Sodium Iodide I 123 100 uCi/1
Sodium Iodide I 123 · CAPSULE, GELATIN COATED · Cardinal Health 418, Inc
Sodium Iodide I 123 is a capsule, gelatin coated containing sodium iodide i 123 at 100 uCi/1, taken oral. Manufactured by Cardinal Health 418, Inc.
Key Facts
- Brand Name
- Sodium Iodide I 123
- Generic Name
- Sodium Iodide I 123
- NDC Code (Product)
48815-1001- Manufacturer
- Cardinal Health 418, Inc
- Strength
- 100 uCi/1
- Dosage Form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA018671
- Marketing Start
- 01/02/2003
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Administration of Sodium Iodide I 123 Capsules is indicated as a diagnostic procedure to be used in evaluating thyroid function and/or morphology.
Dosage & Administration
DOSAGE AND ADMINISTRATION 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 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,…
Warnings
WARNINGS 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.
Contraindications
CONTRAINDICATIONS To date there are no known contraindications to the use of Sodium Iodide I 123 Capsules.
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.
Frequently Asked Questions
What is Sodium Iodide I 123 used for?
Sodium Iodide I 123 contains Sodium Iodide I 123. It is a capsule, gelatin coated taken oral. Consult your doctor for specific uses.
Is Sodium Iodide I 123 a controlled substance?
Sodium Iodide I 123 is not classified as a controlled substance by the DEA.
What is the generic name for Sodium Iodide I 123?
The generic name for Sodium Iodide I 123 is Sodium Iodide I 123. There are 2 other brand versions of Sodium Iodide I 123.
What is the NDC code for Sodium Iodide I 123 100 uCi/1?
The NDC (National Drug Code) for Sodium Iodide I 123 100 uCi/1 is 48815-1001, listed by Cardinal Health 418, Inc.