INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER (INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER).
Inpersol-LC/LM with 3.5% dextrose is a peritoneal dialysis solution that provides osmotic ultrafiltration via dextrose, removing waste products and excess fluid from the blood across the peritoneal membrane. The low calcium (LC) and low magnesium (LM) formulations adjust electrolyte concentrations to manage imbalances.
| Metabolism | Dextrose is metabolized via glycolysis and the citric acid cycle. Electrolytes are not metabolized. |
| Excretion | Renal (via peritoneal dialysis effluent); approximately 60-70% of administered dextrose is absorbed and metabolized, with the remainder removed in dialysate; no significant biliary/fecal elimination. |
| Half-life | Not applicable; dextrose is continuously infused and removed; the half-life of intraperitoneal dextrose is approximately 1-2 hours due to rapid absorption and metabolism, with clinically relevant hyperglycemia managed by insulin. |
| Protein binding | Dextrose has no significant protein binding (<5%); electrolytes may have variable binding (e.g., calcium ~40% bound to albumin). |
| Volume of Distribution | Dextrose distributes primarily in extracellular fluid (Vd ~0.2 L/kg); electrolytes distribute according to their physiological spaces (e.g., sodium: 0.6-0.7 L/kg). |
| Bioavailability | Intraperitoneal administration: dextrose is fully absorbed (100%) into systemic circulation; electrolytes are partially absorbed depending on concentration gradient and dwell time. |
| Onset of Action | Peritoneal administration: ultrafiltration and solute removal begin within minutes; clinical effect on fluid overload and electrolyte balance observed within 1-2 hours. |
| Duration of Action | Peritoneal dwell time: 4-6 hours for standard exchanges; longer dwells (8-12 hours) used overnight; continuous ambulatory peritoneal dialysis provides sustained effect. |
Intraperitoneal administration: 2 to 2.5 liters per exchange, 4 to 5 exchanges per day, as prescribed by physician based on peritoneal equilibration test.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required for GFR reductions as drug is directly instilled into peritoneal cavity; however, monitoring of electrolyte balance and ultrafiltration is necessary. |
| Liver impairment | No specific Child-Pugh based dose adjustments; caution in severe hepatic impairment due to risk of lactate metabolism impairment. |
| Pediatric use | Weight-based: 800 to 1400 mL/m² per exchange, 4 to 5 exchanges per day; adjust dwell time and volume based on body surface area and metabolic needs. |
| Geriatric use | No specific dose adjustment; monitor for fluid overload, electrolyte disturbances, and peritonitis risk more closely due to age-related changes. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER (INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER).
| Breastfeeding | Dextrose is a normal constituent of breast milk and is not expected to pose a risk to the nursing infant. Inpersol-LC/LM is used for peritoneal dialysis; systemic absorption of dextrose is minimal. The milk-to-plasma (M/P) ratio for dextrose is approximately 1, but no specific data for this formulation. Due to low systemic levels, it is likely compatible with breastfeeding. Caution is advised if high glucose concentrations are present in the dialysate. |
| Teratogenic Risk | Inpersol-LC/LM with Dextrose 3.5% is a peritoneal dialysis solution. Dextrose is generally considered safe during pregnancy at therapeutic doses; however, data specific to this formulation are limited. No adequate well-controlled studies in pregnant women. In animal studies, high glucose concentrations have been associated with fetal malformations, but clinical relevance is unknown. Due to potential metabolic effects (e.g., hyperglycemia), caution is advised. First trimester: theoretical risk of neural tube defects if maternal glucose control is poor. Second and third trimesters: risk of macrosomia, neonatal hypoglycemia, and other complications if maternal hyperglycemia occurs. Overall, the teratogenic risk is considered low when blood glucose levels are maintained near normal. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Pre-existing severe hypocalcemia or hypomagnesemia","Hypersensitivity to any component","Clinically significant peritoneal membrane dysfunction","Pre-existing severe hyperglycemia"]
| Precautions | ["Monitor serum electrolytes, particularly calcium and magnesium, to avoid depletion.","Risk of peritonitis; aseptic technique required.","Fluid and electrolyte imbalances may occur.","Monitor glucose levels; dextrose absorption can cause hyperglycemia."] |
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| Fetal Monitoring | Monitor maternal blood glucose levels frequently during therapy to avoid hyperglycemia. Monitor serum electrolytes, fluid balance, and renal function. Assess fetal growth and well-being by ultrasonography as clinically indicated. In patients with gestational diabetes or impaired glucose tolerance, closer glucose monitoring is required. |
| Fertility Effects | No specific studies on fertility effects of Inpersol-LC/LM with Dextrose 3.5% in humans. Dextrose at high concentrations may cause metabolic disturbances that could theoretically affect fertility. However, low systemic absorption from peritoneal dialysis makes significant impact unlikely. |