DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER (DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER).
Delflex with Dextrose 4.25% Low Magnesium is a peritoneal dialysis solution that uses dextrose as an osmotic agent to create a concentration gradient across the peritoneal membrane, allowing for the removal of uremic toxins and excess fluid via ultrafiltration. The low magnesium concentration (0.25 mEq/L) helps prevent hypermagnesemia in patients with renal failure.
| Metabolism | Dextrose is metabolized via glycolysis and the citric acid cycle; magnesium is excreted renally and undergoes reabsorption in the kidneys; other electrolytes are regulated by renal function. No specific enzyme induction or inhibition noted. |
| Excretion | Primarily renal (peritoneal clearance): ~60-80% of glucose absorbed is metabolized; dextrose metabolites (CO2, water) excreted via lungs and kidneys. Magnesium and other electrolytes are removed via peritoneal dialysis; net elimination varies with dialysis prescription. |
| Half-life | Intraperitoneal dextrose: absorption half-life ~1.5-2 hours; elimination of absorbed glucose follows endogenous glucose kinetics (t1/2 ~1-2 hours). Clinical note: Continuous dwell results in steady-state concentrations. |
| Protein binding | Dextrose: negligible binding. Magnesium: ~30% bound to albumin; Low Magnesium formulation minimizes magnesium load. |
| Volume of Distribution | Dextrose: Vd ~0.2-0.3 L/kg (total body water). Magnesium: Vd ~0.5-0.7 L/kg. Clinical meaning: Distributes into extracellular fluid; low Vd reflects limited tissue distribution. |
| Bioavailability | Intraperitoneal: dextrose absorption is 60-80% over a dwell; systemically bioavailable as absorbed glucose. Not applicable for IV or other routes. |
| Onset of Action | Intraperitoneal: ultrafiltration begins within 15-30 minutes of instillation; peak glucose absorption occurs at 1-2 hours. |
| Duration of Action | Intraperitoneal: dwell time typically 4-6 hours; ultrafiltration rate declines after peak absorption. Longer dwells (8-12 hours) may be used with lower dextrose concentrations. |
Intraperitoneal administration: 2 L per exchange, 4 exchanges daily. Dextrose concentration (1.5%, 2.5%, or 4.25%) determined by ultrafiltration needs. Low magnesium formulation selected based on serum magnesium levels.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment for renal impairment; drug is administered intraperitoneally for peritoneal dialysis. Monitor serum electrolytes and ultrafiltration. |
| Liver impairment | No specific adjustment; caution in hepatic impairment due to risk of lactate metabolism impairment with dextrose. Monitor serum lactate and electrolytes. |
| Pediatric use | Weight-based: 30-40 mL/kg per exchange, 4-5 exchanges daily. Adjust dextrose concentration based on ultrafiltration target. Low magnesium product used if hypermagnesemia risk. |
| Geriatric use | No specific dose adjustment; monitor fluid status, electrolytes, and ultrafiltration volume closely due to increased risk of volume overload and electrolyte disturbances. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER (DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER).
| Breastfeeding | It is not known whether Delflex components are excreted in human milk. Dextrose is a normal constituent of milk. Calcium, magnesium, and sodium are present in milk and the additional amounts from dialysis are likely negligible. However, due to potential for systemic absorption of dextrose and electrolyte shifts, caution is advised. No M/P ratio is available. |
| Teratogenic Risk | Delflex with Dextrose 4.25% Low Magnesium is a peritoneal dialysis solution. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted with this solution. In general, peritoneal dialysis may cause electrolyte disturbances and fluid shifts that could affect fetal well-being. Hyperglycemia from dextrose absorption may pose risks during organogenesis (first trimester) and later trimesters. Use only if clearly needed and monitor maternal glucose and electrolytes closely. |
■ FDA Black Box Warning
None
| Serious Effects |
["Pre-existing severe hypokalemia","Hypercalcemia","Severe hyperglycemia uncorrected","Significant abdominal adhesions or fibrosis","Pre-existing peritoneal diaphragmatic defects","History of severe pancreatitis or diverticulitis","Inability to perform dialysis exchanges safely"]
| Precautions | ["Not for intravenous use","Risk of peritonitis","Electrolyte imbalance (hypokalemia, hypomagnesemia, hypocalcemia)","Fluid overload or dehydration","Hyperglycemia, especially in diabetic patients","Abdominal wall hernias","Ileus or mechanical obstruction","Encapsulating peritoneal sclerosis (rare)"] |
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| Fetal Monitoring | Monitor maternal serum electrolytes (sodium, potassium, calcium, magnesium, chloride), blood glucose, and acid-base status regularly. Assess fluid balance with daily weights and intake/output. Monitor fetal heart rate and growth via ultrasound. Watch for signs of peritonitis including abdominal pain, fever, and cloudy effluent. Assess maternal renal function and adequacy of dialysis. |
| Fertility Effects | No studies on fertility effects of Delflex in humans. Dextrose solutions and peritoneal dialysis are not known to directly impair fertility. However, chronic kidney disease and dialysis therapy can be associated with reduced fertility due to hormonal alterations, anemia, and uremia. The solution itself is unlikely to cause independent fertility issues. |