SODIUM IODIDE I 123 capsule, gelatin coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM IODIDE I-123 (UNII: 29UKX3A616) (IODIDE ION I-123 - UNII:98QPV8670C)

Available from:

Curium US LLC

INN (International Name):

SODIUM IODIDE I-123

Composition:

IODIDE ION I-123 100 uCi

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Administration of Sodium Iodide I 123 Capsules is indicated as a diagnostic procedure to be used in evaluating thyroid function and/or morphology. To date there are no known contraindications to the use of Sodium Iodide I 123 Capsules.

Product summary:

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. 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. Curium and the Curium logo are trademarks of a Curium company. ©2018 Curium US LLC. All Rights Reserved. Manufactured by: Curium US LLC Maryland Heights, MO 63043 Made in USA A601I0           R12/2018 CURIUM™

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SODIUM IODIDE I 123- SODIUM IODIDE I 123 CAPSULE, GELATIN COATED
CURIUM US LLC
----------
SODIUM IODIDE I 123 CAPSULES
RX ONLY
_DIAGNOSTIC - FOR ORAL ADMINISTRATION_
DESCRIPTION
Sodium Iodide I 123 (Na
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. 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
123
PHYSICAL CHARACTERISTICS
Iodine-123 decays by electron capture with a physical half-life of
13.2 hours . 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
1
EXTERNAL RADIATION
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
10
10
10
Note that these estimates of attenuation do not take in