Aemcolo (rifamycin)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved November 2018

Specific Treatments:

traveler's diarrhea

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General Information

Aemcolo (rifamycin) is an antibacterial drug.

Aemcolo is specifically indicated for the treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli in adults.

Aemcolo is supplied as a delayed-release tablet for oral administration. The recommended dose is 388 mg (two tablets) orally twice daily for three days. Take each dose with a glass of liquid. Do not take Aemcolo concomitantly with alcohol. Aemcolo can be taken with or without food. Tablets should be swallowed whole. Do not crush, break or chew the tablets. 

Clinical Results

FDA Approval

The FDA approval of Aemcolo was based on  data from two randomized, multi-center, controlled Phase III clinical trials. Trial 1 was conducted at clinical sites in Guatemala and Mexico, and provided the primary evidence for the efficacy of Aemcolo. A second active-controlled trial (Trial 2) was conducted in India, Guatemala and Ecuador, and provided supportive evidence. In both trials Aemcolo was dosed at 388mg twice daily for three days. Aemcolo demonstrated superiority to placebo and non-inferiority to ciprofloxacin for the primary endpoint (time to last unformed stool).

Side Effects

Adverse effects associated with the use of Aemcolo may include, but are not limited to, the following:

headache

constipation

Mechanism of Action

Aemcolo (rifamycin) belongs to the ansamycin class of antibacterial drugs and acts by inhibiting the beta subunit of the bacterial DNA-dependent RNA polymerase, blocking one of the steps in DNA transcription. This results in inhibition of bacterial synthesis and consequently growth of bacteria.

Additional Information

For additional information regarding Aemcolo or traveler's diarrhea, please visit https://www.ariespharma.com/