FDA approved Dextrose 70% in Plastic Container for Caloric and Hydration SupportFDA approved Concentrated Sugar Solution in a Plastic Container for IV Hydration

Dextrose serves as a source of calories and water for hydration when given intravenously. The label does not describe a specific pharmacologic mechanism beyond provision of calories and fluid.

These intravenous solutions are indicated for use in adults and pediatric patients as sources of calories and water for hydration.

These solutions are for intravenous use only. Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient, and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy. When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. Some additives may be incompatible; consult with a pharmacist. When introducing additives, use aseptic techniques, mix thoroughly, and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Trial data not available in label.

Administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. Dextrose Injection USP contains aluminum that may be toxic; aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity; tissue loading may occur at even lower rates of administration. Prolonged infusion of isotonic or hypotonic dextrose in water may increase the volume of extracellular fluid and cause water intoxication. Solutions containing dextrose without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility of agglomeration. Excessive administration of potassium-free dextrose solutions may result in significant hypokalemia; serum potassium levels should be maintained and potassium supplemented as required. In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

Dextrose 70% in a plastic container is a hypertonic intravenous caloric and hydration solution for adults and pediatric patients. Its use requires individualized dosing, attention to peripheral administration technique for hypertonic solutions, and frequent laboratory and clinical monitoring, particularly during prolonged parenteral therapy.