Label: I 123 MINI - iodide ion i-123 capsule 

  • Label RSS
  • NDC Code(s): 51808-102-01
  • Packager: AnazaoHealth Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 05/12

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  • SPL UNCLASSIFIED SECTION

    Dear Medical Professional, Per your order, we have compounded I-123 in Mini Cap form. The characteristics of this compound are:

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  • DESCRIPTION

    Sodium Iodide I-123 (NaI-123) for diagnostic use is supplied for oral administration in a small opaque white gelatin capsule, which is placed inside a red and clear outer capsule. The capsules are available in strengths up to 10 mCi of I-123 at a specific time. Gelatin capsules are compounded, per prescription requirements, using high specific concentration I-123, allowing higher iodine activity in a small easy to swallow capsule size.The radionuclidic composition at calibration is not less than 97.0 percent I-123, not more than 2.9 percent I-125 and not more than 0.1 percent Te-121. The radionuclidic composition at expiration time is not less than 87.2 percent I-123, not more than 12.4 percent I-125 and not more than 0.4 percent Te-121. The ratio of the concentration of I-123 and I-125 changes with time. Iodine-123 has a physical half-life of 13.2 hours.

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  • INDICATIONS AND USAGE

    Administration of Sodium Iodide I-123 is indicated as a diagnostic procedure to be used in evaluating thyroid function and/or morphology

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  • DOSAGE AND ADMINISTRATION

    Anti-thyroid therapy of a severely hyperthyroid patient is usually discontinued three to four days before administration of radioiodide.  For hyperthyroidism, the usual dose range is 4 to 10 mCi.  Toxic nodular goiter and other special situations will require the use of larger doses.  For thyroid carcinoma, 50 mCi is the usual dose for ablation of normal thyroid tissue, and 100 to 150 mCi is the usual subsequent therapeutic dose. Waterproof gloves should be used during the entire handling and administration procedure. Adequate shielding must be maintained.

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  • CLINICAL UTILITY

    .Sodium Iodide I-123 is readily absorbed from the upper gastrointestinal tract. Following absorption, the iodide is distributed primarily within the extracellular fluid of the body. It is trapped and organically bound by the thyroid and concentrated by the stomach, choroid plexus and salivary glands. It is excreted by the kidneys. The fraction of the administered dose which is accumulated in the thyroid gland may be a measure of thyroid function in the absence of unusually high or low iodine intake or administration of certain drugs which influence iodine accumulation by the thyroid gland. Normal subjects can accumulate approximately 10 to 50% of the administered iodine dose in the thyroid gland, however, the normal and abnormal ranges are established by individual physician’s criteria. The mapping (imaging) of Sodium Iodide I-123 distribution in the thyroid gland may provide useful information concerning thyroid anatomy and definition of normal and/or abnormal functioning of tissue within the gland

    Thank you,

    AnazaoHealth Corporation

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    I 123 MINI 
    i 123 mini capsule
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51808-102
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IODIDE ION I-123 (IODIDE ION I-123) IODIDE ION I-123 10 mCi
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM PHOSPHATE, DIBASIC 100 mg
    Product Characteristics
    Color WHITE (one half opaque white and other half red) Score no score
    Shape CAPSULE Size 3mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51808-102-01 2 in 1 VIAL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 05/23/2012
    Labeler - AnazaoHealth Corporation (011038762)
    Establishment
    Name Address ID/FEI Business Operations
    AnazaoHealth Corporation 011038762 MANUFACTURE(51808-102)
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