FDA
Dextrose 60% in Plastic Container
The FDA lists this product in 4 strengths and forms.
Indications
Dextrose Injection is indicated as source of calories and fluid replenishment when mixed with amino acids or other compatible intravenous fluids for patients requiring parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient or contraindicated. Dextrose Injection is indicated as a source of calories when mixed with amino acids or other compatible intravenous fluids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient or contraindicated.
( 1 )
Contraindications
The use of Dextrose Injection is contraindicated in patients:
- Who are severely dehydrated as hypertonic dextrose solution can worsen the patient’s hyperosmolar state [see Warnings and Precautions (5.2)] .
- Known hypersensitivity to dextrose [see Warnings and Precautions (5.3)] . Severe dehydration. ( 4 )
Warnings and precautions
- Pulmonary Embolism due to Pulmonary Vascular Precipitates : If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.1 )
- Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose and administer insulin as needed. ( 5.2 )
- Hypersensitivity Reactions : Monitor for signs and symptoms and discontinue infusion if reactions occur. ( 5.3 )
- Vein Damage and Thrombosis : Administer solutions containing more than 5% dextrose as the final concentration or solutions with an osmolarity of approximately 900 mOsm/L or greater through a central vein. ( 2.2 , 5.4 )
- Hyponatremia: Monitor serum sodium to minimize the risk of hypo- or hyperosmotic hyponatremia. ( 5.5 )
- Risk of Infection : Monitor for signs and symptoms and laboratory parameters. ( 5.6 )
- Refeeding Syndrome : Monitory laboratory parameters. ( 5.7 )
- Hepatobiliary Disorders : Monitor liver function parameters and ammonia levels. ( 5.8 )
- Aluminum Toxicity : Dextrose Injection contains aluminum that may be toxic. Adult patients with impaired renal function and preterm infants are at higher risk. Limit aluminum to less than 4 mcg/kg/day ( 5.9 , 8.4 )