Rifaximin high strength oral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Tablets containing 550 mg rifaximin.
Hepatic encephalopathy: prevention of recurrence
Treatment for the reduction in recurrence of episodes of overt hepatic encephalopathy in adults.
550 mg twice daily as long term treatment.
550 mg twice daily as long term treatment.
Children under 18 years
Precautions and Warnings
Severe hepatic impairment - Child-Pugh score greater than or equal to 10
Consult national/regional policy on the use of anti-infectives
Consider pseudomembranous colitis if patient presents with diarrhoea
May colour urine red
Advise patient not to take ginkgo unless advised by clinician
In a meta-analysis study, combination therapy with rifaximin and lactulose has shown a statistically significant reduction in mortality in hepatic encephalopathy compared to patients that were treated with lactulose alone.
Pregnancy and Lactation
Use rifaximin with caution during pregnancy.
At the time of writing, there is limited data on the use of rifaximin in pregnant women.
Animal studies have shown transient effects on ossification and skeletal variations in the foetus. Reproduction studies conducted in pregnant rats with doses of about 2.5 to 5 times the human clinical dose adjusted for body surface area were teratogenetic as were doses in pregnant rabbits of 2 to 33 times the human clinical dose adjusted for body surface area. The effects included cleft palate, agnathia, jaw shortening, small eyes, incomplete ossification and increased thoracolumbar vertebrae.
It is not known if rifaximin crosses the human placenta. The molecular weight (about 786) is low enough for passive transfer. However less than 1% of the oral dose is absorbed into the systemic circulation.
Briggs (2011) suggests the safest course is to avoid rifaximin in the first trimester. Women should be counselled that in the absence of human pregnancy data an accurate assessment of the embryo-foetal risk cannot be made.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Use rifaximin with caution during breastfeeding.
It is not known whether rifaximin is excreted in human milk. The low molecular weight (about 786) is low enough for excretion into breast milk, however only small amounts are absorbed into systemic circulation.
The risk to the breastfed child is unknown.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Abnormal liver function tests
Loss of balance
Upper respiratory tract infection
Urinary tract infections
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: January 2013
British National Formulary, 64th Edition (2012) Pharmaceutical Press, London.
BNF for Children (2012-2013) Pharmaceutical Press, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Summary of Product Characteristics: Targaxan 550 mg film-coated tablets. Norgine Pharmaceuticals Ltd. Revised March 2021.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Rifaximin Last revised: March 1, 2012
Last accessed: January 18, 2013
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