Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Rifaximin for IBS

Previously approved for travelers’ diarrhea

Publish date:: June 9, 2015

Indications: Rifaximin (Xifaxan) is indicated for irritable bowel syndrome (IBS) with diarrhea. It was previously approved for treatment of travelers’ diarrhea and hepatic encephalopathy.

Dosing: In patients with IBS, the dose is one 550 mg tablet 3 times a day for 14 days, with retreatment for recurrence up to two additional rounds.

Pharmakokinetics: Following oral administration of rifaximin, peak plasma concentration was reached at approximately 1 hour. In patients with IBS, the mean elimination half-life is 6 hours. It is excreted primarily through feces.

Side Effects/Risks: Use with caution in patients with severe hepatic impairment. The most common adverse reactions when used to treat IBS include increased alanine transaminase (ALT) and nausea. Rifaximin should not be used during pregnancy.

Source: Highlights of Prescribing Information: Xifaxan (rifaximin). FDA website. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021361s012lbl.pdf. Revised May 2015. Accessed June 2, 2015.

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