Use in pregnancy: Teratogenic Effects: Reproduction studies have been performed in rabbits using daily oral doses at 3.6 mg/kg and in rats at 10 mg/kg during organogenesis. Results of these studies did not reveal evidence of teratogenicity to the fetus. Oral doses of ketorolac tromethamine at 1.5 mg/kg, which was half of the human oral exposure, administered after gestation day 17 caused dystocia and higher pup mortality in rats. There are no adequate and well-controlled studies in pregnant women. Ketorolac tromethamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects: Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of Acular during late pregnancy should be avoided.
Use in lactation: Caution should be exercised when Acular is administered to a nursing woman.