Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 194 mg) |
Drug Class | Antibacterials |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of travelers’ diarrhea caused by non-invasive strains of Escherichia coli in adults.
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Summary
- Aemcolo (rifamycin) is indicated for the treatment of travelers’ diarrhea caused by non-invasive strains of Escherichia coli in adults.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Coadministration of rifampin with warfarin led to a reduction in warfarin AUC by 15%-74%, necessitating warfarin dose increases of 3-5 times to maintain therapeutic coagulation parameters.
- Rifampin reduced the AUC of direct oral anticoagulants (DOACs) by 20%-67%, indicating a significant reduction in their effectiveness.
- The effectiveness of antiplatelet agents varied with rifampin: clopidogrel's active metabolite increased significantly, while ticagrelor's effectiveness decreased, and prasugrel remained largely unaffected.
- The primary safety concern is the interaction between rifamycins and anticoagulant/antiplatelet (AC/AP) agents, which may lead to risks of thrombosis or bleeding due to changes in drug concentration and efficacy.
- Significant safety risks include the need for dose adjustments of warfarin when coadministered with rifampin, the potential for under-anticoagulation with direct oral anticoagulants (DOACs), and an increased risk of bleeding with clopidogrel due to increased metabolite concentrations.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Aemcolo (rifamycin) Prescribing Information. | 2019 | RedHill Biopharma, Inc. Raleigh, NC |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Effect of genetic variations in drug-metabolizing enzymes and drug transporters on the pharmacokinetics of rifamycins: a systematic review. | 2022 | Pharmacogenomics and Personalized Medicine |
Systematic review of drug-drug interactions between rifamycins and anticoagulant and antiplatelet agents and considerations for management. | 2022 | Pharmacotherapy |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
AGA clinical practice guideline on the pharmacological management of irritable bowel syndrome with diarrhea. | 2022 | Gastroenterology |