NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER (NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER).
Normosol-M and Dextrose 5% is a balanced electrolyte solution with dextrose. It provides free water, electrolytes, and a source of calories. The dextrose is metabolized to carbon dioxide and water, producing energy. The electrolytes help maintain or restore extracellular fluid balance.
| Metabolism | Dextrose is metabolized via glycolysis and Krebs cycle, producing ATP. Acetate and gluconate are converted to bicarbonate in the liver, helping to correct acidosis. |
| Excretion | Renal: Electrolytes and dextrose are excreted renally; dextrose is metabolized to CO2 and water, with no significant fecal or biliary elimination. |
| Half-life | Not applicable; components are endogenous substances with rapid clearance; dextrose half-life ~15-30 min in normal glucose metabolism. |
| Protein binding | Minimal; dextrose and electrolytes exhibit negligible protein binding (<5%). |
| Volume of Distribution | Electrolytes distribute in total body water (0.55-0.65 L/kg); dextrose distributes in extracellular fluid initially then intracellular. |
| Bioavailability | Intravenous: 100%. |
| Onset of Action | Intravenous: Immediate upon infusion (rapid correction of fluid and electrolyte imbalances). |
| Duration of Action | Duration depends on infusion rate; clinical effects persist as long as infusion continues; transient after discontinuation. |
Intravenous infusion; dose determined by fluid and electrolyte needs; typical adult rate: 100-200 mL/hour; maximum rate dependent on clinical condition.
| Dosage form | INJECTABLE |
| Renal impairment | In renal impairment (GFR <30 mL/min), reduce infusion rate and monitor for electrolyte imbalance; avoid in severe renal failure with oliguria. |
| Liver impairment | No specific adjustment; monitor electrolytes in severe hepatic impairment due to risk of fluid overload. |
| Pediatric use | Intravenous infusion; dose individualized based on weight and clinical needs; typical rate: 5-10 mL/kg/hour; maximum rate not to exceed 100 mL/hour in neonates. |
| Geriatric use | Use with caution; lower initial infusion rates recommended due to decreased renal function and risk of fluid overload; monitor closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER (NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER).
| Breastfeeding | Compatible with breastfeeding; dextrose and electrolytes are normal constituents of breast milk; M/P ratio not applicable as components are endogenous. |
| Teratogenic Risk | No evidence of teratogenicity in first trimester; dextrose may cause fetal hyperinsulinemia and macrosomia in second/third trimester if maternal hyperglycemia occurs; electrolyte imbalances may affect fetal homeostasis. |
| Fetal Monitoring |
■ FDA Black Box Warning
WARNING: NOT FOR USE IN PATIENTS WITH KNOWN ALLERGY TO CORN OR CORN PRODUCTS. SOLUTIONS CONTAINING DEXTROSE MAY BE CONTRAINDICATED IN PATIENTS WITH HYPERSENSITIVITY TO CORN.
| Serious Effects |
["Hyperglycemia (relative)","Hypersensitivity to corn or corn products","Patients with conditions causing fluid overload (e.g., pulmonary edema)","Severe metabolic alkalosis","Anuria or severe renal impairment (without adequate monitoring)"]
| Precautions | ["Risk of fluid overload in patients with renal impairment or heart failure","Electrolyte imbalances (e.g., hyperkalemia, hyponatremia) with improper use","Hyperglycemia in diabetic patients; monitor blood glucose","Extravasation may cause tissue damage","Do not administer simultaneously with blood via same IV line (risk of hemolysis)"] |
Loading safety data…
| Monitor maternal blood glucose, serum electrolytes, fluid balance, and urine output; fetal surveillance for growth abnormalities and polyhydramnios if prolonged use. |
| Fertility Effects | No known adverse effects on fertility; used for fluid and electrolyte maintenance, not associated with reproductive toxicity. |