Dextrose Monohydrate

INDICATIONS AND USAGE 50% Dextrose Injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels. The solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. Slow infusion of hypertonic solutions is essential to ensure proper utilization of dextrose and avoid production of hyperglycemia.

DOSAGE AND ADMINISTRATION For peripheral vein administration: Injection of the solution should be made slowly . The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight/hour. About 95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hr. In insulin-induced hypoglycemia, intravenous injection of 10 to 25 grams of dextrose (20 to 50 mL of 50% dextrose) is usually adequate. Repeated doses and supportive treatment may be required in severe cases. A specimen for blood glucose determination should be taken before injecting the dextrose. In such emergencies, dextrose should be administered promptly without awaiting pretreatment test results. For central vein administration: For total parenteral nutrition 50% Dextrose Injection, USP is administered by slow intravenous infusion (a) after admixture with amino acid solutions via an indwelling catheter with the tip positioned in a large central vein, preferably the superior vena cava, or (b) after dilution with sterile water for injection. Dosage should be adjusted to meet individual patient requirements. Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. The maximum rate of dextrose administration which does not result in glycosuria is the same as cited above. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See CONTRAINDICATIONS .

CONTRAINDICATIONS A concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present, nor in the presence of delirium tremens if the patient is already dehydrated. Dextrose injection without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.

ADVERSE REACTIONS Hyperosmolar syndrome, resulting from excessively rapid administration of concentrated dextrose may cause mental confusion and/or loss of consciousness. Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

DESCRIPTION 50% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection for intravenous injection as a fluid and nutrient replenisher. Each mL of fluid contains 0.5 g dextrose, hydrous which delivers 3.4 kcal/gram. The solution has an osmolarity of 2.5 mOsmol/mL (calc.) and a pH of 3.2-6.5. May contain Hydrochloric acid and/or Sodium hydroxide for pH adjustment. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded with the entire unit. Dextrose, USP is chemically designated C 6 H 12 O 6 • H 2 O (D-glucose monohydrate), a hexose sugar freely soluble in water. Dextrose, hydrous has the following formula: Water for Injection, USP is chemically designated H 2 O. The delivery device is composed of a 50 mL glass syringe barrel with rubber stopper, and custom molded IMS injector with Luer Connector. structure

OVERDOSAGE in the event of overhydration or solute overload during therapy, re-evalutate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS .

HOW SUPPLIED 50% Dextrose Injection, USP 25 g/50 mL (0.5 g/mL) is supplied in single-dose prefilled syringes as follows: NDC 51662-1584-1 50% Dextrose Injection, USP 25 g/50 mL (0.5 g/mL) HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Syringe Assembly Directions: USE ASEPTIC TECHNIQUE Do not assemble until ready to use. *CAUTION: IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Also supplied in the following manufacture supplied dosage forms: 50% Dextrose Injection, USP 25 g/50 mL (0.5 g/mL) is supplied in single-dose prefilled syringes as follows: NDC No. Stock No. Container Size Needle 76329-3302-1 3302 50 mL None One shrink wrapped package containing 10 unit cartons, each containing a Luer-JetTM Luer-Lock Prefilled Syringe. Revised 01/21 6933010E © International Medication Systems, Ltd., 2021 International Medication Systems, Ltd. South El Monte, CA 91733, USA An Amphastar Pharmaceuticals Company Printed in USA HOW SUPPLIED