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Sodium zirconium cyclosilicate oral powder

Presentation

Oral formulations of sodium zirconium cyclosilicate.

Drugs List

  • LOKELMA 10g oral powder sachets
  • LOKELMA 5g oral powder sachets
  • sodium zirconium cyclosilicate 10g oral powder sachets
  • sodium zirconium cyclosilicate 5g oral powder sachets
  • Therapeutic Indications

    Uses

    Hyperkalaemia

    Dosage

    Adults

    Correction phase
    10g three times daily until normokalaemia is achieved (typically within 24 to 48 hours).

    If normokalaemia is not achieved after 72 hours of treatment, consider other treatment options.

    Maintenance phase
    Initially 5g once daily, with possible titration up to 10g once daily, or down to 5g once every other day.

    The maximum maintenance dose is 10g once daily.

    Patients on chronic haemodialysis
    Dose only on non-dialysis days. Initially 5g once daily. Titrate the dose up or down weekly in increments of 5g up to 15g once daily in order to achieve normokalaemia. Titration should be based on the pre-dialysis serum potassium value after the long inter dialytic interval.

    Administration

    Empty the full contents of the sachet into around 45ml of water and stir well. The powder will not dissolve. The oral suspension should be drunk while still cloudy and if the powder settles should be stirred again to ensure all the contents are taken.

    Contraindications

    Children under 18 years
    Pregnancy

    Precautions and Warnings

    Restricted sodium intake
    Haemodialysis

    Contains more than 1 mmol (23 mg) sodium per dose
    Advise patient not to take other medicines within 2 hours
    Advise patient to report signs of gastrointestinal perforation immediately
    Monitor serum potassium regularly
    May affect X-ray images
    Discontinue if severe hypokalaemia occurs

    Limited experience exists in patients with serum potassium concentrations greater than 6.5mmol/L.

    Sodium zirconium cyclosilicate may be opaque to X-rays.

    Monitor serum potassium after dose titration and after changes are made to products that affect the serum potassium concentration (e.g. diuretics and renin-angiotensin-aldosterone system inhibitors). Once normokalaemia is established, potassium should be monitored regularly.

    Long term treatment (more than 1 year) has not been studied.

    Sodium zirconium cyclosilicate oral powder contains approximately 400mg sodium per 5g dose.

    Pregnancy and Lactation

    Pregnancy

    Sodium zirconium cyclosilicate is contraindicated during pregnancy.

    The manufacturer recommends that it is preferable to avoid the use of sodium zirconium cyclosilicate during pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. At the time of writing there is no human data available. Risks are unknown.

    Lactation

    Sodium zirconium cyclosilicate is considered safe to use during breastfeeding.

    The manufacturer advises that sodium zirconium cyclosilicate may be used during breastfeeding. The presence of sodium zirconium cyclosilicate in human milk is unknown but due to its physicochemical properties, sodium zirconium cyclosilicate is not systemically absorbed and is not expected to be excreted in breast milk.

    Side Effects

    Abdominal distension
    Abdominal pain
    Constipation
    Diarrhoea
    Fluid overload
    Fluid retention
    Generalised oedema
    Hypersensitivity reactions
    Hypervolaemia
    Hypokalaemia
    Nausea
    Peripheral oedema
    Pruritus
    Rash
    Vomiting

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: June 2020

    Reference Sources

    Summary of Product Characteristics: Lokelma 5g powder for oral suspension. AstraZeneca UK Limited Ltd. Revised April 2020.

    Summary of Product Characteristics: Lokelma 10g powder for oral suspension. AstraZeneca UK Limited Ltd. Revised April 2020.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 18 June 2020

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