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Elliotts B (QOL Medical, LLC)

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INJECTION 10 AMPULE in 1 BOX (67871-007-10) > 10 mL in 1 AMPULE (67871-007-01) Label Information

Complete Elliotts B Information

  • DESCRIPTION

    Elliotts B® Solution is a sterile, nonpyrogenic, isotonic solution containing no bacteriostatic preservatives. Elliotts B Solution is a diluent for intrathecal administration of methotrexate sodium and cytarabine.

    Each 10 mL of Elliotts B Solution contains:

    Sodium Chloride, USP 73 mg
    Sodium Bicarbonate, USP 19 mg
    Dextrose, USP 8 mg
    Magnesium Sulfate 7H2O, USP 3 mg
    Potassium Chloride, USP 3 mg
    Calcium Chloride 2H2O, USP 2 mg
    Sodium Phosphate, dibasic 7H2O, USP 2 mg
    Water for Injection, USP qs 10 mL

    Concentration of Electrolytes:
    Sodium 149 mEq/liter Bicarbonate 22.6 mEq/liter
    Potassium 4.0 mEq/liter Chloride 132 mEq/liter
    Calcium 2.7 mEq/liter Sulfate 2.4 mEq/liter
    Magnesium 2.4 mEq/liter Phosphate 1.5 mEq/liter


    The formulae and molecular weights of the ingredients are:


    INGREDIENT MOLECULAR
    FORMULA
    MOLECULAR
    WEIGHT
    Sodium Chloride
    NaCl
    58.44
    Sodium Bicarbonate
    NaHCO3
    84.01
    Dextrose
    C6H12O6
    180.16
    Magnesium Sulfate 7H2O
    Mg2SO4 7H2O
    246.48
    Potassium Chloride
    KCl
    74.55
    Calcium Chloride 2H2O
    CaCl2 2H2O
    147.01
    Sodium Phosphate, dibasic 7H2O
    Na2HPO4 7H2O
    268.07


    The pH of Elliotts B Solution is 6.0-7.5, and the osmolarity is 288 mOsmol per liter (calculated).


  • CLINICAL PHARMACOLOGY

    Elliotts B Solution provides a buffered salt solution for use as a diluent for the intrathecal administration of methotrexate sodium and cytarabine. It has been demonstrated that Elliotts B Solution is comparable to cere­brospinal fluid in pH, electrolyte composition, glucose content, and osmolarity:


    Comparison of Electrolyte Composition, pH and Nonelectrolytic Constituents of Elliotts B Solution and CSF

    Solution

    Na+
    mEq/L

    K+
    mEq/L

    Ca++
    mEq/L

    Mg++
    mEq/L

    HCO3-
    mEq/L

    Cl-
    mEq/L

    pH

    Phosphorus
    mg/dL

    Glucose
    mg/dL

    Cerebrospinal Fluid

    117-137

    2.3-4.6

    2.2

    2.2

    22.9

    113-127

    7.31

    1.2-2.1

    45-80

    Elliotts B Solution

    149

    4.0

    2.7

    2.4

    22.6

    132

    6.0-7.5

    2.3

    80

    The approximate buffer capacity of Elliotts B Solution is 1.1 X 10-2 equivalents when the challenge solution is 0.01 N HCl and 7.8 X 10-3 equivalents when the challenge solution is 0.01 N NaOH.1


    Compatibility studies with methotrexate sodium and cytarabine indicate these drugs are physically compati­ble with Elliotts B Solution.



  • INDICATIONS AND USAGE

    Elliotts B Solution is indicated as a diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma.


  • CONTRAINDICATIONS

    None known.


  • WARNINGS

    Intrathecal administration of drugs such as methotrexate sodium and cytarabine should be performed by per­sonnel skilled in the technique of lumbar puncture under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents. The labeling for methotrexate sodium and cytarabine should be consulted.


  • PRECAUTIONS


    General

    Particular attention should be taken to assure the maintenance of sterile technique throughout the procedure. (See DOSAGE AND ADMINISTRATION.)

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    No standard mutagenicity or carcinogenicity studies have been conducted with Elliotts B Solution.

    Usage in Pregnancy

    Pregnancy Category C



    All components of Elliotts B Solution are normal body constituents. Animal reproduction studies have not been conducted with Elliotts B Solution.


