Label: POTASSIUM CHLORIDE IN SODIUM CHLORIDE- sodium chloride and potassium chloride injection, solution

  • NDC Code(s): 0338-0691-04, 0338-0695-04, 0338-0704-34
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated 07/14

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Potassium Chloride in Sodium Chloride Injection, USP is a sterile, nonpyrogenic, solution for fluid and electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH and ionic concentration are shown in Table 1.

    *
    Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage.

    Table 1

    Size (mL)

    Composition (g/L)

    *Osmolarity (mOsmol/L) (Calc.)

    pH

    Ionic Concentration (mEq/L)

    Sodium Chloride, USP (NaCl)

    Potassium Chloride, USP (KCl)

    Sodium

    Potassium

    Chloride

    20 mEq/L Potassium Chloride in
    0.45% Sodium Chloride Injection, USP

    1000

    4.5

    1.5

    194

    5.5

    (3.5 to 6.5)

    77

    20

    97

    20 mEq/L Potassium Chloride in
    0.9% Sodium Chloride Injection, USP

    1000

    9

    1.5

    348

    5.5

    (3.5 to 6.5)

    154

    20

    174

    40 mEq/L Potassium Chloride in
    0.9% Sodium Chloride Injection, USP

    1000

    9

    3

    388

    5.5

    (3.5 to 6.5)

    154

    40

    194

    The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system. 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 by tissue culture toxicity studies.

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  • CLINICAL PHARMACOLOGY

    Potassium Chloride in Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.

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  • INDICATIONS AND USAGE

    Potassium Chloride in Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.

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  • CONTRAINDICATIONS

    None known

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  • WARNINGS

    Potassium Chloride in Sodium Chloride Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.

    Potassium Chloride in Sodium Chloride Injection, USP should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present.

    The intravenous administration of Potassium Chloride in Sodium Chloride Injection, USP 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 the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.

    In patients with diminished renal function, administration of Potassium Chloride in Sodium Chloride Injection, USP may result in sodium or potassium retention.

    Potassium salts should never be administered by IV push.

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  • PRECAUTIONS

    Clinical evaluation and periodic laboratory determinations are necessary to 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.

    Caution must be exercised in the administration of Potassium Chloride in Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin.

    Pregnancy

    Teratogenic Effects

    Pregnancy Category C

    Animal reproduction studies have not been conducted with Potassium Chloride in Sodium Chloride Injection, USP. It is also not known whether Potassium Chloride in Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Chloride in Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed.

    Carcinogenesis, mutagenesis, impairment of fertility

    Studies with Potassium Chloride in Sodium Chloride Injection, USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

    Nursing Mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Potassium Chloride in Sodium Chloride Injection, USP is administered to a nursing mother.

    Pediatric Use:

    Safety and effectiveness of Potassium Chloride in Sodium Chloride Injection, USP in pediatric patients have not been established by adequate and well-controlled studies. However, the use of potassium chloride injection in pediatric patients to treat potassium deficiency states when oral replacement therapy is not feasible is referenced in the medical literature.

    For patients receiving potassium supplement at greater than maintenance rates, frequent monitoring of serum potassium levels and serial EKGs are recommended.

    Geriatric Use

    Clinical studies of Potassium Chloride in Sodium Chloride 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.

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

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  • 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.

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  • 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 final filter is recommended during administration of all parenteral solutions, where possible.

    All injections in VIAFLEX Plus plastic containers are intended for intravenous administration using sterile equipment.

    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.

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  • HOW SUPPLIED

    Potassium Chloride in Sodium Chloride Injection, USP in VIAFLEX Plus Plastic Container is available as follows:

    Code

    Size (mL)

    NDC

    Product Name

    2B1357

    1000

    0338-0704-34

    20 mEq/L Potassium Chloride in
    0.45% Sodium Chloride Injection, USP

    2B1764

    1000

    0338-0691-04

    20 mEq/L Potassium Chloride in
    0.9% Sodium Chloride Injection, USP

    2B1984

    1000

    0338-0695-04

    40 mEq/L Potassium Chloride in
    0.9% Sodium Chloride Injection, USP

    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.

