PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER (PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER).
Prismasol B22GK 4/0 is a sterile, bicarbonate-based hemofiltration solution used in continuous renal replacement therapy (CRRT). It replaces electrolytes and buffers in the blood, correcting metabolic acidosis and removing waste products via convection and diffusion. The solution contains bicarbonate as a buffer to maintain acid-base balance.
| Metabolism | Prismasol B22GK 4/0 is not metabolized; its components are excreted or distributed according to physiological homeostasis. The bicarbonate in the solution is handled by the body's acid-base buffering systems. |
| Excretion | Prismasol B22GK 4/0 is a dialysis solution containing electrolytes and buffer (bicarbonate/lactate). It is not systemically absorbed; during continuous renal replacement therapy (CRRT), solutes and fluid are removed via hemofiltration/dialysis. The solution components are eliminated by the dialysis membrane and not subject to systemic excretion. |
| Half-life | Not applicable as a drug; the half-life of infused bicarbonate/lactate in patients is approximately 5–10 minutes for lactate conversion and bicarbonate distribution, but this is not relevant to the solution itself. |
| Protein binding | Negligible (<5%) for the electrolytes and buffer components; no significant protein binding. |
| Volume of Distribution | Not applicable; Prismasol is a replacement/dialysis solution that distributes into the extracellular fluid compartment (~0.2 L/kg) as it is infused, but it is not a drug with a defined Vd. |
| Bioavailability | 100% when administered intravenously via CRRT; solution components are directly infused into the blood. |
| Onset of Action | Immediate upon initiating CRRT; correction of acid-base and electrolyte imbalances begins within minutes of therapy. |
| Duration of Action | Duration is dependent on the duration of CRRT; effects persist only while the solution is being administered and the therapy is ongoing. Continuous therapy maintains effect 24 hours/day. |
Continuous renal replacement therapy (CRRT): 1.5-2.0 L/h effluent rate, typically administered as continuous venovenous hemofiltration (CVVH) or hemodiafiltration (CVVHDF). Route: intravenous via CRRT circuit. Frequency: continuous infusion.
| Dosage form | INJECTABLE |
| Renal impairment | Not applicable. Prismasol B22GK 4/0 is a replacement fluid for CRRT in acute kidney injury; dose adjustments are based on CRRT prescription and patient clearance, not GFR. |
| Liver impairment | No dose adjustment required for hepatic impairment. Monitor electrolytes and acid-base status. |
| Pediatric use | Weight-based: 2000-4000 mL/1.73 m²/h effluent rate, adjusted for body surface area. Typical starting dose: 2-4 L/h/1.73 m². Route: intravenous via CRRT circuit. Frequency: continuous. |
| Geriatric use | No specific dose adjustment; monitor fluid balance, electrolytes, and renal function due to age-related changes. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER (PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER).
| Breastfeeding | PRISMASOL B22GK 4/0 components are endogenous substances normally present in breast milk. No specific M/P ratio data available. The solution is administered intravenously and its constituents equilibrate with maternal plasma. Breastfeeding is considered safe as the amount of electrolytes and buffer excreted into milk is negligible and not expected to cause adverse effects in the infant. No contraindication for breastfeeding. |
| Teratogenic Risk | PRISMASOL B22GK 4/0 is a sterile, nonpyrogenic solution for continuous renal replacement therapy (CRRT) containing electrolytes and buffer. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. The risk of teratogenicity is considered low due to the physiological composition of the solution, similar to normal metabolic constituents. However, the underlying condition requiring CRRT (e.g., acute kidney injury) may pose risks to the fetus. In first trimester, avoid unless benefits outweigh risks. In second and third trimesters, may be used with careful monitoring of maternal fluid and electrolyte balance. |
■ FDA Black Box Warning
None
| Serious Effects |
["Known hypersensitivity to any component of the solution","Severe hypokalemia or hypocalcemia not corrected prior to therapy","Severe metabolic alkalosis"]
| Precautions | ["Monitor serum electrolytes, acid-base status, and fluid balance closely","Risk of electrolyte disturbances (e.g., hyperkalemia, hypokalemia, hypercalcemia)","Risk of metabolic alkalosis with excessive administration","Use with caution in patients with severe hepatic impairment or lactic acidosis","Not for direct intravenous infusion; must be used in conjunction with CRRT machine"] |
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| Fetal Monitoring | Monitor maternal electrolytes (sodium, potassium, calcium, magnesium, chloride, bicarbonate), serum osmolality, acid-base status, fluid balance, and renal function frequently during therapy. Fetal monitoring includes assessment of fetal heart rate and uterine activity if CRRT is performed during pregnancy. Consider maternal hemodynamic monitoring (blood pressure, heart rate) due to fluid shifts. Adjust therapy to maintain maternal homeostasis to minimize fetal risk. |
| Fertility Effects | No known effect on fertility. PRISMASOL B22GK 4/0 contains only physiological electrolytes and buffer; no hormonal or gonadotoxic components. The underlying disease requiring CRRT may impact fertility indirectly. |