DRAXIMAGE® I-131 Diagnostic Capsules

Indications

Sodium Iodide I-131 is indicated for use in performance of the radioactive iodide (RAI) uptake test to evaluate thyroid function. Diagnostic doses may also be employed in localizing metastases associated with thyroid malignancies.

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Assessment of thyroid function and structure through the use of nuclear medicine procedures represents one of the most basic, valuable and still frequently used, techniques in ongoing nuclear medicine practices. The thyroid gland iodine uptake values reflect early phases of the thyroid hormone production relative to the overall thyroid gland function. Iodine uptake studies confirm the thyroid will take up iodine and determine how much.

Common indications for radionuclide thyroid imaging are to differentiate between various types of hypo- or hyperfunction, to assess nodularity and/or ectopic thyroid tissue or evaluation of thyroid cancer and possible metastases – especially after thyroid ablation or surgery.

 

DX-CAPS

Product Overview

Product Name

Sodium Iodide I 131 Capsule Diagnostic USP – Oral

Indications

Sodium iodide I-131 is indicated for the assessment & evaluation of thyroid function.

Description

The capsules are composed of one opaque white half, while the other half is an opaque pink, yellow, orange, grey or green. The capsules are packaged in plastic vials containing 5 capsules and one desiccant packet.

Each capsule contains 3.7 MBq (100 μCi) at time of calibration. The capsule will yield 2.03, 1.11, 0.61, or 0.33 MBq (55, 30, 16.5, or 9 μCi) according to the color-coded decay calendar, which assigns a color and capsule activity for each week of the year. You are invited to consult the color-coded decay calendar provided to help establish which colored capsule is required for your prescribed dose, or calculate correct dosage from the date and time of calibration provided on the container label.

Contraindication

Sodium Iodide I-131 is contraindicated for use in women who are or may become pregnant. Iodine-131 may cause harm to the fetal thyroid gland when administered to pregnant women. Review of the literature has shown that transplacental passage of radioiodide may cause severe, and possibly irreversible, hypothyrodism in neonates. Use of Sodium Iodide I-131 in women of childbearing age should be deferred until the possibility of pregnancy has been ruled out. If this drug is administered to a woman with reproductive potential, the patient should be apprised of the potential hazard to a fetus.Product Insert

Product Insert

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Material Safety Data

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2017 Calendar

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Not all Iodine-131 Is Created Equal

To support health care professionals who care for patients with thyroid conditions like thyroid cancer and hyperthyroidism, Jubilant DraxImage is committed to providing pharmaceutical grade radioactive iodine for accurate diagnosis.

DISCLAIMER:

This information is not intended as medical advice. Responsibility for patient care resides with the healthcare professional on the basis of his or her professional license, experience and knowledge of the patient. For full Prescribing Information including indications, contraindications, warnings, precautions and adverse events, please see the appropriate product labeling.