Xevolac Use In Pregnancy & Lactation

Pregnancy: Reproduction studies in rabbits and rats receiving oral ketorolac tromethamine dosages of 3.6 and 10 mg/kg daily, respectively (about 1.8 and 5 times the maximum recommended human parenteral dosage, respectively), during the period of organogenesis have not revealed evidence of harm to the fetus; however, oral dosages exceeding the maximum recommended human parenteral dosage in rats produced delayed parturition and dystocia, probably secondary to inhibition of prostaglandin synthesis. There are no adequate and controlled studies to date using ketorolac tromethamine in pregnant women. Therefore ketorolac tromethamine is not recommended for use during pregnancy and should be used only when the potential benefits justify the possible risks to the fetus. Ketorolac tromethamine should not be used during late pregnancy or during labor or delivery, since inhibitors of prostaglandin synthesis may have adverse effects on the fetal cardiovascular system (e.g., premature closure of the ductus arteriosus) and on uterine contraction.
Lactation: Because ketorolac is distributed into milk, and because of the potential adverse effects of prostaglandin-inhibiting drugs in neonates, the drug should not be used in nursing women.