Dialyte-AC

• Hemodialysis in End-Stage Renal Disease (ESRD):
  Used as a dialysate solution in patients undergoing intermittent hemodialysis for the removal of waste products, electrolytes, and excess fluid in ESRD.
• Acute Kidney Injury (AKI):
  Occasionally used in patients requiring short-term hemodialysis due to acute renal failure, fluid overload, or severe electrolyte disturbances.
• Alternative to Bicarbonate Dialysate:
  Employed in facilities or emergency settings lacking bicarbonate-buffered systems or in patients with bicarbonate sensitivity.

• Dosage (Dialysate Composition):
  The formulation is not dosed like a drug but used as a dialysate component in a dialysis machine. Key components in a typical acetate-based solution (values may vary slightly):
• Sodium: 136–140 mEq/L
• Acetate (as buffer): 3–4 mEq/L
• Calcium: 2.5–3.5 mEq/L
• Magnesium: 0.5–1.0 mEq/L
• Chloride: Balanced accordingly
• Potassium: Typically 0–4 mEq/L (customized based on patient needs)
• Glucose: Optional; may be added at 100–200 mg/dL
• Administration:
• Administered via dialysis machine into the dialyzer counter-current to blood flow.
• The rate and volume depend on individual dialysis prescriptions (e.g., 500–800 mL/min for 3–5 hours per session).
• Use in Special Populations:
• Pediatrics: Formulation adjusted based on weight, fluid status, and metabolic needs.
• Elderly: No unique dose adjustment; close monitoring for hemodynamic tolerance.
• Pregnancy: No known teratogenic effects from acetate dialysate, but maternal acid-base and fluid status must be closely managed.

Acetate-based hemodialysis solution functions as a dialysate buffer. Acetate diffuses across the dialyzer membrane into the blood, where it is rapidly metabolized in the liver, muscle, and other tissues to bicarbonate. This indirectly corrects metabolic acidosis in patients with renal failure. The solution also facilitates diffusive and convective clearance of uremic toxins, excess electrolytes (e.g., potassium, phosphate), and water from the bloodstream.

• Absorption: Acetate is not absorbed per se; it diffuses into the bloodstream during dialysis.
• Distribution: Once in circulation, acetate is rapidly distributed to hepatic and peripheral tissues.
• Metabolism: Metabolized mainly in the liver and muscles into bicarbonate via the citric acid (Krebs) cycle.
• Excretion: Final metabolic products are exhaled as CO₂ or used in normal bicarbonate buffering.
• Onset/Duration: Rapid onset of buffer effect; duration depends on dialysis session length and patient metabolic rate.

• Pregnancy: No specific FDA category assigned (device-class solution). However, acetate dialysate is considered acceptable in pregnancy when indicated, with close maternal-fetal monitoring.
• Lactation: Safe; no components are expected to enter breast milk in harmful concentrations.
• Caution: Careful acid-base, electrolyte, and fluid balance are essential to avoid maternal hypotension or fetal hypoperfusion.

• Class: Hemodialysis Solution (Dialysate)
• Subclass: Acetate-buffered Dialysate

• Hemodynamic instability or shock (relative): Acetate may cause vasodilation and worsen hypotension.
• Severe lactic acidosis or impaired acetate metabolism (e.g., advanced liver failure).
• Hypersensitivity to components of the solution.

• Hypotension Risk: Acetate can cause vasodilation, especially in high-flux or rapid sessions. Monitor blood pressure.
• Metabolic Alkalosis: Excess conversion to bicarbonate may lead to alkalosis in some patients.
• Cardiac Arrhythmias: Electrolyte shifts (especially potassium or calcium) must be closely monitored during and after dialysis.
• Liver Dysfunction: Impaired acetate metabolism may lead to accumulation and delayed conversion to bicarbonate.
• Muscle cramps or dialysis disequilibrium syndrome: Occurs more frequently with rapid solute removal.

• Common:
• Hypotension
• Nausea
• Muscle cramps
• Headache
• Serious/Rare:
• Arrhythmias due to electrolyte imbalances
• Metabolic alkalosis
• Dialysis disequilibrium syndrome
• Hypocalcemia or hypercalcemia (depending on formulation)
• Seizures (rare, in vulnerable populations)

• Chelating agents (e.g., phosphate binders): May affect calcium levels during dialysis.
• Insulin/glucose adjustments: Dialysate glucose concentration may influence insulin requirements.
• Potassium-altering drugs: Serum potassium must be closely monitored during dialysis, especially if patient is on ACE inhibitors, ARBs, or diuretics.
• No CYP450 or classic drug metabolism interactions, as this is a non-systemic, extracorporeal therapy.

• Recent Trends: Global shift toward bicarbonate-based solutions due to better hemodynamic stability; however, acetate remains relevant in specific settings (e.g., acute dialysis or emergency setups).
• KDIGO Guidelines: Recommend bicarbonate as the buffer of choice, but acetate can be used where bicarbonate is not feasible or tolerated.
• Device Manufacturers: Several updated formulations now use low-acetate concentrations (<3 mEq/L) to minimize side effects.

• Temperature: Store between 15°C and 30°C (59°F–86°F).
• Light & Humidity: Protect from direct sunlight and excessive humidity.
• Handling Precautions:
• Do not use if container is damaged or solution is cloudy or contains particles.
• Mix thoroughly if two-part systems are used.
• Use immediately after opening or mixing.
• Follow aseptic technique to prevent contamination.