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Rifaximin Pregnancy and Breastfeeding Warnings

Rifaximin is also known as: Xifaxan

Rifaximin Pregnancy Warnings

AU: The manufacturer makes no recommendation regarding use during pregnancy. UK: Use is not recommended during pregnancy or in women of childbearing potential not using contraception. US: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B1 US FDA pregnancy category: C Comments: Additional contraceptive precautions recommended; local protocol should be consulted.

Animal studies have revealed evidence of teratogenicity at doses that caused maternal toxicity. There are no controlled data in human pregnancy. AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Rifaximin Breastfeeding Warnings

LactMed: Alternate therapy may be preferred, especially if the nursing infant is premature or younger than 1 month. -AU, UK, US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Unknown Comments: -The development and health benefits of human milk feeding should be considered. -This drug is poorly absorbed orally and is unlikely to reach breast milk or bloodstream of the nursing infant. -The effects in the nursing infant are unknown; adverse effects are unlikely.

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