DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER (DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER).
DELFLEX-LM W/ DEXTROSE 3.5% is a peritoneal dialysis solution. Its mechanism of action involves osmotic ultrafiltration across the peritoneal membrane, facilitated by high dextrose concentration, to remove excess fluid and waste products (e.g., urea, creatinine) from the blood in patients with end-stage renal disease.
| Metabolism | Dextrose is metabolized via glycolysis and the citric acid cycle to carbon dioxide and water, with some absorption from the peritoneal cavity. Lactate (from the buffer) is metabolized primarily in the liver to bicarbonate. |
| Excretion | Peritoneal dialysis: Removal of waste products (urea, creatinine) via peritoneal membrane; approximately 60-80% of urea is removed during a 4-6 hour dwell. Biliary/fecal: minimal (<5%). Renal: negligible as drug is primarily used in renal failure. |
| Half-life | Not applicable for dextrose; for lactate/bicarbonate buffer components, half-life is approximately 2-4 hours in peritoneal cavity with systemic absorption minimal. Clinical context: continuous dialysis maintains steady-state. |
| Protein binding | Dextrose: negligible (<5%); electrolytes: negligible. Peritoneal dialysis solutions per se do not have significant protein binding. |
| Volume of Distribution | Dextrose distributes in total body water (approximately 0.6 L/kg); for dialysate, distribution into peritoneal cavity volume is 2-3 L. |
| Bioavailability | Intraperitoneal: 100% for local effects; systemic absorption of glucose occurs (approximately 60-80% of glucose load) via peritoneal capillaries. |
| Onset of Action | Intraperitoneal: clinical effects begin within 15-30 minutes of instillation (fluid removal and solute clearance). |
| Duration of Action | Dwell time of 4-6 hours for standard exchanges; extended dwells (8-12 hours) used for overnight. Net ultrafiltration occurs throughout dwell, with peak at 2-4 hours. |
Intraperitoneal: 1.5% to 4.25% dextrose solution; 2 to 2.5 L per exchange, typically 4 exchanges per 24 hours; dwell time 4 to 6 hours.
| Dosage form | SOLUTION |
| Renal impairment | Deliver via peritoneal dialysis; no dose adjustment necessary as drug is administered intraperitoneally for renal replacement therapy. |
| Liver impairment | No specific dose adjustment; monitor for signs of hepatic encephalopathy or fluid overload in severe hepatic impairment. |
| Pediatric use | Intraperitoneal: 20 to 40 mL/kg per exchange (typical fill volume 800-1100 mL/m2), 4 to 5 exchanges per 24 hours; dwell time 2 to 6 hours per exchange. |
| Geriatric use | No specific dose adjustment; monitor for fluid and electrolyte balance, and adjust dextrose concentration based on ultrafiltration needs and glucose tolerance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER (DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER).
| Breastfeeding | Excretion into breast milk is expected to be minimal due to high molecular weight, but specific M/P ratio not reported. Compatible with breastfeeding if maternal therapy is necessary; caution due to possible high glucose load in neonates. |
| Teratogenic Risk | No evidence of teratogenicity in animal studies; human data are lacking. However, in case of severe maternal electrolyte disturbances or infection, potential indirect fetal risks may arise. Generally considered low risk if administered appropriately. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to any component; pre-existing hyperglycemia; severe hyponatremia; hypokalemia; hyperlactatemia; or conditions with increased peritoneal permeability (e.g., peritonitis, severe burns).
| Precautions | Risk of peritonitis, abdominal pain, electrolyte disturbances (e.g., hyperglycemia, hypernatremia, hypokalemia), fluid overload, and metabolic acidosis. Use with caution in patients with severe hyponatremia, hypokalemia, or impaired liver function. |
| Food/Dietary | Dietary restrictions typically include low sodium, low potassium, and low phosphorus intake to manage fluid and electrolyte balance. Avoid high-sugar foods if hyperglycemia develops. Consult a renal dietitian for individualized meal planning. |
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| Fetal Monitoring | Monitor maternal and fetal serum electrolytes, fluid balance, and renal function during infusion. Assess for signs of infection, metabolic acidosis, and volume overload. Fetal surveillance recommended in prolonged treatment. |
| Fertility Effects | No known adverse effects on fertility from intraperitoneal dialysis solutions. However, underlying conditions (e.g., renal failure) may affect fertility; no direct reproductive toxicity reported in animal studies. |
| Clinical Pearls | This is a peritoneal dialysis solution containing 3.5% dextrose. Use the lowest dextrose concentration necessary for adequate ultrafiltration to avoid hyperglycemia and metabolic complications. Warm the solution to body temperature before administration to reduce patient discomfort. Monitor serum electrolytes, glucose, and urea regularly. Do not use if solution is discolored or contains particulates. |
| Patient Advice | Store the solution at room temperature and protect from light. · Warm the bag to body temperature before use for comfort. · Inspect the solution for clarity and discard if cloudy or containing particles. · Follow aseptic technique to prevent peritonitis. · Report any signs of infection (fever, abdominal pain, cloudy effluent) immediately. |