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Fidaxomicin oral

Updated 2 Feb 2023 | Fidaxomicin


Oral formulations of fidaxomicin.

Drugs List

  • DIFICLIR 200mg tablets
  • DIFICLIR 40mg/ml oral suspension
  • fidaxomicin 200mg tablets
  • fidaxomicin 40mg/ml oral suspension sugar-free
  • Therapeutic Indications


    Clostridium difficile associated diarrhoea



    200mg twice daily (every 12 hours) for 10 days.


    Children weighing 12.5kg or more
    200mg twice daily (every 12 hours) for 10 days.

    Children weighing between 9kg and 12.5kg
    160mg/4ml twice daily (every 12 hours) for 10 days.

    Children weighing between 7kg and 9kg
    120mg/3ml twice daily (every 12 hours) for 10 days.

    Children weighing between 4kg and 7kg
    80mg/2ml twice daily (every 12 hours) for 10 days.

    Children weighing less than 4kg
    40mg/1ml twice daily (every 12 hours) for 10 days.



    Precautions and Warnings

    Children under 6 months
    Children weighing less than 12.5kg
    Fulminant Clostridioides difficile infection
    Moderate hepatic impairment
    Pseudomembranous enterocolitis
    Severe renal impairment

    Consult national/regional policy on the use of anti-infectives
    Not all formulations are suitable for all age groups/body weights
    May contain sodium benzoate: may increase risk of jaundice in neonates
    Some products may contain soya or soya derivative
    Discontinue if hypersensitivity reactions occur

    Testing for C. difficile colonization or toxin is not recommended in children younger than 1 year due to high rate of asymptomatic colonization unless severe diarrhoea is observed in infants with risk factors for stasis such as Hirschsprung disease, operated anal atresia or other severe motility disorders. Alternate aetiologies should always be looked into and C. difficile enterocolitis be confirmed.

    Pregnancy and Lactation


    Fidaxomicin is contraindicated during pregnancy.

    The manufacturer does not recommend using fidaxomicin during pregnancy.

    At the time of writing there is limited published information regarding the use of fidaxomicin in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.


    Use fidaxomicin with caution during breastfeeding.

    The manufacturer advises that the patient either discontinue fidaxomicin or discontinues breastfeeding. LactMed (2021) suggests because fidaxomicin is poorly absorbed orally, it is unlikely to reach the bloodstream of the infant or cause any adverse effects in breastfed infants. It is unknown whether fidaxomicin is excreted in human milk. No effects on the breastfed infant are anticipated since the systemic exposure to fidaxomicin is low however risk cannot be excluded.

    Side Effects

    Abdominal distension
    Decreased appetite
    Dry mouth
    Hypersensitivity reactions
    Skin reactions


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: March 2020

    Reference Sources

    Summary of Product Characteristics: Dificlir 40mg/ml oral suspension. Tillotts Pharma UK Ltd. Revised February 2021.
    Summary of Product Characteristics: Dificlir 200mg tablets. Tillotts Pharma UK Ltd. Revised February 2020.

    NICE Evidence Services Available at: Last accessed: 06 April 2022

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Fidaxomicin. Last revised: 17 May 2021
    Last accessed: 06 April 2022

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