PRISMASOL BK 0/0 IN PLASTIC CONTAINER
Clinical safety rating: caution
Prismasol BK 0/0 is a sterile, nonpyrogenic bicarbonate-based solution for continuous renal replacement therapy (CRRT) indicated as a replacement fluid or dialysate in hemofiltration, hemodiafiltration, and hemodialysis for patients with acute renal failure requiring renal support. It contains no potassium or calcium, making it suitable for patients with hyperkalemia, hypercalcemia, or when calcium must be administered separately.
Prismasol BK 0/0 is a sterile, nonpyrogenic bicarbonate-buffered replacement solution for continuous renal replacement therapy (CRRT). It acts as an electrolyte and buffer replacement to correct acid-base disturbances and maintain fluid balance during hemofiltration, with no pharmacologic active drug component.
| Metabolism | Not metabolized; components are directly exchanged during the CRRT process and eliminated renally or via the filter. |
| Excretion | Renal (80-100% in urine as unabsorbed, not metabolized); minimal biliary/fecal. |
| Half-life | Not applicable; PRISMASOL is a dialysate solution, not a drug with systemic absorption; components are removed by dialysis. |
| Protein binding | Not applicable; electrolytes and buffer components are not protein-bound. |
| Volume of Distribution | Not applicable; distribution is confined to the extracorporeal circuit and dialyzer; solutes distribute according to body water compartments. |
| Bioavailability | Intravenous via dialyzer; bioavailability is 100% for delivered components. |
| Onset of Action | Immediate upon initiation of hemodialysis or hemofiltration; therapeutic effect is removal of solutes and correction of electrolyte/acid-base imbalances. |
| Duration of Action | Duration equals length of dialysis session; clinical effect continues while the solution circulates. |
Administered as a continuous infusion at rates typically between 1000-4000 mL/hour depending on the desired effluent flow rate, patient fluid balance, and metabolic requirements. The solution is used as dialysate (hemodiafiltration) or replacement fluid (hemofiltration). Must be prescribed and administered under physician supervision using intravenous infusion via a dialyzer or hemofilter.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required; intended for use in patients with acute renal failure. The rate of administration is titrated to achieve desired clearance and fluid balance, not based on GFR. |
| Liver impairment | Data not established; no specific hepatic adjustment is required as the solution does not rely on hepatic metabolism. In patients with hepatic encephalopathy, careful monitoring of fluid balance is recommended. |
| Pediatric use | Safety and efficacy in pediatric patients have not been established. Use is at the discretion of the physician and typically adjusted based on weight and clinical status; no standardized pediatric dosing exists. |
| Geriatric use | No specific geriatric dose adjustment required. Caution in elderly patients with compromised cardiovascular function due to risk of volume overload; monitor fluid balance and electrolytes closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed, weighing potential risks of fluid and electrolyte shifts against the benefit of renal support. CRRT has been used safely in pregnancy in limited reports.
| Placental transfer | Data not established. Small molecule electrolytes and water freely cross the placenta, but the direct perfusion of the placenta with this IV solution is not intended and unlikely to occur in a way that causes harm. |
| Breastfeeding | Excretion into breast milk unknown. Based on composition (electrolytes and bicarbonate), minimal systemic absorption unlikely to affect infant. No M/P ratio available. Use with caution, weighing benefits of maternal treatment against potential risks. |
■ FDA Black Box Warning
Not for intravenous administration without the use of a CRRT machine. Must be used only with appropriate medical supervision.
| Common Effects | Hypotension, Fluid and electrolyte imbalances, Metabolic alkalosis, Hypothermia, Infection at the catheter exit site or peritonitis, Nausea and vomiting, Muscle cramps, Headache, Fever |
| Serious Effects | Severe metabolic alkalosisCardiac arrhythmias from electrolyte disturbancesFluid overload leading to pulmonary edemaAir embolismSepsis due to contaminated solutionHemolysis from hypotonic or hypertonic fluid errorsAcute hypersensitivity reactions |
["Hypersensitivity to any component of the solution","Patients with severe metabolic alkalosis","Concomitant administration of medications incompatible with bicarbonate or calcium-containing solutions"]
| Precautions | ["Monitor serum electrolytes, acid-base status, and fluid balance closely during CRRT","Risk of electrolyte imbalances (e.g., hyperkalemia, hypophosphatemia) if solution composition is not adjusted for patient needs","Use with caution in patients with severe hepatic failure or lactic acidosis as bicarbonate may not correct acidosis adequately","Ensure proper vascular access and CRRT circuit function"] |
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| Teratogenic Risk | PRISMASOL BK 0/0 is a sterile, nonpyrogenic solution for hemofiltration/hemodiafiltration containing only electrolytes and buffer (bicarbonate). No teratogenic effects in animal studies; human data limited. No known risk of structural anomalies based on its composition. However, use in pregnancy only if clearly needed, as the underlying renal condition may pose risks. |
| Fetal Monitoring | Monitor maternal electrolytes, acid-base status, renal function, and blood pressure closely. Fetal monitoring (ultrasound for growth, non-stress test) if used in pregnancy due to underlying renal disease. During hemofiltration, watch for fluid/electrolyte imbalances affecting fetus. |
| Fertility Effects | No known direct effects on fertility. Underlying renal condition requiring hemofiltration may impair fertility, but PRISMASOL BK 0/0 itself not associated with reproductive toxicity. |