Rifaximin

What is Rifaximin?

• Rifaximin (Xifaxan) is a rifamycin antibacterial used as treatment and prevention of travelers’ diarrhea and, in higher doses, for prevention of hepatic encephalopathy in patients with advanced liver disease and to treat diarrhea in patients with irritable bowel syndrome.

Rifaximin

Rifaximin

What are the uses of this medicine?

Rifaximin (Xifaxan) is used for:

• Treatment of travelers’ diarrhea (TD) caused by noninvasive strains of Escherichia coli in adult and pediatric patients 12 years of age and older.
• Reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults.
• Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

Limitations of Use: Travelers’ diarrhea (TD): Do not use in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli

How does this medicine work?

• Rifaximin is an antibacterial drug.
• Rifaximin is a semi-synthetic derivative of rifampin and acts by binding to the beta-subunit of bacterial DNA-dependent RNA polymerase blocking one of the steps in transcription.
• This results in inhibition of bacterial protein synthesis and consequently inhibits the growth of bacteria.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in Xifaxan.

What drug interactions can this medicine cause?

• Caution should be exercised when concomitant use of Xifaxan and a P-gp inhibitor such as cyclosporine is needed.
• Changes in INR have been reported postmarketing in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time.

Is this medicine FDA approved?

• Rifaximin was approved for use as treatment and means of preventing travelers’ diarrhea in 2004.
• In 2009, the indications were expanded to include prevention of hepatic encephalopathy in patients with cirrhosis and in 2015 to treat diarrhea in patients with irritable bowel syndrome.

How should this medicine be used?

Recommended dosage: Travelers’ Diarrhea:

• The recommended dose of Xifaxan is one 200 mg tablet taken orally three times a day for 3 days.

Hepatic Encephalopathy:

• The recommended dose of Xifaxan is one 550 mg tablet taken orally two times a day.

Irritable Bowel Syndrome with Diarrhea:

• The recommended dose of Xifaxan is one 550 mg tablet taken orally three times a day for 14 days.
• Patients who experience a recurrence of symptoms can be retreated up to two times with the same dosage regimen.

Administration:

• Xifaxan can be taken with or without food

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 200 mg and 550 mg tablets

This medicine is available in fallowing brand namesː

• Xifaxan

What side effects can this medication cause?

The most common side effects of this medicine include: In case of Travelers’ Diarrhea:

• Headache

In case of Hepatic Encephalopathy:

• Peripheral edema
• nausea
• dizziness
• fatigue
• ascites

In case of Irritable Bowel Syndrome with Diarrhea:

• ALT increased
• nausea

What special precautions should I follow?

• Xifaxan was not effective in diarrhea complicated by fever and/or blood in the stool or diarrhea due to pathogens other than E. coli. If diarrhea symptoms get worse or persist for more than 24 to 48 hours, discontinue Xifaxan and consider alternative antibiotics
• Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Xifaxan. Evaluate if diarrhea occurs after therapy or does not improve or worsens during therapy.
• Prescribing Xifaxan for travelers’ diarrhea in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
• There is increased systemic exposure in patients with severe hepatic impairment. Use with caution in patients with severe (Child-Pugh Class C) hepatic impairment.
• Concomitant administration of drugs that are P-glycoprotein (P-gp) inhibitors with Xifaxan can substantially increase the systemic exposure to rifaximin. Caution should be exercised when concomitant use of Xifaxan and a P-gp inhibitor such as cyclosporine is needed.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• No specific information is available on the overdosage with Xifaxan.

Treatment of overdosage:

• In the case of overdosage, discontinue Xifaxan, treat symptomatically, and institute supportive measures as required.

Can this medicine be used in pregnancy?

• There are no available data on Xifaxan use in pregnant women to inform any drug-associated risks.

Can this medicine be used in children?

• The safety and effectiveness of Xifaxan has not been established in pediatric patients less than 12 years of age with TD or in patients less than 18 years of age for HE and IBS-D.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• RIFAXIMIN

Inactive ingredient:

• SILICON DIOXIDE
• EDETATE DISODIUM
• GLYCERYL PALMITOSTEARATE
• HYPROMELLOSE, UNSPECIFIED
• MICROCRYSTALLINE CELLULOSE
• PROPYLENE GLYCOL
• FERRIC OXIDE RED
• SODIUM STARCH GLYCOLATE TYPE A POTATO
• TALC (UNII: 7SEV7J4R1U)
• TITANIUM DIOXIDE

Who manufactures and distributes this medicine?

Distributed by:

• Salix Pharmaceuticals, a division of
• Bausch Health US, LLC
• Bridgewater, NJ USA

What should I know about storage and disposal of this medication?

• Store Xifaxan Tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

• Dailymed label info on Rifaximin
• FDA Rifaximin