Make a symptom-based diagnosis of IBS-D with confidence1,2

Irritable bowel syndrome (IBS) affects approximately 10% to 15% of the general adult population in US, yet the condition remains undiagnosed in at least 75% of patients.3

Diagnosis is based on clinical history, symptoms, and physical examination.2,4 In fact, the American College of Gastroenterology does not recommend routine diagnostic testing in patients when symptom-based criteria are fulfilled and alarm features are not present.1,2

Diagnosis should include:

1. History based on Rome IV Criteria2,4
  • Abdominal pain at least 1 day per week for the past 3 months* associated with 2 or more:
    • - defecation
    • - change in stool frequency
    • - change in stool form
2. Exclusion of alarm features2,5
  • Symptom onset after age 50
  • Severe or worsening symptoms
  • Unexplained weight loss
  • Nocturnal diarrhea
  • Rectal bleeding
  • Iron-deficiency anemia
  • Family history of: colon cancer, celiac disease, IBD
3. Physical exam4

Use the “25% Rule” to determine IBS-D subtype4

On days with at least one abnormal bowel movement4:

  • <25% of bowel movements with hard, lumpy stool (type 1 or 2 on the Bristol Stool Form Scale)
  • >25% of bowel movements with loose, watery stool (type 6 or 7 on the Bristol Stool Form Scale)

The Bristol Stool Form Scale has been shown to be a reliable surrogate marker for colonic transit.
Copyright Rome Foundation, Bristol Stool Form Scale developed by Dr. Ken Heaton, University of Bristol, UK


INDICATIONS

XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

IMPORTANT SAFETY INFORMATION
  • XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
  • Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
  • There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients.
  • Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to rifaximin.
  • In clinical studies, the most common adverse reactions for XIFAXAN were:
    • HE (≥10%): Peripheral edema (15%), nausea (14%), dizziness (13%), fatigue (12%), and ascites (11%)
    • IBS-D (≥2%): Nausea (3%), ALT increased (2%)
  • INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required.
  • XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus.

To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for full Prescribing Information.

INDICATIONS

XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

IMPORTANT SAFETY INFORMATION
  • XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.