Label: DEXTROSE- dextrose monohydrate injection, solution

  • NDC Code(s): 0338-0719-06
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 22, 2014

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  • DESCRIPTION

    Dextrose Injections, USP are sterile, nonpyrogenic hypertonic solutions for fluid replenishment and caloric supply in Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. They contain no antimicrobial agents. Composition, osmolarity, pH, and caloric content are shown below.

    Table 1

    Composition

    Osmolarity

    Caloric Content

    How Supplied

    Dextrose Hydrous, USP (g/L)

    (mOsmol/L) (calc.)

    pH

    (kcal/L)

    Size, code, NDC

    2000 mL unit

    70% Dextrose Injection, USP

    700

    3530

    4.0

    (3.2 to 6.5)

    2390

    2B0296

    NDC 0338-0719-06

    Structural formula of Dextrose Hydrous, USP

    The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. 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 tests for plastic containers as well as tissue culture toxicity studies.

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  • CLINICAL PHARMACOLOGY

    Dextrose Injection, USP have value as a source of water and calories. They are capable of inducing diuresis depending on the clinical condition of the patient.

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  • INDICATIONS AND USAGE

    Dextrose Injection, USP are indicated as a caloric component in a parenteral nutrition regimen. They are used with an appropriate protein (nitrogen) source in the prevention of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.

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  • CONTRAINDICATIONS

    The infusion of hypertonic dextrose injections is contraindicated in patients having intracranial or intraspinal hemorrhage, in patients who are severely dehydrated, in patients who are anuric, and in patients in hepatic coma.

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

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  • WARNINGS

    These injections are for compounding only, not for direct infusion.

    Dilute before use to a concentration which will, when administered with an amino acid (nitrogen) source, result in an appropriate calorie to gram of nitrogen ratio and which has an osmolarity consistent with the route of administration.

    Unless appropriately diluted, the infusion of hypertonic dextrose injection into a peripheral vein may result in vein irritation, vein damage, and thrombosis. Strongly hypertonic nutrient solutions should only be administered through an indwelling intravenous catheter with the tip located in a large central vein such as the superior vena cava.

    In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.

    WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

    Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

    Administration by central venous catheter should be used only by those familiar with this technique and its complications.

    Monitor changes in fluid balance, electrolyte concentration, and acid base balance during prolonged parenteral therapy or whenever the conditions of the patient warrants such evaluation.

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  • PRECAUTIONS

    General

    Administration of hypertonic dextrose and amino acid solutions via central venous catheter may be associated with complications which can be prevented or minimized by careful attention to all aspects of the procedure. This includes attention to solution preparation, administration and patient monitoring.

    It is essential that a carefully prepared protocol, based upon current medical practice, be followed, preferably by an experienced medical team.

    The package insert of the protein (nitrogen) source should be consulted for dosage and all precautionary information.

    Monitor changes in fluid balance, electrolyte concentration, and acid base balance during prolonged parenteral therapy or whenever the conditions of the patient warrants such evaluation.

    Care should be taken to avoid circulatory overload, particularly in patients with cardiac insufficiency.

    Caution must be exercised in the administration of these injections to patients receiving corticosteroids or corticotropin.

    These injections should be used with caution in patients with overt or subclinical diabetes mellitus.

    Drug product contains no more than 25 mcg/L of aluminum.

    Pregnancy

    Pregnancy Category C

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

    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 Injections, 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 70% Dextrose Injection, USP is administered to a nursing woman.

    Pediatric Use

    The use of Dextrose in pediatric patients is based on clinical practice (see DOSAGE AND ADMINISTRATION). Because of their hypertonicity, 70% Dextrose Injections must be diluted prior to 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.

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  • ADVERSE REACTIONS

    Too rapid infusion of a hypertonic dextrose solution may result in diuresis, hyperglycemia, glycosuria, and hyperosmolar coma. Continual clinical monitoring of the patient is necessary in order to identify and initiate measures for these clinical conditions.

    Hypersensitivity reactions, including anaphylaxis and chills.

    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.

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  • DOSAGE AND ADMINISTRATION

    Following suitable admixture of prescribed drugs, the dosage is usually dependent upon age, weight and clinical condition of the patient as well as laboratory determinations. See directions accompanying drugs.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

    Do not administer unless solution is clear and seal is intact.

    Use of a final filter is recommended during administration of all parenteral solutions where possible.

    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.

    70% Dextrose Injection, USP in the Pharmacy Bulk Package is intended for use in the preparation of sterile, intravenous admixtures. Additives may be incompatible with the fluid withdrawn from this container. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique. Mix thoroughly. Do not store any unused portion of the 70% Dextrose Injection, USP.

