Description
Ioflupane I 123 is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents, which may be used to find and treat certain diseases or to study the function of the body's organs.
Ioflupane I 123 is used in a procedure called single photon emission computed tomography (SPECT) scan to help your doctor see an image of your brain. This medicine helps to determine if you have symptoms (tremors) that are caused by Parkinsonian syndromes (e.g., Parkinson's disease, multiple system atrophy, and progressive supranuclear palsy).
This medicine is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Ioflupane I 123 is not indicated for use in children. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ioflupane I 123 in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in this population.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:
- Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins before you have a SPECT scan.
You will need to urinate right away and as often as possible for 48 hours after receiving this medicine. Drink plenty of fluids before and after receiving this medicine so you will pass more urine.
Precautions
It is very important that your doctor check your progress very closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.
This medicine may cause allergic reactions. Tell your doctor right away if you have difficulty with breathing or swallowing; fever; hives; itching skin; nausea; reddening of the skin, especially around the ears; swelling of the eyes, face, or inside of the nose; or unusual tiredness or weakness after you have receive this medicine.
While receiving this medicine, you will be exposed to radiation. If you have any questions about this, talk to your doctor.
You will receive a medicine such as potassium iodide, Lugol's solution, or potassium perchlorate before receiving Ioflupane I 123. These medicines will help protect your thyroid gland from radiation (iodine 123). Tell your doctor if you have had an allergic reaction to these medicines or other products containing iodine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Incidence not known
- Difficulty with breathing or swallowing
- fever
- hives
- itching skin
- nausea
- reddening of the skin, especially around the ears
- swelling of the eyes, face, or inside of the nose
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common or rare
- Dizziness or lightheadedness
- dry mouth
- feeling of constant movement of self or surroundings
- headache
- sensation of spinning
Incidence not known
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
