Benefit should outweigh risk

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

Studies in rabbits and rats dosed at 7 times the human oral dose revealed embryolethality and decreased pup survival in rabbits and rats, respectively. In a single uncontrolled study in pregnant women at term awaiting labor and delivery, a prophylactic oral dose of 100 mg per day was administered. This drug readily crossed the placenta, with maternal and fetal whole blood levels approximately equal at delivery; neonatal levels then fell approximately 50% per day for 2 days before declining sharply. No neonatal respiratory and neuromuscular side effects were observed. There are no controlled data in human pregnancy.

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 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.

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There is a lack of information on the long-term use of this drug while breastfeeding. After short term use, the expected half-life of this drug in milk is 9.2 hours.

Not recommended

Excreted into human milk: Yes

Comments: Due to the potential for serious adverse reactions including respiratory depression and muscle weakness in breastfed infants, this drug is not recommended while nursing.

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