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Sodium Iodide I-131

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Overview

What is Sodium Iodide I-131?

Sodium Iodide I 131 (Na I-131) Solution Therapeutic is supplied for oral administration as a stabilized aqueous solution. The solution is available in vials that contain from 185 to 5550 MBq (5 to 150 mCi) iodine-131 at the time of calibration.  Sodium Iodide I 131 Solution Therapeutic is packaged in shielded, screw-cap 15 mL vials.

The solution contains 0.1% sodium bisulfite and 0.2% edetate disodium as stabilizers, 0.5% sodium phosphate anhydrous as a buffer and sodium iodide I-131 at concentrations of 185 or 925 MBq   (5 or 25 mCi) per milliliter.  The pH has been adjusted to between 7.5 and 9. The iodine-131 utilized in the preparation of the solution contains not less than 99% iodine-131 at the time of calibration.  The expiration date is not later than one month after the calibration date. The calibration date and the expiration date are stated on the label.



What does Sodium Iodide I-131 look like?



What are the available doses of Sodium Iodide I-131?

Solution is supplied in 2 concentrations of 5 or 25 mCi per milliliter at the time of calibration.  See full prescribing information for strengths in MBq.

What should I talk to my health care provider before I take Sodium Iodide I-131?

How should I use Sodium Iodide I-131?

Sodium Iodide I 131 Solution Therapeutic is indicated for the treatment of hyperthyroidism and thyroid carcinomas that take up iodide. Palliative effects may be observed in patients with advanced thyroid malignancy if the metastatic lesions take up iodide.

Sodium Iodide I 131 Solution emits radiation and must be handled with safety measures to minimize inadvertent radiation exposure to clinical personnel and patients .


What interacts with Sodium Iodide I-131?

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What are the warnings of Sodium Iodide I-131?

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What are the precautions of Sodium Iodide I-131?

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What are the side effects of Sodium Iodide I-131?

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What should I look out for while using Sodium Iodide I-131?

Sodium Iodide I 131 Solution Therapeutic is contraindicated in:


What might happen if I take too much Sodium Iodide I-131?

In case of exposure to a radioactive dose of sodium iodide I-131 exceeding the intended therapeutic dose provide general supportive care, monitor for bone marrow and thyroid suppression and consider administering a thyroid blocking agent such as potassium iodide (KI) or perchlorate promptly within 4 to 6 hours after the exposure. Thyroid blockade may reduce radiation exposure of thyroid tissue but would not prevent radiation injury to the rest of the body. Assess the benefit of administering a blocking agent against the risk of failure of sodium iodide I-131 therapy.


How should I store and handle Sodium Iodide I-131?

StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and protect from light.StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and protect from light.Sodium Iodide I 131 Solution Therapeutic is supplied in shielded, screw-cap 15 mL vials that contain from 185 to 5550 MBq (5 to 150 mCi) iodine-131 at the time of calibration.  The expiration date is not later than one month after the calibration date. The calibration date and the expiration date are stated on the label. Do not use the product after the expiration date.Storage Store at a controlled room temperature of 20° to 25°C (68° to 77°F). Storage and disposal of Sodium Iodide I 131 Solution Therapeutic 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.The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons li­censed to use byproduct material listed in 10 CFR 35.300, and to persons who hold an equivalent license issued by an Agreement State.Sodium Iodide I 131 Solution Therapeutic is supplied in shielded, screw-cap 15 mL vials that contain from 185 to 5550 MBq (5 to 150 mCi) iodine-131 at the time of calibration.  The expiration date is not later than one month after the calibration date. The calibration date and the expiration date are stated on the label. Do not use the product after the expiration date.Storage Store at a controlled room temperature of 20° to 25°C (68° to 77°F). Storage and disposal of Sodium Iodide I 131 Solution Therapeutic 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.The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons li­censed to use byproduct material listed in 10 CFR 35.300, and to persons who hold an equivalent license issued by an Agreement State.Sodium Iodide I 131 Solution Therapeutic is supplied in shielded, screw-cap 15 mL vials that contain from 185 to 5550 MBq (5 to 150 mCi) iodine-131 at the time of calibration.  The expiration date is not later than one month after the calibration date. The calibration date and the expiration date are stated on the label. Do not use the product after the expiration date.Storage Store at a controlled room temperature of 20° to 25°C (68° to 77°F). Storage and disposal of Sodium Iodide I 131 Solution Therapeutic 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.The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons li­censed to use byproduct material listed in 10 CFR 35.300, and to persons who hold an equivalent license issued by an Agreement State.Sodium Iodide I 131 Solution Therapeutic is supplied in shielded, screw-cap 15 mL vials that contain from 185 to 5550 MBq (5 to 150 mCi) iodine-131 at the time of calibration.  The expiration date is not later than one month after the calibration date. The calibration date and the expiration date are stated on the label. Do not use the product after the expiration date.Storage Store at a controlled room temperature of 20° to 25°C (68° to 77°F). Storage and disposal of Sodium Iodide I 131 Solution Therapeutic 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.The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons li­censed to use byproduct material listed in 10 CFR 35.300, and to persons who hold an equivalent license issued by an Agreement State.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Taken orally, sodium iodide I-131 is rapidly absorbed and distributed within the extracellular fluid of the body.  The iodide is concentrated in the thyroid via the sodium/iodide symporter, and subsequently oxidized to iodine.  The destruction of thyroidal tissue is achieved by the beta emission of sodium iodide I-131. 

Non-Clinical Toxicology
Sodium Iodide I 131 Solution Therapeutic is contraindicated in:

Sodium iodide I-131 may cause thyroiditis with gland enlargement and release of thyroid hormone, particularly when used to treat hyperthyroidism.  The thyroiditis may cause or worsen hyperthyroidism and may cause thyroid storm.  When treating hyperthyroidism, consider pre-treatment with anti-thyroid medication to help deplete the thyroid hormone content within the gland.  Discontinue the anti-thyroid medication at least three days before administration of sodium iodide I-131.  Consider beta-blocker therapy before administration of sodium iodide I-131 to minimize the risk of hyperthyroidism and thyroid storm.  

The following serious adverse reactions are described below and elsewhere in labeling:

Radiation-related adverse reactions are a function of the dose level received by the patient.

The following adverse reactions have been reported with doses of sodium iodide I-131 used in the treatment of benign disease, such as hyperthyroidism:

The following adverse reactions have been reported with doses of sodium iodide I-131 used in the treatment of malignant disease:

              * In patients with iodine-avid brain metastases              ** In patients with iodine-avid lung metastases

Adverse reactions that occur after treatment of benign disease may also occur after treatment of malignant disease. Tenderness, pain on swallowing, sore throat, and cough have been reported, generally around the third day after sodium iodide I-131 administration.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

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Interactions

Interactions

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