Xifaxan Special Precautions

Clinical data have shown that rifaximin is not effective in the treatment of traveller’s diarrhoea caused by invasive enteric pathogens eg, Campylobacter, Salmonella and Shighella, which typically produce dysentery-like diarrhoea characterised by fever, blood in the stool and high stool frequency.
If symptoms worsen, treatment with rifaximin should be interrupted.
If symptoms have not resolved after 3 days of treatment, or recur shortly afterwards, a second course of rifaximin should not be administered.
Clostridium difficile associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, including rifaximin. The potential association of rifaximin treatment with CDAD and pseudomembranous colitis (PMC) cannot be ruled out.
Effects on the Ability to Drive or Operate Machinery: No studies on the effects on the ability to drive and use machines have been performed.
In clinical controlled trials, dizziness has been reported but rifaximin has negligible influence on the ability to drive and use machines.
Use in children: Xifaxan is not recommended for use in children <18 years.
Use in pregnancy and lactation: No clinical data on exposed pregnancies are available. Animal studies have shown reproductive toxicity. (see Preclinical Safety Data under Toxicology under Actions.)
Rifaximin is not recommended during pregnancy and in women of child-bearing potential not using contraception. (see Preclinical Safety Data under Toxicology under Actions.)
It is not known whether rifaximin is excreted in human milk. A decision should be taken whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.