Sodium Iodide I 123

Generic Name: sodium iodide i 123

Over-the-Counter (OTC)

Brand Names:

Sodium Iodide I 123

DESCRIPTION Sodium Iodide I 123 (Na 123 I) 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.

Overview

DESCRIPTION Sodium Iodide I 123 (Na 123 I) 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.

Uses

INDICATIONS AND USAGE Administration of Sodium Iodide I 123 Capsules is indicated as a diagnostic procedure to be used in evaluating thyroid function and/or morphology.

Dosage

DOSAGE AND ADMINISTRATION The recommended oral dose for the average patient (70 kg) is 3.7 to 14.8 MBq (100 to 400 μCi). The lower part of the dosage range 3.7 MBq (100 μCi) is recommended for uptake studies alone, and the higher part 14.8 MBq (400 μCi) for thyroid imaging. The determination of I-123 concentration in the thyroid gland may be initiated at six hours after administering the dose and should be measured in accordance with standardized procedures. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. The capsules can be utilized up to 30 hours after calibration time and date. Thereafter, discard the capsules in accordance with standard safety procedures.

Side Effects

ADVERSE REACTIONS Although rare, reactions associated with the administration of sodium iodide isotopes for diagnostic use include, in decreasing order of frequency, nausea, vomiting, chest pain, tachycardia, itching skin, rash and hives.

Warnings

WARNINGS 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. CONTRAINDICATIONS To date there are no known contraindications to the use of Sodium Iodide I 123 Capsules.

Pregnancy

Pregnancy Category C Animal reproduction studies have not been conducted with this drug. It is also not known whether sodium iodide I-123 can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Sodium iodide I-123 should be given to a pregnant woman only if clearly needed. Ideally, examinations using radiopharmaceuticals, especially those elective in nature, in women of child-bearing capability should be performed during the first few (approximately ten) days following the onset of menses.

Storage

Storage and Handling The contents of the vial are radioactive and adequate shielding and handling precautions must be maintained. Dispense and preserve capsules in tightly-closed containers that are adequately shielded. Store at controlled room temperature 20° to 25°C (68° to 77°F).

Frequently Asked Questions

What is Sodium Iodide I 123 used for?

INDICATIONS AND USAGE Administration of Sodium Iodide I 123 Capsules is indicated as a diagnostic procedure to be used in evaluating thyroid function and/or morphology.

What are the side effects of Sodium Iodide I 123?

ADVERSE REACTIONS Although rare, reactions associated with the administration of sodium iodide isotopes for diagnostic use include, in decreasing order of frequency, nausea, vomiting, chest pain, tachycardia, itching skin, rash and hives.

Can I take Sodium Iodide I 123 during pregnancy?

Pregnancy Category C Animal reproduction studies have not been conducted with this drug. It is also not known whether sodium iodide I-123 can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Sodium iodide I-123 should be given to a pregnant woman only if clearly needed. Ideally, examinations using radiopharmaceuticals, especially those elective in nature, in women of child-bearing capability should be performed during the first few (approximately ten) days following the onset of menses.

What are the important warnings for Sodium Iodide I 123?

WARNINGS 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. CONTRAINDICATIONS To date there are no known contraindications to the use of Sodium Iodide I 123 Capsules.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.