Sodium Iodide I-123 Capsules

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.

Adverse reactions

• 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.