PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER (PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER).
Prismasol BK 0/0/1.2 is a sterile, nonpyrogenic, bicarbonate-buffered solution used for continuous renal replacement therapy (CRRT). It provides electrolyte composition to maintain acid-base balance and electrolyte homeostasis during hemofiltration or hemodialysis. Its mechanism involves correction of metabolic acidosis via bicarbonate buffer, and removal of uremic toxins through convective and/or diffusive clearance.
| Metabolism | Not metabolized; components undergo renal replacement clearance via CRRT circuit. |
| Excretion | PRISMASOL BK 0/0/1.2 is a bicarbonate-based substitution fluid used in continuous renal replacement therapy (CRRT). It is not absorbed systemically; its components are eliminated according to their individual pharmacokinetics during CRRT. Bicarbonate is primarily eliminated via the dialysate/effluent (renal replacement route). Calcium and magnesium are also removed via CRRT. Less than 1% is excreted in feces or bile. |
| Half-life | Not applicable as a drug; the half-life of bicarbonate in CRRT depends on the dialysis dose and patient's metabolic rate. Typical half-life of infused bicarbonate is minutes due to rapid equilibration. The electrolytes are continuously removed during therapy. |
| Protein binding | Negligible; bicarbonate, calcium, and magnesium are free ions with essentially no protein binding (<1%). |
| Volume of Distribution | Electrolytes distribute into extracellular fluid (approximately 0.2 L/kg for bicarbonate, calcium, and magnesium). This reflects the volume of the extracellular space. |
| Bioavailability | Intravenous (via CRRT circuit): 100% bioavailable, as the solution is directly infused into the bloodstream. |
| Onset of Action | Immediate upon entry into the extracorporeal circuit; clinical effects on acid-base and electrolyte balance occur within minutes to hours of starting CRRT. |
| Duration of Action | Therapeutic effect persists as long as CRRT is continued; upon discontinuation, effects dissipate over hours as the patient's endogenous acid-base and electrolyte balance reasserts itself. |
Continuous renal replacement therapy (CRRT): 1.2 mmol/L potassium dialysate/ replacement fluid, infused at a rate of 2000-3000 mL/hour, adjusted to achieve desired electrolyte balance and fluid removal.
| Dosage form | INJECTABLE |
| Renal impairment | Not applicable. This drug is used specifically for renal replacement therapy in patients with acute kidney injury or end-stage renal disease. Dosing is based on CRRT prescription. |
| Liver impairment | No specific hepatic adjustment required. Drug is a dialysate/replacement fluid for CRRT; its components are not hepatically metabolized. |
| Pediatric use | CRRT in pediatric patients: Dose (flow rate) based on body weight, typically 2000-3000 mL/1.73 m²/hour, adjusted to target electrolyte and fluid balance. Consult pediatric nephrology. |
| Geriatric use | No specific geriatric adjustment. Use standard CRRT protocols with careful monitoring of fluid balance and electrolytes due to age-related changes in renal and cardiovascular function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER (PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER).
| Breastfeeding | No data on excretion into breast milk. PRISMASOL components are endogenous substances (electrolytes, bicarbonate); systemic levels after regional citrate anticoagulation are expected to be low. M/P ratio unknown. Benefit of maternal treatment should outweigh potential risk to nursing infant. |
| Teratogenic Risk | PRISMASOL BK 0/0/1.2 is a bicarbonate-based hemofiltration solution. No human or animal data exist on teratogenicity; however, electrolyte and acid-base disturbances from maternal use could theoretically affect fetal development. No known direct teratogenic risk from the solution components at therapeutic levels. |
■ FDA Black Box Warning
None. No FDA-mandated black box warnings.
| Serious Effects |
["Hypersensitivity to any component","Severe hypokalemia (as solution contains no potassium; may exacerbate)","Severe hypernatremia or metabolic alkalosis (use caution)","Incorrect formulation for patient's electrolyte needs"]
| Precautions | ["Electrolyte disturbances: Monitor serum electrolytes, acid-base status, and fluid balance frequently.","Hyperkalemia risk: Contains potassium at low concentration (0 mEq/L in this formulation), but patients may require adjustment.","Extravasation: Avoid extravasation; monitor catheter site.","Use only by trained personnel in appropriate clinical setting."] |
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| Fetal Monitoring | Monitor maternal serum electrolytes (sodium, potassium, calcium, magnesium, chloride), bicarbonate, ionized calcium, pH, and citrate levels. Monitor fetal heart rate and uterine activity during continuous renal replacement therapy. Assess for maternal acid-base or electrolyte disturbances that may affect fetal wellbeing. |
| Fertility Effects | No known direct effects on fertility. Underlying chronic kidney disease or acute renal failure requiring hemofiltration may impact fertility. No specific data on PRISMASOL. |