Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Xifaxan

Descriptions


Rifaximin is used to treat traveler's diarrhea that is caused by a bacteria called Escherichia coli. It is also used to prevent hepatic encephalopathy, which is a condition that occurs when your liver does not work normally. This medicine is also used to treat irritable bowel syndrome with diarrhea. Rifaximin is an antibiotic that works by killing the bacteria and preventing its growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rifaximin in children younger than 12 years of age with traveler's diarrhea, and in children with hepatic encephalopathy and irritable bowel syndrome with diarrhea. Safety and efficacy have not been established in these age groups.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rifaximin in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cholera Vaccine, Live
  • Levoketoconazole
  • Methotrexate

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diarrhea and blood in the stool or
  • Diarrhea and fever or
  • Diarrhea caused by antibiotics or
  • Diarrhea not caused by Escherichia coli—Should not be used in patients with these conditions.
  • Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

You may take this medicine with or without food.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your infection may return.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For treatment of irritable bowel syndrome with diarrhea:
      • Adults—550 milligrams (mg) 3 times a day for 14 days.
      • Children—Use and dose must be determined by your doctor.
    • For treatment of traveler's diarrhea:
      • Adults and children 12 years of age and older—200 milligrams (mg) 3 times a day for 3 days.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    • For preventing hepatic encephalopathy:
      • Adults—550 milligrams (mg) 2 times a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check the progress of you or your child to see if the medicine is working properly and to decide if you or your child should continue to take it. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away if the diarrhea does not stop in 1 or 2 days or if you or your child develop a fever or have blood in your stool.

A person can become dehydrated if too much fluid is lost from the body with diarrhea. Make sure you or your child drink plenty of fluids while you have diarrhea. Check with your doctor right away if you or your child have more than one of the following symptoms: decreased urination, dizziness, dry mouth, increased thirst, or lightheadedness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

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

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

More common

  1. Anxiety
  2. black, tarry stools
  3. bladder pain
  4. bloody or cloudy urine
  5. difficult, burning, or painful urination
  6. dizziness or lightheadedness
  7. frequent urge to urinate
  8. lower back or side pain
  9. muscle spasm
  10. rapid breathing
  11. trouble sleeping

Less common

  1. Blood in the urine
  2. bloody nose
  3. chest pain
  4. continuing ringing or buzzing or other unexplained noise in the ears
  5. fainting
  6. feeling of constant movement of self or surroundings
  7. increased heart rate
  8. sensation of spinning
  9. sunken eyes
  10. ulcers, sores, or white spots in the mouth
  11. unusual bleeding or bruising
  12. unusual tiredness or weakness

Incidence not known

  1. Cracks in the skin
  2. hives or welts, itching skin, or rash
  3. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  4. loss of heat from the body
  5. red, swollen skin
  6. redness of the skin
  7. scaly skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Bloated
  2. constipation
  3. difficulty with moving
  4. excess air or gas in the stomach or intestines
  5. fever
  6. frequent urge to defecate
  7. full feeling
  8. headache
  9. muscle pain or stiffness
  10. pain in the joints
  11. passing gas
  12. stomach pain or bloating
  13. straining while passing stool
  14. swelling of the hands, ankles, feet, or lower legs

Less common

  1. Abnormal dreams
  2. blurred vision
  3. chills
  4. confusion
  5. cough
  6. decreased urination
  7. difficulty having a bowel movement (stool)
  8. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  9. dry lips
  10. dry mouth
  11. ear pain
  12. feeling of warmth
  13. hearing loss
  14. loss of appetite
  15. loss of taste
  16. nausea
  17. painful or difficult urination
  18. pale skin
  19. redness of the face, neck, arms, and occasionally, upper chest
  20. sore throat
  21. sweating
  22. swollen glands
  23. thirst
  24. vomiting
  25. wrinkled skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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