I 123 MINI - iodide ion i-123 capsule 
AnazaoHealth Corporation

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.

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I-123 Mini Caps
Medical Professional Information Sheet

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

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I 123 MINI 
i 123 mini capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:51808-102
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IODIDE ION I-123 (IODIDE ION I-123) IODIDE ION I-12310 mCi
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC100 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)

Revised: 5/2012
Document Id: 130c71b9-1a33-45b2-ab19-e38b6ee0ee68
Set id: ba4a725e-ba46-427c-b309-a5ddc3c881ab
Version: 1
Effective Time: 20120523
 
AnazaoHealth Corporation