Usual Adult Dose for Clostridial Infection

10 mg/kg IV over 60 minutes as a single dose

Use: To reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

No adjustment recommended.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients

Dialysis

Data not available

Other Comments

Administration advice:

• The safety and efficacy of repeat administration of this drug in patients with CDI have not been studied.
• Administer the diluted solution as an IV infusion over 60 minutes using a sterile, nonpyrogenic, low-protein binding 0.2 to 5 micron in-line or add-on filter.
• The diluted solution can be infused via a central line or peripheral catheter.
• Do not administer this drug as an IV push or bolus.
• Do not coadminister other drugs simultaneously through the same infusion line.

• The product does not contain a preservative.
• The diluted solution may be stored either at room temperature for up to 16 hours or under refrigeration at 2C to 8C for up to 24 hours; if refrigerated, allow the IV bag to come to room temperature prior to use.
• Do not freeze the diluted solution.

• Dilute vial contents prior to IV infusion.
• Prepare the diluted solution immediately after removal from refrigerated storage, or the vial may be stored at room temperature and protected from light for up to 24 hours prior to preparation.
• Inspect vial contents for discolorations and particulate matter prior to dilution. The contents should be clear to moderately opalescent and colorless to pale yellow. Do not use the vial if the solution is discolored or contains visible particles.
• Do not shake the vial.
• Withdraw the required volume based on patient weight (in kg) and transfer into an IV bag containing either 0.9% sodium chloride injection or 5% dextrose injection to prepare a diluted solution with a final concentration ranging from 1 mg/mL to 10 mg/mL.
• Mix the diluted solution by gentle inversion; do not shake.
• Discard all unused contents of the vial.

• The contents of the vial are compatible with either 0.9% sodium chloride injection or 5% dextrose injection.

• Limitation of use: This drug is not indicated for the treatment of CDI; it is not an antibacterial drug and should only be used in conjunction with antibacterial drug treatment of CDI.
• The safety and efficacy of repeat administration of this drug in patients with CDI have not been studied.