DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER (DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER).
Provides dextrose as a caloric source and electrolyte replacement in peritoneal dialysis. Dextrose is metabolized to carbon dioxide and water, generating ATP. The high osmolality of the solution promotes ultrafiltration of fluid across the peritoneal membrane, facilitating removal of uremic toxins and excess fluid.
| Metabolism | Dextrose is metabolized via glycolysis and oxidative phosphorylation in peripheral tissues. A small fraction may be absorbed systemically during dialysis; metabolism occurs primarily in the liver and muscles via insulin-dependent pathways. |
| Excretion | Renal excretion of glucose and electrolytes; glucose is completely reabsorbed or metabolized, while electrolytes are excreted proportionally to serum levels and renal function. 100% renal elimination of administered electrolytes. |
| Half-life | Not applicable as a fixed half-life; glucose has a plasma elimination half-life of approximately 15-20 minutes, but this is concentration-dependent. Dialysis solutions are not administered as a single intravenous dose; the components are continuously infused. |
| Protein binding | Glucose: negligible protein binding (<5%); electrolytes: minimal binding (e.g., sodium <10%, potassium <5%, calcium ~45% to albumin). |
| Volume of Distribution | Glucose distributes mainly in extracellular fluid; Vd approximately 0.2 L/kg. Electrolytes distribute according to their physiological spaces: sodium 0.15 L/kg, potassium 0.4 L/kg, calcium 0.1 L/kg. |
| Bioavailability | Intravenous: 100%. |
| Onset of Action | Intravenous: immediate onset of fluid and electrolyte effects upon infusion; glucose effects on blood glucose occur within minutes. |
| Duration of Action | Duration depends on infusion rate and patient status; effects persist for the duration of infusion and for up to 1-2 hours post-infusion for electrolyte balance, and glucose effects last approximately 30-60 minutes after infusion stops. |
Not applicable; dialysate concentrate is used in hemodialysis machines, not administered directly to patients. Dextrose concentration in final dialysate is typically 1.5-2.5 g/dL depending on prescription.
| Dosage form | SOLUTION |
| Renal impairment | Not required as product is used during dialysis; dialysate composition is adjusted based on patient's electrolyte and fluid status. |
| Liver impairment | No adjustment; lactate or acetate in dialysate may require monitoring in severe hepatic failure, but no dose modification defined. |
| Pediatric use | Dialysate dextrose concentration adjusted per pediatric hemodialysis protocol; typical final dextrose 1.5-2.5 g/dL based on ultrafiltration needs. |
| Geriatric use | No specific adjustment; monitor for hypoglycemia or hyperglycemia and adjust dialysate dextrose accordingly. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER (DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER).
| Breastfeeding | Dextrose and electrolytes are normal milk components; M/P ratio unknown but levels in milk reflect maternal plasma. This formulation is considered compatible with breastfeeding when administered to correct maternal deficits. |
| Teratogenic Risk | Dextrose 50% and electrolyte concentrate are essential nutrients and electrolytes; no teratogenic risk is expected at clinically used doses during any trimester. However, hyperglycemia or electrolyte imbalances could pose fetal risks (e.g., macrosomia, hypoxia) if maternal homeostasis is disrupted. |
■ FDA Black Box Warning
Not applicable. The FDA does not require a black box warning for this product.
| Serious Effects |
["Hypersensitivity to any component.","Severe hyperglycemia not controlled by insulin.","Pre-existing severe hypokalemia or hypocalcemia (may worsen).","Peritoneal dialysis is contraindicated in cases of: recent abdominal surgery, abdominal adhesions, diaphragmatic hernia, or severe respiratory insufficiency (may compromise ventilation).","Severe peritonitis or intra-abdominal infections.","uncorrectable mechanical defects (e.g., catheter dysfunction)."]
| Precautions | ["Monitor serum glucose, electrolytes (especially potassium and calcium), and fluid balance closely.","Risk of hyperglycemia, especially in patients with diabetes mellitus.","Peritoneal dialysis can lead to peritonitis, catheter infections, and mechanical complications.","May cause electrolyte disturbances: hypokalemia, hypocalcemia, hypomagnesemia.","Do not use if solution is discolored, cloudy, or contains particulate matter.","Use with caution in patients with severe hepatic impairment (metabolism of lactate may be impaired if lactate is used as buffer)."] |
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| Fetal Monitoring | Monitor maternal blood glucose, electrolytes, fluid status, and acid-base balance. Fetal monitoring via ultrasound for growth and amniotic fluid index. Assess for signs of maternal volume overload or electrolyte disturbances. |
| Fertility Effects | No direct effects on fertility. Indirectly, correction of metabolic derangements may improve reproductive function in patients with underlying disorders like diabetes. |