ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER (ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER).
ISOLYTE P in Dextrose 5% provides electrolytes (sodium, potassium, magnesium, chloride, acetate, phosphate) and dextrose to maintain fluid and electrolyte balance, restore intravascular volume, and supply calories. Dextrose is metabolized to carbon dioxide and water, providing energy. Acetate acts as an alkalinizing agent, metabolized to bicarbonate in the liver.
| Metabolism | Dextrose is metabolized via glycolysis and the citric acid cycle. Acetate is rapidly metabolized to bicarbonate in the liver and peripheral tissues. |
| Excretion | Renal: 100% (electrolytes and dextrose metabolites, primarily water and CO2). No biliary or fecal elimination of significant amount. |
| Half-life | Not applicable as a combination product. Dextrose: 1-2 hours (metabolic clearance). Electrolytes: distribution half-life ~15-30 minutes, elimination depends on renal function; in normal renal function, complete clearance within 2-4 hours. |
| Protein binding | Electrolytes: minimal (<10% for sodium, potassium, chloride, magnesium, calcium/acetate not applicable). Dextrose: not protein bound. |
| Volume of Distribution | Electrolytes: distribute into total body water (0.6 L/kg for adults, higher in neonates). Dextrose: initial Vd 0.2 L/kg, distributes to total body water. Clinical meaning: reflects distribution of water and electrolytes throughout the extracellular and intracellular compartments. |
| Bioavailability | IV: 100%. |
| Onset of Action | IV: Plasma volume expansion within minutes; electrolyte effects immediate upon infusion. |
| Duration of Action | IV: As long as infusion continues; after discontinuation, hemodynamic effects last 30-60 minutes depending on renal excretion and metabolic clearance. Clinical note: primarily used for maintenance and replacement, not for sustained effect. |
Intravenous infusion; dose determined by fluid, electrolyte, and caloric requirements. Typical adult rate: 100-200 mL/hr; maximum infusion rate 10 mL/min.
| Dosage form | INJECTABLE |
| Renal impairment | GFR < 50 mL/min: Use with caution, monitor potassium and phosphate levels. GFR < 30 mL/min: Consider alternative therapy unless potassium and phosphate are low. |
| Liver impairment | Child-Pugh Class C: Use with caution due to risk of fluid overload and electrolyte imbalances; may require reduced infusion rates. |
| Pediatric use | Total daily fluid requirements: 100 mL/kg for first 10 kg, 50 mL/kg for next 10 kg, 20 mL/kg for each kg above 20 kg. Infuse over 24 hours; adjust as needed. |
| Geriatric use | Reduce rate to 50-100 mL/hr; monitor for fluid overload due to decreased renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER (ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER).
| Breastfeeding | Dextrose and electrolytes in Isolyte P are normal constituents of breast milk. No specific M/P ratio is available; however, supplementation with standard electrolytes and dextrose is generally considered compatible with breastfeeding. Systemic effects on the infant are unlikely. |
| Teratogenic Risk | Isolyte P in Dextrose 5% is an electrolyte and carbohydrate solution. Dextrose and standard electrolytes are not known to be teratogenic at normal doses. Fetal risks are unlikely when used as indicated for fluid and electrolyte maintenance. However, in cases of maternal hyperglycemia or fluid overload, potential risks include fetal hyperinsulinism and hypoglycemia. Not a known teratogen. |
■ FDA Black Box Warning
Not for use in patients with intracranial or intraspinal hemorrhage, or in those with known hypersensitivity to any component.
| Serious Effects |
["Hyperkalemia","Hypernatremia","Hyperphosphatemia","Severe hyperglycemia","Renal failure with oliguria or anuria","Liver disease affecting acetate metabolism","Intracranial or intraspinal hemorrhage","Hypersensitivity to any component"]
| Precautions | ["May cause hyperglycemia in patients with diabetes mellitus or glucose intolerance","Risk of hypernatremia, hyperkalemia, or hyperphosphatemia in patients with renal impairment","Use caution in patients with heart failure, renal failure, or conditions causing fluid overload","Monitor serum electrolytes, glucose, and fluid balance","Not for use as a primary hydration fluid in neonates due to risk of hyperglycemia"] |
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| Fetal Monitoring | Monitor maternal serum electrolytes, glucose, fluid balance, and urine output. Assess for signs of fluid overload (edema, pulmonary congestion) or electrolyte disturbances. Fetal monitoring as clinically indicated, especially in cases of maternal hyperglycemia or fluid imbalance. |
| Fertility Effects | No known adverse effects on fertility from dextrose or standard electrolyte solutions. Use as normal fluid therapy is not expected to impair reproductive function. |