Rx Item-AEMCOLO 194 MG DR TAB 36 BY Aries Pharmaceuticals

For: Traveler's Diarrhea

Aemcolo (rifamycin) is a broad spectrum, orally non-absorbable antibiotic for the treatment of traveler's diarrhea caused by noninvasive strains of Escherichia coli.AEMCOLO delayed-release tablets contain 194 mg of rifamycin (equivalent to 200 mg of rifamycin sodium), and are yellow brown, ellipsoidal and film coated. These are packaged in blister cards of 12 tablets contained in a cardboard carton. They are supplied as follows:

NDC (71068-001-10) : child resistant box of 12 tablets.
NDC (71068-001-11) : box of 36 tablets

Store at 20� to 25�C (68 to 77�F) excursions permitted to 15 to 30�C (59� to 86�F). 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 of travelers" diarrhea caused by noninvasive strains of Escherichia coli in adults. (1.1)

Limitations of Use:

AEMCOLO is not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli. (1, 5.1, 14)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AEMCOLO and other antibacterial drugs, AEMCOLO should be used only to treat or prevent infections that are proven or strongly 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 AEMCOLO concomitantly with alcohol. (2.1)
AEMCOLO can be taken with or without food. (2.1)
Swallow AEMCOLO tablets whole. Do NOT crush, break or chew the tablets. (2.2)

DOSAGE FORMS AND STRENGTHS

Delayed-Release Tablets: 194 mg rifamycin. (3)
CONTRAINDICATIONS

AEMCOLO is contraindicated in patients with a known hypersensitivity to 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 Fever and/or Bloody Stool: AEMCOLO was not shown to be effective in patients with diarrhea complicated by fever and/or bloody stool or diarrhea 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 48 hours, and consider alternative antibacterial therapy. (1. 5.1)
Clostridium difficile-associated Diarrhea: Evaluate if diarrhea occurs after therapy or does not improve or worsens during therapy. (5.2)

ADVERSE REACTIONS

Most common adverse reactions (incidence > 2%) are headache and constipation. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Aries Pharmaceuticals Inc. at 888-ARIES-08 (888-274-3708) option 1 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 11/2018

Rx Item-AEMCOLO 194 MG DR TAB 36 BY Arie
RX934935

Rx Item-AEMCOLO 194 MG DR TAB 36 BY Arie
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