INDICATIONS AND USAGE

XIFAXAN Tablets are a rifamycin antibacterial indicated for:

• The treatment of patients (≥ 12 years of age) with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (1.1)

DOSAGE AND ADMINISTRATION

• Travelers’ diarrhea: one 200 mg tablet taken orally three times a day for 3 days (2.1)
• XIFAXAN Tablets can be taken with or without food (2.2)

DOSAGE FORMS AND STRENGTHS

• 200 mg tablets (3)    

CONTRAINDICATIONS

• History of hypersensitivity to rifaximin, or to rifamycin antimicrobial agents, or any of the components of XIFAXAN Tablets (4.1)  

WARNINGS AND PRECAUTIONS

• Travelers' Diarrhea Not Caused by E. coli: XIFAXAN Tablets were not found effective in diarrhea complicated by fever and/or blood in the stool or diarrhea due to pathogens other than Escherichia coli. If diarrhea symptoms get worse or persist for more than 24-48 hours, discontinue treatment with XIFAXAN (5.1)
• Clostridium difficile-Associated Diarrhea: eva luate if diarrhea occurs after therapy or does not improve or worsens during therapy (5.2)

ADVERSE REACTIONS

Most common adverse reactions (≥ 5%) were flatulence, headache, abdominal pain, rectal tenesumus, defecation urgency and nausea (6.1)

to report suspected adverse reactions, contact Salix Pharmaceuticals at 1-866-669-7597 and www.Salix.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

• Pregnancy: Based on animal data, may cause fetal harm (8.1)

1 INDICATIONS AND USAGE

1.1 Travelers’ Diarrhea

1.2 Limitations of Use – Travelers’ Diarrhea

2 DOSAGE AND ADMINISTRATION

2.1 Dosage for Travelers’ Diarrhea

2.2 Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

4.1 Hypersensitivity

5 WARNINGS AND PRECAUTIONS

5.1 Travelers’ Diarrhea Not Caused by Escherichia coli

5.2 Clostridium difficile-Associated Diarrhea

5.3 Development of Drug Resistant Bacteria

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use