Brand Name

    US Brand Name

    Veltassa


    Description

    Patiromer is used to treat hyperkalemia (high potassium in the blood). This medicine is a potassium binder. It should not be used as an emergency treatment for life-threatening hyperkalemia.

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

    This product is available in the following dosage forms:

    • Powder for Suspension

    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

    Appropriate studies have not been performed on the relationship of age to the effects of patiromer in children younger than 12 years of age. 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 patiromer in the elderly. However, elderly patients are more likely to have unwanted side effects (eg, stomach or bowel problems) which may require caution in patients receiving this medicine.

    Breastfeeding

    Studies in women suggest that this medication poses minimal risk to the infant when used during 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Ciprofloxacin
    • Levothyroxine
    • Metformin

    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:

    • Bowel blockage or
    • Constipation, severe or
    • Impaction (bowel movement problem)—Use is not recommended in patients with these conditions. This medicine may not work properly and may worsen these conditions.

    Proper Use

    Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

    You may take this medicine with or without food. Do not heat this medicine (eg, microwave) or add to heated foods or liquids. Do not take this medicine in its dry form.

    To use:

    • Measure 1/3 cup of water. Pour half of the water into a glass.
    • Empty the entire contents of a packet into the glass. You may need more than 1 packet for your prescribed dose.
    • Stir the mixture well.
    • Pour the remaining water into the glass containing the mixture and stir thoroughly. The mixture will look cloudy and the powder will not dissolve. Add more water if the mixture is too thick.
    • Drink the mixture immediately.
    • If some powder remains in the glass, add more water, stir, and drink immediately. Repeat as needed to make sure you get your full dose.
    • You may also use other drinks or soft foods (eg, apple sauce, pudding, yogurt) instead of water to prepare the mixture.

    If you are taking other medicines, use patiromer 3 hours before or 3 hours after these medicines. Patiromer may keep other medicines from working properly.

    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 oral dosage form (powder for suspension):
      • For treatment of hyperkalemia:
        • Adults—At first, 8.4 grams (g) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 25.2 g once a day.
        • Children 12 years of age and older—At first, 4 g once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 25.2 g once a day.
        • Children younger than 12 years of age—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    Store in the refrigerator. Do not freeze.

    You may also store this medicine at room temperature but it must be used within 3 months of being taken out of the refrigerator.


    Precautions

    It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

    This medicine may cause hypomagnesemia (low magnesium levels in the blood). Check with your doctor right away if you have drowsiness, loss of appetite, mood or mental changes, muscle spasms (tetany) or twitching, seizures, nausea or vomiting, trembling, or unusual tiredness or weakness.


    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 immediately if any of the following side effects occur:

    More common

    • Drowsiness
    • loss of appetite
    • mood or mental changes
    • muscle spasms (tetany) or twitching
    • nausea
    • seizures
    • trembling
    • unusual tiredness or weakness
    • vomiting

    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:

    More common

    • Difficulty having a bowel movement

    Less common

    • Bloated or full feeling
    • diarrhea
    • excess air or gas in the stomach or bowels
    • passing gas
    • stomach discomfort

    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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