DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER (DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER).
Dianeal PD-2 with Dextrose 2.5% is a peritoneal dialysis solution that removes waste products and excess fluid from the blood via diffusion and ultrafiltration across the peritoneal membrane. Dextrose creates an osmotic gradient driving fluid removal; electrolytes (sodium, chloride, calcium, magnesium, lactate) correct electrolyte imbalances.
| Metabolism | Dextrose is rapidly absorbed from peritoneal cavity and metabolized via glycolysis and oxidative phosphorylation; lactate is converted to bicarbonate in the liver. |
| Excretion | Renal: negligible; drug is not absorbed systemically. The glucose is metabolized locally in peritoneal cavity and removed with dialysate outflow. |
| Half-life | Not applicable; drug is not systemically absorbed. The peritoneal clearance of glucose follows first-order kinetics with a half-life of approximately 2-3 hours in the peritoneal cavity. |
| Protein binding | Not applicable; glucose is not significantly protein bound. |
| Volume of Distribution | Not applicable; drug remains confined to peritoneal cavity with negligible systemic absorption. The volume of distribution within the peritoneal cavity is approximately 2-3 L. |
| Bioavailability | Intraperitoneal: extremely low systemic bioavailability (<0.1%) as glucose is largely metabolized locally and removed with dialysate; any absorbed glucose enters systemic circulation as normal glucose. |
| Onset of Action | Intraperitoneal: ultrafiltration begins immediately after infusion; peak effect on fluid removal occurs within 1-2 hours after dwell initiation. |
| Duration of Action | Intraperitoneal: 4-6 hours for a typical dwell; longer dwells may cause reabsorption of fluid due to glucose absorption and dissipation of osmotic gradient. |
Intraperitoneal administration: 2 to 2.5 liters per exchange, typically 4 exchanges per day, with dwell times of 4-6 hours during the day and 8-12 hours overnight. Concentration selected based on ultrafiltration needs.
| Dosage form | SOLUTION |
| Renal impairment | Not applicable; the drug is used as peritoneal dialysis solution in patients with end-stage renal disease. Dosing adjustments are based on individual ultrafiltration and metabolic requirements rather than GFR. |
| Liver impairment | No dose adjustment required; however, monitor for metabolic complications in patients with hepatic impairment, especially those with altered glucose metabolism. |
| Pediatric use | Initial volume 10-30 mL/kg per exchange, adjusted based on clinical response and tolerance. Exchange volumes typically 30-40 mL/kg, up to 1 liter in older children. Frequency: 4-5 exchanges per day. |
| Geriatric use | Same as adult dose; monitor for dehydration, electrolyte imbalances, and blood glucose changes. May require lower fill volumes or fewer exchanges if peritoneal membrane function or compliance is reduced. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER (DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER).
| Breastfeeding | Not excreted into milk in significant amounts. Peritoneal dialysis solutions are not absorbed systemically; dextrose and electrolytes are present in maternal plasma but no specific M/P ratio. Considered compatible with breastfeeding; monitor infant for electrolyte disturbances if mother has renal failure. |
| Teratogenic Risk | Dianeal PD-2 with dextrose 2.5% is a peritoneal dialysis solution. Dextrose is not teratogenic at used concentrations; however, maternal metabolic disturbances (e.g., hyperglycemia, electrolyte imbalances) from dialysis may affect fetal development. No specific fetal risks reported, but inadequate dialysis may increase risk of preterm birth and growth restriction. |
■ FDA Black Box Warning
Not for intravenous use. Strict aseptic technique required to prevent peritonitis. Use only if solution is clear and container undamaged.
| Serious Effects |
["Pre-existing severe lactic acidosis","Documented hypersensitivity to any component","Clinically significant mechanical defects of peritoneal cavity (e.g., surgical leaks, diaphragmatic defects)","Pre-existing severe hyperglycemia if cannot be controlled","Abdominal conditions that compromise peritoneal integrity (e.g., bowel perforation, recent surgery)"]
| Precautions | ["Monitor for peritonitis, catheter-related infections, and mechanical complications","Risk of hyperglycemia, especially in diabetic patients","Fluid and electrolyte imbalances (e.g., hypernatremia, hypokalemia)","Peritoneal membrane failure with long-term use","Not for patients with severe lactic acidosis or uncorrectable mechanical defects"] |
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| Fetal Monitoring | Monitor maternal electrolytes, renal function, blood glucose, fluid status, and peritoneal membrane function. Fetal monitoring includes serial ultrasound for growth, amniotic fluid volume, and biophysical profile. Assess for signs of infection or catheter dysfunction. |
| Fertility Effects | No direct effects on fertility. Impaired renal function in women requiring dialysis may reduce fertility due to hormonal imbalances and uremia. Correction with dialysis may improve ovulatory function. |