Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: A
US FDA pregnancy category: B

Comments: May reduce efficacy of oral contraceptives.

Animal studies have failed to reveal evidence of teratogenicity, impaired fertility, or fetal harm. The effects during labor and delivery are unknown. There are no controlled data in human pregnancy.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

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Following a single oral dose of 1 g in 6 women, peak milk levels of this drug occurred at 4 to 5 hours after the dose. Average milk levels were 0.69 mg/L (range 0.46 to 0.88 mg/L) at 4 hours and 0.81 mg/L (range 0.39 to 1.3 mg/L) at 5 hours after the dose. From this data, it is expected that an exclusively breastfed infant would receive a maximum of about 0.1 mg/kg/day with a maternal dose of 500 mg 3 times a day (about 0.25% to 0.5% of a typical infant dose).

Use is considered acceptable; caution is recommended.

Excreted into human milk: Yes (in small amounts)

Comments: Rash and disruption of the infant's gastrointestinal flora resulting in diarrhea or thrush have been reported, rarely.

See references