Pentetate calcium trisodium (Intravenous, Inhalation)

Pentetate Calcium Trisodium is used to get rid of harmful substances, like plutonium, americium, or curium from your body.

This medicine is only available with your doctor's prescription.

To prevent radiation contamination of other people or the environment:

• Use a normal toilet instead of a urinal
• Flush the toilet several times after each use
• Completely clean up any spilled urine with a tissue and flush it away
• Wash your hands thoroughly with soap after urinating or having a bowel movement
• Immediately wash clothes and linens soiled with urine, feces, or blood; wash them separately from other clothes

Do not swallow any solid substances that may be coughed up. Dispose of solid substances in a sink or toilet. Flush several times if placed in the toilet or flush the sink by washing your hands thoroughly with soap after disposal.

Take extra precautions when handling urine, feces, and substances coughed up by children to avoid further exposure to the caregiver or the child.

If you are breast-feeding your baby, talk to your doctor about how long you must formula feed your baby and how to dispose of breast milk containing harmful substances.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it will provide. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing the use of pentetate calcium trisodium in children with its use in other age groups. However, when given by injection, this medicine is not expected to cause different side effects or problems in children compared to adults.

Geriatric

Many medicines have not been studied specifically in older adults. Therefore, it may not be known if they work the same way in older people as they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of pentetate calcium trisodium in the elderly with its use in other age groups.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Certain medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or near meal times or with specific foods due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Asthma—May be worsened by pentetate calcium trisodium given by inhalation.

• Hemochromatosis (iron disorder)—May increase the risk of serious side effects.

• Kidney disease—May reduce the rate at which harmful substances can be eliminated. Dialysis may be necessary to help remove these harmful substances.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they might need medical attention.

Because of how these medicines work in the body, there is a chance they could cause additional unwanted effects that may not show up until months or years after using the medicine. These may include certain types of cancer, such as leukemia or bladder cancer. Talk to your doctor about these possible effects.

Check with your doctor right away if any of the following side effects occur:

Incidence unknown

• Chest pain
• cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives
• itching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• skin rash
• tightness in chest
• unusual tiredness or weakness
• wheezing

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also have ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Incidence unknown

• 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 site
• blistering, crusting, irritation, itching, or reddening of skin
• cracked, dry, scaly skin
• diarrhea
• headache
• lightheadedness
• metallic taste
• nausea
• swelling

Other side effects not listed may also happen 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.

Available Dosage Forms:

• Solution

Therapeutic Class: Heavy Metal Chelator

Harmful substances may accumulate in your bladder. Therefore, to increase the flow of urine and decrease the time your bladder contains these harmful substances, your doctor may instruct you to drink plenty of liquids and urinate often while being treated with pentetate calcium trisodium to help eliminate the harmful substances.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inhalation dosage formTo help with the removal of harmful substances in individuals breathing in the harmful substances Adults—1 gram once a day. Children—Use and dose must be determined by your doctor.
• For parenteral dosage form To help with the removal of harmful substances in individuals exposed by some other way than breathing in the substances Adults—1 gram once a day. Children—14 milligrams per kilogram (mg/kg) once a day.

Missed Dose

Call your doctor or pharmacist for instructions.