Source: FDA, National Drug Code (US) Revision Year: 2020
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.
| Dosage Forms and Strengths |
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XIFAXAN is a pink-colored biconvex tablet and is available in the following strengths:
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| How Supplied |
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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:
Salix Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807 USA |
| Drug | Countries | |
|---|---|---|
| XIFAXAN | Australia, Brazil, Hong Kong, Malta, Netherlands, New Zealand, Poland, Singapore, United States |
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