ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER (ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER).
ISOLYTE M in Dextrose 5% is a crystalloid solution that provides water, electrolytes, and calories. Dextrose is metabolized to carbon dioxide and water, yielding energy. The electrolytes (sodium, potassium, magnesium, chloride, acetate, and gluconate) maintain or restore intravascular volume and acid-base balance. Acetate and gluconate are bicarbonate precursors, metabolized in the liver and peripheral tissues to generate bicarbonate, thus correcting metabolic acidosis.
| Metabolism | Dextrose undergoes glycolysis and the Krebs cycle to produce ATP, carbon dioxide, and water. Acetate is metabolized in the liver and peripheral tissues to form acetyl-CoA, which enters the Krebs cycle, generating bicarbonate. Gluconate is metabolized via the pentose phosphate pathway to produce ribulose-5-phosphate and eventually bicarbonate. |
| Excretion | Primarily renal; >90% of infused water and electrolytes are excreted unchanged via kidneys with minimal biliary or fecal elimination. |
| Half-life | No true terminal half-life; infused components (water and electrolytes) follow endogenous kinetics. Dextrose half-life approx. 1-2 hours, electrolytes distribute and are excreted based on renal function. |
| Protein binding | Negligible for water and electrolytes; dextrose not bound. Total protein binding <5%. |
| Volume of Distribution | Sodium distributes primarily in extracellular fluid (Vd ~0.2 L/kg); water distributes in total body water (Vd ~0.6 L/kg). Dextrose distributes in extracellular and intracellular fluid with Vd ~0.2 L/kg initial. |
| Bioavailability | Intravenous: 100% bioavailability for all components; not administered by other routes. |
| Onset of Action | Intravenous: immediate (seconds to minutes) for hemodynamic effects; electrolyte correction begins within minutes of infusion. |
| Duration of Action | Duration of electrolyte repletion correlates with infusion rate (1-2 hours per liter typically); volume effect lasts for duration of infusion plus renal excretion (2-4 hours after stop). Clinical duration depends on ongoing losses. |
Intravenous infusion; dose determined by fluid and electrolyte requirements; typical adult rate 100-200 mL/hour.
| Dosage form | INJECTABLE |
| Renal impairment | Use with caution; monitor serum potassium and adjust infusion rate based on renal function; no specific GFR-based dose reduction defined. |
| Liver impairment | No specific adjustment required; monitor electrolytes in severe hepatic impairment. |
| Pediatric use | Intravenous infusion; dose individualized based on weight and clinical status; typical rate 5-10 mL/kg/hour. |
| Geriatric use | Use with caution due to possible renal impairment; monitor fluid and electrolyte status; adjust rate to avoid volume overload. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER (ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER).
| Breastfeeding | Dextrose and electrolytes are normal constituents of breast milk and are not expected to cause adverse effects in the breastfed infant at recommended doses. The M/P ratio is not applicable as components are endogenous. Use caution with high volumes or maternal glucose intolerance, but generally considered compatible with breastfeeding. |
| Teratogenic Risk | Isolyte M in Dextrose 5% is an intravenous electrolyte and caloric solution. At therapeutic doses, no teratogenic risk has been identified in animal studies; however, human data are limited. Inadvertent administration of large volumes leading to hyperglycemia or electrolyte imbalances (e.g., hyponatremia) could pose risks to the fetus. Use only when clearly needed and monitor maternal glucose and electrolytes closely. |
■ FDA Black Box Warning
None
| Serious Effects |
["Absolute: Hypersensitivity to any component, hypernatremia, hyperkalemia, hypermagnesemia, hyperchloremia, or severe metabolic alkalosis.","Relative: Severe renal impairment, oliguria, or conditions with risk of fluid overload (e.g., congestive heart failure, pulmonary edema)."]
| Precautions | ["Use with caution in patients with renal impairment, heart failure, or conditions causing fluid overload.","Monitor serum electrolytes, blood glucose, and fluid balance.","Risk of hyperglycemia, hyperosmolarity, and dilutional hyponatremia.","Do not administer simultaneously with blood products through the same IV line due to risk of hemolysis.","Avoid rapid infusion to prevent metabolic acidosis from lactate accumulation (acetate may cause alkalosis if excessive)."] |
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| Fetal Monitoring | Monitor maternal serum electrolytes (sodium, potassium, magnesium, calcium, chloride), glucose, acid-base status, renal function, and fluid balance. Fetal monitoring (ultrasound, fetal heart rate) is indicated if maternal metabolic disturbances occur. Assess for signs of fluid overload (e.g., hypertension, edema) or electrolyte imbalance. |
| Fertility Effects | No known adverse effects on fertility from dextrose or electrolytes at therapeutic doses. However, underlying conditions requiring this solution may impact fertility. No specific human studies available. |