Sodium Iodide I 123 Capsules

/Sodium Iodide I 123 Capsules
Sodium Iodide I 123 Capsules2018-09-06T09:12:40+00:00

Prescription Drug Name:

Sodium Iodide I 123 Capsules

ID:

6b26fa17-b31e-418f-8d61-44ba97cc513b

Code:

34391-3

DESCRIPTION


id: e4c4a2e7-2436-4340-a517-6dea36ae8d9c
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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 2. Radionuclidic Concentration of I-125

PERCENT OF TOTAL RADIOACTIVITY:
IODINE-125

Physical Characteristics


id: 6c98f33b-2514-4195-ba02-17865f9099d4
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

Iodine-123 decays by electron capture with a physical half-life of 13.2 hoursKocher, David C., Radioactive Decay Data Tables. DOE/TIC-11026, 122 (1981).. The photon that is useful for detection and imaging studies is listed in Table 1.

Table 1. Principal Radiation Emission Data
 Radiation  Mean %
Disintegration
 Energy
(keV)
 Gamma-2  83.4  159

External Radiation


id: 8fc3b427-3641-4e19-82f8-508762c82099
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

The specific gamma ray constant for I-123 is 1.6 R/hr-mCi at 1 cm. The first half-value thickness of lead (Pb) for I-123 is 0.005 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from the interposition of various thicknesses of Pb is shown in Table 2. For example, the use of 1.63 cm of lead will decrease the external radiation exposure by a factor of about 1,000.

Table 2. Radiation Attenuation by Lead Shielding
 Shield
Thickness (Pb), cm
 Coefficient of
Attenuation
 0.005
0.10
0.88
1.63
2.48
 0.5
10-1

10-2

10-3

10-4

Note that these estimates of attenuation do not take into consideration the presence of radionuclidic contaminants. To correct for physical decay of I-123, the fractions that remain at selected intervals after the time of calibration are shown in Table 3.
Table 3. Iodine I-123 Decay Chart: Half-Life 13.2 Hours
 
Hours
 Fraction
Remaining
   
Hours
 Fraction Remaining
  *Time of Calibration
 0*
3
6
9
12
15
 1.000
0.854
0.730
0.623
0.533
0.455
   18
21
24
27
30
 0.389
0.332
0.284
0.242
0.207

CLINICAL PHARMACOLOGY


id: efe1fd00-1d80-4103-85a1-78aa873bc9f9
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Sodium iodide I-123 is readily absorbed from the upper gastrointestinal tract. Following absorption, the iodide is distributed primarily within the extracellular fluid of the body. It is trapped and organically bound by the thyroid and concentrated by the stomach, choroid plexus and salivary glands. It is excreted by the kidneys. The fraction of the administered dose which is accumulated in the thyroid gland may be a measure of thyroid function in the absence of unusually high or low iodine intake or administration of certain drugs which influence iodine accumulation by the thyroid gland. Accordingly, the patient should be questioned carefully regarding previous medications and/or procedures involving radiographic media. Normal subjects can accumulate approximately 10 to 50% of the administered iodine dose in the thyroid gland, however, the normal and abnormal ranges are established by individual physician’s criteria. The mapping (imaging) of sodium iodide I-123 distribution in the thyroid gland may provide useful information concerning thyroid anatomy and definition of normal and/or abnormal functioning of tissue within the gland.

INDICATIONS AND USAGE


id: 333d0581-89d0-4b1c-b8b5-6d02f60b2a40
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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

CONTRAINDICATIONS


id: 73ca25aa-2e52-40d2-9128-a388fe344e29
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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

WARNINGS


id: 4a800497-7576-4313-84c5-b83d124b6be7
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

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.

ADVERSE REACTIONS


id: f2cf1bba-c594-4895-9922-e8f724cd0cbd
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

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.

DOSAGE AND ADMINISTRATION


id: bb978b58-e9a7-460e-9f51-3e753fccf345
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

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.

Radiation Dosimetry


id: 53474a7c-bf24-46d2-b2d2-621b9591866a
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

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. Absorbed Radiation Dose Estimates as a Function of Maximum Thyroid Uptake for Sodium Iodide I-123* at Time of Calibration and Expiry Compared to Sodium Iodide I-131
   Estimated Radiation Absorbed Doses
 I-123
mGy/14.8 MBq
(rads/400 μCi)
 I-131
mGy/3.7 MBq
(rads/100 μCi)
 Target Organ  Maximum Thyroid
Uptake (%)
 TOC  TOE  
  *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
  Metabolic model in MIRD Dose Estimate Report 5 followed for I-123 and I-125
  Metabolic model in ICRP 30 followed for Te-121
  Bladder voiding interval 4.8 hours.
 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)
 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)
 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)
 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)
 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)
 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)
 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)
 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)

HOW SUPPLIED


id: c94820d8-f837-43d0-b8a7-662a2bb250b1
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Catalog Number 601,602. Sodium Iodide I 123 is supplied as capsules for oral administration in strengths of 3.7 MBq (100 µCi) (red and white) (NDC 69945-601-10) and 7.4 MBq (200 µCi) (green and white) (NDC 69945-602-20) at time of calibration. Each gelatin capsule contains sucrose as a filler. The capsules are packaged in plastic vials containing one capsule of a single strength per vial. The plastic vial is packaged in a lead shield. A package insert is supplied with each lead shield.

Storage and Handling


id: b37fc9c1-bcb7-4e0e-bada-80e17f59f27d
displayName: STORAGE AND HANDLING SECTION
FDA Article Code: 44425-7

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). Storage and disposal of Sodium Iodide I 123 Capsules should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide. Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2015 Mallinckrodt. Manufactured by: Mallinckrodt Nuclear Medicine LLC
Maryland Heights, MO 63043
Made in USA A601I0           Rev 10/2015 Mallinckrodt™

Pharmaceuticals

PRINCIPAL DISPLAY PANEL – A601C0


id: 8afb057c-97d6-4796-8cb9-45d03d8f96d1
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Sodium Iodide I 123 Capsules

DIAGNOSTIC
For Oral Administration Only
Store at Controlled Room Temperature
20º to 25°C (68º to 77°F)

READ PACKAGE INSERT FOR DIRECTIONS FOR USE

Rx only WARNING: Radioactive drugs must be handled only by qualified personnel in conformity with regulations of the U.S. Nuclear Regulatory Commission or state regulatory agencies where applicable. Bottle containing drug should be kept in this container or within a heavier shield.

Manufactured by:
Mallinckrodt Nuclear Medicine LLC
Maryland Heights, MO 63043
Made in USA

Mallinckrodt™

Pharmaceuticals

CAUTION RADIOACTIVE MATERIAL

A601C0
R10/2015

PRINCIPAL DISPLAY PANEL – A602C0


id: 1b0455b4-4623-4ca6-a11d-56a5299e959e
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Sodium Iodide I 123 Capsules

DIAGNOSTIC
For Oral Administration Only
Store at Controlled Room Temperature
20º to 25°C (68º to 77°F)

READ PACKAGE INSERT FOR DIRECTIONS FOR USE

Rx only

WARNING: Radioactive drugs must be handled only by qualified personnel in conformity with regulations of the U.S. Nuclear Regulatory Commission or state regulatory agencies where applicable. Bottle containing drug should be kept in this container or within a heavier shield.

Manufactured by:
Mallinckrodt Nuclear Medicine LLC
Maryland Heights, MO 63043
Made in USA

CAUTION RADIOACTIVE MATERIAL Mallinckrodt™

Pharmaceuticals