DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER (DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER).
Intraperitoneal administration of Dianeal with 4.25% dextrose creates an osmotic gradient across the peritoneal membrane, promoting ultrafiltration and removal of uremic toxins and excess fluid.
| Metabolism | Dextrose is absorbed into systemic circulation and metabolized via glycolysis and oxidative phosphorylation. |
| Excretion | Peritoneal dialysis: Dextrose is metabolized systemically and eliminated primarily as CO2. Unchanged dextrose undergoes renal elimination only in anuric patients on dialysis, with minimal biliary/fecal excretion (<2%). |
| Half-life | Dextrose: approximately 1.5–2 hours (systemic half-life in renal impairment; peritoneal equilibration half-life for dextrose in dialysate is 1–2 hours, reflecting absorption). |
| Protein binding | Dextrose: negligible (<5%) binding to plasma proteins, primarily albumin. |
| Volume of Distribution | Dextrose: 0.2–0.3 L/kg (approximates extracellular fluid volume; distributes freely in ECF). |
| Bioavailability | Intraperitoneal: essentially complete absorption of dextrose from dialysate into systemic circulation (bioavailability ~100% over dwell time). |
| Onset of Action | Intraperitoneal: Ultrafiltration begins within 5–10 minutes of instillation, with peak plasma volume contraction occurring at 1–2 hours. |
| Duration of Action | Intraperitoneal: Ultrafiltration continues for 2–6 hours depending on dwell time; typical dwell (4–6 hours) achieves maximum fluid removal. Extended dwells (8–12 hours) may cause net reabsorption. |
Intraperitoneal administration: 2 liters infused over 10-20 minutes, dwell time 4-6 hours, then drain over 15-20 minutes; 4 exchanges per 24 hours.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required for GFR-based modifications; drug is removed during dialysis. |
| Liver impairment | No dose adjustment required for Child-Pugh classification; drug is not hepatically metabolized. |
| Pediatric use | Concentration adjusted to 2.5% or 4.25% dextrose based on fluid removal needs; typical exchange volume 30-40 mL/kg per exchange, 4-5 exchanges per day; dose titrated to clinical response. |
| Geriatric use | Monitor for fluid and electrolyte imbalances; use lower dextrose concentrations if possible to avoid hyperglycemia; no specific dose adjustment based on age alone. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER (DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER).
| Breastfeeding | No data on excretion into breast milk. Dextrose is a normal blood constituent. M/P ratio unknown. Use with caution; benefits of breastfeeding likely outweigh risks given minimal systemic absorption. |
| Teratogenic Risk | No human studies; animal studies not available. Dextrose is a normal metabolic substrate. However, peritoneal dialysis itself may pose risks (e.g., infection, electrolyte imbalances) that could affect pregnancy. No known teratogenicity attributed to Dianeal components. |
■ FDA Black Box Warning
Not for intravenous use. Strict aseptic technique required to prevent peritonitis and other complications.
| Serious Effects |
["Hypersensitivity to any component","Pre-existing severe hyperglycemia or hyperosmolar coma","Severe metabolic acidosis","Documented loss of peritoneal function or extensive adhesions compromising dialysis","Abdominal wall infection or peritonitis"]
| Precautions | ["Monitor for signs of peritonitis (cloudy effluent, abdominal pain, fever)","Assess fluid and electrolyte balance","Adjust dextrose concentration based on ultrafiltration needs","Risk of hyperglycemia in diabetic patients","Monitor serum albumin as protein loss may occur"] |
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| Fetal Monitoring |
| Monitor serum electrolytes, glucose, renal function, and fluid status regularly. Assess for peritonitis signs. Fetal monitoring as per standard obstetric care; consider growth scans due to potential maternal metabolic disturbances. |
| Fertility Effects | No direct evidence of fertility impairment. Underlying renal disease may affect fertility. Dialysis can improve fertility by correcting uremic milieu. |