I 123 Mini

Name: I 123 Mini

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:

I 123 Mini 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.

I 123 Mini 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.

Package label.principal display panel

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
1 NDC:51808-102-01 2 CAPSULE (CAPSULE) 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 Operations
AnazaoHealth Corporation 011038762 MANUFACTURE(51808-102)
Revised: 05/2012   AnazaoHealth Corporation
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