Rifaximin
Generic Name: rifaximin
Brand Names:
Xifaxan
11 DESCRIPTION XIFAXAN tablets contain rifaximin, a non-aminoglycoside semi-synthetic, nonsystemic antibiotic derived from rifamycin SV. Rifaximin is a structural analog of rifampin. The chemical name for rifaximin is (2 S ,16 Z ,18 E ,20 S ,21 S ,22 R ,23 R ,24 R ,25 S ,26 S ,27 S ,28 E )-5,6,21,23,25-pentahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadeca-[1,11,13]trienimino)benzofuro[4,5-e]pyrido[1,2-á]-benzimidazole-1,15(2 H )-dione,25- acetate.
Overview
11 DESCRIPTION XIFAXAN tablets contain rifaximin, a non-aminoglycoside semi-synthetic, nonsystemic antibiotic derived from rifamycin SV. Rifaximin is a structural analog of rifampin. The chemical name for rifaximin is (2 S ,16 Z ,18 E ,20 S ,21 S ,22 R ,23 R ,24 R ,25 S ,26 S ,27 S ,28 E )-5,6,21,23,25-pentahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadeca-[1,11,13]trienimino)benzofuro[4,5-e]pyrido[1,2-á]-benzimidazole-1,15(2 H )-dione,25- acetate.
Uses
1 INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. XIFAXAN is a rifamycin antibacterial indicated for: • Treatment of travelers’ diarrhea (TD) caused by noninvasive strains of Escherichia coli in adult and pediatric patients 12 years of age and older.
Dosage
2 DOSAGE AND ADMINISTRATION Condition Recommended Oral Dosage TD ( 2.1 ) 200 mg 3 times a day for 3 days HE ( 2.2 ) 550 mg 2 times a day IBS-D ( 2.3 ) 550 mg 3 times a day for 14 days. Patients who experience recurrence can be retreated up to 2 times with the same regimen. XIFAXAN can be taken with or without food. ( 2.4 ) 2.1 Dosage for Travelers’ Diarrhea The recommended dosage of XIFAXAN is 200 mg taken orally three times a day for 3 days. 2.2 Dosage for Hepatic Encephalopathy The recommended dosage of XIFAXAN is 550 mg taken orally two times a day. 2.3 Dosage for Irritable Bowel Syndrome with Diarrhea The recommended dosage of XIFAXAN is 550 mg taken orally three times a day for 14 days.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: • Clostridium difficile -associated diarrhea [see Warnings and Precautions ( 5.2 )] Most common adverse reactions: • TD (≥2%): Headache ( 6.1 ) • HE (≥10%): Peripheral edema, nausea, constipation, dizziness, fatigue, urinary tract infection, insomnia, anemia, pruritus, and ascites ( 6.1 ) • IBS-D (≥2%): ALT increased, nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS Warfarin: Monitor INR and prothrombin time; dose adjustment of warfarin may be needed to maintain target INR range. ( 7.2 ) 7.1 P-glycoprotein Inhibitors Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further 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 [see Warnings and Precautions ( 5.5 ), Clinical Pharmacology ( 12.3 )]. 7.2 Warfarin Changes in INR have been reported postmarketing in patients receiving rifaximin and warfarin concomitantly.
Warnings
5 WARNINGS AND PRECAUTIONS • Travelers’ Diarrhea Not Caused by E. coli : 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. ( 5.1 ) • Clostridium difficile -Associated Diarrhea: Evaluate if diarrhea occurs after therapy or does not improve or worsens during therapy. ( 5.2 ) • Hepatic Impairment: Use with caution in patients with severe (Child-Pugh Class C) hepatic impairment. ( 5.4 , 8.7 ) • Concomitant P-glycoprotein (P-gp) inhibitors (e.g., cyclosporine): Caution should be exercised when concomitant use of XIFAXAN and a P-glycoprotein inhibitor is needed. 4 CONTRAINDICATIONS XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis [see Adverse Reactions ( 6.2 )] .
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on XIFAXAN use in pregnant women to inform any drug-associated risks. Teratogenic effects were observed in animal reproduction studies following administration of rifaximin to pregnant rats and rabbits during organogenesis at doses approximately 0.9 to 5 times and 0.7 to 33 times, respectively of the recommended human doses of 600 mg to 1,650 mg per day. In rabbits, ocular, oral and maxillofacial, cardiac, and lumbar spine malformations were observed.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING The 550 mg tablet is a pink-colored, oval, biconvex tablet with “rfx” debossed on one side and plain on the other. It is available in the following presentations: Bottles of approximately 360 tablets, NDC 55154-6777-8 Storage 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 Temperatur...
Frequently Asked Questions
What is Rifaximin used for?▼
1 INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. XIFAXAN is a rifamycin antibacterial indicated for: • Treatment of travelers’ diarrhea (TD) caused by noninvasive strains of Escherichia coli in adult and pediatric patients 12 years of age and older.
What are the side effects of Rifaximin?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: • Clostridium difficile -associated diarrhea [see Warnings and Precautions ( 5.2 )] Most common adverse reactions: • TD (≥2%): Headache ( 6.1 ) • HE (≥10%): Peripheral edema, nausea, constipation, dizziness, fatigue, urinary tract infection, insomnia, anemia, pruritus, and ascites ( 6.1 ) • IBS-D (≥2%): ALT increased, nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Rifaximin during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on XIFAXAN use in pregnant women to inform any drug-associated risks. Teratogenic effects were observed in animal reproduction studies following administration of rifaximin to pregnant rats and rabbits during organogenesis at doses approximately 0.9 to 5 times and 0.7 to 33 times, respectively of the recommended human doses of 600 mg to 1,650 mg per day. In rabbits, ocular, oral and maxillofacial, cardiac, and lumbar spine malformations were observed.
What are the important warnings for Rifaximin?▼
5 WARNINGS AND PRECAUTIONS • Travelers’ Diarrhea Not Caused by E. coli : 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. ( 5.1 ) • Clostridium difficile -Associated Diarrhea: Evaluate if diarrhea occurs after therapy or does not improve or worsens during therapy. ( 5.2 ) • Hepatic Impairment: Use with caution in patients with severe (Child-Pugh Class C) hepatic impairment. ( 5.4 , 8.7 ) • Concomitant P-glycoprotein (P-gp) inhibitors (e.g., cyclosporine): Caution should be exercised when concomitant use of XIFAXAN and a P-glycoprotein inhibitor is needed. 4 CONTRAINDICATIONS XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis [see Adverse Reactions ( 6.2 )] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.