Rifaximin

Instructions

May take with or without food

The recommended dose for traveler's diarrhea is 200 mg 3 times daily for 3 days and the recommended dose for hepatic encephalopathy is 550 mg twice daily. Rifaximin may be administered with or without meals.

Dosage Forms And Strengths

XIFAXAN is a pink-colored biconvex tablet and is available in the following strengths:

• 200 mg – a round tablet debossed with “Sx” on one side.
• 550 mg – an oval tablet debossed with “rfx” on one side.

Storage And Handling

The 200 mg tablet is a pink-colored, round, biconvex tablet with “Sx” debossed on one side. It is available in the following presentation:

NDC 65649-301-03, bottles of 30 tablets

The 550 mg tablet is a pink-colored, oval, biconvex tablet with “rfx” debossed on one side. It is available in the following presentations:

NDC 65649-303-02, bottles of 60 tablets
NDC 65649-303-03, carton of 60 tablets, Unit Dose
NDC 65649-303-04, carton of 42 tablets, Unit Dose

Store XIFAXAN Tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Distributed by:Salix Pharmaceuticals, Bridgewater, NJ 08807 USA. Revised: Nov 2015

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking rifaximin and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Serious side effects have been reported with rifaximin including the following:

• watery or bloody diarrhea that may be accompanied by stomach pain and fever during treatment or up to 2 months after treatment has stopped
• an allergic reaction, which could include symptoms such as hives, rash, itching, difficulty breathing or swallowing, hoarseness, and swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, and lower legs

Rifaximin can cause dizziness. Do not drive or operate heavy machinery until you know how rifaximin affects you.

Do not take rifaximin if you:

• are allergic to rifaximin or to any of its ingredients
• are allergic to any rifamycin antimicrobial agents including rifabutin (Mycobutin), rifampin (Rifadin, Rifamate, Rifater, Rimactane), and rifapentine (Priftin)

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Rifamycin antibiotic;11 12 structural analog of rifampin.1 11 12

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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 rifaximin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to rifaximin 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.

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.

Interactions with 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 rifaximin, 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 rifaximin 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
• Eliglustat

Interactions with Food/Tobacco/Alcohol

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 rifaximin. 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.

Use rifaximin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Take with or without food.
• Take rifaximin at the same time of day.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Gas.
• Headache.
• Dizziness.
• Belly pain.
• Upset stomach.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Hepatic encephalopathy: Reduction in the risk of overt hepatic encephalopathy recurrence in adults

Irritable bowel syndrome with diarrhea: Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults

Traveler's diarrhea: Treatment of traveler's diarrhea caused by noninvasive strains of E. coli in adults and pediatric patients ≥12 years of age

Limitations of use: Rifaximin should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea caused by pathogens other than E. coli.

Traveler's diarrhea: Oral: Children ≥12 years and Adolescents: Refer to adult dosing.

Frequency of adverse events generally higher following treatment for hepatic encephalopathy (HE). Percentages are presented for HE unless otherwise stated.

>10%:

Cardiovascular: Peripheral edema (15%)

Central nervous system: Dizziness (13%), fatigue (12%)

Hepatic: Ascites (11%)

Gastrointestinal: Nausea (14%; irritable bowel syndrome with diarrhea 2% to 3%)

2% to 10%:

Central nervous system: Headache (travelers' diarrhea 10%), depression (7%)

Dermatological: Pruritus (9%), skin rash (5%)

Gastrointestinal: Abdominal pain (>2% to 9%), pseudomembranous colitis (<5%; travelers' diarrhea or irritable bowel syndrome with diarrhea <2%)

Hematologic & oncologic: Anemia (8%)

Hepatic: Increased serum ALT (irritable bowel syndrome with diarrhea 2%)

Neuromuscular & skeletal: Muscle spasm (9%), arthralgia (6%), increased creatine phosphokinase (<5%; travelers' diarrhea or irritable bowel syndrome with diarrhea <2%)

Respiratory: Nasopharyngitis (7%), dyspnea (6%), epistaxis (>2% to 5%)

Miscellaneous: Fever (6%)

All indications: <2% (Limited to important or life-threatening): Anaphylaxis, Clostridium difficile associated diarrhea, exfoliative dermatitis, hypersensitivity reaction

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience flatulence, headache, dizziness, abdominal pain, or nausea. Have patient report immediately to prescriber swelling of arms or legs, abdominal edema, severe loss of strength and energy, shortness of breath, or signs of Clostridium difficile (C. diff)-associated diarrhea (stomach pain or cramps, very loose or watery stools, or bloody stools) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

200 mg orally 3 times a day for 3 days

Comments:
-Should not use in patients with diarrhea complicated by fever and/or blood in the stool or diarrhea caused by pathogens other than Escherichia coli

Use: For the treatment of travelers' diarrhea due to noninvasive strains of E coli

550 mg orally twice a day

Comments:
-In trials, lactulose was used concomitantly in 91% of patients; differences in treatment effect of patients not using concomitant lactulose could not be assessed.

Use: For reduction in risk of overt hepatic encephalopathy recurrence

12 years or older: 200 mg orally 3 times a day for 3 days

Comments:
-Should not use in patients with diarrhea complicated by fever and/or blood in the stool or diarrhea caused by pathogens other than E coli

Use: For the treatment of travelers' diarrhea due to noninvasive strains of E coli

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Caution is recommended.

Comments:
-This drug was not studied in hepatic encephalopathy patients with Model for End-stage Liver Disease (MELD) scores greater than 25; in the controlled trial, only 8.6% of patients had MELD scores over 19.
-Systemic exposure increased with more severe liver dysfunction.

Substance Name

Rifaximin

CAS Registry Number

88747-56-2

Drug Class

Anti-Infective Agents

Gastrointestinal Agents

Rifamycins

LactMed Record Number

987

Last Revision Date

20130907

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.