DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER (DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER).
Delflex-LM with Dextrose 2.5% is a peritoneal dialysis solution. Dextrose provides osmotic gradient for ultrafiltration; lactate (LM) is a bicarbonate precursor that buffers metabolic acidosis. The solution replaces fluid and electrolytes while removing waste products via diffusion and convection across the peritoneal membrane.
| Metabolism | Dextrose is metabolized via glycolysis and oxidative phosphorylation; lactate is converted to bicarbonate in the liver and kidneys via lactate dehydrogenase. |
| Excretion | Peritoneal dialysis fluid components: dextrose is metabolized to CO2 and water; lactate is converted to bicarbonate in liver; electrolytes are variably reabsorbed. ~70% of administered dextrose is absorbed; elimination primarily via metabolic pathways. |
| Half-life | Dextrose: ~1-2 hours for plasma glucose levels; lactate: ~30-60 minutes for conversion to bicarbonate. |
| Protein binding | Dextrose: negligible; lactate: <10% bound to albumin. |
| Volume of Distribution | Dextrose: Vd ~0.25 L/kg (total body water); lactate: Vd ~0.5 L/kg. |
| Bioavailability | Not applicable: intraperitoneal administration bypasses gastrointestinal absorption; dextrose absorption ~70-80% of administered dose over dwell time. |
| Onset of Action | Immediate upon instillation into peritoneal cavity; glucose absorption begins within 15-30 minutes. |
| Duration of Action | For dialysis: 4-6 hours per exchange; glucose effects on plasma glucose last 2-4 hours post-exchange. |
Intraperitoneal administration: 2 liters of 2.5% dextrose solution per exchange, typically 4 exchanges daily (8 liters total). Adjust volume and frequency based on patient's dry weight, residual renal function, and peritoneal membrane transport characteristics.
| Dosage form | SOLUTION |
| Renal impairment | Dosing is titrated based on residual renal function and peritoneal dialysis adequacy. For patients with GFR <10 mL/min, standard regimen is used. Adjust exchange volume and number to achieve weekly Kt/V ≥1.7. |
| Liver impairment | No specific Child-Pugh based dose adjustments; monitor for glucose intolerance and fluid overload. In severe hepatic impairment, consider reduced dextrose concentration to avoid hyperglycemia. |
| Pediatric use | Initial exchange volume: 10-20 mL/kg per exchange, up to 1100 mL/m² body surface area per exchange. Number of exchanges: 4-5 per day. Titrate based on ultrafiltration and metabolic control. |
| Geriatric use | Start with lower exchange volumes (1.5-2 liters) and monitor for fluid overload and electrolyte imbalances. Adjust dextrose concentration to minimize hyperglycemia. Use same exchange frequency as adults. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER (DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER).
| Breastfeeding | No data on excretion into breast milk. Clinically insignificant systemic absorption suggests minimal risk to nursing infant. Caution with additives (e.g., dextrose, electrolytes). M/P ratio not available. |
| Teratogenic Risk | Peritoneal dialysis solutions are generally considered low risk due to minimal systemic absorption. No specific teratogenic effects reported; however, electrolyte imbalances or metabolic disturbances from improper use could theoretically affect fetal development. Use only if clearly indicated. |
■ FDA Black Box Warning
None
| Serious Effects |
Pre-existing severe lactic acidosis, hypersensitivity to any component, documented inability to perform peritoneal dialysis, recent abdominal surgery with prosthetic material, severe abdominal wall infection or burn, pregnancy (relative).
| Precautions | Peritonitis risk; monitor for hyperglycemia, volume overload, hypokalemia, hypomagnesemia, and acidosis; strict aseptic technique; not for IV use; monitor serum electrolytes and glucose. |
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| Fetal Monitoring | Monitor maternal electrolytes, renal function, fluid balance, and acid-base status. Assess for signs of infection (peritonitis), metabolic complications, and uterine activity in pregnant patients. Fetal monitoring as per gestational age and clinical condition. |
| Fertility Effects | No known direct effects on fertility. Underlying renal disease may impact fertility; dialysis can improve fertility by managing uremia. However, peritoneal dialysis complications (e.g., peritonitis) could indirectly affect fertility. |