{"adverse_reactions":["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. Allergic type reactions have been reported infrequently following the administration of iodine-containing radiopharmaceuticals."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility in male or female animals."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY 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 concentrated and organically bound by the thyroid and concentrated by the stomach, choroid plexus, and salivary glands. It is also promptly excreted by the kidneys. The normal range of urinary excretion in 24 hours is reported to be 37% to 75% of the administered dose, varying with thyroid and renal function. The iodide concentrating mechanism of the thyroid, variously termed the iodide \"trap\" or \"pump,\" accounts for an iodide concentration approximately 25 times that of the plasma level, but may increase to as much as 500 times under certain conditions. \"Trapped\" iodide is oxidized to iodine and organically incorporated so rapidly that the trap contains less than 0.2% free iodide in comparison to organically bound iodine. This process results in a further concentration of iodine in the thyroid gland to about 500-fold that of blood. The iodinated organic compounds consist chiefly of thyroxine (T4) and triiodothyronine (T3), which are bound to thyroglobulin in the follicular colloid. The T4 and T3 are released by enzymatic proteolysis of thyroglobulin into the blood, where they are specifically bound and transported by plasma thyroid binding proteins. These reactions are mostly under the control of anterior-pituitary thyroid stimulating hormone (TSH) and hypothalamic thyroid releasing factor (TRF). Thyroid uptake is usually increased in hyperthyroidism and in goiter with impaired hormone synthesis. Uptake is usually decreased in hypothyroidism and normal or decreased in hyperthyroidism treated with iodide. It should be noted that the uptake of tracer iodine is a function of stable iodide concentration in the serum as well as of alterations in thyroid physiology."],"contraindications":["CONTRAINDICATIONS None known."],"description":["DESCRIPTION Sodium Iodide I 123 (I-123) for diagnostic use is supplied as capsules for oral administration. At calibration time, each capsule has an activity of 3.7 MBq (100 microCi) or 7.4 MBq (200 microCi). Each gelatin capsule contains not more than 20 mcg of sodium hydroxide, not more than 3 mcg of sodium thiosulfate, and not more than 1 g of sucrose. Sodium iodide is an odorless and colorless compound, freely soluble in water. The I-123 is produced in an accelerator by bombardment of enriched Xe-124 with protons [Xe-124 (p,2n) Cs-123 → Xe-123 → I-123]. The radionuclidic composition at calibration time is not less than 99.5% I-123 and not more than 0.5% all other nuclides (Te-121, I-125, I-131, I-126, I-124, I-130, I-121 and Na-24). The radionuclidic composition at expiration time is not less than 98.28% I-123 and not more than 1.72% all other nuclides (Te-121, I-125, I-131, I-126, I-124, I-130, I-121 and Na-24). Molecular Formula: Na 123 I Molecular Weight: 145.99"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION The recommended oral dose range of Sodium Iodide I 123 capsules for diagnostic studies of thyroid function in the average adult patient (70 kg) is 3.7 MBq (100 microCi) to 14.8 MBq (400 microCi). The lower portion of the range 3.7 MBq (100 microCi) is recommended for uptake studies alone, and the higher portion 14.8 MBq (400 microCi) for thyroid imaging. Concentration of I-123 in the thyroid gland should be measured in accordance with standardized procedures. Consideration should be given to the use of proper instrumentation in thyroid imaging with Sodium Iodide I 123 capsules. The determination of I-123 concentration in the thyroid gland may be initiated at six hours after administration of the dose. Use contents of the capsule up to 24 hours after calibration time and date. Thereafter, discard the capsule with its contents. The user should wear waterproof gloves at all times when handling the capsule. