DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER (DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER).
Intraperitoneal administration of dextrose creates an osmotic gradient that promotes ultrafiltration and removal of uremic toxins and excess fluid across the peritoneal membrane, while electrolytes in the solution correct imbalances.
| Metabolism | Dextrose is absorbed across the peritoneal membrane and systemically metabolized via glycolysis and oxidation. |
| Excretion | Primarily renal; glucose is reabsorbed or metabolized; electrolytes follow renal handling. Not applicable as a drug; dialysate components are removed via peritoneal dialysis effluent. |
| Half-life | Not applicable (combination product); dextrose follows glucose kinetics (~1.5–2 h); electrolytes have no half-life. |
| Protein binding | Negligible for dextrose and electrolytes; dextrose not protein-bound. |
| Volume of Distribution | Intraperitoneal space ~0.05–0.1 L/kg; distributes into peritoneal cavity and extracellular fluid. |
| Bioavailability | Intraperitoneal administration results in ~100% local exposure; systemic absorption of dextrose ~60–80% of instilled load. |
| Onset of Action | Immediate upon intraperitoneal instillation; ultrafiltration and solute removal begin within minutes. |
| Duration of Action | Varies with dwell time (typically 4–6 h for CAPD); glucose absorption and ultrafiltration rate decline over time. |
Intraperitoneal administration: 2 liters per exchange, 4 exchanges per day, via continuous ambulatory peritoneal dialysis (CAPD).
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required. Dosing based on peritoneal dialysis prescription, not GFR. |
| Liver impairment | No specific adjustment. Use with caution in severe hepatic impairment due to potential lactate metabolism issues. |
| Pediatric use | Weight-based: Initial volume 10-30 mL/kg per exchange, 4-5 exchanges per day. Titrate to achieve target ultrafiltration and clearance. |
| Geriatric use | No specific adjustment; monitor fluid and electrolyte status closely due to higher risk of volume overload or dehydration. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER (DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER).
| Breastfeeding | Compatible with breastfeeding. Dextrose from peritoneal dialysate is not excreted into breastmilk in clinically relevant amounts. M/P ratio not applicable. |
| Teratogenic Risk | No known teratogenic risk. Peritoneal dialysis with Dianeal 4.25% dextrose is not absorbed systemically in significant amounts. No fetal harm reported from intraperitoneal dextrose. |
| Fetal Monitoring |
■ FDA Black Box Warning
Not for intravenous use; for intraperitoneal use only.
| Serious Effects |
["Hypersensitivity to any component","Pre-existing severe hyperglycemia or lactic acidosis","Significant peritoneal adhesions or structural defects compromising dialysis","Recent abdominal surgery or trauma"]
| Precautions | ["Monitor serum electrolytes, blood glucose, and volume status closely.","Risk of hyperglycemia, particularly in diabetic patients.","Peritonitis risk due to catheter contamination.","Do not use if solution is discolored or contains particulate matter."] |
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| Monitor maternal serum electrolytes, glucose, and acid-base status. Assess fetal growth and well-being via ultrasound if maternal metabolic disturbances occur. |
| Fertility Effects | No known adverse effects on fertility. Fertility is not impaired by intraperitoneal dextrose. |