Xifaxan
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FDA Labeling Changes
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Uses
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 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.
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)].
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 EncephalopathyXIFAXAN 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)].
History
There is currently no drug history available for this drug.
Other Information
XIFAXAN tablets contain rifaximin, a non-aminoglycoside semi-synthetic, nonsystemic antibiotic derived from rifamycin SV. Rifaximin is a structural analog of rifampin. The chemical name for rifaximin is (2S,16Z,18E,20S,21S,22R,23R,24R,25S,26S,27S,28E)-5,6,21,23,25-pentahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadeca-[1,11,13]trienimino)benzofuro[4,5-e]pyrido[1,2-á]-benzimidazole-1,15(2H)-dione,25-acetate. The empirical formula is C43H51N3O11 and its molecular weight is 785.9. The chemical structure is represented below:
XIFAXAN Tablets for oral administration are film-coated and contain 200 mg or 550 mg of rifaximin.
Inactive ingredients:
Each 200 mg tablet contains colloidal silicon dioxide, disodium edetate, glycerol palmitostearate, hypromellose, microcrystalline cellulose, propylene glycol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide.
Each 550 mg tablet contains colloidal silicon dioxide, glycerol palmitostearate, microcrystalline cellulose, polyethylene glycol/macrogol, polyvinyl alcohol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide.
Sources
Xifaxan Manufacturers
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Physicians Total Care, Inc.
![Xifaxan (Rifaximin) Tablet [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Xifaxan | Physicians Total Care, Inc.
2.1 Dosage for Travelers’ DiarrheaThe recommended dose of XIFAXAN is one 200 mg tablet taken orally three times a day for 3 days. XIFAXAN can be administered orally, with or without food [see Clinical Pharmacology (12.3)].
2.2 Dosage for Hepatic EncephalopathyThe recommended dose of XIFAXAN is one 550 mg tablet taken orally two times a day, with or without food[see Clinical Pharmacology (12.3)].
2.1 Dosage for Travelers’ DiarrheaThe recommended dose of XIFAXAN is one 200 mg tablet taken orally three times a day for 3 days. XIFAXAN can be administered orally, with or without food [see Clinical Pharmacology (12.3)].
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Dispensing Solutions, Inc.
Xifaxan | Dispensing Solutions, Inc.
2.1 Dosage for Travelers’ DiarrheaThe recommended dose of XIFAXAN is one 200 mg tablet taken orally three times a day for 3 days. XIFAXAN can be administered orally, with or without food [see Clinical Pharmacology (12.3)].
2.2 Dosage for Hepatic EncephalopathyThe recommended dose of XIFAXAN is one 550 mg tablet taken orally two times a day, with or without food[see Clinical Pharmacology (12.3)].
2.1 Dosage for Travelers’ DiarrheaThe recommended dose of XIFAXAN is one 200 mg tablet taken orally three times a day for 3 days. XIFAXAN can be administered orally, with or without food [see Clinical Pharmacology (12.3)].
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Salix Pharmaceuticals, Inc.
Xifaxan | Salix Pharmaceuticals, Inc.
2.1 Dosage for Travelers’ DiarrheaThe recommended dose of XIFAXAN is one 200 mg tablet taken orally three times a day for 3 days.
2.2 Dosage for Hepatic EncephalopathyThe recommended dose of XIFAXAN is one 550 mg tablet taken orally two times a day.
2.3 Dosage for Irritable Bowel Syndrome with DiarrheaThe recommended dose of XIFAXAN is one 550 mg tablet taken orally three times a day for 14 days. Patients who experience a recurrence of symptoms can be retreated up to two times with the same dosage regimen.
2.4 AdministrationXIFAXAN can be taken with or without food [see Clinical Pharmacology (12.3)].
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Carilion Materials Management
Xifaxan | Carilion Materials Management
2.1 Dosage for Travelers’ DiarrheaThe recommended dose of XIFAXAN is one 200 mg tablet taken orally three times a day for 3 days. XIFAXAN can be administered orally, with or without food [see Clinical Pharmacology ( )]. 12.3
2.2 Dosage for Hepatic EncephalopathyThe recommended dose of XIFAXAN is one 550 mg tablet taken orally two times a day, with or without food . [see Clinical Pharmacology ( )] 12.3
2.1 Dosage for Travelers’ DiarrheaThe recommended dose of XIFAXAN is one 200 mg tablet taken orally three times a day for 3 days. XIFAXAN can be administered orally, with or without food [see Clinical Pharmacology ( )]. 12.3
![Xifaxan (Rifaximin) Tablet [Dispensing Solutions, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8eba0d26-06de-4ceb-9f69-efadd0375633&name=NDC68258-1107-XX------SALIX.jpg)
![Xifaxan (Rifaximin) Tablet [Salix Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1&name=XIFAXANCarton.jpg)
![Xifaxan (Rifaximin) Tablet [Carilion Materials Management]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=49df84cd-0ef6-446b-b2af-556abc665ad9&name=68151-4980.jpg)
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