PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive 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. |
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 | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER (PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER).
| Breastfeeding | Excreted into breast milk in low amounts; M/P ratio not established; compatible with breastfeeding with monitoring of infant electrolytes. |
| 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 |
■ 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 |
Absolute: Hypersensitivity to any component, pre-existing severe metabolic alkalosis, documented non-functioning peritoneal membrane, or conditions compromising peritoneal integrity (e.g., extensive adhesions, diaphragmatic defects). Relative: Uncontrolled hyperglycemia, severe hypokalemia, or recent abdominal surgery.
| 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. |
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| 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. |