Drugs List

Therapeutic Indications

Uses

Clostridium difficile associated diarrhoea

Contraindications

Pregnancy

Precautions and Warnings

Children under 6 months
Children weighing less than 12.5kg
Breastfeeding
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

Pregnancy

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.

Lactation

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
Angioedema
Constipation
Decreased appetite
Dizziness
Dry mouth
Dysgeusia
Dyspnoea
Flatulence
Headache
Hypersensitivity reactions
Nausea
Pruritus
Rash
Skin reactions
Urticaria
Vomiting

Presentation

Oral formulations of fidaxomicin.

Drugs List

Therapeutic Indications

Uses

Clostridium difficile associated diarrhoea

Dosage

Adults

Children

Contraindications

Pregnancy

Precautions and Warnings

Children under 6 months
Children weighing less than 12.5kg
Breastfeeding
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

Pregnancy

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.

Lactation

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
Angioedema
Constipation
Decreased appetite
Dizziness
Dry mouth
Dysgeusia
Dyspnoea
Flatulence
Headache
Hypersensitivity reactions
Nausea
Pruritus
Rash
Skin reactions
Urticaria
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: 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: www.nice.org.uk Last accessed: 06 April 2022

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Fidaxomicin. Last revised: 17 May 2021
Last accessed: 06 April 2022