DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER (DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER).
Dianeal PD-2 with Dextrose 3.5% is a peritoneal dialysis solution. Dextrose provides an osmotic gradient that facilitates the removal of uremic toxins and excess fluid from the blood across the peritoneal membrane into the dialysate. The solution also contains electrolytes to correct imbalances.
| Metabolism | Dextrose is absorbed from the dialysate into the systemic circulation and undergoes normal glucose metabolism via glycolysis and subsequent oxidation or storage. No significant hepatic or renal metabolism of the drug components. |
| Excretion | Peritoneal dialysis (PD) with 3.5% dextrose solution results in elimination of excess fluid and solutes via the peritoneal membrane. Dextrose is absorbed systemically and metabolized. The primary route of elimination of dialytic waste products (e.g., urea, creatinine) is via the peritoneal fluid itself, which is drained. Less than 1% of dextrose is excreted unchanged in urine. Biliary/fecal excretion is negligible. |
| Half-life | The elimination half-life of dextrose from the systemic circulation is approximately 3.5-4.5 hours after intraperitoneal administration. Clinically, this reflects the rate of glucose absorption and metabolism, which can be altered in patients with impaired glucose tolerance or diabetes. |
| Protein binding | Dextrose is not significantly bound to plasma proteins. Binding fraction: <1% (negligible). |
| Volume of Distribution | The apparent volume of distribution for dextrose is approximately 0.25 L/kg, reflecting primarily extracellular fluid distribution. For the dialysate volume itself, Vd is equal to the instilled volume (typically 1.5-2.5 L). |
| Bioavailability | Intraperitoneal administration: Dextrose is absorbed systemically with an estimated bioavailability of 60-80% of the instilled amount, depending on dwell time and peritoneal membrane characteristics. |
| Onset of Action | Intraperitoneal administration: The onset of ultrafiltration and solute removal begins immediately upon instillation, with peak glucose concentration in dialysate reached within 30-60 minutes. |
| Duration of Action | The duration of a single dwell is typically 4-8 hours, depending on the exchange protocol. Ultrafiltration rate declines as glucose is absorbed and the osmotic gradient diminishes. For continuous ambulatory peritoneal dialysis (CAPD), exchanges are performed 4-5 times daily. Automated PD uses shorter cycles over 8-10 hours. |
2 to 3 liters intraperitoneally, 4 exchanges daily, with dwell times of 4-6 hours for CAPD; or 2 to 2.5 liters intraperitoneally, cycler-assisted, 3-5 cycles nightly for APD. Dextrose 3.5% solution used based on ultrafiltration needs.
| Dosage form | SOLUTION |
| Renal impairment | Not applicable as drug is dialysate; dosing and exchange volume may be adjusted based on residual renal function and peritoneal transport characteristics. No GFR-based dose reduction specified. |
| Liver impairment | No dosage adjustment required for hepatic impairment; drug is locally acting and not systemically metabolized. |
| Pediatric use | 800-1100 mL/m² body surface area intraperitoneally per exchange, 4-5 exchanges daily; volume adjusted per tolerance and ultrafiltration goals. |
| Geriatric use | No specific age-related dose adjustment; consider reduced exchange volumes if poor tolerance, monitor ultrafiltration and electrolyte balance. |
| 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 3.5% IN PLASTIC CONTAINER (DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER).
| Breastfeeding | Dextrose is a normal constituent of breast milk. Peritoneal dialysis solutions are not systemically absorbed; therefore, no significant excretion into breast milk is expected. Breastfeeding is considered safe during peritoneal dialysis with this solution. M/P ratio: Not applicable (dextrose is endogenous). |
| Teratogenic Risk | Dianeal PD-2 with Dextrose 3.5% is a peritoneal dialysis solution. Dextrose is a physiological sugar and not teratogenic. No fetal risks are anticipated from the dextrose component. However, the underlying renal disease and uremia carry significant risks for adverse pregnancy outcomes including preterm birth, intrauterine growth restriction, and preeclampsia. The solution itself is not associated with teratogenicity in any trimester. |
■ FDA Black Box Warning
Not for intravenous use. Peritoneal dialysis must be performed under aseptic technique to prevent peritonitis. Dialysis solution is for single use only; discard any unused portion.
| Serious Effects |
Absolute: Documented hypersensitivity to any component of the solution; pre-existing severe hyperglycemia or uncontrolled diabetes; presence of surgical wounds or stomas in the abdominal wall; pre-existing fungal or bacterial peritonitis; conditions that compromise the integrity of the peritoneal membrane (e.g., extensive adhesions, diaphragmatic defects). Relative: Severe electrolyte imbalances; severe malnutrition; recent abdominal surgery; abdominal wall or skin infections; pregnancy (use only if clearly needed).
| Precautions | Risk of peritonitis and catheter-related infections; monitor for signs of infection. Electrolyte disturbances (hyperglycemia, hypernatremia, hypokalemia) may occur. Monitor serum glucose, electrolytes, and fluid status. Dose may need adjustment in diabetes or patients with glucose intolerance. Mechanical complications (catheter obstruction, leakage, hernia). Loss of protein and amino acids can occur with prolonged therapy; ensure adequate nutrition. |
| Food/Dietary |
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| Fetal Monitoring | Monitor maternal serum electrolytes, glucose, renal function, and acid-base status regularly. Assess peritoneal dialysis adequacy (Kt/V). Fetal monitoring includes serial ultrasound for growth, amniotic fluid volume, and biophysical profile. Screen for preeclampsia and preterm labor. Monitor maternal blood pressure and fluid status. |
| Fertility Effects | No direct effects on fertility from the dialysis solution. Chronic renal disease may impair fertility due to uremia and hormonal disturbances. Peritoneal dialysis may improve fertility by correcting uremic milieu. No specific adverse effects on gametes or reproductive function. |
| No direct food interactions with the dialysis solution itself. However, patients on peritoneal dialysis require dietary restrictions: limit sodium, potassium, phosphorus, and fluid intake to manage electrolyte balance and fluid status. Consult renal dietitian for individual plan. Avoid high-potassium foods (bananas, oranges, potatoes) and high-phosphorus foods (dairy, nuts, colas). |
| Clinical Pearls | This is a peritoneal dialysis solution containing 3.5% dextrose, used for continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD). Higher dextrose concentration (3.5%) provides greater ultrafiltration. Monitor for hyperglycemia, especially in diabetic patients; insulin adjustments may be needed. Assess effluent for clarity; cloudy effluent indicates peritonitis. Warm solution to body temperature before infusion to reduce discomfort. Use aseptic technique to prevent infection. Check catheter exit site for signs of infection. Not for intravenous use. |
| Patient Advice | Warm the dialysis bag to body temperature before use. · Inspect solution for clarity; do not use if cloudy or contains particles. · Use strict sterile technique when connecting tubing to prevent infection. · Monitor blood glucose levels regularly if you have diabetes. · Report abdominal pain, fever, or cloudy dialysis fluid immediately. · Keep a log of your daily weight and dialysis exchanges. · Do not reuse solutions or administration sets. · Store unopened bags at room temperature, away from heat and light. |