Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: 5% Dextrose Injection, USP is supplied in single dose flexible plastic containers as follows: Product Code Unit of Sale Strength Each 252300 NDC 65219-234-10 Package of 60 free flex ® + bags 2.5 grams per 50 mL (50 mg per mL) NDC 65219-234-01 50 mL in a 100 mL free flex ® + bag 262300 NDC 65219-236-10 Package of 50 free flex ® + bags 5 grams per 100 mL (50 mg per mL) NDC 65219-236-01 100 mL free flex ® + bag 262325 NDC 65219-238-25 Package of 30 free flex ® + bags 12.5 grams per 250 mL (50 mg per mL) NDC 65219-238-01 250 mL free flex ® + bag 262450 NDC 65219-240-50 Package of 20 free flex ® + bags 25 grams per 500 mL (50 mg per mL) NDC 65219-240-01 500 mL free flex ® + bag Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. Lake Zurich, IL 60047 www.fresenius-kabi.com/us Revised: August 2024 Figure; PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 50 mL Bag Label free flex ® + NDC 65219-234-01 5% Dextrose Injection, USP 2.5 grams per 50 mL (50 mg per mL) For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 50 mL Bag Label; PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 50 mL Case Label NDC 65219-234-10 252300 5% Dextrose Injection, USP 50 mL x 60 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 50 mL Case Label; PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 100 mL Bag Label free flex ® + NDC 65219-236-01 5% Dextrose Injection, USP 5 grams per 100 mL (50 mg per mL) For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 100 mL Bag Label; PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 100 mL Case Label NDC 65219-236-10 262300 5% Dextrose Injection, USP 100 mL x 50 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 100 mL Case Label; PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 250 mL Bag Label NDC 65219-238-01 5% Dextrose Injection, USP 12.5 grams per 250 mL (50 mg per mL) For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 50 mL Case Label; PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 250 mL Case Label NDC 65219-238-25 262325 5% Dextrose Injection, USP 250 mL x 30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 250 mL Case Label; PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 500 mL Bag Label NDC 65219-240-01 5% Dextrose Injection, USP 25 grams per 500 mL (50 mg per mL) For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 500 mL Bag Label; PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 500 mL Case Label NDC 65219-240-50 262450 5% Dextrose Injection, USP 500 mL x 20 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 500 mL Case Label
- HOW SUPPLIED: 5% Dextrose Injection, USP is supplied in single dose flexible plastic containers as follows: Product Code Unit of Sale Strength Each 252300 NDC 65219-234-10 Package of 60 free flex ® + bags 2.5 grams per 50 mL (50 mg per mL) NDC 65219-234-01 50 mL in a 100 mL free flex ® + bag 262300 NDC 65219-236-10 Package of 50 free flex ® + bags 5 grams per 100 mL (50 mg per mL) NDC 65219-236-01 100 mL free flex ® + bag 262325 NDC 65219-238-25 Package of 30 free flex ® + bags 12.5 grams per 250 mL (50 mg per mL) NDC 65219-238-01 250 mL free flex ® + bag 262450 NDC 65219-240-50 Package of 20 free flex ® + bags 25 grams per 500 mL (50 mg per mL) NDC 65219-240-01 500 mL free flex ® + bag Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. Lake Zurich, IL 60047 www.fresenius-kabi.com/us Revised: August 2024 Figure
- PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 50 mL Bag Label free flex ® + NDC 65219-234-01 5% Dextrose Injection, USP 2.5 grams per 50 mL (50 mg per mL) For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 50 mL Bag Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 50 mL Case Label NDC 65219-234-10 252300 5% Dextrose Injection, USP 50 mL x 60 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 50 mL Case Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 100 mL Bag Label free flex ® + NDC 65219-236-01 5% Dextrose Injection, USP 5 grams per 100 mL (50 mg per mL) For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 100 mL Bag Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 100 mL Case Label NDC 65219-236-10 262300 5% Dextrose Injection, USP 100 mL x 50 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 100 mL Case Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 250 mL Bag Label NDC 65219-238-01 5% Dextrose Injection, USP 12.5 grams per 250 mL (50 mg per mL) For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 50 mL Case Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 250 mL Case Label NDC 65219-238-25 262325 5% Dextrose Injection, USP 250 mL x 30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 250 mL Case Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 500 mL Bag Label NDC 65219-240-01 5% Dextrose Injection, USP 25 grams per 500 mL (50 mg per mL) For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 500 mL Bag Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 500 mL Case Label NDC 65219-240-50 262450 5% Dextrose Injection, USP 500 mL x 20 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. PACKAGE LABEL - PRINCIPAL DISPLAY – 5% Dextrose 500 mL Case Label
Overview
5% Dextrose Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose monohydrate, 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. The solution pH is 4.3 (3.2 to 6.5). This solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 5% Dextrose Injection, USP is a parenteral fluid and nutrient replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: Water for Injection, USP is chemically designated H 2 O. The flexible container is fabricated from a specially formulated non-plasticized film containing polypropylene and thermoplastic elastomers ( free flex ® bag). The free flex ® + bag has a needle-free injection port and can accept standard luer lock syringes to add medication. The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. Structural Formula
Indications & Usage
: Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.
Dosage & Administration
: The dose is dependent upon the age, weight and clinical condition of the patient. As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, 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 (see PRECAUTIONS ).
Warnings & Precautions
WARNINGS: Excessive administration of potassium-free solutions may result in significant hypokalemia. The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
Contraindications
: 5% Dextrose Injection, USP 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
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. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, 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 (see PRECAUTIONS ).
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