Label Changes for:
Prismasol and Phoxillum Renal Replacement Solution
Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known hypersensitivities to these products.
WARNINGS AND PRECAUTIONS
Electrolyte and Volume Abnormalities (revised)
- PHOXILLUM and PRISMASOL solutions can affect electrolytes and volume and may result in hyperkalemia or hyperphosphatemia. Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorous, other electrolytes and acid-base balance throughout the procedure. Abnormalities may be corrected by changing the formulation of replacement solution and/or dialysate, supplementation, or adjusting flow rates appropriately.
- PHOXILLUM replacement solutions contain hydrogen phosphate, a weak acid that may increase the risk of metabolic acidosis.
ADVERSE REACTIONS (addition)
The following adverse reactions have been identified with other similar products and therefore, may occur with use of these products:
- Metabolic acidosis
- Acid-base disorders
- Electrolyte imbalance
- Hyperphosphatemia (for phosphate containing solutions)
- Fluid imbalance
DRUG INTERACTIONS (revised)
- As with the use of other replacement solutions, blood concentrations of dialyzable drugs may be reduced by CRRT due to their removal by the hemofilter or hemodiafilter.