Indicated for the treatment of travelers’ diarrhea (TD) caused by non-invasive strains of Escherichia coli in adults.

AEMCOLO is not indicated in patients with diarrhea complicated by fever or bloody stool or due to pathogens other than noninvasive strains of Escherichia coli. AEMCOLO was not shown to be effective in patients with diarrhea complicated by fever and/or bloody stool. Patients with these conditions treated with AEMCOLO had prolonged time to last unformed stool (TLUS). The effectiveness of AEMCOLO in travelers’ diarrhea caused by pathogens other than E. coli has not been demonstrated. 

The recommended dose of AEMCOLO is 388 mg (two tablets) orally twice daily (in the morning and evening) for three days. Take each dose with a glass of liquid (6-8 ounces).

Do NOT take AEMCOLO concomitantly with alcohol.

Discontinue AEMCOLO if diarrhea gets worse or persists more than 48 hours and consider alternative antibacterial therapy.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which may lead to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile may cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

The pharmacokinetics of rifamycin (taken as AEMCOLO) in patients with impaired renal or hepatic function have not been studied.

Rifamycin is a substrate of P-glycoprotein (P-gp) and anticipated to be an inhibitor of P-gp and breast cancer resistant protein (BCRP) in the gut.

There are no available data on AEMCOLO use in pregnant women to inform any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies: maternal toxicity, decreased fetal weight, and slightly delayed fetal ossifications.

There is no information regarding the presence of AEMCOLO in human milk, the effects on the breastfed infant, or the effects on milk production. Systemic absorption of AEMCOLO in humans is negligible following oral administration of the recommended dose of AEMCOLO; therefore, exposure to a breastfed infant through breast milk is expected to be negligible There are no animal lactation data following oral rifamycin administration. Following single intravenous injection of rifamycin to lactating ewes, rifamycin has been shown to pass into milk.

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• Use in patients under the age of 18. GoToSource

• Clostridium difficile colitis, pediatric bacterial diarrhea and helicobacter pylori gastritis and chronic gastrointestinal disorders including hepatic encephalopathy, small bowel bacterial overgrowth, inflammatory-bowel disease, irritable-bowel syndrome and pouchitis. GoToSource

• Intestinal gas and gas-related symptoms, diverticular disease, ulcerative colitis, and active crohn’s disease. GoToSource

• IBS-D. GoToSource

Development of resistant strains of difficile-associated diarrhea. GoToSource

Headache and constipation. GoToSource

No major injury lawsuits reported.