Dialyte-A

The Acidic Component of HCO3 Hemodialysis Solution is indicated exclusively for use in the preparation of bicarbonate-based dialysate used during hemodialysis treatment for patients with:

• End-stage renal disease (ESRD) and severe chronic kidney disease (CKD) requiring extracorporeal blood purification.
• Correction of metabolic acidosis frequently observed in renal failure.
• Maintenance of acid-base and electrolyte balance during hemodialysis sessions.
• Use in hemodiafiltration and continuous renal replacement therapy (CRRT) modalities as part of dialysate formulation.

Clinically accepted off-label uses include:

• Dialysate preparation for acute kidney injury (AKI) patients undergoing dialysis.
• Adjunct in specialized dialysis protocols requiring custom electrolyte and acid-base correction.

• The acidic concentrate is not administered directly to patients; it is mixed with bicarbonate concentrate and purified water within dialysis machines to produce dialysate fluid.
• Standard dialysate bicarbonate concentration is typically between 30 to 40 mEq/L, adjusted based on patient-specific acid-base status.
• Electrolyte concentrations are determined by the acidic component composition and mixing ratios.
• No dosing adjustments for elderly, pediatric, renal, or hepatic impairment populations are necessary since it is an external dialysate component.
• Dialysis sessions are usually conducted 3 times per week for maintenance dialysis patients, with dialysate prepared fresh for each session.

Composition per 1 Liter Solution

1.      Sodium Chloride (NaCl): 161.43 g

2.      Potassium Chloride (KCl): 5.49 g

3.      Calcium Chloride (CaCl₂): 9.75 g

4.      Magnesium Chloride (MgCl₂): 3.74 g

5.      Glacial Acetic Acid (CH₃COOH): 8.85 g

6.      Highly Purified Water: q.s. to 1 liter

The acidic component contains glacial acetic acid and chloride salts (sodium chloride, potassium chloride, calcium chloride, magnesium chloride). When combined with bicarbonate concentrate and water, the solution forms dialysate that:

• Facilitates diffusion of bicarbonate ions into the blood, neutralizing hydrogen ions and correcting metabolic acidosis.
• The acetic acid acts as a precursor that metabolizes to bicarbonate in vivo.
• Electrolytes in the solution maintain plasma electrolyte concentrations by diffusion, preventing imbalances during dialysis.
• This balanced dialysate environment ensures optimal blood pH and electrolyte homeostasis throughout the dialysis procedure.

• Absorption: Not applicable; dialysate fluid is extracorporeal and does not undergo systemic absorption.
• Distribution: Electrolytes and bicarbonate ions equilibrate between the blood and dialysate compartments across the dialysis membrane.
• Metabolism: Acetic acid metabolizes rapidly to bicarbonate by cellular metabolism.
• Excretion: The resultant CO2 from bicarbonate buffering is eliminated via pulmonary exhalation.
• Onset: Blood acid-base correction begins immediately upon dialysate contact with blood.
• Half-life: Not applicable due to continuous supply during dialysis.

• No direct systemic administration; dialysate bicarbonate use is standard in pregnant and lactating dialysis patients.
• No known teratogenic or lactation-related risks.
• Close clinical monitoring advised for pregnant patients undergoing dialysis to maintain maternal-fetal acid-base balance.

• Dialysate Acid Concentrate
• Buffer Precursor and Electrolyte Replacement in Hemodialysis

• Hypersensitivity to any component (acetic acid, sodium chloride, potassium chloride, calcium chloride, magnesium chloride).
• Severe metabolic alkalosis or electrolyte imbalances where additional bicarbonate or electrolytes may exacerbate the condition.
• Incompatibility with incorrect dialysate mixing protocols or dialysis machines.

• Must be mixed correctly with bicarbonate concentrate and purified water before use.
• Monitor patients for electrolyte imbalances (e.g., hyperkalemia, hypocalcemia) and acid-base disturbances.
• Risk of metabolic alkalosis if bicarbonate is over-supplied.
• Use aseptic techniques to avoid contamination of concentrate.
• Patients with cardiac conditions or arrhythmias require careful dialysate electrolyte monitoring.
• Dialysis machines must be compatible with concentrate composition to avoid precipitation or equipment malfunction.

• Usually well tolerated as part of dialysate.
• Potential adverse effects relate to incorrect dialysate composition causing:
• Electrolyte disturbances such as hypokalemia, hyperkalemia, hypocalcemia.
• Metabolic alkalosis.
• Muscle cramps, hypotension, or tetany secondary to electrolyte shifts.
• Rare risk of infection if contamination occurs during preparation.

• No direct drug-drug or drug-food interactions.
• Indirect interactions possible with medications affecting electrolyte levels (e.g., potassium-sparing diuretics, ACE inhibitors).
• No involvement with CYP450 enzymes or other metabolic pathways.

• Guidelines from KDIGO, FDA, and NICE emphasize individualized dialysate bicarbonate and electrolyte concentrations to reduce risks of alkalosis and cardiac arrhythmias.
• Recent concentrate formulations have improved chemical stability, reducing precipitation risk.
• Recommendations highlight the importance of regular monitoring of pre- and post-dialysis acid-base status to guide dialysate composition.

• Store concentrate at 20°C to 25°C (68°F to 77°F).
• Protect from freezing, excessive heat, and light.
• Keep containers tightly sealed and use aseptic handling to prevent contamination.
• Use within manufacturer-specified time after opening.
• No reconstitution required; concentrate is used directly in dialysis machine mixing.