Sodium zirconium cyclosilicate (oral route)


    Brand Name

    US Brand Name

    Lokelma


    Description

    Sodium zirconium cyclosilicate 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 sodium zirconium cyclosilicate in the pediatric population. 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 sodium zirconium cyclosilicate in the elderly.

    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.

    • Dabigatran Etexilate

    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 impaction or
    • Constipation, severe or
    • Surgery for bowel movement disorder, history of—Use has not been studied in patients with these conditions. This medicine may not work properly and may worsen these conditions.
    • Heart failure or
    • Kidney disease (eg, hemodialysis patients)—Use with caution. May increase risk for more side effects.

    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.

    To use:

    • Empty the contents of the packet into a glass filled with 3 tablespoons or more of water.
    • Stir well and drink immediately.
    • If some powder is still in the glass, add more water. Stir and drink it right away. Repeat as needed to make sure you get your full dose.

    If you are taking other medicines, use sodium zirconium cyclosilicate 2 hours before or 2 hours after these medicines. Sodium zirconium cyclosilicate 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, 10 grams (g) 3 times a day for up to 48 hours. For patients receiving dialysis, the dose is usually 5 g once a day taken on non-dialysis days. Your doctor may adjust your dose as needed.
        • Children—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

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    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.


    Precautions

    It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

    This medicine may cause swelling in the different parts of your body. This is more likely if you have heart failure or kidney disease. You may also need to adjust your sodium intake while using this medicine. Talk to your doctor if you have any concerns.

    Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests (eg, abdominal or stomach X-ray) may be affected by this medicine.

    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 immediately if any of the following side effects occur:

    More common

    • Swelling

    Less common

    • Decreased urine
    • dry mouth
    • increased thirst
    • irregular heartbeat
    • loss of appetite
    • mood changes
    • muscle pain or cramps
    • nausea
    • numbness or tingling in the hands, feet, or lips
    • seizures
    • unusual tiredness or weakness
    • vomiting

    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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