U.S Spect products | Others
Sodium Iodide I-123 Capsules
This information is intended for U.S. healthcare professionals only.
Sodium Iodide I 123 (Na 123I) for diagnostic use is supplied in capsules for oral administration. The capsules are available in strengths of 3.7 and 7.4 megabecquerels (MBq) (100 and 200 μCi) I-123 at time of calibration.
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. Graph 1 shows the minimum concentration of I-123 as a function of time and Graph 2 shows the maximum concentration of I-125 as a function of time.
Indication & Usage
Administration of Sodium Iodide I 123 Capsules is indicated as a diagnostic procedure to be used in evaluating thyroid function and/or morphology.
Important risk information
Warnings and precautions
- Females of childbearing age and pediatric patients should not be studied unless the benefits anticipated from the performance of the test outweigh the possible risk of exposure to the amount of ionizing radiation associated with the test.
- Do not use after the expiration time and date stated on the label.
- The prescribed Sodium Iodide I-123 dose should be administered as soon as practical from the time of receipt of product (i.e., as close to calibration time as possible), in order to minimize the fraction of radiation exposure due to the relative increase of radionuclidic contaminants with time.
- Sodium Iodide I-123 capsules are radioactive and must be handled with care and appropriate safety measures, including adequate shielding of the preparation, should be used to minimize radiation exposure to clinical personnel and the patient consistent with proper patient management.
- Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
- Serious adverse reactions may include chest pain, tachycardia, rash and hives.
- Other adverse reactions, although rare, include nausea, vomiting and itching skin.
Use in specific populations
- Breast feeding: I-123 is excreted in human milk. Bottle feedings should be substituted for breast feedings if the agent must be administered to the mother during lactation.
- Safety and effectiveness in pediatric patients have not been established.
Frequently asked questions
The product is calibrated for noon CT on Monday, Tuesday, Wednesday and Thursday.
Iodine-123 decays by electron capture with a physical half-life of 13.2 hours.
Call Curium Pharmacovigilance / Product Monitoring Department at 866.789.2211
How is this product supplied
|Vial, capsule||1||Each||100 uCi||N60110||69945-601-10|
|Vial, capsule||1||Each||200 uCi||N60220||69945-602-20|