DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER (DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER).
Removes waste products (e.g., urea, creatinine) and excess fluid from the blood through peritoneal dialysis by diffusion and osmosis across the peritoneal membrane.
| Metabolism | Dextrose is metabolized via glycolysis; lactate is converted to bicarbonate in the liver. No significant hepatic metabolism for electrolyte components. |
| Excretion | Delflex-LM with Dextrose 1.5% (icodextrin) is a peritoneal dialysis solution. Icodextrin is metabolized to oligosaccharides and primarily eliminated via the peritoneal cavity during dialysis. Renal excretion is minimal (<1%). The majority of icodextrin and its metabolites are removed with the dialysate effluent. |
| Half-life | The terminal half-life of icodextrin (as total icodextrin-derived oligosaccharides) is approximately 5-8 hours after a single dwell, reflecting clearance from the plasma compartment. Clinically, sustained levels can occur with repeated exchanges. |
| Protein binding | Icodextrin and its metabolites are minimally protein-bound (<5%), primarily to albumin. |
| Volume of Distribution | The apparent volume of distribution (Vd) for icodextrin-derived oligosaccharides is approximately 0.1-0.2 L/kg, reflecting distribution mainly in the extracellular fluid and limited distribution into cells. |
| Bioavailability | Bioavailability: Not applicable for the intraperitoneal route (100% exposure to peritoneal cavity). For systemic absorption, 60-70% of the administered icodextrin dose is absorbed across the peritoneum into the systemic circulation during a dwell, but this is not a standard bioavailability measure. |
| Onset of Action | Intraperitoneal: Ultrafiltration begins within 30-60 minutes of instillation, with peak effects at 4-6 hours. |
| Duration of Action | Intraperitoneal: Ultrafiltration and solute removal continue for up to 12 hours (long-dwell). Typical dwell times range from 8-12 hours for continuous ambulatory peritoneal dialysis (CAPD). |
Intraperitoneal administration: 2 liters per exchange, 4 exchanges daily; dwell time 4-6 hours; concentration selected based on ultrafiltration needs.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required for renal impairment as drug is administered intraperitoneally for peritoneal dialysis. |
| Liver impairment | No specific pediatric dosing available; use adult dosing with caution and monitor for signs of fluid overload or electrolyte imbalance. |
| Pediatric use | Individualized based on body weight: typical starting volume 30-40 mL/kg per exchange, 4-5 exchanges daily; adjust to achieve adequate ultrafiltration and solute clearance. |
| Geriatric use | Use same dosing as younger adults; monitor fluid and electrolyte status closely due to increased risk of fluid overload and electrolyte disturbances. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER (DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER).
| Breastfeeding | Excreted into breast milk in negligible amounts; M/P ratio not established. Compatible with breastfeeding. |
| Teratogenic Risk | No known teratogenic effects in humans; intraperitoneal administration of dialysis solutions during pregnancy may cause maternal fluid and electrolyte disturbances that secondarily affect the fetus. Use only if clearly needed. |
| Fetal Monitoring |
■ FDA Black Box Warning
Not for intravenous use. Use only for intraperitoneal administration.
| Serious Effects |
["Severe hyperglycemia or uncontrolled diabetes","Peritoneal adhesions or fibrosis compromising membrane function","Active intra-abdominal infection or peritonitis","Pre-existing severe lactic acidosis","Hypersensitivity to any component"]
| Precautions | ["Monitor for peritonitis, electrolyte imbalances, and fluid overload","Use with caution in patients with severe hyperglycemia or lactic acidosis","Mechanical complications (e.g., catheter malfunction, leakage) may occur"] |
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| Monitor maternal serum electrolytes, fluid status, blood glucose, and signs of peritonitis. Assess fetal growth and well-being via ultrasound and nonstress test as clinically indicated. |
| Fertility Effects | No known adverse effects on fertility. |