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).

Antidiarrheal agents

Antidiarrheal agents include bulk forming agents, hydroscopic agents, bile acid resins, bismuth, inhibitors of intestinal motility, non-absorbed antibiotics and hormones. Bulk forming agents include methylcellulose; hydroscopic agents include pectin and kaolin; bile acid resins are cholestyramine, colestipol and colesevalam; inhibitors of intestinal motility include opioids such as diphenoxylate and loperamide. Antibiotics include rifamycin and rifaximin which are non-absorbed and are used for travelers' diarrhea. Hormones with antidiarrheal activity include octretide and somatostatin. Most antidiarrheal agents are active locally in the small intestine and colon and are largely not absorbed. Some, however, have been implicated in rare causes of liver injury (senna, cascara, cholestyramine). Telotristat is a relatively new agent that inhibits the synthesis of serotonin and is used specifically for the diarrhea of carcinoid syndrome.

• Cholestyramine
• Colesevelam
• Colestipol
• Crofelemer
• Difenoxin
• Diphenoxylate
• Kaolin
• Loperamide
• Methylcellulose
• Octreotide
• Pectin
• Rifamycin
• Rifaximin
• Somatostatin
• Telotristat

Antiemetics are a diverse group of medications that act at different points in the pathways that regulate nausea and vomiting. These include antihistamines, anticholinergic agents, phenothiazines, serotonin type 3 receptor blockers, centrally acting benzamides, cannabinoid receptor agonists, substance P antagonists and miscellaneous.

Anticholinergic Agents

• Hyoscyamine, Methscopolamine, Scopolamine

Antihistamines

• Cyclizine, Dimenhydrinate, Hydroxyzine, Meclizine, and Promethazine

Cannabinoid Receptor Agonists

• Dronabinol, Nabilone, Tetrahydrocannabinol
• Phenothiazines [See Antipsychotic Agents]
• Chlorpromazine, Prochlorperazine

Serotonin 5-HT3 Receptor Antagonists

• Alosetron, Dolasetron, Granisetron, Ondansetron, Palonosetron

Substance P/Neurokinin 1 Receptor Antagonists

• Aprepitant, Fosaprepitant, Rolapitant

Miscellaneous

• Dexamethasone, Metoclopramide, Trimethobenzamide

Acid peptic disease/antiulcer agents that include antacids, the histamine type 2 receptor blockers (H2 blockers), and the proton pump inhibitors (PPIs). These agents are some of the most commonly taken medications and are very well tolerated, most being available both by prescription and over-the-counter. While many of these drugs are approved for use in duodenal and gastric ulcer disease, their major use is for acid reflux and indigestion.

Histamine H2 Receptor Antagonists (H2 Blockers) Cimetidine, Famotidine, Nizatidine, Ranitidine

Proton Pump Inhibitors

• Dexlansoprazole, Esomeprazole, Lansoprazole, Omeprazole, Pantoprazole, Rabeprazole

Cathartics, laxatives or agents for constipation include bulk forming agents, osmotic agents, stool wetting agents, nonspecific stimulants, prokinetic agents and agents that increase fluid secretion. Many of these therapies are not systemically absorbed and none are considered particularly hepatotoxic. Naldemedine and naloxegol are opioid antagonists and are used to treat the constipation associated with opioid use.

• Bisacodyl
• Cascara Sagrada
• Castor Oil
• Docusate
• Fiber, Bran
• Lactulose
• Magnesium Sulfate
• Methylcellulose
• Naldemedine (Opioid Antagonist)
• Naloxegol (Opioid Antagonist)
• Plecanatide (for Chronic Idiopathic Constipation)
• Prucalopride (for Chronic Idiopathic Constipation)
• Senna

Inflammatory bowel disease encompasses several disorders, most commonly ulcerative colitis and Crohn colitis. Agents can be classified as 5-aminosalicyclic acid (5-ASA) based agents, immunosuppressive drugs, antitumor necrosis factor agents, corticosteroids, antibiotics and miscellaneous.

5-Aminosalicyclic Acid (5-ASA) Derivatives

• Balsalazide, Mesalamine, Olsalazine, Sulfasalazine

Immunosuppressive Agents

• Azathioprine, Mercaptopurine, Methotrexate

Tumor Necrosis Factor Antagonists

• Adalimumab, Certolizumab, Golimumab, Infliximab

Miscellaneous

• Metronidazole, Natalizumab, Vedolizumab

Irritable Bowel Syndrome Agents Antimuscarinics/Antispasmodics [See Anticholinergic agents

• Dicyclomine, Glycopyrrolate, Hyoscyamine, Methscopolamine

Prokinetic Agents - See Serotonin 5-ht4 receptor agonists Alosetron, Cisapride, Domperidone, Linaclotide, Lubiprostone, Metoclopramide, Plecanatide, Prucalopride, Tegaserod

Other

• Eluxadoline

• Dailymed label info on Rifaximin
• FDA Rifaximin

Rifaximin Resources
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