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  • DIRECTION FOR USE OF VIAFLEX PLUS PLASTIC CONTAINER

    Warning: Do not use plastic containers in series connections. 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.

    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 directions below.

    Preparation for Administration

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

    To Add Medication

    Warning: 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.
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  • SPL UNCLASSIFIED SECTION

    Baxter Healthcare Corporation
    Deerfield, IL 60015 USA

    Printed in USA

    07-19-73-072

    Rev. May 2014

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

    For Product Information

    1-800-933-0303

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  • PACKAGE LABELING - PRINCIPLE DISPLAY PANEL

    Potassium Chloride and Sodium Chloride Representative Container Label  NDC 0338-0704-34

    Container Label

    Container Label

    LOT EXP

    2B1357
    NDC 0338-0704-34

    20 mEq
    Potassium Chloride

    (20 mEq/L)
    Potassium Chloride in
    0.45% Sodium Chloride Injection USP

    1000 mL

    EACH 100 mL CONTAINS 450 mg SODIUM CHLORIDE USP
    150 mg POTASSIUM CHLORIDE USP pH 5.5 (3.5 TO 6.5)
    mEq/L SODIUM 77 POTASSIUM 20 CHLORIDE 97

    OSMOLARITY 194 mOsmol/L (CALC) HYPOTONIC STERILE
    NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE
    INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE WHEN
    INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX
    THOROUGHLY DO NOT STORE USUAL DOSAGE INTRAVENOUSLY
    AS DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONS
    SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT
    STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED
    IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS
    CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP
    AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE
    AVOID EXCESSIVE HEAT SEE INSERT

    VIAFLEX PLUS CONTAINER PL 146 PLASTIC

    BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF
    BAXTER INTERNATIONAL INC

    Baxter 
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA

    MADE IN USA

    FOR PRODUCT INFORMATION
    1-800-933-0303

    Potassium Chloride in Sodium Chloride Representative Carton Label NDC 0338-0704-34

    Carton Label

    2B-13-57X 14-1000 ML

    VIAFLEX PLUS CONTAINER

    20 mEq POTASSIUM CHLORIDE IN
    0.45% SODIUM CHLORIDE INJ

    EXP
    XXXXX

    SECONDARY BAR CODE
    (17) YYMM00 (10) XXXXX

    LOT
    XXXXX

    PRIMARY BAR CODE
    (01) 50303380704342

    Potassium Chloride in Sodium Chloride Representative Container Label NDC 0338-0691-04

    Container Label

    LOT EXP

    2B1764
    NDC 0338-0691-04
    DIN 00786209

    1000 mL

    EACH 100 mL CONTAINS 900 mg SODIUM CHLORIDE USP
    150 mg POTASSIUM CHLORIDE USP pH 5.5 (3.5 TO 6.5)
    mEq/L SODIUM 154 POTASSIUM 20 CHLORIDE 174
    OSMOLARITY 348 mOsmol/L (CALC) STERILE
    NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE
    INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE
    WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX
    THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS
    DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONS
    SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT
    STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED
    IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS
    CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER
    OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY
    TO USE AVOID EXCESSIVE HEAT SEE INSERT

    VIAFLEX PLUS CONTAINER PL 146 PLASTIC
    BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF
    BAXTER INTERNATIONAL INC

    FOR PRODUCT INFORMATION 1-800-933-0303

    Baxter 

    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN USA

    DISTRIBUTED IN CANADA BY
    BAXTER CORPORATION
    TORONTO ONTARIO CANADA

    Potassium Chloride in Sodium Chloride Representative Carton Label NDC 0338-0691-04

