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Indications
Dosage
How Supplied

INDICATIONS

Therapeutic doses of Sodium Iodide I 131 Solution USP prepared with HICON™ are indicated for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid.

DOSAGE AND ADMINISTRATION

The concentrated Sodium Iodide I 131 Solution USP provided with HICON™ must not be used for direct administration to patients. It must be diluted and prepared as described in the Drug Handling And Dosage Form Preparation section.

The recommended dosage for orally administered Sodium Iodide I 131 Solution USP is based on the thyroid gland uptake as well as the size of the gland. Thyroidal uptake and size should be determined by the physician prior to treatment and may be useful in calculating the therapeutic dose to be administered to the individual patient. Recommended dosages of orally administered Sodium Iodide I-131 are:

Disease Therapy

Antihyperthyroid Therapy: Oral dose of 148 to 370 megabecquerels (4 to 10 millicuries).

Toxic nodular goiters and other serious thyroid conditions may require larger dosages.

Antineoplastic Ablation of normal thyroid tissue: Initial oral dose of 1.1 to 3.7 gigabecquerels (30 to 100 millicuries).

Subsequent ablation of metastases with oral dose of 3.7 to 7.4 giga-becquerels (100 to 200 millicuries).

General Dosing Information

Patients should be adequately hydrated before and after administration of radioiodide to assure rapid urinary elimination of the iodide that is not absorbed by the thyroid gland.

Radiation Dosimetry

Following administration of Sodium Iodide I-131, about 40 percent of the activity has an effective half-life of 0.34 days and 60 percent has an effective half-life of 7.61 days. On this basis, the estimated absorbed radiation dose to an average adult (70 kg) from an oral dose of 370 MBq (10 mCi) of Sodium Iodide I-131 is shown in Table 4.

Table 4 : Absorbed Radiation Doses I-131

Tissue mGy/370 MBq Rads/10 mCi
Thyroid 350,000 350,000
Testes 92 9.2
Ovaries 93 9.3
Whole body 160 16.0

Method of Calculation: A Schema for Absorbed-Dose Calculations for Biologically Distributed Radionuclides, MIRD Pamphlet No. 1, J Nucl Med Suppl, 1:7, 1968.

Drug Handling And Final Dosage Form Preparation

Drug Handling
  1. The concentrated Sodium Iodide I 131 Solution USP provided with HICON™ should not be used after the expiration date stated on the container label.
  2. The solution should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The solution should not be used if cloudy, discolored, or found to contain particulate matter. However, it is well known that glass tends to darken in the presence of high radioactivity.
  3. Care should be taken to minimize radiation exposure to the patient consistent with proper patient management and to insure minimum radiation exposure to occupational workers. Waterproof gloves should be used during the entire handling and administration procedure. Adequate shielding should be maintained during the life of the product.
Preparation of Dilute Sodium Iodide I 131 Solution USP
  1. Using the calibration date and radionuclidic concentration on the label of the product vial, calculate the required volume to produce the necessary dose in MBq or mCi.
  2. Using a shielded syringe, remove the required volume.
  3. Using the shielded syringe, transfer the required volume to a suitably shielded receiving vial.
  4. Add diluent solution to the receiving vial to produce a final dose of the desired volume. The recommended diluent is Purified Water USP containing 0.2 % Sodium Thiosulfate USP as a reducing agent. The use of acidic diluents may cause the pH to drop below 7.5 and stimulate the volatilization of Iodine I-131 hydriodic acid.
  5. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
  6. The finished preparation should not be used after the expiration date stated on the container label.
Preparation of Sodium Iodide I 131 Capsules USP

1. The kit includes one large gelatin capsule and one small gelatin capsule for each dose prepared. Each large capsule is empty and each small capsule contains approximately 300 mg of Dibasic Sodium Phosphate Anhydrous USP as the absorbing buffer.

2. Using the calibration date and radionuclidic concentration on the label of the product vial, calculate the required volume to produce the necessary dose in MBq or mCi.

3. Open one LARGE capsule by pulling apart the capsule into two pieces as illustrated below:

Pull apart the capsule into two pieces - Illustration

4. Insert an unopened SMALL capsule into the bottom half of the empty large capsule as illustrated below:

Insert an unopened SMALL capsule into the bottom half of the empty large capsule - Illustration

5. With an appropriate syringe, withdraw the required volume of Sodium Iodide I 131 Solution USP (maximum 150 μL) from the vial as illustrated below:

Withdraw the required volume - Illustration

6. Inject into the center of the SMALL capsule through the top as illustrated below:

Inject into the center of the SMALL capsule - Illustration

7. Slip the upper half of the large capsule over the bottom half to completely cover the small capsule and push down gently until locked as illustrated below:

Slip the upper half of the large capsule over the bottom half - Illustration

8. After dispensing, the patient dose should be measured in a suitable radioactivity calibration system immediately prior to administration.

9. Store the capsule in a suitable polypropylene container and place inside a lead pot until use. The capsule should be used within seven days.

HOW SUPPLIED

Each HICON™ kit of 9.25 GBq (250 mCi) includes:

  1. a blister package of ten small hard gelatin capsules each containing approximately 300 mg of Dibasic Sodium Phosphate Anhydrous USP as absorbing buffer.
  2. a blister package of ten empty large hard gelatin capsules.
  3. a 1 mL vial containing 0.25 mL of Sodium Iodide I 131 Solution USP, therapeutic oral solution containing approximately 9.25 GBq (250 mCi) at time of calibration.

Each HICON™ kit of 18.5 GBq (500 mCi) includes:

  1. two blister packages of ten small hard gelatin capsules each containing approximately 300 mg of Dibasic Sodium Phosphate Anhydrous USP as absorbing buffer.
  2. two blister packages of ten empty large hard gelatin capsules.
  3. a 1 mL vial containing 0.5 mL of Sodium Iodide I 131 Solution USP, therapeutic oral solution containing approximately 18.5 GBq (500 mCi) at time of calibration.

Each HICON™ kit of 37 GBq (1,000 mCi) includes:

  1. four blister packages of ten small hard gelatin capsules each containing approximately 300 mg of Dibasic Sodium Phosphate Anhydrous USP as absorbing buffer.
  2. four blister packages of ten empty large hard gelatin capsules.
  3. a 1 mL vial containing 1 mL of Sodium Iodide I 131 Solution USP, therapeutic oral solution containing approximately 37 GBq (1,000 mCi) at time of calibration.

Each mL of the aqueous product that comes with HICON™ contains:

37 gigabecquerels of Sodium Iodide I-131
< 2.0 mg of Disodium Edetate Dihydrate USP
< 4.4 mg of Sodium Thiosulphate Pentahydrate USP
< 40 mg of Dibasic Sodium Phosphate Anhydrous USP

Complete assay data are available on the container.

Storage

The Sodium Iodide I 131 Solution USP provided with HICON™ should be stored between 2° C and 25° C (36° F and 77° F).

NDC 65174-880-25 (for 250 mCi vial size)
NDC
65174-880-50 (for 500 mCi vial size)
NDC 65174-880-00 (for 1,000 mCi vial size)

Manufactured by: Jubilant DraxImage Inc., Kirkland, Québec, Canada.

Last reviewed on RxList: 10/6/2011
This monograph has been modified to include the generic and brand name in many instances.

Indications
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