XIFAXAN- rifaximin tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Salix Pharmaceuticals, Inc.

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)]. X

Product summary:

The 200 mg tablet is a pink-colored, round, biconvex tablet with “Sx” debossed on one side and plain on the other. It is available in the following presentation: 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: 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
SALIX PHARMACEUTICALS, INC.
----------
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:
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)
Limitations of Use
TD: Should 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)
DOSAGE AND ADMINISTRATION
CONDITION
RECOMMENDED ORAL
DOSAGE
TD ( 2.1)
200 mg 3 times a day for 3
days
HE ( 2.2)
550 mg 2 times a day
IBS-D ( 2.3)
550 mg 3 times a day for 14
days. Patients who experience
recurrence can be retreated
up to 2 times with the same
regimen.
XIFAXAN can be taken with or without food. ( 2.4)
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
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)
_Clostridium difficile_-Associated Diarrhea: Evaluate i