PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER
Clinical safety rating: caution
PRISMASOL BK 4/2.5 is a sterile, nonpyrogenic, bicarbonate-buffered hemofiltration solution indicated for use as a replacement fluid and/or dialysate in continuous renal replacement therapy (CRRT) for patients with acute kidney injury. It provides physiological electrolyte concentrations (sodium, potassium, calcium, magnesium, chloride), bicarbonate as a buffer, and glucose to correct metabolic acidosis and electrolyte imbalances during CRRT.
Prismasol BK 4/2.5 is a bicarbonate-buffered hemofiltration solution used in continuous renal replacement therapy (CRRT). It provides electrolyte and buffer replacement to correct metabolic acidosis and maintain acid-base balance, with no direct pharmacological activity. Its mechanism of action is based on the physical removal of solutes and water via convection and diffusion across a hemofilter membrane.
| Metabolism | Not metabolized. The components are electrolytes and bicarbonate buffer that undergo physiological distribution and renal elimination when kidney function allows. |
| Excretion | PRISMASOL BK 4/2.5 is a bicarbonate-buffered hemodialysis solution; its components are electrolytes and buffer. Elimination is primarily via dialysis: the solution itself is not systemically absorbed; rather, solutes are removed during therapy. Endogenous potassium is excreted renally (95%) and fecally (5%). Bicarbonate is regenerated via renal and metabolic processes. |
| Half-life | Not applicable as a drug; the half-life of infused bicarbonate is approximately 15 minutes due to rapid buffering and renal excretion. Potassium's half-life is about 1-1.5 hours in normal renal function but prolonged in renal failure. |
| Protein binding | Electrolytes and bicarbonate are not protein-bound. Potassium is minimally bound (<5%) to albumin; bicarbonate binding is negligible. |
| Volume of Distribution | For potassium: Vd ~0.4-0.6 L/kg (total body water). Bicarbonate distributes into extracellular fluid (0.2 L/kg). |
| Bioavailability | Not applicable as a drug; administered directly into the bloodstream during dialysis (100% bioavailability via extracorporeal route). |
| Onset of Action | Immediate upon start of dialysis: correction of acidosis and electrolyte imbalances occurs within minutes to hours, depending on flow rate and patient status. |
| Duration of Action | Effects are transient and last only during and shortly after dialysis (typically 4-hour session). Sustained benefit requires repeated treatments. |
Administered only via an extracorporeal circuit as part of continuous venovenous hemofiltration (CVVH), hemodialysis (CVVHD), or hemodiafiltration (CVVHDF). The dose is prescribed as effluent flow rate, typically 20–35 mL/kg/hour. For a 70 kg patient, total effluent flow (replacement fluid plus dialysate) is 1400–2450 mL/hour; the proportion of PRISMASOL BK 4/2.5 used as replacement fluid and/or dialysate is adjusted to achieve target fluid removal and metabolic control. Total daily volume commonly 24–72 L.
| Dosage form | INJECTABLE |
| Renal impairment | Not applicable; PRISMASOL BK 4/2.5 is indicated for patients with acute kidney injury requiring CRRT. The administration rate is adjusted based on clinical parameters (fluid status, electrolytes, acid-base balance) rather than residual renal function. |
| Liver impairment | Use with caution in severe hepatic impairment (Child-Pugh C). The solution contains lactic acid (4.0 mEq/L) as a pH adjuster; lactate clearance may be impaired, leading to hyperlactatemia. Frequent monitoring of blood lactate and acid-base status is recommended. Consider an alternative bicarbonate-based solution without lactate if lactic acidosis develops. No formal dose adjustment for the solution itself; the CRRT prescription may require modification based on metabolic response. |
| Pediatric use | Safety and effectiveness in pediatric patients have not been established in controlled trials. Dosing should be determined by a pediatric nephrologist, taking into account the patient's weight, clinical status, and metabolic demands. Flow rates are scaled proportionally from adult recommendations (e.g., using body surface area or weight-based effluent flow). |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
No adequate studies in pregnant women. PRISMASOL BK 4/2.5 is used for acute kidney injury, which may occur during pregnancy. If CRRT is clinically indicated, the solution may be used after careful risk-benefit assessment. Components (electrolytes, glucose, bicarbonate) are physiological substances unlikely to cause fetal harm when used as directed. Monitor maternal-fetal status closely.
| Placental transfer | Electrolytes, glucose, and bicarbonate cross the placenta via passive and active transport mechanisms, but the intact solution is not transferred from the CRRT circuit. The maternal-fetal gradient of these substances is determined by physiological regulation, not by the solution directly. |
| Breastfeeding | Components are considered safe during breastfeeding due to minimal systemic absorption. M/P ratio is not applicable. |
■ FDA Black Box Warning
None. Prismasol BK 4/2.5 is not a drug and does not carry FDA boxed warnings. However, it is for prescription use only and should be administered under medical supervision.
| Common Effects | Mild electrolyte imbalances, Fluid retention, Hypotension, Muscle cramps, Nausea, Vomiting, Headache, Fever |
| Serious Effects | Hypotension, severe electrolyte disturbances (hyperkalemia, hypokalemia, hypercalcemia, hypocalcemia, hypermagnesemia), metabolic acidosis or alkalosis, fluid overload, air embolism, catheter-related infection/sepsis, hemorrhage, thrombosis, severe allergic reactions. |
["Severe metabolic alkalosis","Hypersensitivity to any component of the solution","Use as a direct intravenous infusion without CRRT circuit"]
| Precautions | ["Monitor serum electrolytes, acid-base status, and fluid balance closely during therapy","Use with caution in patients with severe electrolyte disturbances or metabolic alkalosis","Not for intravenous infusion directly; must be used with appropriate CRRT equipment","Risk of fluid overload or hypovolemia; adjust infusion rates based on patient response","Possible incompatibility with other medications; check drug compatibility prior to co-administration"] |
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| Geriatric use | No specific dose adjustment for elderly patients. Initial CRRT prescription is based on ideal body weight and metabolic parameters. Geriatric patients are at increased risk for fluid shifts, electrolyte imbalances, and hemodynamic instability; monitor more frequently. |
| Teratogenic Risk | PRISMASOL BK 4/2.5 is a peritoneal dialysis solution containing electrolytes and dextrose. No teratogenic risk is expected as it is not systemically absorbed. No fetal risks have been identified in any trimester. |
| Fetal Monitoring | Monitor serum electrolytes, renal function, and fluid balance in pregnant patients on peritoneal dialysis. |
| Fertility Effects | No effects on fertility have been reported. |