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:

Cardinal Health 418, Inc

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 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:

Sodium Iodide I 123 is supplied as capsules for oral administration in strengths of 3.7 MBq (100 µCi) and 7.4 MBq (200 µCi) at time of calibration. Each gelatin capsule contains 0.45 - 0.65 g of sucrose. The capsules are packaged in plastic vials containing either one or five capsules of a single strength per vial. The plastic vial is packaged in a lead shield with a label identical to that affixed to the plastic vial. A package insert is supplied with each lead shield. The -I (Iodine) content for a 100 µCi capsule is 5.2 ng and the -I content for a 200 µCi capsule is 10.4 ng at TOC. Dispense and preserve capsules in well-closed containers that are adequately shielded. Store at room temperature, below 86°F. The contents of the capsules are radioactive. Adequate shielding and handling precautions must be maintained. THIS PACKAGE INSERT ISSUED APRIL 2018 Cardinal Health Denver, CO 80011     [phone] Sodium Iodide I 123 1-020-16

Authorization status:

New Drug Application

Summary of Product characteristics

SODIUM IODIDE I 123- SODIUM IODIDE I 123 CAPSULE, GELATIN COATED
CARDINAL HEALTH 418, INC
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SODIUM IODIDE I 123
DIAGNOSTIC-CAPSULES
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. Each capsule contains 0.3 µg - 3 µg Sodium
Thiosulfate as a stabilizer.
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 all others (I 121 or 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 all others. The ratio of the concentration of I 123 and I
125 changes with time. Graph 1
shows the maximum concentration of each as a function of time.
GRAPH 1 RADIONUCLIDIC CONCENTRATION OF I 123 AND I 125
PHYSICAL CHARACTERISTICS
Sodium Iodide I 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
Kocher, David C., Radioactive Decay Data Tables, DOE/TIC-11026, 122,
(1981)
RADIATION
MEAN %/DISINTEGRATION
MEAN ENERGY
(KEV)
Gamma-2
83.4
159
123
1
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
Shleien, Bernard, The Health Physics and Radiological Health Handbook,
Table 6.1.2, 169, (1992)
SHIELD THICKNESS (PB), CM
COEFFICIENT OF ATTENUATION
0.036
0.5
0.120