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  • DIRECTIONS FOR USE OF VIAFLEX PLASTIC PHARMACY BULK PACKAGE CONTAINER

    To Open

    Tear overpouch 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.

    For compounding only, not for direct infusion.

    Preparation for Admixing

    1.
    The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).
    2.
    Suspend container from eyelet support.
    3.
    Remove plastic protector from outlet port at bottom of container.
    4.
    Attach solution transfer set. Refer to complete directions accompanying set.
     
    Note: The closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents.
    5.
    The VIAFLEX plastic container should not be written on directly since ink migration has not been investigated. Affix accompanying label for date and time of entry notation.
    6.
    Once container closure has been penetrated, withdrawal of contents should be completed without delay. After initial entry, maintain contents at room temperature (25°C/77°F) and dispense within 4 hours.
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  • HOW SUPPLIED

    See Table 1.

    Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25°C/77°F).

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  • SPL UNCLASSIFIED SECTION

    Baxter Healthcare Corporation
    Deerfield, IL 60015 USA

    Printed in USA

    Distributed in Canada by
    Baxter Corporation
    Mississauga, ON L5N 0C2

    Baxter, PL 146, and Viaflex are trademarks of Baxter International Inc.

    07-19-69-266 Revised December 2014

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  • PACKAGE LABELING - PRINCIPAL DISPLAY PANEL

    Dextrose Representative Container Label

    Container Label

    Container Label

    LOT
    EXP

    2B0296
    NDC 0338-0719-06

    2000 mL
    DIN 02014874

    DEXTROSE
    Injection USP

    70%

    Pharmacy Bulk Package
    Not For Direct Infusion
    Must Be Diluted

    Rx Only

    EACH 100 mL CONTAINS 70 g DEXTROSE HYDROUS USP
    IN WATER FOR INJECTION USP

    pH 4.0 (3.2 to 6.5) SPECIFIC GRAVITY 1.24 (CALC)

    HYPERTONIC OSMOLARITY 3530 mOsmol/L (CALC)

    STERILE NONPYROGENIC

    CONTAINS NO MORE THAN 25 µg/L OF ALUMINUM

    COLOR VARIATION FROM LIGHT YELLOW TO AMBER IS NORMAL
    AND DOES NOT ALTER EFFICACY

    DOSAGE AND ADMINISTRATION SEE PACKAGE INSERT

    CAUTION DO NOT USE UNLESS SOLUTION IS CLEAR CLOSURE
    IS INTACT AND CONTAINER IS UNDAMAGED

    CHECK FOR MINUTE LEAKS BY SQUEEZING FIRMLY
    IF LEAKS ARE FOUND DISCARD AS STERILITY MAY BE IMPAIRED

    AFFIX ACCOMPANYING LABEL FOR DATE AND TIME OF ENTRY

    WITHIN 4 HOURS AFTER INITIAL ENTRY DISCARD CONTAINER
    AND UNUSED CONTENTS

    STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
    ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE
    AVOID EXCESSIVE HEAT PROTECT FROM FREEZING

    VIAFLEX CONTAINER

    PL 146 PLASTIC

    Baxter Logo

    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA

    DISTRIBUTED IN CANADA BY
    BAXTER CORPORATION
    Mississauga, ON L5N 0C2

    MADE IN USA

    BAXTER PL 146
    AND VIAFLEX ARE
    TRADEMARKS OF BAXTER
    INTERNATIONAL INC

    70%

    Dextrose Carton Label

    Carton Label

    Carton Label

    2B0296H

    6 - 2000ML
    VIAFLEX CONTAINER

    70% DEXTROSE INJECTION, USP
    (70% DEXTROSE IN WATER)

    PROTECT FROM FREEZING

    EXP
    XXXXX

    SECONDARY BAR CODE
    (17) YYMM00 (10) XXXXX

    LOT
    XXXXX

    PRIMARY BAR CODE
    (01) 50303380719063

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  • INGREDIENTS AND APPEARANCE
    DEXTROSE 
    dextrose monohydrate injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0719
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 70 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0338-0719-06 2000 mL in 1 BAG; Type 0: Not a Combination Product 07/02/1991
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020047 07/02/1991
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    Name Address ID/FEI Business Operations
    Baxter Healthcare Corporation 059140764 ANALYSIS(0338-0719) , LABEL(0338-0719) , MANUFACTURE(0338-0719) , PACK(0338-0719) , STERILIZE(0338-0719)
    Establishment
    Name Address ID/FEI Business Operations
    Baxter Healthcare Corporation 194684502 ANALYSIS(0338-0719)
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