DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER (DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER).
Delflex (icodextrin) is an iso-osmotic, high molecular weight glucose polymer that acts as a colloid osmotic agent in peritoneal dialysis. It induces ultrafiltration across the peritoneal membrane by creating an osmotic gradient, removing excess fluid and uremic toxins from the blood.
| Metabolism | Icodextrin is primarily metabolized by alpha-amylase into maltose, maltotriose, and other oligosaccharides. These metabolites are then further metabolized in tissues or excreted renally. A small fraction may be eliminated via the peritoneal route. |
| Excretion | Peritoneal dialysis fluid components: Delflex solutions are not absorbed systemically in significant amounts. The small amount of glucose absorbed (approx. 10-30% of instilled dose depending on dwell time and dextrose concentration) is metabolized via normal pathways. Water and electrolytes are removed via peritoneal dialysis. No renal or biliary excretion of the solution itself; glucose metabolites are excreted renally (CO2 and H2O). |
| Half-life | Not applicable; the solution acts locally in the peritoneal cavity. For absorbed dextrose, plasma glucose disappearance half-life is approximately 1-2 hours in patients with normal insulin response. In diabetic patients, half-life may be prolonged. |
| Protein binding | No significant protein binding; the components (glucose, electrolytes) are not bound to plasma proteins. |
| Volume of Distribution | Not applicable; the solution remains largely in the peritoneal cavity. Absorbed glucose distributes into total body water (Vd approximately 0.55 L/kg for glucose). |
| Bioavailability | Not applicable; administered intraperitoneally and acts locally. Systemic absorption of glucose is partial and variable (10-30% depending on dwell time, dextrose concentration, and peritoneal transport characteristics). |
| Onset of Action | Peritoneal dialysis: ultrafiltration and solute removal begin immediately upon instillation of the solution into the peritoneal cavity. |
| Duration of Action | Duration of dialysis effect depends on dwell time: typical dwell times range from 1-2 hours (for continuous ambulatory peritoneal dialysis) to longer periods (4-8 hours for overnight dwell). Clinical effect (fluid removal) continues as long as the solution is in the peritoneal cavity. |
Intraperitoneal administration: 2 liters per exchange, 4 exchanges per day (total 8 L/day). Exchange volumes typically 2-2.5 L per exchange, dwell time 4-6 hours.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment needed as drug is used for peritoneal dialysis; dosing may be adjusted based on residual renal function, but no specific GFR-based guidelines. |
| Liver impairment | No dose adjustment required for hepatic impairment as drug is not hepatically metabolized. |
| Pediatric use | Weight-based dosing: 30-40 mL/kg per exchange, 4-5 exchanges per day. Adjust based on body surface area and clinical response. |
| Geriatric use | No specific dose adjustments for elderly; monitor fluid balance and electrolytes. Use lower exchange volumes if fluid overload risk. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER (DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER).
| Breastfeeding | Limited data; dextrose and amino acids are endogenous substances normally present in breast milk. M/P ratio not established. Systemic absorption from intraperitoneal administration is minimal, and infant exposure via milk is negligible. Use with caution. |
| Teratogenic Risk | Intraperitoneal administration of dextrose and amino acid solutions is not associated with teratogenicity in animal studies. However, electrolyte imbalances and metabolic disturbances during pregnancy may adversely affect fetal development. Risks are low with proper monitoring. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Absolute: Known hypersensitivity to icodextrin or any component of the solution.","Absolute: Pre-existing severe metabolic acidosis (unrelated to uremia).","Absolute: Anuria or severe oliguria (unless on dialysis).","Relative: Severe hyperglycemia (consider alternative dextrose-based solutions).","Relative: Significant peritoneal membrane failure (e.g., ultrafiltration failure).","Relative: Lactation (safety not established)."]
| Precautions | ["Should not be used in patients with known allergy to starch, icodextrin, or dextrose.","May cause hypokalemia, hypomagnesemia, and hypocalcemia; monitor electrolytes closely.","Risk of peritonitis, catheter-related infections, and mechanical complications (e.g., leakage, hernias).","May interfere with certain laboratory tests (e.g., glucose oxidase methods, leading to falsely elevated glucose readings).","Use with caution in patients with severe liver disease or significant peritoneal membrane dysfunction.","Monitor for signs of volume overload or depletion."] |
| Food/Dietary |
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| Fetal Monitoring | Routine monitoring of serum electrolytes, blood glucose, fluid balance, and renal function is required. In pregnancy, increased frequency of fetal heart rate monitoring and ultrasonography for growth and amniotic fluid volume may be warranted due to potential metabolic shifts. |
| Fertility Effects | No adverse effects on fertility reported in animal studies. Data are insufficient to assess effects on human fertility. |
| No direct food interactions with DELFLEX W/ DEXTROSE 1.5% as it is administered intraperitoneally. However, diet may need adjustment for overall fluid and glucose management. Monitor glucose intake if diabetic. Avoid high-potassium foods if hyperkalemic from renal failure. Generally, follow renal diet: low sodium, low phosphorus, controlled potassium. |
| Clinical Pearls | DELFLEX W/ DEXTROSE 1.5% is a peritoneal dialysis solution used in continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD). Key pearls: Monitor effluent for turbidity or fibrin clots, which may indicate peritonitis. Use only if solution is clear and seal intact. Avoid air infusion; prime tubing carefully. Warm solution to body temperature before instillation to reduce discomfort and improve clearance. Check glucose concentration (1.5% is low osmolality) – may be insufficient for ultrafiltration in hypervolemic patients. Do not add medications without compatibility check. |
| Patient Advice | Wash hands thoroughly before handling the solution and tubing. · Inspect the bag for leaks, cloudiness, or particulate matter before use. · Warm the solution to body temperature (e.g., by placing on a heating pad) before infusion to prevent cramping. · Record daily weight, blood pressure, and effluent characteristics (color, clarity, volume). · Report signs of infection: cloudy effluent, abdominal pain, fever, or chills. · Keep a log of exchanges and bring to clinic visits. · Do not reuse or resterilize single-use containers. · Follow strict aseptic technique to prevent peritonitis. |