Application Nr Approved Date Route Status External Links
NDA021361 2004-05-25 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage 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 A Rifamycin Antibacterial Indicated For: The Treatment Of Patients (≥ 12 Years Of Age) With Travelers’ Diarrhea (td) Caused By Noninvasive Strains Of Escherichia Coli (1.1) Reduction In Risk Of Overt Hepatic Encephalopathy (he) Recurrence In Patients ≥ 18 Years Of Age (1.2) Limitations Of Use 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) 1.1 Travelers’ Diarrhea Xifaxan 200 Mg Is Indicated For The Treatment Of Patients (≥ 12 Years Of Age) With Travelers’ Diarrhea Caused By Noninvasive Strains Of Escherichia Coli [ See Warnings And Precautions (5), Clinical Pharmacology (12.4) And Clinical Studies (14.1)]. 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. 1.2 Hepatic Encephalopathy Xifaxan 550 Mg Is Indicated For Reduction In Risk Of Overt Hepatic Encephalopathy (he) Recurrence In Patients ≥ 18 Years Of Age. In The Trials Of Xifaxan For He, 91% Of The Patients Were Using Lactulose Concomitantly. Differences In The Treatment Effect Of Those Patients Not Using Lactulose Concomitantly Could Not Be Assessed. Xifaxan Has Not Been Studied In Patients With Meld (model For End-Stage Liver Disease) Scores > 25, And Only 8.6% Of Patients In The Controlled Trial Had Meld Scores Over 19. There Is Increased Systemic Exposure In Patients With More Severe Hepatic Dysfunction [see Warnings And Precautions (5.4), Use In Specific Populations (8.7), Clinical Pharmacology (12.3)].

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
3. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
4. Ferric Oxide Red FERRIC OXIDE RED Molecular
5. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Rifaximin RIFAXIMIN ZINC169311801

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