Aemcolo®

Aemcolo®(rifamycin)

AEMCOLO is a rifamycin antibacterial indicated for the treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli in adults. AEMCOLO is not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AEMCOLO and other antibacterial drugs, AEMCOLO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. For additional information, please visit www.Aemcolo.com or for U.S. prescribing information, click here.

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Indication

Aemcolo is indicated for the treatment of Travelers’ Diarrhea (TD) caused by noninvasive strains of Escherichia coli in adults.

It is not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli.

Important Safety Information

Aemcolo is contraindicated in patients with a known hypersensitivity to rifamycin, any of the other rifamycin class antimicrobial agents, or any of the components in Aemcolo.

Aemcolo should be swallowed whole. Do not crush, break or chew the tablets. Do not take Aemcolo concomitantly with alcohol.

The most common adverse reactions (incidence >2%) are headache and constipation.

Clostridium difficile - Associated Diarrhea has been reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs after therapy or does not improve or worsens during therapy.

Risk of Persistent or Worsening Diarrhea Complicated by Fever and/or Bloody Stool: Aemcolo was not shown to be effective in patients with diarrhea complicated by fever and/or bloody stool or diarrhea due to pathogens other than noninvasive strains of E. coli and is not recommended for use in such patients. Discontinue use if diarrhea gets worse or persists more than 48 hours, and consider alternative antibacterial therapy.

You can report any side effects to RedHill Biopharma Inc. at 1-833-ADR-HILL or by contacting the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.