Brand names: Xifaxan
Rifamycin Antibacterial
Route: Oral
Contraindications
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 )] . History of hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components of XIFAXAN ( 4 )
Pregnancy & Breastfeeding
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. Ocular malformations were observed in both rats and rabbits at doses that caused reduced maternal body weight gain [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Advise pregnant women of the potential risk to a fetus. Data Animal Data Rifaximin was teratogenic in rats at doses of 150 to 300 mg/kg (approximately 2.5 to 5 times the recommended dose for TD [600 mg per day], and approximately 1.3 to 2.6 times the recommended dose for HE [1,100 mg per day], and approximately 0.9 to 1.8 times the recommended dose for IBS-D [1,650 mg per day] adjusted for body surface area). Rifaximin was teratogenic in rabbits at doses of 62.5 to 1,000 mg/kg (approximately 2 to 33 times the recommended dose for TD [600 mg per day], and approximately 1.1 to 18 times the recommended dose for HE [1,100 mg per day], and approximately 0.7 to 12 times the recommended dose for IBS-D [1,650 mg per day] adjusted for body surface area). These effects include cleft palate, agnathia, jaw shortening, hemorrhage, eye partially open, small eyes, brachygnathia, incomplete ossification, and increased thoracolumbar vertebrae. A pre and postnatal development study in rats showed no evidence of any adverse effect on pre and postnatal development at oral doses of rifaximin up to 300 mg/kg per day (approximately 5 times the recommended dose for TD [600 mg per day], an
2 interactions on record
P-glycoprotein inhibitor that significantly increased systemic exposure of rifaximin. In hepatic impairment, potential additive effect of reduced metabolism may further increase rifaximin exposure. Caution should be exercised.
Source: NLP:rifaximin
Changes in INR reported postmarketing. Monitor INR and prothrombin time; dose adjustment of warfarin may be needed to maintain target INR range.
Source: NLP:rifaximin