iology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of
Fertility
14 CLINICAL STUDIES
14.1 Travelers’ Diarrhea
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information
are not listed.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 Travelers’ Diarrhea
AEMCOLO is indicated for the treatment of travelers’ diarrhea (TD) caused by non-invasive strains ofEscherichia coli in adults.
Limitations of Use
AEMCOLO is not indicated in patients with diarrhea complicated by fever or bloody stool or due topathogens other than noninvasive strains of Escherichia coli [see Warnings and Precautions (5),
Clinical Studies (14)].
1.2 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of AEMCOLOand other antibacterial drugs, AEMCOLO should be used only to treat or prevent infections that areproven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibilityinformation are available, they should be considered in selecting or modifying antibacterial therapy. Inthe absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric
selection of therapy.
2 DOSAGE AND ADMINISTRATION
2.1 Basic Dosing Information
The recommended dose of AEMCOLO is 388 mg (two tablets) orally twice daily (in the morning andevening) for three days. Take each dose with a glass of liquid (6-8 ounces). Do NOT take AEMCOLOconcomitantly with alcohol. AEMCOLO can be taken with or without food.
2.2 Important Administration Instructions
AEMCOLO must be taken orally. Swallow the tablets whole. Do NOT crush, break or chew thedelayed-release tablets.
3 DOSAGE FORMS AND STRENGTHS
AEMCOLO is a yellow-brown, ellipsoidal, film-coated, delayed-release tablet debossed on one sidewith “SV2”. Each delayed-release tablet contains 194 mg of rifamycin.
4 CONTRAINDICATIONS
AEMCOLO is contraindicated in patients with a known hypersensitivity to rifamycin, any of the otherrifamycin class antimicrobial agents (e.g. rifaximin), or any of the components in AEMCOLO.
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Persistent or Worsening of Diarrhea Complicated by Fever and/or Bloody StoolAEMCOLO was not shown to be effective in patients with diarrhea complicated by fever and/orbloody stool. Patients with these conditions treated with AEMCOLO had prolonged time to lastunformed stool (TLUS). The effectiveness of AEMCOLO in travelers’ diarrhea caused by pathogensother than E. coli has not been demonstrated. AEMCOLO is not recommended for use in patientswith diarrhea accompanied by fever or bloody stools or due to pathogens other than noninvasivestrains of E. coli [see Indications and Usage (1), Clinical Studies (14)].
Discontinue AEMCOLO if diarrhea gets worse or persists more than 48 hours and consideralternative antibacterial therapy.
5.2 Clostridium difficile-Associated Diarrhea
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterialagents, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterialagents alters the normal flora of the colon which may lead to overgrowth of C. difficile.
C. difficile produces toxins A and |
