Benefit should outweigh risk

AU TGA pregnancy category: B2
US FDA pregnancy category: B

This drug crosses the placental barrier and appears in cord blood. Case reports of use throughout pregnancy for the treatment of hyperuricemia associated with gout and renal dysfunction have not documented drug-induced adverse fetal outcomes. In addition, one study evaluating the efficacy of single-dose ampicillin plus probenecid for the treatment of urinary tract infection during pregnancy failed to reveal evidence of adverse fetal effects. There are no adequate and well controlled studies in pregnant women.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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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Limited data has shown maternal doses of up to 2 g/day have resulted in low levels excreted into human milk. In animal studies, this drug has increased breastmilk excretion of cimetidine, possibly via an interaction with an active transport mechanism in the breast. The implications of enhanced excretion of drugs given with this drug have not been studied, however, only a few drugs are known to undergo active transport into breast milk. For infants older than 2 months, this drug is not expected to cause adverse effects.

Caution is recommended.

Excreted into human milk: Yes

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