Aemcolo FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (First approved November 16, 2018)
Brand name: Aemcolo
Generic name: rifamycin
Dosage form: Delayed-Release Tablets
Company: Cosmo Technologies, Ltd.
Treatment for: Traveler's Diarrhea

Aemcolo (rifamycin) is a broad spectrum, orally non-absorbable antibiotic for the treatment of traveler’s diarrhea caused by noninvasive strains of Escherichia coli.

Limitations of Use: 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. Aemcolo should be taken exactly as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the immediate treatment and increase the likelihood that bacteria will develop resistance and will not be treatable by Aemcolo or other antibacterial drugs in the future.

DOSAGE AND ADMINISTRATION

• The recommended dosage of Aemcolo is 388 mg (two tablets) orally twice daily for three days.
• Take each dose with a a full glass of liquid (6-8 ounces). Do NOT take Aemcolo concomitantly with alcohol.
• Aemcolo may be taken with or without food.
• Swallow Aemcolo tablets whole. Do NOT crush, break or chew the tablets.

CONTRAINDICATIONS
Aemcolo is contraindicated in patients with a known hypersensitivity to rifamycin, any of the other rifamycin class antimicrobial agents (e.g. rifaximin), or any of the other ingredients in Aemcolo.

WARNINGS AND PRECAUTIONS

• 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.
• Clostridium difficile-associated Diarrhea: Diarrhea is a common problem caused by antibacterial drugs, which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery or bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of Aemcolo. If diarrhea occurs after therapy, or does not improve or worsens during therapy, patients should contact their physician as soon as possible.

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

Development timeline for Aemcolo

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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