PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER (PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER).
PrismaSol is a sterile solution containing electrolytes and bicarbonate buffer, used in continuous renal replacement therapy (CRRT) to correct fluid and electrolyte imbalances and acid-base disturbances. It acts as a replacement fluid to maintain electrolyte and acid-base homeostasis by providing physiologic concentrations of electrolytes and a bicarbonate buffer.
| Metabolism | Not metabolized; PrismaSol components are electrolytes and buffer that are excreted renally or removed by CRRT. |
| Excretion | Not applicable; PRISMASOL BK 0/3.5 is a renal replacement therapy solution not systemically absorbed. Solutes are removed via continuous renal replacement therapy (CRRT) circuit, with clearance dependent on operational parameters. |
| Half-life | Not applicable as the drug is not systemically present; half-life refers to solutes in the patient's blood during CRRT, which is determined by the therapy and patient factors, not the solution. |
| Protein binding | Not applicable; components are inorganic ions and buffer (bicarbonate) that are not protein-bound. Bicarbonate: negligible binding; calcium, magnesium, potassium, sodium: unbound. |
| Volume of Distribution | Not applicable; the solution is not a drug with systemic distribution. Its components distribute according to the patient's extracellular fluid volume and are administered directly into the blood via CRRT. |
| Bioavailability | 100% via the intravenous route through the CRRT circuit, as the entire dose is delivered directly into the bloodstream. |
| Onset of Action | Not applicable; the solution is not administered for a pharmacodynamic effect. Its function (electrolyte and buffer replacement) begins immediately upon initiation of CRRT. |
| Duration of Action | Not applicable; the effect persists for the duration of CRRT therapy. Clinical effect is continuous as long as the solution is infused via the CRRT circuit. |
Continuous renal replacement therapy (CRRT): 2000 mL bag, flow rate 1000-2000 mL/h (dose tailored to target electrolyte balance and acid-base status). For continuous ambulatory peritoneal dialysis (CAPD): 2000 mL per exchange, 4 exchanges per day (individualized). Intravenous or intraperitoneal route.
| Dosage form | INJECTABLE |
| Renal impairment | Not applicable; the drug is used as a dialysis solution in patients with renal failure. Dosing is adjusted based on dialysis prescription and patient's electrolyte levels, not GFR. |
| Liver impairment | No specific adjustment required for hepatic impairment; dose based on clinical and electrolyte monitoring. |
| Pediatric use | CRRT: 1000-2000 mL/m² per hour (flow rate) with adjustment to target electrolyte goals. Peritoneal dialysis: 30-40 mL/kg per exchange, 4-5 exchanges per day. |
| Geriatric use | Use standard adult dosing with careful monitoring of fluid and electrolyte status due to potential age-related changes in renal and cardiac function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER (PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER).
| Breastfeeding | Safety in breastfeeding is presumed based on component profile. No measurable M/P ratio exists; filtered components are expected in breast milk at negligible levels. Use caution due to potential electrolyte imbalances from maternal treatment. |
| Teratogenic Risk | Teratogenic risk is negligible as PRISMASOL BK 0/3.5 is a sterile hemofiltration solution with balanced electrolytes and no glucose. No fetal risks are associated with its use, but risks from the underlying renal disease may apply. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to any component.","Severe alkalosis or hypernatremia that cannot be corrected.","Active bleeding with hemodynamic instability not related to uremia."]
| Precautions | ["Use only for intravenous infusion via CRRT circuit.","Monitor serum electrolytes, acid-base status, and fluid balance frequently.","Risk of electrolyte disturbances (e.g., hyperkalemia, hypo/hypernatremia, hypercalcemia).","Risk of metabolic alkalosis due to bicarbonate content.","Administration via central venous access only.","Do not administer for blood transfusion or as a carrier solution for medications unless specified."] |
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| Fetal Monitoring |
| Monitor maternal electrolytes, acid-base status, and renal function frequently. Fetal monitoring as indicated for maternal renal condition, with attention to uterine blood flow during hemodialysis. |
| Fertility Effects | No direct impact on fertility. Fertility may improve with optimized renal function from continuous renal replacement therapy (CRRT) using this solution. No reproductive toxicity data available. |