Xifaxan - Patient Counseling InformationXifaxan - Patient Counseling Information

Xifaxan – Patient Counseling Information

Xifaxan – Patient Counseling Information:

Persistent Diarrhea

For those patients being treated for travelers’ diarrhea, discontinue Xifaxan if diarrhea persists more than 24-48 hours or worsens. Advise the patient to seek medical care for fever and/or blood in the stool [see Warnings and Precautions (5.1)].

Clostridium difficile-Associated Diarrhea

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.  Treatment with antibiotics alters the normal flora of the colon which may lead to C. difficile.  Patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic.  If diarrhea occurs after therapy or does not improve or worsens during therapy, advise patients to contact a physician as soon as possible [see Warnings and Precautions (5.4)].

Administration with Food

Inform patients that Xifaxan may be taken with or without food.

Antibacterial Resistance

Counsel patients that antibacterial drugs including Xifaxan should only be used to treat bacterial infections.  They do not treat viral infections (e.g., the common cold).  When Xifaxan is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.  Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Xifaxan or other antibacterial drugs in the future.

Severe Hepatic Impairment

Patients should be informed that in patients with severe hepatic impairment (Child-Pugh C) there is an increase in systemic exposure to Xifaxan [see Warnings and Precautions (5.4)].

Manufactured for:

Salix Pharmaceuticals, Inc.

Raleigh, NC 27615

Xifaxan® is a trademark of Salix Pharmaceuticals, Inc., under license from Alfa Wassermann S.p.A.
Copyright © Salix Pharmaceuticals, Inc.

Rifaximin for Travelers’ Diarrhea and Hepatic encephalopathy is protected by US Patent Nos. 7,045,620; 7,612,199; 7,902,206 and 7,906,542. Rifaximin for Travelers’ Diarrhea is also protected by US Patent No. 7,928,115.

Web site: www.Salix.com

All rights reserved.

VENART-156-2

OCT 2011

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