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration."],"effective_time":"20241120","general_precautions":["General The contents of the capsule are radioactive. Adequate shielding of the preparation must be maintained at all times. Do not use after the expiration time and date (24 hours after calibration time) stated on the label. The uptake of I-123 may be decreased by recent administration of iodinated contrast materials, by intake of stable iodine in any form, or by thyroid, antithyroid, and certain other drugs. Accordingly, the patient should be questioned carefully regarding diet, previous medication, and procedures involving radiographic contrast media. Sodium Iodide I 123 capsules, as well as other radioactive drugs, must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. Care should also be taken to minimize radiation exposure to the patient consistent with proper patient management. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides."],"geriatric_use":["Geriatric Use Clinical studies of Sodium Iodide I 123 capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function."],"how_supplied":["HOW SUPPLIED Sodium Iodide I 123 capsules for oral administration are supplied as follows: 3.7 MBq (100 microCi) (Product No. 2033), orange capsule: NDC 17156-370-05 7.4 MBq (200 microCi) (Product No. 2034), orange & white capsule: NDC 17156-740-05 At calibration time, each capsule has an activity of 3.7 MBq (100 microCi) or 7.4 MBq (200 microCi). Each gelatin capsule contains not more than 20 mcg of sodium hydroxide, not more than 3 mcg of sodium thiosulfate, and not more than 1 g of sucrose. The single-dose capsule is supplied with a desiccant in a plastic container that is enclosed in a labeled lead shield. This radiopharmaceutical is licensed by the Illinois Emergency Management Agency for distribution to persons licensed pursuant to 32 Ill. Admin. Code Section 330.260(c) and Section 335, Subpart D, 335.3010 and Subpart E, 335.4010 or under equivalent licenses of an Agreement State or a Licensing State. STORAGE Store capsule at room temperature below 30°C (86°F). Do not use and discard capsule 24 hours after calibration time and date. DISPOSAL Users should monitor the amount of radioactivity present prior to disposal of this product. Storage and/or disposal of Sodium Iodide I 123 capsules should be in accordance with the conditions of Agreement State licenses and regulations, or other regulatory agency authorized to license the use of radionuclides."],"how_supplied_table":["
3.7 MBq (100 microCi) (Product No. 2033), orange capsule:NDC 17156-370-05
7.4 MBq (200 microCi) (Product No. 2034), orange & white capsule:NDC 17156-740-05
"],"id":"6ed48b52-d8bc-43a1-a7c7-84b64bd614df","indications_and_usage":["INDICATIONS AND USAGE Sodium Iodide I 123 capsules are indicated for use in the evaluation of thyroid function and/or morphology."],"nursing_mothers":["Nursing Mothers Since I-123 is excreted in human milk, formula-feeding should be substituted for breast-feeding if the agent must be administered to the mother during lactation."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 3.7 MBq Capsule Box Label Product No. 2033 Contains sodium iodide I-123, carrier-free. Rx Only Recommended Dosage: See Prescribing Information Store at room temperature below 30°C (86°F). Expiration Time: 24 hours after calibration time and date. NDC 17156-370-05 Sodium Iodide I 123 3.7 MBq (100 microCi) Capsules For Oral Use Only CAUTION RADIOACTIVE MATERIAL 41NS-2033 Mfd by: GE Healthcare Medi-Physics, Inc., Arlington Heights, IL 60004 Mfd for: NorthStar Medical Radioisotopes, LLC, Beloit, WI 53511 NorthStar ® MEDICAL RADIOISOTOPES, LLC NUMBER OF CAPSULES: 1 CALIB. DATE: DDMMMYYYY ACTIVITY PER CAPSULE: 3.7 MBq (100 microCi) TIME: 1200 PXT TOTAL ACTIVITY: 3.7 MBq (100 microCi) LOT NO.: 2033NS- YYXXXN PRINCIPAL DISPLAY PANEL - 3.7 MBq Capsule Box Label","PRINCIPAL DISPLAY PANEL - 7.4 MBq Capsule Box Label Product No. 2034 Contains sodium iodide I-123, carrier-free. Rx Only Recommended Dosage: See Prescribing Information Store at room temperature below 30°C (86°F). Expiration Time: 24 hours after calibration time and date