INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER (INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER).
Provides osmotic gradient for peritoneal dialysis; glucose and icodextrin facilitate ultrafiltration and removal of waste products across the peritoneal membrane.
| Metabolism | Glucose is absorbed across peritoneum and metabolized systemically. Icodextrin is metabolized by alpha-amylase to maltose and maltotriose. |
| Excretion | Primarily removed via peritoneal dialysis; minimal renal excretion (less than 5% unchanged). Dextrose is metabolized to CO2 and water. Biliary/fecal excretion negligible. |
| Half-life | Not applicable as a traditional half-life; removal is dependent on peritoneal dialysis dwell time and membrane transport characteristics. Effective clearance half-life during dialysis is approximately 2-4 hours depending on exchange schedule. |
| Protein binding | Dextrose not protein bound; electrolytes and buffer ions have negligible protein binding (<10% for calcium, magnesium). |
| Volume of Distribution | Distributes primarily into extracellular fluid; Vd approximates total body water (0.5-0.7 L/kg) for dialysate components. |
| Bioavailability | 100% via intraperitoneal route; not absorbed systemically in significant amounts except dextrose (partial absorption across peritoneum). |
| Onset of Action | Immediate upon instillation into peritoneal cavity; ultrafiltration begins within minutes. |
| Duration of Action | Dwell time 4-6 hours for standard exchanges; longer dwells (8-12 hours) for overnight. Duration of ultrafiltration effect correlates with osmotic gradient. |
2 L intraperitoneally via an indwelling peritoneal catheter, dwell time 4-6 hours, 4 exchanges per day
| Dosage form | SOLUTION |
| Renal impairment | Not applicable; drug is used for renal replacement therapy |
| Liver impairment | No adjustment required |
| Pediatric use | 30-40 mL/kg per exchange, 4-5 exchanges per day, with dwell time based on clinical clearance |
| Geriatric use | No specific adjustment; monitor fluid and electrolyte balance |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER (INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER).
| Breastfeeding | Icodextrin and its metabolites may be excreted in human milk. No data on M/P ratio. Use with caution during breast-feeding; consider the benefit of dialysis against potential risks to the infant. |
| Teratogenic Risk | Category D (positive evidence of human fetal risk). Icodextrin and its metabolite maltose may accumulate in pregnancy. Inadequate controlled studies in pregnant women; however, potential benefits may warrant use despite potential risks. First trimester: Possible teratogenic effects based on animal studies (fetal developmental delays and skeletal anomalies). Second and third trimesters: Risk of maternal and fetal electrolyte disturbances, hypoglycemia, and infections due to peritoneal dialysis. Avoid use unless essential. |
■ FDA Black Box Warning
Not for intravenous administration.
| Serious Effects |
["Hypersensitivity to icodextrin or any component","Severe hyperglycemia","Pre-existing severe metabolic disorders","Abdominal conditions compromising peritoneal function (e.g., hernias, adhesions)"]
| Precautions | ["Monitor serum electrolytes and glucose levels","Risk of peritonitis","Fluid overload or dehydration","Hyperglycemia, especially with dextrose solutions","Maltose interference with glucose monitoring systems"] |
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| Fetal Monitoring | Monitor maternal serum electrolytes, glucose, renal function, and peritoneal membrane function. Monitor fetal growth and well-being via ultrasound and non-stress testing. Assess for signs of peritonitis, volume overload, and metabolic acidosis. Monitor maternal blood pressure and weight. |
| Fertility Effects | Icodextrin and dextrose solutions may potentially affect fertility. In animal studies, no specific fertility impairment was observed. Clinical significance in humans is unknown. Patients with end-stage renal disease often have reduced fertility; dialysis therapy may improve overall health and thus may support fertility. |