DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER (DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER).
Intraperitoneal administration of hypertonic dextrose solution creates an osmotic gradient across the peritoneal membrane, facilitating ultrafiltration and removal of uremic toxins through peritoneal dialysis.
| Metabolism | Dextrose undergoes rapid cellular uptake and metabolism via glycolysis and subsequent oxidative phosphorylation; minimal hepatic metabolism. |
| Excretion | Peritoneal dialysis solution; dextrose is metabolized and eliminated via peritoneal dialysis; approximately 70-80% of dextrose is absorbed systemically and metabolized; the non-absorbed fraction is removed with dialysate outflow; lactate (buffer) is converted to bicarbonate in the liver and eliminated via respiration and urine. |
| Half-life | Dextrose terminal half-life is approximately 1-2 hours in normal metabolism; in peritoneal dialysis, continuous removal leads to variable half-life depending on dwell time and ultrafiltration; clinical context: continuous exposure during dwell. |
| Protein binding | Dextrose: negligible (<1%); not bound to proteins. |
| Volume of Distribution | Dextrose: Vd 0.2-0.4 L/kg (total body water); distributes throughout extracellular and intracellular fluid. |
| Bioavailability | Intraperitoneal: 100% (directly into peritoneal cavity); systemic absorption of dextrose occurs via peritoneal capillaries (70-80% absorbed over dwell). |
| Onset of Action | Intraperitoneal: Ultrafiltration onset within 15-30 minutes; peak effect at 2-4 hours. |
| Duration of Action | Intraperitoneal: Ultrafiltration duration corresponds to dwell time (typically 4-6 hours with 4.25% dextrose); longer dwell may lead to diminished ultrafiltration due to glucose absorption. |
Intraperitoneal administration: 2 liters per exchange, 4 exchanges per day, or as prescribed for continuous ambulatory peritoneal dialysis (CAPD); may adjust volume and frequency based on patient's fluid and electrolyte status.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required for renal impairment; however, monitor serum electrolytes and fluid balance closely in patients with residual renal function. |
| Liver impairment | No specific dose adjustment recommended; use with caution in severe hepatic impairment due to risk of electrolyte disturbances and fluid overload. |
| Pediatric use | Individualized based on weight, body surface area, and peritoneal dialysis prescription; typical exchange volume: 30-40 mL/kg per exchange, 4-5 exchanges per day for CAPD; adjust dextrose concentration based on ultrafiltration needs. |
| Geriatric use | No specific dose adjustment; monitor for fluid overload and electrolyte imbalances, adjust dextrose concentration and exchange volume as needed, consider reduced volume and frequency in patients with compromised cardiac or renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER (DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER).
| Breastfeeding | Unknown if icodextrin or dextrose metabolites excreted in human milk. M/P ratio not established. Caution in breastfeeding women; consider benefits vs risks. |
| Teratogenic Risk | Insufficient human data; animal studies not available. Icodextrin and dextrose are not known teratogens, but risks cannot be excluded. In first trimester, theoretical risk of metabolic disturbance; second and third trimesters, possible volume overload. Use only if clearly needed. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Pre-existing severe hyperglycemia","Hypersensitivity to dextrose or any component","Clinically significant peritoneal membrane abnormalities (e.g., extensive adhesions, recent surgery)","Severe respiratory acidosis (relative contraindication)"]
| Precautions | ["Peritonitis: Use strict aseptic technique; monitor for signs of infection","Mechanical complications: Catheter malfunction, leakage, hernia","Metabolic disturbances: Hyperglycemia, hyperosmolarity, electrolyte imbalances","Hypersensitivity: Rare allergic reactions to components","Volume overload: Monitor ultrafiltration and body weight"] |
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| Fetal Monitoring |
| Monitor serum electrolytes, glucose, renal function, and volume status. Assess for signs of peritoneal infection, ultrafiltration failure, and metabolic acidosis. Fetal monitoring as per gestational age. |
| Fertility Effects | No known effect on fertility; limited human data. Icodextrin not associated with reproductive toxicity in animal studies. |