This drug should be used during pregnancy only if the benefit outweighs the risk.

US FDA pregnancy category: Not assigned.

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies have revealed evidence of fetotoxicity associated with maternal toxicity, but did not show adverse developmental effects or embryolethality. In rats administered this drug orally during organogenesis, maternal toxicity was observed at the 540 mg/kg dose (about 4.6 times the human exposure based on AUC at the clinical dose of 960 mg), but no adverse developmental effects were seen and embryofetal survival was not affected at doses up to 540 mg/kg. In rabbits administered this drug orally during organogenesis, lower fetal body weights and a reduction in the number of ossified metacarpals in fetuses were observed at the 100 mg/kg dose (about 2.6 times the human exposure based on AUC at the clinical dose of 960 mg), which was associated with maternal toxicity (including decreased body weight gain and food consumption during the dosing phase); no adverse developmental effects were observed and embryofetal survival was not affected at doses up to 100 mg/kg. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

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Breastfeeding is not recommended during use of this drug and for 1 week after the last dose.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the child.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-Because this drug is highly bound to plasma proteins (89%), the amount in milk is likely to be low; however, there is the potential for toxicity in the breastfed child.

See references