Sodium Iodide I 123 label

Sodium Iodide I 123

Sodium Iodide I 123 Recall

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Side Effects & Adverse Reactions

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.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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

History

There is currently no drug history available for this drug.

Other Information

Sodium Iodide I-123 (Na123I) 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.

Graph 1. Radionuclidic Concentration of I-123
PERCENT OF TOTAL RADIOACTIVITY
IODINE-123

Graph 1

Graph 2. Radionuclidic Concentration of I-125
PERCENT OF TOTAL RADIOACTIVITY:
IODINE-125

Graph 2

Sodium Iodide I 123 Manufacturers

  • Mallinckrodt Inc.
    Sodium Iodide I 123 | Mallinckrodt Inc.
    No Recall

    Sodium Iodide I 123 | Mallinckrodt Inc.

    Sodium Iodide I 123 | Mallinckrodt Inc.

    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. The user should wear waterproof gloves at all times when handling the capsules or container.

  • Cardinal Health 418, Inc
    Sodium Iodide I 123 | Cardinal Health 418, Inc
    No Recall

    Sodium Iodide I 123 | Cardinal Health 418, Inc

    Sodium Iodide I 123 | Cardinal Health 418, Inc

    The recommended oral dose for the average patient (70 kg) is 3.7 to 14.8 MBq (100-400 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 radioactive calibration system immediately prior to administration. The capsules can be utilized up to thirty (30) hours after calibration time and date. Thereafter, discard the capsules in accordance with standard safety procedures. The user should wear waterproof gloves at all times when handling the capsules or container.

    Radiation Dosimetry

    The estimated absorbed radiation doses to several organs of an average patient (70 kg) from oral administration of the maximum dose of 14.8 MBq (400 µCi) of I 123 are shown in Table 4 for thyroid uptakes of 5, 15, and 25%. For comparison at these three values of thyroid uptake, the estimated radiation doses from doses of 3.7 MBq (100 µCi) I 131, also used as thyroid imaging agent, are also included.

    Table 4 Radiation Dose Estimates as a Function of Maximum Thyroid Uptake for I 123* Sodium Iodide At Time of Calibration and Expiry Compared to I 131 *Concentration at Time of Calibration: 97% I 123, 2.9% I 125, 0.1% Te 121
    Concentration at Time of Expiry: 87.2% I 123, 12.4% I 125, 0.4% Te 121
    All Iodine Kinetics treated as in MIRD Dose Estimate Report 5. Bladder voiding interval, 4.8 hours.
    Tellurium 121 dosimetry taken from ICRP 30.

    Target Organ

    Maximum
    Thyroid
         Uptake (%)     

    Estimated Radiation Absorbed Doses

    I 123
    mGy/14.8 MBq
    (rads/400 µCi)

    I 131
    mGy/3.7 MBq
    (rads/100 µCi)

    TOC

    TOE

    Thyroid

    5

    25

    (2.5)

    75

    (7.5)

    260

    (26)

    15

    77

    (7.7)

    230

    (23)

    780

    (78)

    25

    130

    (13)

    410

    (41)

    1300

    (130)

    Liver

    5

    0.089

    (0.0089)

    0.13

    (0.013)

    0.16

    (0.016)

    15

    0.10

    (0.010)

    0.18

    (0.018)

    0.28

    (0.028)

    25

    0.11

    (0.011)

    0.24

    (0.024)

    0.41

    (0.041)

    Ovaries

    5

    0.18

    (0.018)

    0.19

    (0.019)

    0.18

    (0.018)

    15

    0.17

    (0.017)

    0.18

    (0.018)

    0.18

    (0.018)

    25

    0.16

    (0.016)

    0.18

    (0.018)

    0.17

    (0.017)

    Red Marrow

    5

    0.12

    (0.012)

    0.16

    (0.016)

    0.15

    (0.015)

    15

    0.12

    (0.012)

    0.18

    (0.018)

    0.21

    (0.021)

    25

    0.13

    (0.013)

    0.19

    (0.019)

    0.27

    (0.027)

    Stomach Wall     

    5

    0.96

    (0.096)

    0.98

    (0.098)

    1.7

    (0.17)

    15

    0.89

    (0.089)

    0.91

    (0.091)

    1.5

    (0.15)

    25

    0.82

    (0.082)

    0.85

    (0.085)

    1.4

    (0.14)

    Small Intestine

    5

    0.70

    (0.070)

    0.71

    (0.071)

    1.2

    (0.12)

    15

    0.65

    (0.065)

    0.67

    (0.067)

    1.1

    (0.11)

    25

    0.60

    (0.060)

    0.62

    (0.062)

         0.99     

         (0.099)     

    Testes

    5

    0.076

    (0.0076)

    0.089

    (0.0089)

    0.12

    (0.012)

    15

    0.072

    (0.0072)

    0.087

    (0.0087)

    0.12

    (0.012)

    25

         0.068     

         (0.0068)     

         0.085     

         (0.0085)     

    0.12

    (0.012)

    Bladder

    5

    1.7

    (0.17)

    1.7

    (0.17)

    2.9

    (0.29)

    15

    1.6

    (0.16)

    1.6

    (0.16)

    2.7

    (0.27)

    25

    1.4

    (0.14)

    1.5

    (0.15)

    2.4

    (0.24)

    Skeleton

    5

    0.11

    (0.011)

    0.16

    (0.016)

    0.12

    (0.012)

    15

    0.12

    (0.012)

    0.18

    (0.018)

    0.18

    (0.018)

    25

    0.14

    (0.014)

    0.21

    (0.021)

    0.24

    (0.024)

    Total Body

    5

    0.11

    (0.011)

    0.16

    (0.016)

    0.24

    (0.024)

    15

    0.14

    (0.014)

    0.25

    (0.025)

    0.47

    (0.047)

    25

    0.17

    (0.017)

    0.35

    (0.035)

    0.70

    (0.070)