    Carton Label

    2B1764X 14-1000 ML

    VIAFLEX ® PLUS CONTAINER

    20 MEQ POTASSIUM CHLORIDE IN
    0.9% SODIUM CHLORIDE INJ

    EXP
    XXXXX

    SECONDARY BAR CODE
    (17) XXXXX (10) XXXXX

    LOT
    XXXXX

    PRIMARY BAR CODE
    (01) 50303380691048

    Potassium Chloride in Sodium Chloride Representative Container Label NDC 0338-0695-04

    Container Label

    LOT EXP

    2B1984
    NDC 0338-0695-04
    DIN 00786217

    1000 mL

    EACH 100 mL CONTAINS 900 mg SODIUM CHLORIDE USP
    300 mg POTASSIUM CHLORIDE USP pH 5.5 (3.5 TO 6.5)
    mEq/L SODIUM 154 POTASSIUM 40 CHLORIDE 194
    OSMOLARITY 388 mOsmol/L (CALC) STERILE
    NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE
    INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE
    WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX
    THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS
    DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONS
    SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT
    STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED
    IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS
    CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER
    OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY
    TO USE AVOID EXCESSIVE HEAT SEE INSERT

    VIAFLEX PLUS CONTAINER PL 146 PLASTIC
    BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF
    BAXTER INTERNATIONAL INC

    FOR PRODUCT INFORMATION 1-800-933-0303

    Baxter 

    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN USA

    DISTRIBUTED IN CANADA BY
    BAXTER CORPORATION
    TORONTO ONTARIO CANADA

    Potassium Chloride in Sodium Chloride Representative Carton Label NDC 0338-0695-04

    Carton Label

    2B-19-84X 14-1000 ML

    VIAFLEX ® PLUS CONTAINER

    40 mEq POTASSIUM CHLORIDE IN
    0.9% SODIUM CHLORIDE INJ

    EXP
    XXXXX

    SECONDARY BAR CODE
    (17) YYMM00 (10) XXXXX

    LOT
    XXXXX

    PRIMARY BAR CODE
    (01) 50303380695046

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  • INGREDIENTS AND APPEARANCE
    POTASSIUM CHLORIDE IN SODIUM CHLORIDE 
    potassium chloride and sodium chloride injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0338-0695
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 900 mg  in 100 mL
    POTASSIUM CHLORIDE (POTASSIUM CATION and CHLORIDE ION) POTASSIUM CHLORIDE 300 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0338-0695-04 14 in 1 CARTON 02/02/1979
    1 1000 mL in 1 BAG; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA017648 02/02/1979
    POTASSIUM CHLORIDE IN SODIUM CHLORIDE 
    potassium chloride and sodium chloride injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0338-0691
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 900 mg  in 100 mL
    POTASSIUM CHLORIDE (POTASSIUM CATION and CHLORIDE ION) POTASSIUM CHLORIDE 150 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0338-0691-04 14 in 1 CARTON 02/02/1979
    1 1000 mL in 1 BAG; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA017648 02/02/1979
    POTASSIUM CHLORIDE IN SODIUM CHLORIDE 
    potassium chloride and sodium chloride injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0338-0704
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 450 mg  in 100 mL
    POTASSIUM CHLORIDE (POTASSIUM CATION and CHLORIDE ION) POTASSIUM CHLORIDE 150 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0338-0704-34 14 in 1 CARTON 02/02/1979
    1 1000 mL in 1 BAG; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA017648 02/02/1979
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    Name Address ID/FEI Business Operations
    Baxter Healthcare Corporation 059140764 MANUFACTURE(0338-0695, 0338-0691, 0338-0704), ANALYSIS(0338-0695, 0338-0691, 0338-0704), LABEL(0338-0695, 0338-0691, 0338-0704), PACK(0338-0695, 0338-0691, 0338-0704), STERILIZE(0338-0695, 0338-0691, 0338-0704)
    Establishment
    Name Address ID/FEI Business Operations
    Baxter Healthcare Corporation 194684502 ANALYSIS(0338-0695, 0338-0691, 0338-0704)
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