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Medical Industry Feature: Clinical Trial Data on an IBS-D Treatment

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INDICATION

XIFAXAN® (rifaximin) 550 mg tablets are indicated 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.
Read Additional Important Safety Information >>
CONTINUE TO PROGRAM
Salix Xifaxan

Clinical Trial Data on an IBS-D Treatment

Clinical Trial Data on an IBS-D Treatment
RestartResume

    Please see below for Important Safety Information and full Prescribing Information.

    • Overview

      Please click here for full Prescribing Information.

      Tune in as Drs. Darren Brenner and Mark Pimentel review the safety and efficacy findings from the clinical studies TARGET 1, 2, and 3 and provide their perspectives on how they use XIFAXIN (rifaximin) in their practice. Plus, you’ll also hear from a patient who shares how being treated with XIFAXIN has helped her. 

    • Indication and Important Safety Information

      INDICATION

      XIFAXAN® (rifaximin) 550 mg tablets are indicated 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 in IBS-D (≥2%) were nausea (3%) and 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.

      ©2020 Salix Pharmaceuticals or its affiliates. XIFI.0353.USA.19

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