RVP

Drug Catalog - Product Detail

DEXTROSE 50% WTR SYR IV SOL 50ML X 10

NDC Mfr Size Str Form
00409-7517-16 HOSPIRA 50 50% SOLUTION
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Generic Name
DEXTROSE MONOHYDRATE
Substance Name
DEXTROSE MONOHYDRATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Application Number
NDA019445
Description
Descprition 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 2.53 mOsmol/mL (calc.), a pH of 4.2 (3.2 to 6.5) and may contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) 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 structural formula: Water for Injection, USP is chemically designated H 2 O. The syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material. Formula1.jpg
How Supplied
How Supplied 50% Dextrose Injection, USP is supplied in single-dose containers as follows: 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.] Abboject® is a trademark of Abbott Labaratories. LifeShield® is the trademark of ICU Medical, Inc. and is used under license. For Medical Information about 50% Dextrose Injection, please visit www.pfizermedinfo.com or call 1-800-438-1985 Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 0409-4902-34 Bundle containing 10 Lifeshield® Abboject® Unit of Use Syringe NDC 0404-9846-50 1 LIfeshield® Abboject® Unit of Use Syringe per bag (Syringe bears NDC 0409-4902-64) 25 g/50 mL (0.5 g/mL) NDC 0409-6648-02 Tray containing 25 50 mL Single-Dose Fliptop Vials NDC 0404-9847-50 1 Single-Dose Fliptop Vial per bag (Vial bears NDC 0409-6648-16) 25 g/50 mL (0.5 g/mL) NDC 0409-7517-16 Bundle containing 10 Ansyr™ II Plastic Syringe NDC 0404-9845-50 1 Ansyr™ II Plastic Syringe per bag (Syringe bears NDC 0409-7517-66) 25 g/50 mL (0.5mg/mL) Image1.jpg
Indications & Usage
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 insure proper utilization of dextrose and avoid production of hyperglycemia.
Dosage and Administration
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 ata 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 venous 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 .