Fecal Microbiota Spores, Live Dosage

Medically reviewed by Drugs.com. Last updated on Dec 6, 2023.

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer