Pentetate calcium trisodium (intravenous route, inhalation route)


    Description

    Pentetate Calcium Trisodium is used to remove harmful substances, such as plutonium, americium, or curium from your body.

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

    This product is available in the following dosage forms:

    • Solution

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, 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

    Although there is no specific information comparing use of pentetate calcium trisodium in children with use in other age groups, this medicine when given by injection is not expected to cause different side effects or problems in children than it does in adults.

    Geriatric

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

    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 medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Asthma—May be worsened by pentetate calcium trisodium given by inhalation.
    • Hemochromatosis (iron disorder)—May increase the chance for serious side effects.
    • Kidney disease—May lower the rate at which the harmful substances can be removed. Dialysis may be needed to increase removal of these harmful substances.

    Proper Use

    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 form
      • To 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.


    Precautions

    To prevent radiation contamination of other persons or environment:

    • Using a normal toilet instead of a urinal
    • Flushing toilet several times after each use
    • Completely cleaning up any spilled urine with a tissue and flushing it away
    • Washing hands thoroughly with soap after urinating or a bowel movement
    • Immediately laundering clothes and linens soiled with urine, feces or blood; washing them separately from other clothes

    Avoid swallowing any solid substances that may be coughed up. Dispose of solid substances in sink or toilet. Flush several times if put in toilet or flush sink by washing hands thoroughly with soap after disposal.

    Extra precaution in handling urine, feces, and substances coughed up by children to avoid additional exposure to the caregiver or to 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 the breast milk containing harmful substances.


    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.

    Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These may include certain types of cancer, such as leukemia or bladder cancer. Discuss these possible effects with your doctor.

    Check with your doctor immediately 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 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:

    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 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.






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