Xifaxan (Rifaximin)

(ri fax' I men)

Rifaximin 200-mg tablets are used to treat traveler's diarrhea caused by certain bacteria in adults and children at least 12 years of age. Rifaximin 550-mg tablets are used to prevent episodes of hepatic encephalopathy (changes in thinking, behavior, and personality caused by a build-up of toxins in the brain in people who have liver disease) in adults who have liver disease and to treat irritable bowel syndrome (with diarrhea) in adults. Rifaximin is in a class of medications called antibiotics. Rifaximin treats traveler's diarrhea and irritable bowel syndrome by stopping the growth of the bacteria that cause diarrhea. Rifaximin treats hepatic encephalopathy by stopping the growth of bacteria that produce toxins and that may worsen liver disease. Rifaximin will not work to treat traveler's diarrhea that is bloody or occurs with fever. Antibiotics such as rifaximin will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Rifaximin comes as a tablet to take by mouth with or without food. When rifaximin is used to treat traveler's diarrhea, it is usually taken three times a day for 3 days. When rifaximin is used to prevent episodes of hepatic encephalopathy, it is usually taken twice a day. When rifaximin is used to treat irritable bowel syndrome, it is usually taken three times a day for 14 days. To help you remember to take rifaximin, take it around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rifaximin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. If you are taking rifaximin to treat traveler's diarrhea, your symptoms should improve within 24 to 48 hours after you start taking the medication. If your symptoms do not go away or they get worse, or if you develop a fever or bloody diarrhea, call your doctor. If you are taking rifamaxin to treat irritable bowel syndrome and your symptoms return after you have finished your treatment, call your doctor. Take rifaximin as directed, even if you feel better. If you are taking rifaximin to treat traveler's diarrhea or irritable bowel syndrome and you stop taking it too soon or if you skip doses, your infection may not be completely cured and the bacteria may become resistant to antibiotics. If you are taking rifaximin to prevent hepatic encephalopathy, do not stop taking it without talking to your doctor as you may experience symptoms of encephalopathy.

Before taking rifaximin,
• tell your doctor and pharmacist if you are allergic to rifaximin, rifabutin (Mycobutin), rifampin (Rifadin, Rifamate, Rifater, Rimactane), rifapentine (Priftin), any other medications, or any of the ingredients in rifaximin capsules. Ask your doctor or pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or have recently taken. Be sure to mention cyclosporine (Gengraf, Neoral, Restasis, Sandimmune) or other antibiotics. Your doctor may have to change the doses of your medications, monitor you carefully for side effects or treat your diarrhea differently.
• tell your doctor if you have or have ever had liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking rifaximin, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Rifaximin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• stomach pain
• dizziness
• excessive tiredness
• headache
• muscle tightening
• joint pain

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• watery or bloody diarrhea that may occur along with stomach cramps and fever during your treatment or for 2 months afterward
• hives
• rash
• itching
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness

Rifaximin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor. Do not let anyone else take your medication. Ask your pharmacist if you have any questions about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.