication should not be used for injection or peritoneal perfusion, and the dialysis solution must be used immediately after preparation. It should be noted that insoluble residues may form if more than 2 hours elapse after mixing. It is advisable to adjust the temperature to body temperature during use.

Side effects and when to seek care immediately

Serious side effects

  • Altered consciousness
  • consciousness disturbance
  • headache (including severe headache)
  • seizures
  • elevated blood pressure
  • rapid blood pressure drop.

Mild side effects

  • Hypoglycemia
  • hypercalcemia
  • osteoporosis
  • osteomalacia
  • fibrous osteitis
  • headache
  • nausea
  • vomiting
  • seizures
  • altered consciousness
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  • discomfort
  • fatigue
  • hypotension
  • shock symptoms
  • elevated blood pressure
  • limb paralysis
  • general fatigue
  • chest discomfort
  • rapid blood pressure drop
  • consciousness disturbance.

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

Storage

This medication should be stored in a sealed container at room temperature between 1°C and 30°C. Storing it this way helps maintain the effectiveness of the medication and prevents deterioration.

Appearance and packaging

Appearance

A colorless and transparent liquid filled in a plastic container.

Package unit

12.6L/container

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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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.