NDC 17156-740-05 Sodium Iodide I 123 7.4 MBq (200 microCi) Capsules For Oral Use Only CAUTION RADIOACTIVE MATERIAL 41NS-2034 Mfd by: GE Healthcare Medi-Physics, Inc., Arlington Heights, IL 60004 Mfd for: NorthStar Medical Radioisotopes, LLC, Beloit, WI 53511 NorthStar ® MEDICAL RADIOISOTOPES, LLC NUMBER OF CAPSULES: 1 CALIB. DATE: DDMMMYYYY ACTIVITY PER CAPSULE: 7.4 MBq (200 microCi) TIME: 1200 PXT TOTAL ACTIVITY: 7.4 MBq (200 microCi) LOT NO.: 2034NS- YYXXXN PRINCIPAL DISPLAY PANEL - 7.4 MBq Capsule Box Label"],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"precautions":["PRECAUTIONS General The contents of the capsule are radioactive. Adequate shielding of the preparation must be maintained at all times. Do not use after the expiration time and date (24 hours after calibration time) stated on the label. The uptake of I-123 may be decreased by recent administration of iodinated contrast materials, by intake of stable iodine in any form, or by thyroid, antithyroid, and certain other drugs. Accordingly, the patient should be questioned carefully regarding diet, previous medication, and procedures involving radiographic contrast media. Sodium Iodide I 123 capsules, as well as other radioactive drugs, must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. Care should also be taken to minimize radiation exposure to the patient consistent with proper patient management. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility in male or female animals. Pregnancy 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 reproduction capacity. Sodium Iodide I 123 capsules should be given to a pregnant woman only if clearly needed. Ideally, examinations using radiopharmaceuticals, especially those elective in nature, in women of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses. Nursing Mothers Since I-123 is excreted in human milk, formula-feeding should be substituted for breast-feeding if the agent must be administered to the mother during lactation. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies of Sodium Iodide I 123 capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function."],"pregnancy":["Pregnancy 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 reproduction capacity. Sodium Iodide I 123 capsules should be given to a pregnant woman only if clearly needed. Ideally, examinations using radiopharmaceuticals, especially those elective in nature, in women of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses."],"set_id":"0cf4a157-8cc7-4fcf-a96a-c6d1b247099b","spl_product_data_elements":["SODIUM IODIDE I-123 SODIUM IODIDE I-123 SODIUM IODIDE I-123 IODIDE ION I-123 Sodium Thiosulfate Sucrose Sodium Hydroxide SODIUM IODIDE I-123 SODIUM IODIDE I-123 SODIUM IODIDE I-123 IODIDE ION I-123 Sodium Thiosulfate Sucrose Sodium Hydroxide orange and white"],"spl_unclassified_section":["Rx ONLY","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 Kocher, David C., Radioactive Decay Data Tables, DOE/TIC-11026, 122 (1981) Radiation Mean %/Disintegration Mean Energy (keV) Gamma-2 83.4 159","EXTERNAL RADIATION The specific gamma ray constant for I-123 is 11.2 µC/Kg-MBq-hr (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 coefficients of attenuation of the radiation emitted by this radionuclide can be achieved by the interposition of various thicknesses of Pb and 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 Method of Calculation: Data supplied by Oak Ridge Associated Universities, Radiopharmaceutical Internal Dose Information Center, 1984. Shield Thickness (Pb) cm Coefficient of Attenuation 0.005 0.5 0.1 10 -1 0.88 10 -2 1.63 10 -3 2.48 10 -4 To permit correction for the physical decay of I-123, the fractions that remain at selected intervals after the time of calibration are shown in Table 3. Table 3. Physical Decay Chart: Iodine-123, Half-Life 13.2 Hours Hours Fraction Remaining 0 Calibration Time 1 3 0.854 6 0.73 9 0.623 12 0.533 15 0.455 18 0.389 21 0.332 24 0.284","RADIATION DOSIMETRY The estimated absorbed radiation doses to several organs of an average patient (70 kg) from oral administration of 14.8 MBq (400 microCi) of I-123 are shown in