XIFAXAN- rifaximin tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health 107, LLC

INN (International Name):

RIFAXIMIN

Composition:

RIFAXIMIN 550 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 550 mg tablet is a pink-colored, oval, biconvex tablet with “rfx” debossed on one side and plain on the other. It is available in the following presentations: 550 mg, Available in bottles of approximately 360 tablets, NDC 55154-6777-8 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
CARDINAL HEALTH 107, LLC
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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.
INDICATIONS AND USAGE
XIFAXAN is a rifamycin antibacterial indicated for:
•
•
•
Limitations of Use
•
DOSAGE AND ADMINISTRATION
CONDITION
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 2 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
•
•
•
•
®
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 complicated by fever
and/or blood in the stool or diarrhea due to pathogens other than _E.
coli_. If diarrhea symptoms get
worse or persist for more than 24 to 48 hours, discontinue XIFAXAN and
consider alternative
antibiotics (5.1)
_Cl