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Rebyota Generic Name & Formulations
Legal Class
General Description
How Supplied
Single-dose cartons—6
Manufacturer
Generic Availability
NO
Rebyota Indications
Indications
Prevention of recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent CDI.
Limitations of Use
Not for treatment of CDI.
Rebyota Dosage and Administration
Adult
For rectal use only. Empty bladder and bowel before administration. Give a single dose (150mL) 24–72hrs after the last dose of antibiotics for CDI.
Children
<18yrs: not established.
Rebyota Contraindications
Not Applicable
Rebyota Boxed Warnings
Not Applicable
Rebyota Warnings/Precautions
Warnings/Precautions
Manufactured from human fecal matter. Risk of transmissible infectious agents. Potential presence of food allergens. Acute allergic reactions. Have appropriate medical treatment immediately available.
Rebyota Pharmacokinetics
See Literature
Rebyota Interactions
Interactions
Avoid any oral antibiotic therapy for up to 8 weeks after Rebyota administration.
Rebyota Adverse Reactions
Adverse Reactions
Abdominal pain, diarrhea, abdominal distention, flatulence, nausea.
Rebyota Clinical Trials
See Literature
Rebyota Note
Not Applicable
Rebyota Patient Counseling
See Literature
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