DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER (DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER).
Delflex with 4.25% dextrose is a peritoneal dialysis solution that removes waste products, electrolytes, and excess fluid from the blood via diffusion and ultrafiltration across the peritoneal membrane. Dextrose creates an osmotic gradient, drawing fluid and solutes from the capillaries into the peritoneal cavity.
| Metabolism | Dextrose is absorbed systemically and metabolized via glycolysis and the Krebs cycle. No hepatic metabolism for the solution components; waste removal is achieved through peritoneal dialysis. Insulin may be required to manage hyperglycemia. |
| Excretion | Renal: >90% as unchanged glucose and electrolytes; negligible biliary/fecal elimination. |
| Half-life | Not applicable as a combination solution; glucose half-life ~1.5-2 hours in normal renal function; prolonged in renal impairment. |
| Protein binding | Minimal (<10%); glucose and electrolytes do not significantly bind to plasma proteins. |
| Volume of Distribution | Glucose: ~0.2 L/kg (extracellular fluid); electrolytes distribute according to body water compartments. |
| Bioavailability | Intraperitoneal: ~70-80% for glucose absorption; electrolytes 100% bioavailable via peritoneal route. |
| Onset of Action | Intraperitoneal: Immediate via peritoneal dialysis. |
| Duration of Action | Intraperitoneal: 4-6 hours per dwell; ultrafiltration and solute clearance persist during dwell time. |
Intraperitoneal administration: 2 to 2.5 liters per exchange, 4 to 5 exchanges per day, as part of continuous ambulatory peritoneal dialysis (CAPD).
| Dosage form | SOLUTION |
| Renal impairment | Not applicable; drug is used for renal replacement therapy in end-stage renal disease. |
| Liver impairment | No specific adjustments; monitor for metabolic acidosis and electrolyte imbalances in severe hepatic impairment. |
| Pediatric use | Weight-based: 30 to 40 mL/kg per exchange, 4 to 5 exchanges per day; adjust based on residual renal function and ultrafiltration needs. |
| Geriatric use | No specific dose adjustments; monitor glucose and electrolyte levels closely due to higher risk of hyperglycemia and fluid overload. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER (DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER).
| Breastfeeding | It is unknown whether Delflex components are excreted in human milk. Dextrose and electrolytes are endogenous substances. The M/P ratio is not available. Caution is advised; consider risk of infant exposure to small amounts of dialysate components. |
| Teratogenic Risk | Delflex w/ Dextrose 4.25% Low Magnesium Low Calcium is a peritoneal dialysis solution. There are no adequate studies in pregnant women. Peritoneal dialysis itself may pose risks (e.g., infection, preterm labor). Dextrose may cause maternal hyperglycemia and fetal hyperinsulinism. Use only if clearly needed, weighing risks vs benefits. Trimester-specific risks are not established; reports of congenital anomalies are not directly attributed to the solution. |
■ FDA Black Box Warning
Peritoneal dialysis solutions with dextrose, including Delflex with 4.25% dextrose, are contraindicated in patients with pre-existing severe hyperglycemia or who are hypersensitive to any component of the product. The solution is for peritoneal administration only, not for intravenous use. Strict sterile technique in catheter placement and fluid exchange is required to prevent peritonitis.
| Serious Effects |
["Hypersensitivity to any component","Pre-existing severe hyperglycemia or uncontrolled diabetes","Peritoneal adhesions, fibrosis, or sclerosis","Abdominal wall infection or peritonitis","Recent abdominal surgery or trauma","Severe pulmonary disease (risk of respiratory compromise)","Collagen vascular disease (e.g., scleroderma)","Uncorrectable mechanical defects (e.g., catheter malfunction)"]
| Precautions | ["Hyperglycemia and hyperosmolar syndrome, especially in patients with diabetes mellitus","Peritonitis and exit-site infections; strict aseptic technique required","Electrolyte imbalances (hypokalemia, hypomagnesemia, hypocalcemia) due to low magnesium and low calcium formulation","Protein loss and malnutrition","Fluid overload or dehydration (monitor fluid balance)","Hernias and abdominal discomfort","Peritoneal catheter complications"] |
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| Fetal Monitoring | Monitor maternal blood glucose, electrolytes (potassium, magnesium, calcium), fluid balance, and signs of peritonitis. Monitor fetal heart rate and growth (ultrasound) as part of standard obstetric care. Assess for preterm labor symptoms. |
| Fertility Effects | No specific studies on fertility effects. Chronic kidney disease and dialysis may impair fertility due to uremia, hormonal imbalances, and comorbidities. The solution itself is unlikely to directly affect fertility. |