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

Irritable bowel syndrome (IBS) affects approximately 10 to 15% of the general adult population in the US, yet the condition remains undiagnosed in at least 75% of patients.2

Diagnosis is based on clinical history, symptoms, physical examination, and exclusion of alarm features.1 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.3*

*Additional testing recommendations were proposed in 2019 by the American Gastroenterological Association’s (AGA) Clinical Practice Guideline Committee to help clinicians choose appropriate laboratory tests to exclude other diagnoses in the setting of suspected functional diarrhea or IBS-D.4

Diagnosis should include:

1. History based on Rome IV Criteria1
  • 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

With symptom onset at least 6 months prior to diagnosis1

2. Exclusion of alarm features1,5,6
  • 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
  • Fever
3. Physical exam1

Use the “25% Rule” to determine IBS-D subtype1

On days with at least one abnormal bowel movement1:

  • <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

IBD = inflammatory bowel disease

IBS-D = irritable bowel syndrome with diarrhea

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.

References: 1. Mearin F, Lacy BE, Chang L, et al. Bowel disorders. Gastroenterology. 2016;150(6):1393-1407. 2. Hungin APS, Chang L, Locke GR, Dennis EH, Barghout V. Irritable bowel syndrome in the United States: prevalence, symptom patterns and impact. Aliment Pharmacol Ther. 2005;21(11):1365-1375. 3. Ford AC, Moayyedi P, Lacy BE, et al; Task Force on the Management of Functional Bowel Disorders. American College of Gastroenterology monograph on the management of irritable bowel syndrome and chronic idiopathic constipation. Am J Gastroenterol. 2014;109(suppl 1):S2-S26. 4. Smalley W, Falck-Ytter C, Carrasco-Labra A, Wani S, Lytvyn L, Falck-Ytter Y. AGA Clinical Practice Guidelines on the laboratory evaluation of functional diarrhea and diarrhea-predominant irritable bowel syndrome in adults (IBS-D). Gastroenterology. 2019;157(3):851-854. 5. American College of Gastroenterology Task Force on Irritable Bowel Syndrome; Brandt LJ, Chey WD, Foxx-Orenstein AE, et al. An evidence-based systemic review on the management of irritable bowel syndrome. Am J Gastroenterol. 2009;104(suppl 1):S1-S35. 6. Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006;130(5):1480-1491. 7. Palsson OS, Whitehead WE, van Tilburg MAL, et al. Development and validation of the Rome IV diagnostic questionnaire for adults. Gastroenterology. 2016;150(6):1481-1491. 8. Pimentel M, Lembo A, Chey WD, et al. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011;364(1):22-32. 9. Rezaie A, Heimanson Z, McCallum R, Pimentel M. Lactulose breath testing as a predictor of response to rifaximin in patients with irritable bowel syndrome with diarrhea. Am J Gastroenterol. 2019;114(12):1886-1893. 10. Zhong W, Lu X, Shi H, et al. Distinct microbial populations exist in the mucosa-associated microbiota of diarrhea predominant irritable bowel syndrome and ulcerative colitis. J Clin Gastroenterol. 2019;53(9):660-672.

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.