Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 5% Dextrose Injection USP is supplied sterile and nonpyrogenic in partial fill polyolefin containers. The 100/150 mL product is packaged 64 per case. The 50/100 mL product is packaged 84 per case. The 25/100 mL product is packaged 116 per case. NDC REF Fill/Container (mL) 5% Dextrose Injection USP 0264-1510-36 S5104-5410 25/100 0264-1510-31 S5104-5384 50/100 0264-1510-32 S5104-5264 100/150 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.; PRINCIPAL DISPLAY PANEL - 100 mL Partial Fill 5% Dextrose Injection USP NDC 0264-1510-32 REF S5104-5264 100 mL Partial Fill in 150 mL PAB ® Container Each mL contains: Hydrous Dextrose USP 50 mg Water for Injection USP qs pH: 4.5 (3.5-6.5) Calc. Osmolarity: 250 mOsmol/liter Do not administer simultaneously with blood. Sterile, nonpyrogenic. Single dose container. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNING: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. See Package Insert. Not made with natural rubber latex, PVC, or DEHP. Rx only PAB is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-465 LD-216-3 LOT EXP S5104-5264 Container Label; PRINCIPAL DISPLAY PANEL - 50 mL Partial Fill 5% Dextrose Injection USP NDC 0264-1510-31 REF S5104-5384 50 mL Partial Fill in 100 mL PAB ® Container Each mL contains: Hydrous Dextrose USP 50 mg; Water for Injection USP qs pH: 4.5 (3.5-6.5) Calc. Osmolarity: 250 mOsmol/liter Do not administer simultaneously with blood. Sterile, nonpyrogenic. Single dose container. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNING: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. See Package Insert. Rx Only Not made with natural rubber latex, PVC, or DEHP. PAB is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-466 LD-215-3 LOT EXP S5104-5384 Container Label; PRINCIPAL DISPLAY PANEL - 25 mL Partial Fill 5% Dextrose Injection USP NDC 0264-1510-36 REF S5104-5410 25 mL Partial Fill in 100 mL PAB ® Container Each mL contains: Hydrous Dextrose USP 50 mg; Water for Injection USP qs pH: 4.5 (3.5-6.5) Calc. Osmolarity: 250 mOsmol/liter Do not administer simultaneously with blood. Sterile, nonpyrogenic. Single dose container. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNING: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. See Package Insert. Rx only Not made with natural rubber latex, PVC, or DEHP. PAB is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-467 LD-214-3 LOT EXP S5104-5410 Container Label
- HOW SUPPLIED 5% Dextrose Injection USP is supplied sterile and nonpyrogenic in partial fill polyolefin containers. The 100/150 mL product is packaged 64 per case. The 50/100 mL product is packaged 84 per case. The 25/100 mL product is packaged 116 per case. NDC REF Fill/Container (mL) 5% Dextrose Injection USP 0264-1510-36 S5104-5410 25/100 0264-1510-31 S5104-5384 50/100 0264-1510-32 S5104-5264 100/150 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.
- PRINCIPAL DISPLAY PANEL - 100 mL Partial Fill 5% Dextrose Injection USP NDC 0264-1510-32 REF S5104-5264 100 mL Partial Fill in 150 mL PAB ® Container Each mL contains: Hydrous Dextrose USP 50 mg Water for Injection USP qs pH: 4.5 (3.5-6.5) Calc. Osmolarity: 250 mOsmol/liter Do not administer simultaneously with blood. Sterile, nonpyrogenic. Single dose container. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNING: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. See Package Insert. Not made with natural rubber latex, PVC, or DEHP. Rx only PAB is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-465 LD-216-3 LOT EXP S5104-5264 Container Label
- PRINCIPAL DISPLAY PANEL - 50 mL Partial Fill 5% Dextrose Injection USP NDC 0264-1510-31 REF S5104-5384 50 mL Partial Fill in 100 mL PAB ® Container Each mL contains: Hydrous Dextrose USP 50 mg; Water for Injection USP qs pH: 4.5 (3.5-6.5) Calc. Osmolarity: 250 mOsmol/liter Do not administer simultaneously with blood. Sterile, nonpyrogenic. Single dose container. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNING: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. See Package Insert. Rx Only Not made with natural rubber latex, PVC, or DEHP. PAB is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-466 LD-215-3 LOT EXP S5104-5384 Container Label
- PRINCIPAL DISPLAY PANEL - 25 mL Partial Fill 5% Dextrose Injection USP NDC 0264-1510-36 REF S5104-5410 25 mL Partial Fill in 100 mL PAB ® Container Each mL contains: Hydrous Dextrose USP 50 mg; Water for Injection USP qs pH: 4.5 (3.5-6.5) Calc. Osmolarity: 250 mOsmol/liter Do not administer simultaneously with blood. Sterile, nonpyrogenic. Single dose container. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNING: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. See Package Insert. Rx only Not made with natural rubber latex, PVC, or DEHP. PAB is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-467 LD-214-3 LOT EXP S5104-5410 Container Label
Overview
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
Indications & Usage
5% Dextrose Injection USP is indicated for use in adults and pediatric patients as sources of calories and water for hydration. This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. Consult prescribing information for INDICATIONS AND USAGE of drug additives to be administered in this manner.
Dosage & Administration
This solution is for intravenous use only. As directed by a physician. Dosage is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. Do not use plastic container in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use only if solution is clear and container and seals are intact. When using this product as a diluent or vehicle for administration of drug additives, consult the prescribing information of the drug to be used. Addition of medication should be accomplished using aseptic technique in order to assure sterility. Physicochemical studies have shown that the container and solution can withstand freezing. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Pediatric Use 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. There is no specific pediatric dose. The dose is dependent on weight, clinical condition, and laboratory results. Follow recommendations of appropriate pediatric reference text. See WARNINGS and PRECAUTIONS .
Warnings & Precautions
WARNINGS 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 concentrations of administered parenteral solutions. Prolonged infusion of isotonic or hypotonic dextrose in water may increase the volume of extracellular fluid and cause water intoxication. Solutions containing dextrose without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility of agglomeration. Excessive administration of potassium-free dextrose solutions may result in significant hypokalemia. Serum potassium levels should be maintained and potassium supplemented as required. In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.
Contraindications
Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products. Do not administer 5% Dextrose Injection USP simultaneously with blood through the same infusion set because hemolysis or pseudoagglutination 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. The physician should also be alert to the possibility of adverse reactions to drug additives diluted and administered from the plastic partial fill container. Prescribing information for drug additives to be administered in this manner should be consulted. 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.
Drug Interactions
Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
Storage & Handling
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.
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