RIFAXIMIN (Oral-Local)?

Some commonly used brand names are:

In the U.S.?

• Xifaxan

? Not commercially available in Canada.

Category

• Antidiarrheal
• Antibacterial

Description

Rifaximin (rif-AX-i-min)is a medicine used to treat travelers' diarrhea caused by a bacteria calledE. Coli.

This medicine is available only with your doctor's prescription, in thefollowing dosage forms:

Oral
• Tablets (U.S.)

Before Using This Medicine

In decidingto use a medicine, the risks of taking the medicine must be weighed againstthe good it will do. This is a decision you and your doctor will make. Forrifaximin, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to rifaximin, rifampin or rifabutin. Also tell your doctorand pharmacist if you are allergic to any other substances, such as foods,preservatives, or dyes.

Pregnancy?Rifaximin has not been studied in pregnant women.However, studies in animals have shown that rifaximin may cause birth defectsor other problems. Before taking this medicine, make sure your doctor knowsif you are pregnant or if you become pregnant.

Breast-feeding?It is not known whether rifaximin passes intobreast milk. However, rifaximin is not recommended during breast-feeding,because it may cause unwanted effects in nursing babies.

Children?Studies on this medicine have been done only inadult patients, and there is no specific information comparing the use ofrifaximin in children under 12 years of age with use in other age groups.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsof problems in older people. There is no specific information comparing useof rifaximin in the elderly with use in other age groups.

Other medical problems?The presence of other medical problems mayaffect the use of rifaximin. Make sure you tell your doctor if you have anyother medical problems, especially:

• Pseudomembranous colitis?Rifaximin may also cause this seriousside effect.

Proper Use of This Medicine

Do not use rifaximin to treat your diarrhea if you have a fever or if thereis blood in your stools. Contact your doctor.

Importance of diet and fluid intake while treatingdiarrhea:

• In addition to using medicine for diarrhea, itis very important that you replace the fluid lost by the body and follow aproper diet. For the first 24 hours, you should eat gelatin, and drinkplenty of caffeine-free clear liquids, such as ginger ale, decaffeinatedcola, decaffeinated tea, and broth. During the next 24 hours you may eat blandfoods, such as cooked cereals, bread, crackers, and applesauce. Fruits, vegetables,fried or spicy foods, bran, candy, caffeine, and alcoholic beverages may makethe condition worse.
• If too much fluid has been lost by the body due to the diarrhea,a serious condition (dehydration) may develop. Check with your doctor as soonas possible if any of the following signs or symptoms of too much fluid lossoccur:
  • Decreased urination
  • Dizziness and lightheadedness
  • Dryness of mouth
  • Increased thirst
  • Wrinkled skin

Dosing?The dose of rifaximin will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of rifaximin. If your dose is different,do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For diarrhea
    • Adults and children 12 years of age and older?200 milligramstaken three times a day for 3 days.
    • Children under 12 years of age?Use and dose must be determinedby your doctor.

Missed dose?If you miss a dose of this medicine, take itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Check with your doctor if your diarrhea does not stop in 1 or2 days or if you develop a fever or if you have blood in your stools.

Side Effects of This Medicine

Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

Check with your doctorimmediately if any of the following side effects occur:

Incidence not determined

Hives or welts; itching skin; large, hive-like swelling on face, eyelids, lips, tongue, throat,hands, legs, feet, sex organs; rash; redness of skin

Other side effects may occur that usuallydo not need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome.

More common

Headache

Less common

Difficulty having a bowel movement (stool); vomiting

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.