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.


OCT 2011

Xifaxan Clinical Studies

Xifaxan Clinical Studies: Travelers’ Diarrhea The efficacy of Xifaxan given as 200 mg orally taken three times a day for 3 days was evaluated in 2 randomized, multi‑center, double-blind, placebo-controlled studies in adult subjects with travelers’ diarrhea.  One study was conducted at clinical sites in Mexico, Guatemala, and Kenya (Study 1).  The other study was … Continue reading

Xifaxan Nonclinical Toxicology

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Xifaxan – Clinical Pharmacology

Xifaxan – Clinical Pharmacology: Mechanism of Action Rifaximin is an antibacterial drug [see Clinical Pharmacology (12.4)]. Pharmacokinetics Absorption Travelers’ Diarrhea Systemic absorption of rifaximin (200 mg three times daily) was evaluated in 13 subjects challenged with shigellosis on Days 1 and 3 of a three-day course of treatment.  Rifaximin plasma concentrations and exposures were low … Continue reading


Xifaxan USE IN SPECIFIC POPULATIONS: Pregnancy Pregnancy Category C There are no adequate and well controlled studies in pregnant women.  Rifaximin has been shown to be teratogenic in rats and rabbits at doses that caused maternal toxicity. Xifaxan tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the … Continue reading

Xifaxan Adverse Reactions

Xifaxan Adverse Reactions: Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.   Travelers’ Diarrhea The safety of Xifaxan … Continue reading

Xifaxan Warnings and Precautions

Xifaxan Warnings and Precautions: Travelers’ Diarrhea Not Caused by Escherichia coli Xifaxan was not found to be effective in patients with diarrhea complicated by fever and/or blood in the stool or diarrhea due to pathogens other than Escherichia coli. Discontinue Xifaxan if diarrhea symptoms get worse or persist more than 24-48 hours and alternative antibiotic … Continue reading

Xifaxan Dosage and Administration

Xifaxan Dosage and Administration: The recommended dose of Xifaxan is one 200 mg tablet taken orally three times a day for 3 days.  Xifaxan can be administered orally, with or without food [see Clinical Pharmacology (12.3)]. Dosage for Hepatic Encephalopathy The recommended dose of Xifaxan is one 550 mg tablet taken orally two times a … Continue reading

Indications and Usage for Xifaxan

Indications and Usage for Xifaxan: To reduce the development of drug-resistant bacteria and maintain the effectiveness of Xifaxan and other antibacterial drugs, Xifaxan when used to treat infection should be used only to treat or prevent infectionsthat are proven or strongly suspected to be caused by susceptible bacteria.  When culture and susceptibility information are available, … Continue reading

Xofigo – Patient Counseling Information

Xofigo – Patient Counseling Information: Advise patients: • To be compliant with blood cell count monitoring appointments while receiving Xofigo. Explain the importance of routine blood cell counts. Instruct patients to report signs of bleeding or infections. • To stay well hydrated and to monitor oral intake, fluid status, and urine output while being treated … Continue reading