DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER (DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER).
Peritoneal dialysis solution; dextrose provides osmotic gradient for ultrafiltration and solute removal; low magnesium formulation reduces magnesium accumulation in renal failure patients.
| Metabolism | Dextrose is metabolized via glycolysis and oxidative phosphorylation; magnesium and electrolytes are handled by renal excretion (limited in renal failure). |
| Excretion | Renal: 99% (as glucose and electrolytes), biliary/fecal: <1% |
| Half-life | Terminal elimination half-life not applicable; drug effects persist as long as solution remains in peritoneal cavity (dwell time 4–8 hours for CAPD). |
| Protein binding | No significant protein binding for glucose or electrolytes; magnesium <30% bound to albumin. |
| Volume of Distribution | Vd approximately 0.2 L/kg (distributes primarily in extracellular fluid; glucose distributes into total body water). |
| Bioavailability | Intraperitoneal: 100% (directly absorbed into peritoneal cavity); oral: not applicable. |
| Onset of Action | Intraperitoneal: Ultrafiltration begins within 5–10 minutes; peak glucose concentration in peritoneal fluid at 30–60 minutes. |
| Duration of Action | Ultrafiltration and solute removal last for the duration of dwell (typically 4–8 hours in CAPD; longer for automated PD). |
Intraperitoneal administration: 2 liters per exchange, 4 exchanges per day; dextrose concentration and fill volume adjusted based on ultrafiltration needs.
| Dosage form | SOLUTION |
| Renal impairment | No adjustment necessary; drug is used for renal replacement therapy in ESRD patients; dosing tailored to individual peritoneal membrane characteristics and transport status. |
| Liver impairment | No specific adjustment; however, caution in severe hepatic impairment due to potential for lactate accumulation. |
| Pediatric use | Weight-based: 30-40 mL/kg per exchange, 4-5 exchanges per day; dextrose concentration and fill volume individualized based on metabolic and fluid balance needs. |
| Geriatric use | Use lowest effective dextrose concentration and monitor fluid and electrolyte status closely due to higher risk of dehydration, hyperglycemia, and volume depletion. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER (DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER).
| Breastfeeding | It is not known whether components of Delflex with Dextrose 1.5% Low Magnesium (dextrose, electrolytes) are excreted in human milk. Dextrose is a normal constituent of milk, and intraperitoneal administration is unlikely to cause significant systemic levels. Low magnesium content may not affect milk magnesium levels. M/P ratio is not available. Benefit of breastfeeding should be weighed against potential risk to the infant. |
| Teratogenic Risk | Delflex with Dextrose 1.5% Low Magnesium is a peritoneal dialysis solution. No adequate and well-controlled studies in pregnant women. Animal reproduction studies are not available. Dextrose is considered safe in pregnancy when used as a caloric source, but intraperitoneal administration may cause maternal hyperglycemia, which could lead to fetal macrosomia and neonatal hypoglycemia if persistent. Magnesium levels are low, so theoretical risk of hypomagnesemia affecting fetal development (e.g., skeletal abnormalities, growth restriction) if maternal magnesium deficiency occurs. Overall, risk is likely low but not definitively established. Use only if clearly needed. |
■ FDA Black Box Warning
Not for intravenous use; strict sterile technique required to prevent peritonitis; may cause severe electrolyte disturbances.
| Serious Effects |
["Hypersensitivity to any component","Severe hyperglycemia or glucose intolerance not manageable with insulin","Pre-existing severe hypomagnesemia","Active intra-abdominal infection or peritonitis","Documented loss of peritoneal function or extensive adhesions"]
| Precautions | ["Monitor serum electrolytes, glucose, and magnesium levels closely","Risk of hyperglycemia in diabetic patients due to dextrose absorption","May cause hypomagnesemia if magnesium levels become too low","Risk of peritonitis with contamination","Fluid overload or dehydration depending on tonicity","Use caution in patients with severe electrolyte disorders"] |
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| Fetal Monitoring | Monitor maternal blood glucose levels regularly to prevent hyperglycemia, especially in gestational diabetes. Assess serum electrolytes including magnesium, calcium, potassium, and phosphorus periodically. Monitor fetal growth via ultrasound if prolonged use. In late pregnancy, monitor fetal heart rate and uterine activity if signs of preterm labor or fluid imbalance. |
| Fertility Effects | No specific studies on fertility with peritoneal dialysis solutions. Chronic renal failure and dialysis can impair fertility due to hormonal disturbances. Delflex with Dextrose 1.5% Low Magnesium is not expected to directly impact fertility, but underlying disease and dialysis may reduce fertility. |