FDA approved Dextrose 5% and Sodium Chloride 0.11% in Plastic Container for HydrationFDA approved New IV Fluid for Hydration and Electrolytes

Dextrose 5% and sodium chloride 0.11% provides electrolytes, calories, and water for hydration when administered intravenously. The label does not describe a specific pharmacologic mechanism beyond provision of these substrates.

These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes, calories, and water for hydration. There is no specific pediatric dose; the dose is dependent on weight, clinical condition, and laboratory results.

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. In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of fluid containing 0.9% sodium chloride (154 mEq each of sodium and chloride). 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.

The 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. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. Infusion of isotonic (0.9%) sodium chloride during or immediately after surgery may result in excessive sodium retention; use the patient's circulatory system status as a guide. Excessive administration of potassium-free dextrose solutions may result in significant hypokalemia; serum potassium levels should be maintained and potassium supplemented as required. Solutions containing dextrose and low electrolyte concentrations should not be administered simultaneously with blood through the same infusion set because of the possibility of pseudoagglutination or hemolysis. These solutions are contraindicated where the administration of sodium or chloride could be clinically detrimental. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

The label positions this solution as a source of electrolytes, calories, and water for hydration in adults and pediatric patients, with dosing individualized by clinical condition and laboratory results. It does not provide comparative efficacy or outcome data, so its place relative to other intravenous fluids is not established in the label.