Drug Detail:Fidaxomicin (Fidaxomicin [ fye-dax-oh-mye-sin ])
Drug Class: Macrolides
Usual Adult Dose for Clostridial Infection
200 mg orally twice a day for 10 days
Use: For the treatment of Clostridioides difficile-associated diarrhea (CDAD)
Usual Pediatric Dose for Clostridial Infection
6 Months to Less Than 18 Years:
Oral suspension:
- Weight 4 to less than 7 kg: 80 mg orally twice a day
- Weight 7 to less than 9 kg: 120 mg orally twice a day
- Weight 9 to less than 12.5 kg: 160 mg orally twice a day
- Weight at least 12.5 kg: 200 mg orally twice a day
Tablets:
- Weight at least 12.5 kg: 200 mg orally twice a day
Duration of therapy: 10 days
Use: For the treatment of CDAD
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
Data not available
Precautions
CONTRAINDICATIONS:
Known hypersensitivity to the active component or any of the ingredients
Safety and efficacy have not been established in patients younger than 6 months.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Administer with or without food.
- Administer tablets to pediatric patients weighing at least 12.5 kg and able to swallow tablets; if unable to swallow tablets, may administer the oral suspension
- Remove the oral suspension from the refrigerator 15 minutes before each administration.
- Shake the oral suspension vigorously until consistency is even.
- Use an oral dosing syringe to administer the oral suspension.
Storage requirements:
- Granules for oral suspension: Store in original package at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F); do not open pouch until time of use.
- Reconstituted oral suspension: Store capped in original bottle in refrigerator at 2C to 8C (36F to 46F) for up to 12 days; discard after 12 days.
- Tablets: Store in original bottle at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
Reconstitution/preparation techniques:
- Oral suspension: The manufacturer product information should be consulted.
General:
- To reduce the development of drug-resistant organisms and maintain effective therapy, this drug should be used only to treat infections proven or strongly suspected to be caused by C difficile.
- Culture and susceptibility information should be considered when selecting/modifying antibacterial therapy or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy.
Patient advice:
- Read the US FDA-approved patient labeling (Patient Information).
- Avoid missing doses and complete the entire course of therapy.
