NDC 0338-0023 Dextrose

Dextrose Monohydrate

NDC Product Code 0338-0023

NDC 0338-0023-02

Package Description: 250 mL in 1 BAG

NDC 0338-0023-03

Package Description: 500 mL in 1 BAG

NDC 0338-0023-04

Package Description: 1000 mL in 1 BAG

NDC Product Information

Dextrose with NDC 0338-0023 is a a human prescription drug product labeled by Baxter Healthcare Corporation. The generic name of Dextrose is dextrose monohydrate. The product's dosage form is injection, solution and is administered via intravenous form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1795477, 1795480, 1795481, 1795607, 1795609, 1795610, 1795612, 1795616, 1795618 and 1795621.

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Dextrose Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Baxter Healthcare Corporation
Labeler Code: 0338
FDA Application Number: NDA016694 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-25-1971 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Dextrose Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid replenishment and caloric supply in single dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, and caloric content are shown in Table 1.Table 1 Size(mL)* DextroseHydrous, USP (g/L)Osmolarity(mOsmol/L)(calc.)pHCaloricContent(kcal/L)5% DextroseInjection, USP25502524.0 (3.2 to 6.5)170Quad pack50Single packQuad packMulti pack100 Single pack Quad packMulti pack150250500100010% DextroseInjection, USP250 500 10001005054.0 (3.2 to 6.5)340The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological test for plastic containers as well as by tissue culture toxicity studies.

Clinical Pharmacology

Dextrose Injection, USP has value as a source of water and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

Indications And Usage

Dextrose Injection, USP is indicated as a source of water and calories.

Contraindications

Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Warnings

Dextrose Injection, USP should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis.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 dilutive states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections. Excessive administration of dextrose injections may result in significant hypokalemia. In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.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.

General

Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers. Dextrose Injection, USP should be used with caution in patients with overt or subclinical diabetes mellitus.

Other

There are no adequate and well controlled studies with Dextrose Injection, USP in pregnant women and animal reproduction studies have not been conductedwith this drug. Therefore, it is not known whether Dextrose Injection, USP can cause fetal harm when administered to a pregnant woman. Dextrose Injection, USP should be given during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Baxter Healthcare CorporationDeerfield, IL 60015 USA Printed in USA 07 19 000 180 Rev. February 2018Baxter and Viaflex are trademarks of Baxter International Inc.

Labor And Delivery

Intrapartum maternal intravenous infusion of glucose-containing solutions may produce maternal hyperglycemia with subsequent fetal hyperglycemia and fetal metabolic acidosis. Fetal hyperglycemia can result in increased fetal insulin levels which may result in neonatal hypoglycemia following delivery. Consider the potential risks and benefits for each specific patient before administering Dextrose Injection , USP.

Nursing Mothers

It is not known whether this drug is present in human milk. Because many drugs are present in human milk, caution should be exercised when a Dextrose Injection, USP is administered to a nursing woman.

Pediatric Use

The use of Dextrose Injection, USP in pediatric patients is based on clinical practice (see DOSAGE AND ADMINISTRATION).Newborns – especially those born premature and with low birth weight - are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death.

Geriatric Use

Clinical studies of Dextrose Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions

Hypersensitivity reactions, including anaphylaxis and chills.Reactions which may occur because of the injection 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.

Dosage And Administration

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.Do not administer unless solution is clear and seal is intact.All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment. The dosage selection 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. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

How Supplied

Dextrose Injection, USP in VIAFLEX plastic container is available as follows:CodeSize(mL)NDCProduct Name  25   2B0080 Quad pack 0338-0017-10 5% Dextrose Injection, USP   50   2B0086Single pack0338-0017-415% Dextrose Injection, USP2B0081Quad pack 0338-0017-112B0088 Multi pack 0338-0017-31  100   2B0087Single pack0338-0017-48 5% Dextrose Injection, USP 2B0082Quad pack0338-0017-182B0089Multi pack0338-0017-382B00611500338-0017-012B00622500338-0017-022B00635000338-0017-032B0064 1000 0338-0017-04 2B0162 250 0338-0023-02 10% Dextrose Injection, USP 2B01635000338-0023-032B0164 1000 0338-0023-04 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F); brief exposure up to 40°C/104°F does not adversely affect the product.

Directions For Use Of Viaflex Plastic Container

For Information on Risk of Air Embolism – see PRECAUTIONS

To Open

Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow “To Add Medication” directions below.

Preparation For Administration

  • 1.Suspend container from eyelet support. 2.Remove protector from outlet port at bottom of container. 3.Attach administration set. Refer to complete directions accompanying set.

To Add Medication

Additives may be incompatible.

To Add Medication Before Solution Administration

  • 1.Prepare medication site. 2.Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. 3.Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.

To Add Medication During Solution Administration

  • 1.Close clamp on the set. 2.Prepare medication site. 3.Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. 4.Remove container from IV pole and/or turn to an upright position. 5.Evacuate both ports by squeezing them while container is in the upright position. 6.Mix solution and medication thoroughly. 7.Return container to in-use position and continue administration.

* Please review the disclaimer below.