HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use XIFAXAN safely and effectively. See full prescribing information for XIFAXAN.
XIFAXAN ® (rifaximin) tablets, for oral use
Initial U.S. Approval: 2004
To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
INDICATIONS AND USAGE
XIFAXAN is a rifamycin antibacterial indicated for:
•Treatment of travelers’ diarrhea (TD) caused by noninvasive strains of Escherichia coli in adult and pediatric patients 12 years of age and older ( 1.1)
•Reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults ( 1.2)
•Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults ( 1.3)
Limitations of Use
•TD: Do not use in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli ( 1.1, 5.1)
DOSAGE AND ADMINISTRATION
Condition Recommended Dosage Regimen
TD (2.1) One 200 mg tablet 3 times a day for 3 days
HE (2.2) One 550 mg tablet 2 times a day
BS-D (2.3) One 550 mg tablet 3 times a day for 14 days. Patients who experience recurrence can be retreated up to two times with the same regimen.
XIFAXAN can be taken with or without food. ( 2.4)
DOSAGE FORMS AND STRENGTHS
200 mg and 550 mg tablets (3)
CONTRAINDICATIONS
History of hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components of XIFAXAN (4)
WARNINGS AND PRECAUTIONS
•Travelers’ Diarrhea Not Caused by E. coli: XIFAXAN was not effective in diarrhea complicated by fever and/or blood in the stool or diarrhea due to pathogens other than E. coli. If diarrhea symptoms get worse or persist for more than 24 to 48 hours, discontinue XIFAXAN and consider alternative antibiotics ( 5.1)
•Clostridium difficile-Associated Diarrhea: eva luate if diarrhea occurs after therapy or does not improve or worsens during therapy ( 5.2)
•Hepatic Impairment: Use with caution in patients with severe (Child-Pugh Class C) hepatic impairment ( 5.4, 8.7)
•Concomitant P-glycoprotein (P-gp) inhibitors (e.g., cyclosporine): Caution should be exercised when concomitant use of XIFAXAN and a P-glycoprotein inhibitor is needed ( 5.5, 7.1)
ADVERSE REACTIONS
Most common adverse reactions:
•TD (≥2%): Headache ( 6.1)
•HE (≥10%): Peripheral edema, nausea, dizziness, fatigue, and ascites ( 6.1)
•IBS-D (≥2%): ALT increased, nausea ( 6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 and www.Salix.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Warfarin: Monitor INR and prothrombin time; dose adjustment of warfarin may be needed to maintain target INR range. (7.2)
USE IN SPECIFIC POPULATIONS
Pregnancy: May cause fetal harm (8.1)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 12/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or prevent infections that are pro |