Table 4 for thyroid uptakes of 5%, 15%, and 25%. The figures in Table 4 represent the maximum possible absorbed radiation dose when the recommended dose of Sodium Iodide I 123 capsules are administered at calibration or at expiry. Table 4. Radiation Dose Estimates for I-123 Sodium Iodide Estimated Radiation Absorbed Dose TOC Concentrations assumed by Oak Ridge for calculations: Time of Calibration: 99.5% I-123, 0.5% Te-121. Time of Expiry: 98.3% I-123, 1.7% Te-121. TOE Organ Maximum Thyroid Update (%) mGy 14.8 MBq rad 400 microCi mGy 14.8 MBq rad 400 microCi I-123 data supplied by Oak Ridge Associated Universities, Radiopharmaceutical Internal Dose Information Center, 1991. Bladder (voiding interval = 4.8 hrs.) 5 1.4 0.14 1.5 0.15 15 1.3 0.13 1.4 0.14 25 1.2 0.12 1.3 0.13 Stomach Wall 5 0.98 0.098 1 0.1 15 0.91 0.091 0.96 0.096 25 0.83 0.083 0.89 0.089 Small Intestine 5 0.26 0.026 0.37 0.037 15 0.25 0.025 0.36 0.036 25 0.23 0.023 0.34 0.034 Liver 5 0.1 0.01 0.15 0.015 15 0.1 0.01 0.15 0.015 25 0.097 0.0097 0.15 0.015 Ovaries 5 0.22 0.022 0.34 0.034 15 0.21 0.021 0.32 0.032 25 0.2 0.02 0.31 0.031 Bone Surfaces 5 0.14 0.014 0.19 0.019 15 0.15 0.015 0.2 0.02 25 0.16 0.016 0.21 0.021 Red Marrow 5 0.1 0.01 0.15 0.015 15 0.1 0.01 0.16 0.016 25 0.1 0.01 0.16 0.016 Testes 5 0.11 0.011 0.19 0.019 15 0.094 0.0094 0.19 0.019 25 0.089 0.0089 0.18 0.018 Thyroid 5 9.5 0.95 9.5 0.95 15 29 2.9 29 2.9 25 51 5.1 51 5.1 Total Body 5 0.11 0.011 0.16 0.016 15 0.12 0.012 0.17 0.017 25 0.13 0.013 0.18 0.018","Manufactured for: NorthStar Medical Radioisotopes, LLC Beloit, WI 53511 1-844-438-6659 Manufactured by: GE Healthcare Medi-Physics, Inc. Arlington Heights, IL 60004 Revised March 2024"],"spl_unclassified_section_table":["
Table 1. Principal Radiation Emission DataKocher, David C., Radioactive Decay Data Tables, DOE/TIC-11026, 122 (1981)
RadiationMean %/DisintegrationMean Energy (keV)
Gamma-283.4159
","
Table 2. Radiation Attenuation by Lead ShieldingMethod of Calculation: Data supplied by Oak Ridge Associated Universities, Radiopharmaceutical Internal Dose Information Center, 1984.
Shield Thickness (Pb) cmCoefficient of Attenuation
0.0050.5
0.110-1
0.8810-2
1.6310-3
2.4810-4
","
Table 3. Physical Decay Chart: Iodine-123, Half-Life 13.2 Hours
HoursFraction Remaining
0Calibration Time1
30.854
60.73
90.623
120.533
150.455
180.389
210.332
240.284
","
Table 4. Radiation Dose Estimates for I-123 Sodium Iodide
Estimated Radiation Absorbed Dose
TOCConcentrations assumed by Oak Ridge for calculations: Time of Calibration: 99.5% I-123, 0.5% Te-121. Time of Expiry: 98.3% I-123, 1.7% Te-121.TOE
OrganMaximum Thyroid Update (%)mGy 14.8 MBqrad 400 microCimGy 14.8 MBqrad 400 microCi
I-123 data supplied by Oak Ridge Associated Universities, Radiopharmaceutical Internal Dose Information Center, 1991.
Bladder (voiding interval = 4.8 hrs.)51.40.141.50.15
151.30.131.40.14
251.20.121.30.13
Stomach Wall50.980.09810.1
150.910.0910.960.096
250.830.0830.890.089
Small Intestine50.260.0260.370.037
150.250.0250.360.036
250.230.0230.340.034
Liver50.10.010.150.015
150.10.010.150.015
250.0970.00970.150.015
Ovaries50.220.0220.340.034
150.210.0210.320.032
250.20.020.310.031
Bone Surfaces50.140.0140.190.019
150.150.0150.20.02
250.160.0160.210.021
Red Marrow50.10.010.150.015
150.10.010.160.016
250.10.010.160.016
Testes50.110.0110.190.019
150.0940.00940.190.019
250.0890.00890.180.018
Thyroid59.50.959.50.95
15292.9292.9
25515.1515.1
Total Body50.110.0110.160.016
150.120.0120.170.017
250.130.0130.180.018
"],"storage_and_handling":["STORAGE Store capsule at room temperature below 30°C (86°F). Do not use and discard capsule 24 hours after calibration time and date.","DISPOSAL Users should monitor the amount of radioactivity present prior to disposal of this product. Storage and/or disposal of Sodium Iodide I 123 capsules should be in accordance with the conditions of Agreement State licenses and regulations, or other regulatory agency authorized to license the use of radionuclides."],"version":"4","warnings":["WARNINGS Females of childbearing age and pediatric patients under 18 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."]}