Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Fidaxomicine

Generic name
Fidaxomicine
Brand name
ATC Code
A07AA12

Pharmacokinetics in children

No information is present at this moment.

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

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Available formulations

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Dosages

Clostridium difficile infection
  • Oral
    • < 4 kg
      • 80 mg/day in 2 doses.
      • Duration of treatment:

        10 days

    • 4 up to 7 kg
      • 160 mg/day in 2 doses.
      • Duration of treatment:

        10 days

    • 7 up to 9 kg
      • 240 mg/day in 2 doses.
      • Duration of treatment:

        10 days

    • 9 up to 12.5 kg
      • 320 mg/day in 2 doses.
      • Duration of treatment:

        10 days

    • ≥ 12.5 kg
      • 400 mg/day in 2 doses.
      • Duration of treatment:

        10 days

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

The safety profile is expected to be similar to that of adults, although incidental urticaria has also been reported in children.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Children <1 year: Testing for C. difficile colonization or the toxin is not recommended in children <1 year due to common asymptomatic colonization, unless severe diarrhea in infants with risk factors for stasis, such as Hirschsprung's disease, operated on anal atresia or other serious bowel motility disorders. C. difficile enterocolitis must be demonstrated in this population, and always look for an alternative medical cause.

 

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Reference

  1. Astellas Pharma, SmPC Dififlir EU 1/11/733 22-08-2016 susp: 5-12-2011, www.geneesmiddelinformatiebank.nl

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Changes

Changes