  • ADVERSE REACTIONS

    Adverse reactions may occur with any given intrathecal injection due to the chemotherapy or the technique of intrathecal administration.  (See product labeling for methotrexate sodium and cytarabine.)


    Preservative-free methotrexate sodium and cytarabine should be used to minimize adverse reactions due to preservatives.


    If an adverse reaction does occur, discontinue the administration, evaluate the patient, institute appropriate therapeutic countermeasures and, if possible, save the remainder of the unused solution(s) for examination.


  • DRUG ABUSE AND DEPENDENCE

    There is no potential for drug abuse or drug dependence.


  • OVERDOSAGE

    Elliotts B Solution is a diluent. In the event of a drug, fluid or solute overload following administration, evalu­ate the patient's condition, and institute appropriate corrective treatment. (See product labeling for methotrexate sodium and cytarabine.)


  • DOSAGE AND ADMINISTRATION

    See product labeling for methotrexate sodium and cytarabine.


    Elliotts B Solution is intended for intrathecal administration only.  Elliotts B Solution does not contain antibac­terial preservatives and introduction of contaminated solutions into the cerebrospinal fluid may have extremely serious consequences. Therefore, administration of intrathecal solutions should be accomplished as soon as possible after preparation.


    A sterile filter-needle should be used to withdraw the contents of the ampule.


    Intrathecal drug products should be inspected visually for particulate matter and discoloration prior to admin­istration.

    Preparation and Administration Precautions

    Elliotts B Solution is a diluent for the cytotoxic anticancer agents, methotrexate sodium and cytarabine. Care should be exercised in the handling and preparation of infusion solutions with these products. (See product labeling for methotrexate sodium and cytarabine.)


  • HOW SUPPLIED

    NDC SIZE
    67871-007-10
    10 mL ampule
    Elliotts B Solution is available in single-use clear glass ampules, packaged 10 ampules per box.

    Store at controlled room temperature, 20º-25ºC (68º-77ºF) [See USP].

    Preservative Free.  Discard unused portion.  Use only if solution is clear and ampule is intact.

    Distributed by:
    QOL Medical, LLC
    Vero Beach, FL 32963
    1-866-528-4750
    www.elliottsbsolution.com

  • REFERENCES:

    1. Cradock JC, et al. Evaluation of some pharmaceutical aspects of intrathecal methotrexate sodium, cytara­bine and hydrocortisone sodium succinate.  American Journal of Hospital Pharmacy (1978); 35:402.

    Rev. 12/11
    Part No. 210



  • PACKAGING

    Ampule labeling:

    Ampule Labeling

    Box labeling:

    Box Labeling


  • INGREDIENTS AND APPEARANCE
    ELLIOTTS B 
    sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate injection
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67871-007
    Route of Administration INTRATHECAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    sodium chloride (UNII: 451W47IQ8X) (sodium cation - UNII:LYR4M0NH37, chloride ion - UNII:Q32ZN48698) sodium chloride 73 mg  in 10 mL
    sodium bicarbonate (UNII: 8MDF5V39QO) (bicarbonate ion - UNII:HN1ZRA3Q20) sodium bicarbonate 19 mg  in 10 mL
    anhydrous dextrose (UNII: 5SL0G7R0OK) (anhydrous dextrose - UNII:5SL0G7R0OK) anhydrous dextrose 8 mg  in 10 mL
    magnesium sulfate (UNII: DE08037SAB) (magnesium cation - UNII:T6V3LHY838) magnesium sulfate 3 mg  in 10 mL
    potassium chloride (UNII: 660YQ98I10) (potassium cation - UNII:295O53K152) potassium chloride 3 mg  in 10 mL
    calcium chloride (UNII: M4I0D6VV5M) (calcium cation - UNII:2M83C4R6ZB) calcium chloride 2 mg  in 10 mL
    sodium phosphate (UNII: SE337SVY37) (phosphate ion - UNII:NK08V8K8HR) sodium phosphate 2 mg  in 10 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R) 10 mL  in 10 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67871-007-10 10 in 1 BOX
    1 NDC:67871-007-01 10 mL in 1 AMPULE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020577 09/27/2006
    Labeler - QOL Medical, LLC (140026258)