Use in pregnancy: As with other drugs known to inhibit prostaglandin synthesis, use of Arcoxia should be avoided in late pregnancy because it may cause premature closure of the ductus arteriosus.
Reproductive studies conducted in rats and rabbits have demonstrated no evidence of developmental abnormalities at doses up to 15 mg/kg/day and 45 mg/kg/day, respectively (approximately 1.5 times [rat] and approximately 3 times [rabbit] the human dose [90 mg] based on systemic exposure). However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women. Arcoxia should be used during the first 2 trimesters of pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: Etoricoxib is excreted in the milk of lactating rats. It is not known whether Arcoxia is excreted in human milk. Because many drugs are excreted in human milk and because of the possible adverse effects of drugs that inhibit prostaglandin synthesis on nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
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