Label: I 123 MINI capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 23, 2012

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

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

  • 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.

  • 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

  • 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.

  • 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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    130c71b9-figure-01
    130c71b9-figure-02
  • INGREDIENTS AND APPEARANCE
    I 123 MINI 
    i 123 mini capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51808-102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODIDE ION I-123 (UNII: 8YWR746RPQ) (IODIDE ION I-123 - UNII:8YWR746RPQ) IODIDE ION I-12310 mCi
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) 100 mg
    Product Characteristics
    ColorWHITE (one half opaque white and other half red) Scoreno score
    ShapeCAPSULESize3mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51808-102-012 in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other05/23/2012
    Labeler - AnazaoHealth Corporation (011038762)
    Establishment
    NameAddressID/FEIBusiness Operations
    AnazaoHealth Corporation011038762MANUFACTURE(51808-102)