dextrose - Generic Medications

Each mL of 5% Dextrose Injection USP contains: Hydrous Dextrose USP 50 mg; Water for Injection USP qs pH: 4.5 (3.5–6.5) Calculated Osmolarity: 250 mOsmol/liter Calories per 100 mL: 17 This solution is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration. The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Hydrous Dextrose USP 198.17 Not made with natural rubber latex, PVC, or DEHP. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition site. Each is covered by a tamperproof barrier. Refer to the Directions for Use of the container to properly identify the ports. No vapor barrier is necessary. Chemical Structure

Each 100 mL of 5% Dextrose Injection USP contains: Hydrous Dextrose USP 5 g; Water for Injection USP qs pH: 4.4 (3.5–6.5); Calculated Osmolarity: 250 mOsmol/liter Calories per liter: 170 Each 100 mL of 10% Dextrose Injection USP contains: Hydrous Dextrose USP 10 g; Water for Injection USP qs pH: 4.4 (3.5–6.5); Calculated Osmolarity: 505 mOsmol/liter, hypertonic Calories per liter: 340 Dextrose Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration. The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Hydrous Dextrose USP 198.17 Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container. Chemical Structure

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 C6H12O6 ∙ H2O (D-glucose monohydrate), a hexose sugar freely soluble in water. Dextrose, hydrous has the following structural formula: Water for Injection, USP is chemically designated H2O. 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. STRUCTURE

Dextrose Injection, USP 20%, 30%, 40%, 50% and 70% are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration ( 2.1 )] . Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes. See Table 1 for the content and characteristics of these concentrated solutions . The solutions contain no bacteriostatic, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution. The pH is 4.3 (range is 3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Table 1. Contents and Characteristics of Dextrose Injection 20%, 30%, 40%, 50%, and 70% Strength Fill Volume Amount of Dextrose Hydrous per Container kcal Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous. per Container mOsmol per liter 20% (0.2 grams/mL) 500 mL 100 grams 340 1009 30% (0.3 grams/mL) 500 mL 150 grams 510 1514 40% (0.4 grams/mL) 500 mL 200 grams 680 2018 50% (0.5 grams/mL) 500 mL 250 grams 850 2523 70% (0.7 grams/mL) 500 mL 350 grams 1190 3532 Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula: Dextrose may be derived from corn. Water for Injection, USP is chemically designated H 2 O. Dextrose Injection contains no more than 25 mcg/L of aluminum. Structural Formula for Dextrose Injection, USP

Each 100 mL of 70% Dextrose Injection USP contains: Hydrous Dextrose USP 70 g; Water for Injection USP qs pH: 4.0 (3.2-6.5); Calculated Osmolarity: 3532 mOsmol/liter, hypertonic. Specific gravity 1.233 at 25°C Calories per liter: 2380 calculated on the basis of 3.4 kcal/g of dextrose, hydrous 70% Dextrose Injection USP is sterile, nonpyrogenic and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration after appropriate admixture or dilution as a caloric source. The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Hydrous Dextrose USP 198.17 Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during use. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Dextrose Molecular Formula

25% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection administered by intravenous injection to restore blood glucose levels in hypoglycemia and as a source of carbohydrate calories. Each milliliter (mL) of fluid contains dextrose, hydrous, 250 mg which delivers 3.4 kcal/gram (0.85 kcal/mL). The solution has an osmolarity of 1.39 mOsmol/mL (calc.). pH is 4.5 (3.2 to 6.5). May contain hydrochloric acid and sodium hydroxide 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. 25% Dextrose Injection, USP is a dextrose (glucose) and nutrient (carbohydrate) replenisher. Dextrose, USP is chemically designated D-glucose monohydrate, (C6H12O6• H2O), a hexose sugar freely soluble in water. It has the following structural formula: 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