NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER (NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER).
Normosol-R and Dextrose 5% is a balanced electrolyte solution with dextrose. The dextrose provides caloric support and prevents ketosis. The electrolytes (sodium, potassium, magnesium, chloride, acetate, gluconate) maintain osmotic balance and acid-base homeostasis. Acetate and gluconate serve as bicarbonate precursors to correct acidosis.
| Metabolism | Dextrose is metabolized via glycolysis and the Krebs cycle to carbon dioxide and water, yielding energy. Electrolytes (sodium, potassium, magnesium, chloride, acetate, gluconate) are not metabolized but are excreted or incorporated into body pools. |
| Excretion | Renal elimination of water and electrolytes; dextrose is metabolized to CO2 and water, with <5% excreted unchanged. Biliary/fecal excretion negligible. |
| Half-life | Dextrose: <15 minutes (rapid cellular uptake and metabolism). Electrolytes distribute and are excreted with kinetics dependent on renal function; no plasma half-life defined. |
| Protein binding | None to minimal (<1%) for electrolytes and dextrose. |
| Volume of Distribution | Electrolytes distribute in total body water (~0.6 L/kg); dextrose distributes in extracellular fluid (~0.2 L/kg). Clinical meaning: glucose distributes primarily in ECF, electrolytes throughout TBW. |
| Bioavailability | Intravenous: 100%. |
| Onset of Action | Intravenous: Immediate for volume expansion; glucose effect within minutes. |
| Duration of Action | Intravenous: 1–2 hours for volume effect; glucose effect persists during infusion; clinical duration depends on rate and patient status. |
Intravenous infusion; dose depends on fluid and electrolyte needs. Typical adult dose: 500-1000 mL over 1-4 hours, may repeat based on clinical status.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in severe renal impairment (oliguria, anuria) due to risk of fluid overload and electrolyte abnormalities. Use with caution in mild-moderate impairment; monitor fluid balance and serum electrolytes. |
| Liver impairment | Caution in severe hepatic impairment due to risk of fluid retention and electrolyte imbalances. No specific dose adjustment guidelines; monitor closely. |
| Pediatric use | Weight-based: 10-20 mL/kg as an initial bolus; maintenance based on calculated daily fluid requirements. Adjust for ongoing losses. Monitor electrolytes and glucose. |
| Geriatric use | Use caution due to increased risk of fluid overload, renal impairment, and electrolyte disturbances. Initiate at lower doses and monitor vital signs, urine output, and serum electrolytes frequently. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER (NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER).
| Breastfeeding | Excreted in breast milk in minimal amounts; considered compatible with breastfeeding. Dextrose may transiently affect milk glucose levels. No M/P ratio available. |
| Teratogenic Risk | Normosol-R and Dextrose 5% is a balanced electrolyte solution with dextrose. No known teratogenic effects in first trimester; safe when used appropriately. In second and third trimesters, avoid excess fluid to prevent maternal hyperglycemia and neonatal hypoglycemia. Dextrose can cause fetal hyperinsulinemia and rebound hypoglycemia if maternal glucose poorly controlled. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hyperglycemia (if dextrose is contraindicated), hypernatremia, hyperkalemia, hypermagnesemia, hypercalcemia, metabolic alkalosis, severe fluid overload, severe renal impairment with oliguria, known allergy to any component."]
| Precautions | ["Monitor serum electrolytes, glucose, and fluid balance; risk of hyperglycemia, hyperosmolarity, and fluid overload in renal or cardiac impairment; caution in patients with hyponatremia or hypokalemia; acetate and gluconate can worsen metabolic alkalosis."] |
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| Fetal Monitoring | Monitor maternal serum electrolytes, glucose, fluid balance, and urine output. Fetal monitoring for heart rate and growth if prolonged use or maternal hyperglycemia. |
| Fertility Effects | No known adverse effects on fertility. As a replacement solution, it does not alter reproductive function. |