DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER (DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER).
DIANEAL 137 with 1.5% dextrose is a peritoneal dialysis solution that removes waste products and excess fluid from the blood by creating a concentration gradient across the peritoneal membrane via diffusion and ultrafiltration. Dextrose acts as an osmotic agent to drive fluid removal.
| Metabolism | Dextrose in the solution is absorbed systemically and metabolized via glycolysis and the citric acid cycle; approximately 60-80% of dextrose is absorbed during dwell time. |
| Excretion | Dianeal 137 with 1.5% dextrose is a peritoneal dialysis solution. Dextrose is metabolized systemically; glucose is absorbed via peritoneal route and undergoes endogenous metabolism. Icodextrin (if applicable) is metabolized to maltose and excreted renally, but for this standard solution, elimination is primarily via metabolism to CO2 and water; less than 5% excreted unchanged in urine. No biliary or fecal elimination of intact dextrose. |
| Half-life | Not applicable for dextrose as it is an endogenous substance. Exogenous dextrose in peritoneal dialysis is rapidly metabolized; plasma glucose half-life is approximately 1-2 hours after absorption, but this varies with metabolic state. |
| Protein binding | Dextrose does not bind to plasma proteins; negligible binding. |
| Volume of Distribution | Not applicable for dextrose; glucose distributes into total body water (approximately 0.6 L/kg). |
| Bioavailability | Intraperitoneal administration results in systemic absorption of dextrose; bioavailability is approximately 60-80% over a typical dwell, as some glucose is metabolized locally or remains in the peritoneal cavity. |
| Onset of Action | Ultrafiltration and solute removal begin within minutes of intraperitoneal instillation; peak osmotic effect occurs at about 30-60 minutes with 1.5% dextrose. |
| Duration of Action | Dwell time typically 4-6 hours for standard exchanges; longer duration (e.g., overnight) is possible with reduced ultrafiltration over time due to dissipation of osmotic gradient. |
Intraperitoneal administration: 2 liters per exchange, typically 4 exchanges per day for continuous ambulatory peritoneal dialysis (CAPD).
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required; drug is used for renal replacement therapy in end-stage renal disease. |
| Liver impairment | No dosage adjustment needed; peritoneal dialysis solutions are not hepatically metabolized. |
| Pediatric use | Initial exchange volume: 30-40 mL/kg per exchange, adjusted to clinical tolerance and adequacy targets. |
| Geriatric use | Similar to adult dosing; monitor for glucose intolerance and electrolyte disturbances. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER (DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER).
| Breastfeeding | Dextrose is a normal constituent of milk. No significant transfer of peritoneal dialysis solutions into breast milk is expected. M/P ratio not applicable. Compatible with breastfeeding; monitor infant for electrolyte disturbances if maternal dialysis is ongoing. |
| Teratogenic Risk | Dianeal 137 with Dextrose 1.5% is used for peritoneal dialysis. Dextrose is not teratogenic at therapeutic doses. There is no increased risk of fetal malformations. However, metabolic complications (e.g., hyperglycemia, electrolyte imbalances) in the mother may adversely affect the fetus, especially in the second and third trimesters. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Pre-existing severe hyperglycemia (blood glucose > 300 mg/dL) unless controlled.","Hypersensitivity to any component.","Clinically significant electrolyte imbalances (e.g., hypernatremia, hypokalemia) that cannot be corrected.","Mechanical defects in the peritoneal cavity (e.g., leaks, hernias, surgical wounds) that hinder dialysis.","Severe peripheral vascular disease or other conditions precluding peritoneal catheter placement."]
| Precautions | ["Monitor for peritonitis, abdominal pain, or cloudy effluent.","Risk of electrolyte imbalances (e.g., hypernatremia, hypokalemia) and volume overload.","Monitor blood glucose due to dextrose absorption, especially in diabetic patients.","Hypersensitivity reactions may occur.","Do not use if solution is discolored or contains particulates.","Use strict aseptic technique to reduce infection risk."] |
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| Fetal Monitoring | Monitor maternal serum electrolytes, glucose, and fluid status. Assess fetal growth and well-being via ultrasound and non-stress tests in third trimester. Monitor for signs of peritonitis or catheter complications. |
| Fertility Effects | No known direct effects on fertility. Chronic renal failure itself may impair fertility. Dialysis may improve general health and potentially restore fertility in women with end-stage renal disease. |