HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use AEMCOLO safely and effectively. See full prescribing information
for AEMCOLO.
AEMCOLO(rifamycin)delayed-release tablets, for oral use.
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
AEMCOLO is a rifamycin antibacterial indicated for the treatment oftravelers’ diarrhea caused by noninvasive strains of Escherichia coli in
adults. (1.1)
Limitations of Use:
AEMCOLO is not recommended for use in patients with diarrheacomplicated by fever and/or bloody stool or due to pathogens otherthan noninvasive strains of E. coli. (1, 5.1, 14)
To reduce the development of drug-resistant bacteria and maintain theeffectiveness of AEMCOLO and other antibacterial drugs, AEMCOLOshould be used only to treat or prevent infections that are proven orstrongly suspected to be caused by bacteria (1.2).
DOSAGE AND ADMINISTRATION
• The recommended dosage of AEMCOLO is 388 mg (two tablets)orally twice daily for three days. (2.1)
• Take each dose with a glass of liquid. Do NOT take AEMCOLOconcomitantly with alcohol. (2.1)
• AEMCOLO can be taken with or without food. (2.1)
• Swallow AEMCOLO tablets whole. Do NOT crush, break or chewthe tablets. (2.2)
DOSAGE FORMS AND STRENGTHS
Delayed-Release Tablets: 194 mg rifamycin. (3)
CONTRAINDICATIONS
AEMCOLO is contraindicated in patients with a known hypersensitivityto rifamycin, any of the other rifamycin class antimicrobial agents (e.g.rifaximin), or any of the components in AEMCOLO (4)
WARNINGS AND PRECAUTIONS
• Risk of Persistent or Worsening Diarrhea Complicated by Feverand/or Bloody Stool: AEMCOLO was not shown to be effective inpatients with diarrhea complicated by fever and/or bloody stool ordiarrhea 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 48hours, and consider alternative antibacterial therapy. (1. 5.1)
• Clostridium difficile-associated Diarrhea: eva luate if diarrheaoccurs after therapy or does not improve or worsens duringtherapy. (5.2)
ADVERSE REACTIONS
Most common adverse reactions (incidence > 2%) are headache andconstipation. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AriesPharmaceuticals Inc. at 888-ARIES-08 (888-274-3708) option 1 orFDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised:11/2018
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Travelers’ Diarrhea
1.2 Usage
2 DOSAGE AND ADMINISTRATION
2.1 Basic Dosing Information
2.2 Important Administration Instructions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Diarrhea Complicated by Fever and/or Bloody Stool
5.2 Clostridium difficile-Associated Diarrhea
5.3 Development of Drug-Resistant Bacteria
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microb |
