Fecal Microbiota Spores, Live Dosage
Medically reviewed by drugclasses.com. Last updated on Dec 6, 2023.
Applies to the following strengths: brpk
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Clostridial Infection
4 capsules orally once a day for 3 consecutive days
Comments:
- Limitations of use: This drug is not indicated for the treatment of Clostridioides difficile infection (CDI).
Use: For the prevention of recurrence of CDI following antibacterial treatment for recurrent CDI
Renal Dose Adjustments
Renal dysfunction: Data not available
Liver Dose Adjustments
Liver dysfunction: Data not available
Precautions
CONTRAINDICATIONS: None
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Antibacterial treatment for recurrent CDI should be completed 2 to 4 days before initial administration of this drug.
- Drink 269 mL (10 ounces) of magnesium citrate on the day before and at least 8 hours before first dose; in clinical studies, patients with impaired renal function received polyethylene glycol electrolyte solution (i.e., 250 mL of GoLYTELY; not approved for this use) in place of magnesium citrate prior to first dose of this drug.
- Do not eat or drink (except for a small amount of water) for at least 8 hours prior to taking the first dose.
- Take each dose (4 capsules) on an empty stomach before the first meal of the day.
Storage requirements:
- Store this drug in the original packaging at 2C to 25C (36F to 77F).
- Do not store in the freezer.
General:
- This drug contains bacterial spores; therefore, antibacterials should not be administered concurrently during treatment.
Patient advice:
- Read the US FDA-approved patient labeling (Patient Information).
- Understand that this drug is made from human fecal matter and may have food allergens.
- Do not take this drug concurrently with antibiotics.
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