Xifaxan

DRUG DESCRIPTION

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-??]-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® (rifaximin) Structural Formula Illustration

XIFAXAN (rifaximin) tablets for oral administration are film-coated and contain 200 mg or 550 mg of rifaximin.

Inactive ingredients: Each tablet contains colloidal silicon dioxide, disodium edetate, glycerol palmitostearate, hypromellose, microcrystalline cellulose, propylene glycol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide.

What are the possible side effects of rifaximin (Xifaxan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using rifaximin and call your doctor at once if you have a fever or diarrhea that is watery or bloody.

Less serious side effects may be more likely to occur, such as:

  • bloating, gas, stomach pain;
  • feeling like you need to empty your bowel urgently;
  • feeling like your bowel is not completely empty;
  • nausea, vomiting,...

Read All Potential Side Effects and See Pictures of Xifaxan »

What are the precautions when taking rifaximin (Xifaxan)?

Before taking rifaximin, tell your doctor or pharmacist if you are allergic to it; or to other rifamycins (rifampin, rifabutin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Xifaxan »


Xifaxan Consumer (continued)

SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking rifaximin, tell your doctor or pharmacist if you are allergic to it; or to other rifamycins (rifampin, rifabutin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Xifaxan Patient Information Including Side Effects

Brand Names: Xifaxan

Generic Name: rifaximin (Pronunciation: rif AX i min)

  • What is rifaximin (Xifaxan)?
  • What are the possible side effects of rifaximin (Xifaxan)?
  • What is the most important information I should know about rifaximin (Xifaxan)?
  • What should I discuss with my healthcare provider before taking rifaximin (Xifaxan)?
  • How should I take rifaximin (Xifaxan)?
  • What happens if I miss a dose (Xifaxan)?
  • What happens if I overdose (Xifaxan)?
  • What should I avoid while taking rifaximin (Xifaxan)?
  • What other drugs will affect rifaximin (Xifaxan)?
  • Where can I get more information?

What is rifaximin (Xifaxan)?

Rifaximin is an antibiotic that fights bacterial infection only in the intestines. It is used to treat travelers' diarrhea caused by E. coli. Most people get this infection by eating food or drinking fluids that have been contaminated with the bacteria.

Rifaximin works differently from other antibiotics because it passes through your stomach and into your intestines without being absorbed into your blood stream. Because rifaximin treats only the intestinal tract, it will not treat infections of other parts of the body.

Rifaximin may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of rifaximin (Xifaxan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using rifaximin and call your doctor at once if you have a fever or diarrhea that is watery or bloody.

Less serious side effects may be more likely to occur, such as:

  • bloating, gas, stomach pain;
  • feeling like you need to empty your bowel urgently;
  • feeling like your bowel is not completely empty;
  • nausea, vomiting, constipation;
  • headache;
  • fever;
  • vaginal itching or discharge; or
  • mild itching or skin rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about rifaximin (Xifaxan)?

Rifaximin works differently from other antibiotics because it passes through your stomach and into your intestines without being absorbed into your blood stream. Because rifaximin affects only the intestinal tract, it will not treat infections of other parts of the body.

Do not use this medication if you are allergic to rifaxmin, or if you have diarrhea with a fever, or watery or bloody diarrhea.

Rifaximin is not likely to cause serious side effects. You may have some stomach discomfort such as bloating, gas, stomach pain, nausea, vomiting, constipation, or feeling like you need to empty your bowel urgently, and then feeling like your bowel is not completely empty.

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