DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER (DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER).
Intraperitoneal administration of dextrose and electrolytes creates an osmotic gradient that promotes ultrafiltration and removal of uremic toxins and excess fluid across the peritoneal membrane. Low magnesium formulation reduces magnesium load in patients with hypermagnesemia or renal impairment.
| Metabolism | Dextrose is metabolized peripherally and via peritoneal absorption into glucose and subsequently to CO2 and water. Electrolytes are not metabolized but excreted or retained according to patient needs. |
| Excretion | Peritoneal dialysis fluid components; dextrose is metabolized; electrolytes are absorbed/excreted via peritoneal route; no significant renal or biliary elimination. |
| Half-life | Not applicable; dextrose metabolism is rapid; dwell time in peritoneal cavity determines effect, typical 4-6 hours for dialysis. |
| Protein binding | Negligible for dextrose and electrolytes. |
| Volume of Distribution | Not applicable; components are confined to peritoneal cavity and rapidly equilibrate with extracellular fluid. |
| Bioavailability | 100% via intraperitoneal route; dextrose and electrolytes are directly available. |
| Onset of Action | Immediate upon infusion into peritoneal cavity; fluid removal and solute clearance begin within dwell. |
| Duration of Action | Dwell time 4-6 hours for standard exchanges; continuous ambulatory peritoneal dialysis (CAPD) uses 4-5 exchanges per day. |
Intraperitoneal instillation of 2 L (or as prescribed) of 2.5% dextrose-containing peritoneal dialysis solution, typically exchanged 4 times daily. The volume and frequency are individualized based on patient's size, residual renal function, and ultrafiltration needs.
| Dosage form | SOLUTION |
| Renal impairment | Not applicable; product is used as replacement therapy in end-stage renal disease. Dose adjustments for residual renal function not routinely performed; dialysis prescription tailored to achieve target Kt/V and ultrafiltration. |
| Liver impairment | No dosage adjustment provided for Child-Pugh classes. Use with caution in severe hepatic impairment due to risk of lactic acidosis if dextrose is metabolized; monitor serum lactate and glucose. |
| Pediatric use | Weight-based dosing: Initial volume 10-20 mL/kg per exchange, gradually increased as tolerated. Typical fill volume 30-40 mL/kg, frequency 4-5 exchanges daily. Adjust to achieve adequate dialysis adequacy (Kt/V) and fluid balance. |
| Geriatric use | No specific dose adjustment; consider reduced fill volume (1.5-2 L) due to decreased peritoneal surface area and lower tolerance. Monitor for fluid overload and electrolyte disturbances more frequently. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER (DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER).
| Breastfeeding | No information available on excretion into human milk. The components (dextrose, electrolytes) are normal blood constituents and unlikely to cause adverse effects in the breastfed infant. Caution is advised. |
| Teratogenic Risk | Delflex with Dextrose 2.5% Low Magnesium is a peritoneal dialysis solution. No teratogenic effects are expected as the components are physiologic and absorbed systemically in minimal amounts. Data on human pregnancy are limited, but animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Use only if clearly needed. |
■ FDA Black Box Warning
Not for intravenous use. Use only for peritoneal dialysis. Re-evaluate patient if severe abdominal pain, cloudy effluent, or signs of peritonitis occur.
| Serious Effects |
["Hypersensitivity to any component","Severe hypermagnesemia","Pre-existing severe metabolic alkalosis","Documented loss of peritoneal function or extensive adhesions compromising dialysis","Marked hyperglycemia (relative contraindication)"]
| Precautions | ["Monitor serum electrolytes (especially magnesium, potassium, and calcium) and fluid balance frequently","Use with caution in patients with severe hyperglycemia, hypokalemia, or metabolic acidosis","Risk of peritonitis; ensure sterile technique during administration","May cause hyperglycemia and fluid overload in susceptible patients"] |
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| Fetal Monitoring | Monitor fluid and electrolyte balance, maternal weight, blood pressure, urine output, and serum electrolytes. Fetal monitoring with ultrasound and non-stress test may be considered in pregnant patients requiring dialysis. |
| Fertility Effects | No data available on fertility effects. Peritoneal dialysis may affect menstrual regularity and fertility due to underlying renal disease. |