DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER (DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER).
Creates an osmotic gradient across the peritoneal membrane, facilitating ultrafiltration and diffusion of solutes (e.g., urea, creatinine, electrolytes) from blood into the dialysate, which is then drained.
| Metabolism | Dextrose is metabolized systemically via glycolysis and oxidation, primarily in the liver and peripheral tissues. Icodextrin (if present) is metabolized by amylase to maltose and maltotriose. |
| Excretion | Primarily excreted via peritoneal dialysis fluid removal; glucose is metabolized systemically. Renal excretion negligible as dialysis solution is not absorbed significantly. Fecal excretion minimal. |
| Half-life | Not applicable as a single entity; the dextrose component has a plasma half-life of approximately 15-20 minutes after absorption, reflecting rapid insulin-mediated clearance. |
| Protein binding | <5% (glucose); primarily unbound in plasma. |
| Volume of Distribution | 0.15-0.25 L/kg (dextrose); distributes mainly in extracellular fluid. |
| Bioavailability | Intraperitoneal: 70-80% of dextrose absorbed over 4-6 hours dwell. |
| Onset of Action | Intraperitoneal: Ultrafiltration begins within 5-10 minutes of instillation; peak effect on fluid removal at 30-60 minutes. |
| Duration of Action | Intraperitoneal: Ultrafiltration effect lasts for the duration of dwell (typically 4-6 hours); glucose absorption occurs throughout dwell. |
Intraperitoneal (IP) administration: 2 liters per exchange, 4 exchanges daily, with dwell time of 4-6 hours. Dextrose concentration (2.5%) selected based on ultrafiltration needs.
| Dosage form | SOLUTION |
| Renal impairment | Not applicable as drug is used for renal replacement therapy. Dosing is independent of residual renal function; peritoneal dialysis dose may be adjusted based on peritoneal membrane transport characteristics and adequacy targets (Kt/V). |
| Liver impairment | No specific adjustments for hepatic impairment. Monitor for metabolic acidosis and electrolyte imbalances in severe hepatic disease. |
| Pediatric use | Dose based on body surface area (BSA) or weight: typical exchange volume 30-40 mL/kg per exchange, 4-5 exchanges daily. Dextrose concentration titrated to ultrafiltration needs. Use approved pediatric formulation (lower volume containers). |
| Geriatric use | No specific dose adjustment. Monitor for overhydration, electrolyte disturbances, and malnutrition. May require lower exchange volumes or shorter dwell times if intolerance occurs. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER (DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER).
| Breastfeeding | Safety during breastfeeding is not established. Dextrose and electrolytes are normal blood constituents and would be present in breast milk at low concentrations. The M/P ratio is not known. The risk to the infant from the solution itself is likely minimal, but the mother's underlying renal disease and potential for peritonitis may require treatment that could affect breastfeeding. Clinical judgment advised. |
| Teratogenic Risk | Dianeal 137 with Dextrose 2.5% is a peritoneal dialysis solution. Dextrose is a physiological substance and not associated with teratogenicity at therapeutic doses. However, the underlying condition of renal failure and the peritoneal dialysis procedure itself pose risks. In the first trimester, there is no direct teratogenic effect from the solution components. In the second and third trimesters, potential risks include metabolic disturbances (e.g., hyperglycemia, electrolyte imbalances) and infection (peritonitis), which can indirectly affect fetal well-being. No specific human data on the solution's teratogenicity; animal studies not conducted. |
■ FDA Black Box Warning
Not for intravenous use. Do not add additives directly to the solution. Careful monitoring of electrolyte and fluid balance required.
| Serious Effects |
["Documented hypersensitivity to dextrose, icodextrin (if present), or any component","Severe hyperglycemia or hyperlactatemia","Pre-existing severe peritonitis or abdominal infection","Significant abdominal adhesions or ileus","Recent abdominal surgery or trauma"]
| Precautions | ["Peritonitis risk due to catheter-related infections","Fluid and electrolyte imbalances (e.g., hyperglycemia, hypokalemia, hypernatremia)","Hypersensitivity reactions","Abdominal complications (e.g., hernias, leaks)","Impaired liver function (icodextrin metabolites accumulation in cirrhosis)"] |
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| Fetal Monitoring | Monitor maternal blood glucose, electrolytes (sodium, potassium, calcium, magnesium), serum osmolarity, and acid-base status. Fetal monitoring includes serial ultrasounds for growth, amniotic fluid index, and biophysical profile. Assess for signs of peritonitis (abdominal pain, cloudy effluent) and complications of dialysis (hypotension, infection). |
| Fertility Effects | No direct effects on fertility from the solution components. However, chronic renal failure itself often impairs fertility due to hormonal disturbances, uremia, and anemia. Peritoneal dialysis may improve overall health and potentially restore some reproductive function, but data are limited. |