Pronunciation:

rif-AX-i-min

Brand Names:

• Xifaxan

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antibiotic

Chemical—

Rifamycin

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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

Breast-feeding—

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.

Other medicines—

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 of This Medicine:

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) three 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) three 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) two 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 While Using This Medicine:

It is very important that your doctor check the progress of you or your child to see if the medicine is working properly. This will allow your doctor to decide if you or your child should continue to take it.

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 of This Medicine:

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

Black, tarry stools

dizziness or lightheadedness

muscle spasm

rapid breathing

shortness of breath

trouble sleeping

Less common

Blood in the urine

bloody nose

chest pain

continuing ringing or buzzing or other unexplained noise in the ears

fainting

feeling of constant movement of self or surroundings

increased heart rate

sensation of spinning

sunken eyes

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

Incidence not known

Cracks in the skin

hives or welts, itching skin, or rash

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of heat from the body

red, swollen skin

redness of the skin

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

Bloated

difficulty with moving

excess air or gas in the stomach or intestines

fever

frequent urge to defecate

full feeling

headache

lower back or side pain

muscle pain or stiffness

pain in the joints

passing gas

stomach pain

straining while passing stool

swelling of the hands, ankles, feet, or lower legs

Less common

Abnormal dreams

blurred vision

chills

confusion

cough

decreased urination

difficulty having a bowel movement (stool)

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

dry lips

dry mouth

ear pain

feeling of warmth

hearing loss

lightheadedness

loss of appetite

loss of taste

nausea

painful or difficult urination

pale skin

redness of the face, neck, arms, and occasionally, upper chest

sore throat

sweating

swollen glands

thirst

vomiting

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.