Ioflupane I-123 is in a group of drugs called diagnostic radiopharmaceuticals (RAY dee oh far ma SOO tik als). Ioflupane I-123 is a radioactive agent that allows images of the brain to be detected by a gamma camera.

Ioflupane I-123 is used to detect brain signs of Parkinson's disease in people with symptoms such as tremors, loss of balance or coordination, shuffling walk, or other movement problems.

Ioflupane I-123 may also be used for purposes not listed in this medication guide.

Before using ioflupane I-123 tell your doctor about all your medical conditions or allergies, all medicines you use, and if you are pregnant or breastfeeding.

Ioflupane I-123 is given as an infusion into a vein. A healthcare provider will give you this injection about 3 to 6 hours before your radiologic test.

At least 1 hour before you are treated with ioflupane I-123, you will be given a liquid drink that contains medicine to protect your thyroid from harmful radioactive effects of ioflupane I-123.

Drink plenty of liquid before you receive ioflupane I-123, and for at least 48 hours afterward. Follow your doctor's instructions about the types and amount of liquids you should drink before and after your test. Ioflupane I-123 is radioactive and it can cause dangerous effects on your bladder if it is not properly eliminated from your body through urination.

Expect to urinate often during the first 48 hours after your test. You will know you are getting enough extra fluid if you are urinating more than usual during this time. Urinating often will help rid your body of the radioactive iodine.

Usual Adult Dose for Computed Tomography:

111 to 185 MBq (3 to 5 mCi) intravenously after administration of thyroid blocking agent

Thyroid Blocking Agent:
-Administer Potassium Iodide Oral Solution or Lugol's Solution (equivalent to 100 mg iodide) or potassium perchlorate (400 mg) to block uptake of iodine 123 by the patient's thyroid at least 1 hour before using this drug.

Comments:
-Begin single photon emission computed tomography (SPECT) imaging 3 to 6 hours following administration of this drug.
-Dosing is based upon the radioactivity determined using a suitably calibrated instrument immediately prior to administration.

Uses:
-Visualization of striatal dopamine transporter using SPECT brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS).
-To help differentiate essential tremor from tremor due to PS (idiopathic Parkinson's disease, multiple system atrophy and progressive supranuclear palsy).
-As an adjunct to other diagnostic evaluations.

You should not receive ioflupane I-123 if you are allergic to it. Tell your doctor if you have ever had any type of reaction to another contrast agent, or to iodine.

Tell your doctor if you have ever had:

• a thyroid disorder;

• kidney disease;

• liver disease; or

• if you have ever had an allergic reaction to potassium iodide or Lugol's Solution.

Older adults may need kidney function tests before receiving ioflupane I-123. Your kidney function may also need to be watched closely after you have received ioflupane I-123.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

You should not breastfeed within 6 days after using ioflupane I-123. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Since ioflupane I-123 is used only given once before your radiologic test, it does not have a daily dosing schedule.

Call your doctor if you will not be able to complete your radiologic test within 3 to 6 hours after you receive your injection.

Since ioflupane I-123 is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Do not allow yourself to become dehydrated during the first few days after receiving ioflupane I-123. Follow your doctor's instructions about the type and amount of liquids you should drink.

Get emergency medical help if you have any of these signs of an allergic reaction: hives, itching, skin redness; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects of ioflupane I-123 may include:

• pain, swelling, burning, or irritation around the IV needle;

• headache;

• dizziness, spinning sensation;

• dry mouth; or

• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• buspirone;

• a diet pill or stimulant medicine;

• ADHD medications--amoxapine, amphetamine, methamphetamine, methylphenidate, Adderall, Ritalin, and others;

• an antidepressant--bupropion, citalopram, paroxetine, sertraline; or

• medicine to treat Parkinson's disease--benztropine, selegiline.

This list is not complete. Other drugs may affect ioflupane I-123, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.