XIFAXAN- rifaximin tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RIFAXIMIN (UNII: L36O5T016N) (RIFAXIMIN - UNII:L36O5T016N)

Available from:

Avera McKennan Hospital

INN (International Name):

RIFAXIMIN

Composition:

RIFAXIMIN 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. XIFAXAN is indicated for the treatment of travelers’ diarrhea (TD) caused by noninvasive strains of Escherichia coli in adults and pediatric patients 12 years of age and older. Limitations of Use XIFAXAN should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli [see Warnings and Precautions (5.1), Clinical Pharmacology (12.4), Clinical Studies (14.1)]. XIFAXAN is indicated for re

Product summary:

The 200 mg tablet is a pink-colored, round, biconvex tablet with “Sx” debossed on one side. It is available in the following presentation: NDC 69189-0309-1 single dose pack with 1 tablet as repackaged by Avera McKennan Hospital Storage Store XIFAXAN Tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

XIFAXAN- RIFAXIMIN TABLET
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XIFAXAN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR XIFAXAN.
XIFAXAN (RIFAXIMIN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF XIFAXAN AND OTHER
ANTIBACTERIAL DRUGS, XIFAXAN SHOULD BE USED ONLY TO TREAT OR PREVENT
INFECTIONS THAT ARE PROVEN OR STRONGLY
SUSPECTED TO BE CAUSED BY BACTERIA.
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
XIFAXAN is a rifamycin antibacterial indicated for:
•
•
•
Limitations of Use
•
DOSAGE AND ADMINISTRATION
CO NDITIO N
RECOMMENDED DOSAGE REGIMEN
TD (2.1)
One 200 mg tablet 3 times a day for 3 days
HE (2.2)
One 550 mg tablet 2 times a day
IBS-D (2.3)
One 550 mg tablet 3 times a day for 14 days. Patients who
experience recurrence can be retreated up to two times with
the same regimen.
•
DOSAGE FORMS AND STRENGTHS
200 mg and 550 mg tablets (3)
CONTRAINDICATIONS
History of hypersensitivity to rifaximin, rifamycin antimicrobial
agents, or any of the components of XIFAXAN (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions:
•
•
®
Indications and Usage, Irritable Bowel Syndrome with Diarrhea (1.3)
5/2015
Dosage and Administration, Irritable Bowel Syndrome with Diarrhea
(2.3) 5/2015
Treatment of travelers’ diarrhea (TD) caused by noninvasive strains
of _Escherichia coli_ in adult and pediatric patients
12 years of age and older (1.1)
Reduction in risk of overt hepatic encephalopathy (HE) recurrence in
adults (1.2)
Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults
(1.3)
TD: Do not use in patients with diarrhea complicated by fever or blood
in the stool or diarrhea due to pathogens other
than _Escherichia coli _(1.1, 5.1)
XIFAXAN can be taken with or without food. (2.4)
Travelers’ Diarrhea Not Caused by _E. coli_: XIFAXAN was not
effective in diarrhea