Japrolox Use In Pregnancy & Lactation

This product should be administered to women who are or are possibly pregnant only when the anticipated therapeutic benefits are considered to outweigh any potential risk. If such administration is deemed necessary, caution should be exercised such as limiting the drug to the minimum effective use and monitoring amniotic fluid volume and findings suggestive of constriction of the foetal ductus arteriosus with consideration given to the gestational age and duration of administration as necessary. Renal impairment and decreased urine output in foetuses as well as accompanying oligohydramnios have been reported following use of cyclooxygenase inhibitors (oral dosage form or suppository) in pregnant women. It has been reported that constriction of the foetal ductus arteriosus occurred in pregnant women who had been administered cyclooxygenase inhibitors (preparations with expected systemic effects) in their second trimester of pregnancy.
This drug should not be used in women in the late stages of pregnancy. [Delayed parturition has been reported in an animal study (in rats).]
Fetal arterial vasoconstriction has been reported in a study on rats receiving the drug in the late stages of gestation.
Administration of this drug to nursing mothers should be avoided. If administration of this drug is judged to be essential, nursing should be discontinued. [Preclinical studies have showed that loxoprofen is excreted into milk in rats.]