DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER (DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER).
Delflex with Dextrose 3.5% is a peritoneal dialysis solution that uses a high concentration of dextrose to create an osmotic gradient, drawing water and solutes from the blood across the peritoneal membrane into the dialysate, thereby removing excess fluid and waste products from the body. Dextrose is metabolized locally and systemically.
| Metabolism | Dextrose is metabolized via glycolysis and glucose oxidation pathways in the liver, kidneys, and other tissues. Fructose and metabolites are further processed in the liver. |
| Excretion | Renal: >90% unchanged drug; biliary/fecal: minimal (<5%) |
| Half-life | 3-5 hours (prolonged in renal impairment; anuria up to 24-36 hours) |
| Protein binding | Negligible (<5%) |
| Volume of Distribution | 0.25-0.35 L/kg (approximates extracellular fluid volume) |
| Bioavailability | IP: 60-80% (variable depending on dwell time, membrane permeability, and inflammation) |
| Onset of Action | Intraperitoneal (IP): within 30-60 minutes for ultrafiltration |
| Duration of Action | IP: 4-8 hours per exchange (dwell time); continuous ambulatory peritoneal dialysis (CAPD) protocols |
Intraperitoneal administration: 2000 mL per exchange, typically 4 exchanges per day, with dwell times of 4-6 hours (CAPD) or cycler-adjusted for APD.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment for GFR; drug is used for renal replacement therapy. Peritoneal dialysis itself adjusts for renal failure. |
| Liver impairment | No specific Child-Pugh based adjustments. Use with caution in severe hepatic impairment due to potential lactate accumulation. |
| Pediatric use | Weight-based dosing: Initial volume 600-800 mL/m² per exchange, up to 40 mL/kg per exchange, with frequency adjusted to achieve ultrafiltration goals. |
| Geriatric use | No specific dose adjustment; monitor fluid and electrolyte balance closely due to potential comorbidities and reduced physiological reserves. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER (DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER).
| Breastfeeding | Minimal excretion into breast milk due to large molecular weight and low systemic absorption; M/P ratio not determined. Considered compatible with breastfeeding. |
| Teratogenic Risk | No evidence of teratogenicity in animal studies; dialysis solution with low systemic absorption. First trimester: theoretical risk from electrolyte imbalances. Second and third trimesters: risk of maternal hypotension, uterine hypoperfusion. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to any component of the solution","Severe lactic acidosis or other metabolic acidosis unrelated to renal failure","Pre-existing severe hyperglycemia or uncontrolled diabetes mellitus","Abdominal conditions that increase risk of leakage or infection (e.g., recent abdominal surgery, bowel obstruction)"]
| Precautions | ["Must be used with caution in patients with respiratory failure or compromise due to potential volume overload","Monitor for hyperglycemia, especially in diabetic patients, as dextrose can cause significant glucose absorption","Risk of peritonitis; sterile technique required during catheter insertion and exchanges","Electrolyte imbalances, particularly potassium and magnesium, require monitoring","Do not use if solution is discolored, cloudy, or contains particulate matter"] |
| Food/Dietary | No food interactions known. However, patients on peritoneal dialysis should follow a renal diet low in sodium, potassium, and phosphorus, and may need to restrict fluid intake based on urine output and ultrafiltration. Dextrose absorption from the dialysate can contribute to caloric intake and may affect glycemic control. |
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| Monitor maternal vital signs, fluid status, electrolytes, and fetal heart rate during dialysis. Assess uterine activity for preterm contractions. |
| Fertility Effects | No known direct effects on fertility. Underlying renal disease may impact fertility; dialysis may improve reproductive function in women with ESRD. |
| Clinical Pearls | DELFLEX W/ DEXTROSE 3.5% is a peritoneal dialysis solution. Ensure the solution is warmed to body temperature (37°C) before instillation to prevent discomfort and hypothermia. Monitor for signs of peritonitis (cloudy effluent, abdominal pain, fever) and check effluent cell count and culture if suspected. Assess patient's serum glucose and electrolyte levels regularly; dextrose may cause hyperglycemia. Adjust dwell time and volume based on patient's residual renal function and ultrafiltration needs. In patients with diabetes, insulin may need to be added to the dialysate or adjusted systemically. |
| Patient Advice | Warm the solution to body temperature before use to prevent abdominal discomfort. · Use strict sterile technique when connecting and disconnecting the transfer set to prevent infection. · Report any signs of infection such as cloudy dialysis fluid, abdominal pain, or fever immediately. · Monitor your blood glucose levels regularly, especially if you have diabetes, as the dextrose in the solution can raise blood sugar. · Follow your prescribed dwell time and exchange schedule exactly as instructed. · Weigh yourself daily to monitor fluid balance and report any rapid weight gain or shortness of breath. |