PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER
Clinical safety rating
cautionComprehensive clinical and safety monograph for PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER (PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER).
The drug is a bicarbonate-based peritoneal dialysis solution that buffers metabolic acidosis, removes uremic toxins, and corrects electrolyte imbalances via diffusion and ultrafiltration across the peritoneal membrane. It does not have a traditional receptor-mediated mechanism.
| Metabolism | The solution components (bicarbonate, lactate, dextrose, electrolytes) are not metabolized by the liver; bicarbonate and lactate are buffer precursors converted via endogenous pathways; dextrose is absorbed and metabolized systemically; electrolytes are regulated by renal and non-renal mechanisms. |
| Excretion | Primarily renal excretion; ~70% of calcium dose and ~60% of magnesium dose excreted unchanged in urine. Fecal elimination accounts for ~20% and ~30%, respectively. Biliary excretion is minimal. |
| Half-life | Calcium: terminal half-life 4-6 hours in patients with normal renal function; magnesium: terminal half-life 3-5 hours. Prolonged in renal impairment. |
| Protein binding | Calcium: ~40-50% bound to albumin; magnesium: ~25-30% bound to albumin. Binding decreases in hypoalbuminemia. |
| Volume of Distribution | Calcium: 0.25-0.4 L/kg; magnesium: 0.5-0.7 L/kg. Indicates distribution into extracellular fluid and bone (calcium) or intracellular and bone (magnesium). |
| Bioavailability | Intravenous: 100%. Intraperitoneal: ~70-80% (dependent on dwell time and concentration). Oral: ~30-40% for calcium and ~40-60% for magnesium (varies with formulation and GI factors). |
| Onset of Action | Intravenous: immediate (within minutes). Intraperitoneal: gradual (within 30-60 minutes). Oral/enteral: rapid (within 15-30 minutes). |
| Duration of Action | Intravenous: serum calcium/magnesium levels normalize over 2-4 hours; clinical effects (e.g., improved neuromuscular excitability) persist 4-6 hours. Intraperitoneal: sustained effects over several hours due to continuous absorption. |
| Molecular Weight | 136.06 |
Intravenous infusion only. Each 1000 mL bag contains 4 g of amino acids and 2.5 g of lipids. Typical adult dose: 1.5-2.0 g/kg/day of amino acids (equivalent to 37.5-50 mL/kg/day) and 1.0-1.5 g/kg/day of lipids. Administer at a rate not to exceed 0.11 g/kg/hour of amino acids and 0.15 g/kg/hour of lipids. For a 70 kg patient, this equals approximately 2.6-3.5 L/day.
| Dosage form | INJECTABLE |
| Renal impairment | For GFR 30-60 mL/min: reduce amino acid dose to 0.8 g/kg/day. For GFR <30 mL/min: reduce to 0.6 g/kg/day. Lipids may require adjustment based on triglyceride levels. Avoid in severe renal failure unless on dialysis. |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B: reduce amino acids to 1.0 g/kg/day. Child-Pugh C: avoid use or reduce to 0.5 g/kg/day with close monitoring for encephalopathy. Lipids may be given at standard doses but monitor triglycerides. |
| Pediatric use | Neonates and infants: amino acids 2.0-3.0 g/kg/day, lipids 1.0-3.0 g/kg/day. Children 1-10 years: amino acids 1.5-2.5 g/kg/day, lipids 1.0-2.0 g/kg/day. Administer via continuous infusion over 24 hours. Monitor serum triglycerides, bilirubin, and liver function. |
| Geriatric use | Use caution; start at low end of adult dosing (amino acids 1.2 g/kg/day, lipids 1.0 g/kg/day). Monitor renal function (creatinine clearance) and fluid status due to increased risk of fluid overload. No specific dose adjustments except based on renal function. |
| 1st trimester | Limited data; no known teratogenicity. Use only if clearly needed. |
| 2nd trimester | Considered safe; no significant risk reported. |
| 3rd trimester | Safe for use during delivery (calcium replacement). |
Clinical note
Comprehensive clinical and safety monograph for PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER (PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER).
| Placental transfer | Crosses placenta; both calcium and phosphate are actively transported. |
| Breastfeeding | Minimal excretion into breast milk; compatible with breastfeeding. |
| Lactation Rating | Safe |
| Teratogenic Risk | Limited data; no evidence of teratogenicity in animal studies; avoid if possible in first trimester due to theoretical risks of uremic toxin accumulation. |
| Fetal Monitoring | Maternal: serum electrolytes, renal function, blood pressure. Fetal: growth scans, amniotic fluid volume, and Doppler velocimetry if indicated. |
| Fertility Effects | No direct effects on fertility; underlying renal disease may impair fertility; correction of uremia may improve reproductive function. |
■ FDA Black Box Warning
Not for intravenous use. Peritoneal dialysis should be performed under strict aseptic technique to prevent peritonitis. Use only in patients with intact peritoneal membrane and no contraindications to peritoneal dialysis.
| Serious Effects |
HypercalcemiaHyperphosphatemiaSevere renal impairment (anuria)
| Precautions | Monitor serum electrolytes, glucose, and acid-base status frequently. Risk of hyperglycemia, hypernatremia, hypokalemia, hypocalcemia, and metabolic alkalosis. Peritonitis and catheter-related infections are major complications. Avoid in patients with severe lactic acidosis or hypokalemia. Use caution in patients with glucose intolerance or liver disease. |
| Food/Dietary | No specific food interactions. However, patients should maintain a diet appropriate for chronic kidney disease on peritoneal dialysis, including controlled intake of potassium, phosphorus, and fluids as directed by their healthcare provider. |
| Clinical Pearls | PHOXILLUM BK 4/2.5 is a peritoneal dialysis solution containing 4% icodextrin and 2.5% amino acids. It is used for one exchange per day in continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD). Avoid use in patients with known hypersensitivity to icodextrin or amino acids. Monitor serum osmolality and glucose levels, as icodextrin may interfere with glucose oxidase-based glucometers, leading to falsely elevated readings. Use with caution in patients with liver disease due to potential amino acid accumulation. |
| Patient Advice | Use only one bag per day, typically for the long dwell (overnight). · Do not use if the solution is cloudy or the bag is damaged. · Store at room temperature, away from direct sunlight. · Monitor for signs of infection like redness, swelling, or drainage at the catheter site. · Report any unusual abdominal pain or cloudy effluent immediately. · If using a glucose meter, ensure it is not affected by icodextrin; consider using a glucose dehydrogenase-based meter. · Maintain a balanced diet as amino acids may affect protein intake needs. |
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