DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER (DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER).
Delflex with Dextrose 2.5% is a peritoneal dialysis solution that provides osmotic ultrafiltration and electrolyte replacement. Dextrose creates an osmotic gradient across the peritoneal membrane, promoting fluid removal. The solution corrects electrolyte imbalances and removes metabolic waste products via diffusion and convection.
| Metabolism | Dextrose in the solution is absorbed across the peritoneal membrane and metabolized systemically via glycolysis and oxidative phosphorylation. Non-dextrose components are primarily eliminated through dialysis and renal excretion (if residual renal function exists). |
| Excretion | Renal: 100% (as unchanged drug in urine; no metabolism) |
| Half-life | 2 hours (peritoneal dwell time; systemic absorption minimal; continuous ambulatory peritoneal dialysis (CAPD) exchanges every 4-6 hours maintain steady state) |
| Protein binding | Negligible (<5%, not bound to plasma proteins) |
| Volume of Distribution | 0.25-0.5 L/kg (distributes primarily in extracellular fluid; small Vd reflects limited distribution due to high water solubility and rapid renal clearance) |
| Bioavailability | Intraperitoneal: 100% (directly active in peritoneal cavity; systemic absorption is slow and incomplete, with approximately 60-80% of glucose absorbed during a 4-6 hour dwell) |
| Onset of Action | Intraperitoneal: immediate upon instillation (ultrafiltration begins within minutes; glucose absorption and osmotic gradient established within 15-30 minutes) |
| Duration of Action | Intraperitoneal: 4-6 hours (dwell time for CAPD; prolonged dwells (8-12 hours) used in automated peritoneal dialysis; glucose absorption reduces osmotic gradient over time) |
Intraperitoneal administration: 2-3 L per exchange, 4 exchanges per day, with dwell times of 4-6 hours; typical total volume 8-12 L daily.
| Dosage form | SOLUTION |
| Renal impairment | Contraindicated in severe renal impairment; dose modification not applicable as drug is used for peritoneal dialysis in ESRD patients. |
| Liver impairment | No specific Child-Pugh adjustments; monitor for metabolic acidosis and fluid overload in severe hepatic impairment. |
| Pediatric use | Weight-based: 30-40 mL/kg per exchange, up to 4 exchanges daily; initial fill volume 10-20 mL/kg, titrated to tolerance. |
| Geriatric use | Use lower initial fill volumes (1-2 L) and longer dwell times; monitor for hypotension, volume depletion, and electrolyte imbalances. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER (DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER).
| Breastfeeding | No data on excretion of components into breast milk. Delflex components (dextrose, electrolytes) are endogenous substances normally present in milk. Risk to nursing infant considered low. M/P ratio not available. |
| Teratogenic Risk | Delflex with dextrose 2.5% is a peritoneal dialysis solution. No studies on teratogenic risk in humans. Animal reproduction studies not conducted. Dextrose is generally considered safe in pregnancy when used clinically. However, peritoneal dialysis itself may pose risks (e.g., peritonitis, metabolic disturbances) that could affect fetal outcomes. Use during pregnancy only if clearly needed. |
■ FDA Black Box Warning
Not for intravenous use. Peritoneal dialysis solutions are for intraperitoneal administration only. Improper use can lead to severe complications including peritonitis, fluid overload, and electrolyte disturbances.
| Serious Effects |
["Pre-existing severe hyperglycemia or uncontrolled diabetes mellitus","Documented allergy to any component of the solution","Severe hepatic failure (relative contraindication)","Lactic acidosis (relative contraindication)","Peritoneal adhesions or fibrosis limiting dialysis effectiveness"]
| Precautions | ["Monitor serum electrolytes, glucose, and fluid balance regularly.","Risk of peritonitis with improper catheter care.","May cause hyperglycemia, especially in diabetic patients.","Use with caution in patients with severe hepatic impairment or lactic acidosis.","Monitor for catheter-related infections."] |
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| Fetal Monitoring | Monitor maternal serum electrolytes, glucose, acid-base status, fluid balance, and signs of peritonitis. In pregnancy, monitor fetal growth and well-being via ultrasound and nonstress tests as appropriate. Adjust dialysis prescription based on maternal metabolic parameters. |
| Fertility Effects | No known effects on fertility. Dextrose and electrolytes at therapeutic concentrations are not expected to impair reproductive function. |